Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN #1205)
Phase: NA
Conditions: Improve the Informed Consent Process
Sponsor: Medical College of Wisconsin

BMT CTN 1205  
Easy-to-Read Informed Consent (ETRIC) for 
Hematopoietic Cell Transplantation Clinical Trials 
NCT02081248 

Easy-to-Read Informe
Tran
BMT
Na
Ellen Denzen, M.S.3 
Peter Dawson, Ph.D. 4 
Amy Foley, M.A.3, 5 
Iris Gersten, M.S.4 
Mary Horowitz, M.D.2, 6 
Mitchell Horwitz, M.D.7 
Lensa Idossa, M.P.H.3 
 
Sponsored
National
N
1 The Cleveland Clinic  
2 Medical College of Wisconsin
3 National Marrow Donor Progr
4 The EMMES Corporation 
5 CIBMTR, Minneapolis 
 
 
 
___________________________
Approval Signature (Protocol Chair/Off
 
 
ed Consent (ETRIC) for Hematop
nsplantation Clinical Trials  
 
T CTN PROTOCOL 1205 
Version 5.0 
 
 
Study Chairpersons 
avneet S Majhail, M.D., M.S.1 
Ryan Spellecy, Ph.D.2 
 
Steven Joffe, M.D.8 
Naynesh Kamani, M.D
Roberta King, M.P.H.3
Heather Moore, M.P.H
Alyssa Ramirez4 
Sergey Tarima, Ph.D.2
 
d by the National Institutes of Health 
l Heart, Lung, and Blood Institute 
National Cancer Institute 
 
 
n 
ram 
6 CIBMTR, Milwaukee 
7 Duke University 
8 University of Pennsylvan
9 American Association of
________  
_______________________
fficer) 
 
Approval Signature (Protocol Ch
poietic Cell 
D.9 
3 
H.,CHES3 
2 
nia 
f Blood Banks
____________ 
air/Officer) 

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i 
 
Core Center Participants: 
Affiliate Center Participants: 
BMT at Northside Hospital 
City of Hope National Medical Center 
Duke Medical Center 
H. Lee Moffitt Cancer Center 
Johns Hopkins University 
Case Western Reserve University Consortia 
   - University Hospitals of Cleveland   
   - Cleveland Clinic 
   - West Virginia University Hospital 
University of Florida Consortia 
   - Emory University 
   - University of Florida (Shands) 
University of Michigan Consortia 
   - Mayo Clinic, Rochester 
University of Minnesota 
University of Nebraska Consortia 
   - University of Nebraska 
   - University of Kansas Hospital 
University of Pennsylvania 
Ohio State Consortium 
    - Ohio State University 
    - Roswell Park Cancer Institute 
    - University of North Carolina 
    - Virginia Commonwealth University 
Washington University/Barnes Jewish Hospital 
Florida Hospital Cancer Institute 
Jewish Hospital  
Karmanos Cancer Institute 
Loyola University Medical Center 
Medical College of Wisconsin 
 
 
 
 

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PROTOCOL SYNOPSIS – BMT CTN PROTOCOL 1205 
 
Easy-to-Read Informed Consent (ETRIC) for  
Hematopoietic Cell Transplantation Clinical Trials  
 
Study Chairs: 
Navneet S Majhail, M.D., M.S. 
 
Ryan Spellecy, Ph.D. 
 
Study Design: 
This study will be conducted as a supplement to the BMT CTN 1101 
and 1301 clinical trials. Note that the BMT CTN 0901 trial and BMT 
CTN 1203 trial were removed as parent trials due to their closure on 
April 18, 2014 and May 13, 2016, respectively.  The study has two 
parts:  
(1) Randomized Study: Randomized, multicenter, prospective 
comparative study of ETRIC or standard consent form to improve 
patient comprehension of BMT CTN parent clinical trials. 
Patients who are being considered for one of the clinical trials will 
be approached, and on providing verbal consent to 1205, will be 
randomized to and will undergo the consent process for the parent 
trial using either ETRIC or standard consent form. Assessments 
will be conducted for patient comprehension of the clinical trial 
and satisfaction and anxiety related to the consent process.  
(2) Evaluation Study: To understand barriers to implementation of 
ETRIC, site visits to 9 transplant centers participating in the BMT 
CTN parent studies will be conducted with semi-structured 
interviews of IRB administrators, site protocol investigators, and 
study coordinators. Sites will include centers that are participating 
and are not participating in the ETRIC study.  
 
Primary Objective: 
Primary objective of the randomized study is to compare objective 
comprehension scores on the Quality of Informed Consent (part A) 
instrument between patients randomized to the ETRIC versus the 
standard consent arms.  
 
Secondary Objectives: 
Secondary objectives of the randomized study are to compare the 
following measures between the two arms: (1) subjective 
comprehension scores on the Quality of Informed Consent (part B) 
instrument and the 
modified 
Deaconess 
Informed Consent 
Comprehension Test instrument, (2) state anxiety scores on State 
Trait Anxiety Inventory instrument, (3) satisfaction scores, (4) time 
taken for information location, and (5) patient consent rates on parent 
clinical trials. 
 
Eligibility: 
 Inclusion and exclusion criteria for the ETRIC study will be the same 
as the eligibility criteria for the BMT CTN parent studies. Additional 
inclusion criterion specific for the ETRIC study will include:  

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iii 
1. Adult patients (≥ 18 years) 
2. Speaking and reading proficiency in English  
3. Willing and able to provide informed consent for the ETRIC 
study  
4. Stated willingness to comply with study procedures and 
reporting requirements   
 
Study Interventions: 
Each ETRIC form for the parent protocols will have a two-column 
format with specific attention towards enhancing readability and 
processability including layout, organization of content, typography, 
and using plain language.  
 
The standard consent form for the parent protocols will have a single 
column format and will lack the formatting and readability 
enhancements of the ETRIC form.  
 
The content of both forms will be similar and both will contain all 
federally required elements for informed consent. Individual clinical 
trial sites will be allowed to make modifications to the ETRIC and the 
standard consent forms to meet requirements of their local IRBs. The 
protocol team will ensure that any such modifications to the ETRIC 
form conform to the easy-to-read format.  
 
Accrual Objective: 
198 patients will be randomized 1:1 between the two study arms for 
the randomized study.  
 
Accrual Period: 
3 years for the randomized study.   
 
Study Duration: 
For the randomized study, assessments will occur within 7 business 
days of the consent discussion for the parent studies. No subsequent 
patient followup is planned for this study.   
 
Statistical Issues: 
For the randomized study, patients will be randomized 1:1 between 
the ETRIC and standard consent arms. A total of 198 patients will be 
accrued in this study (99 in each arm), which will allow detection of a 
0.5 standard deviation difference with 80% power in the mean 
Quality of Informed Consent part A comprehension scores between 
the two study arms.  
  
 
 
 

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TABLE OF CONTENTS 
 
 
1. 
BACKGROUND AND RATIONALE .............................................................................. 1-1 
1.1. 
Informed Consent in HCT Clinical Trials ....................................................................... 1-1 
1.2. 
Development of ETRIC Form for the BMT CTN ............................................................ 1-3 
1.3. 
ETRIC vs. Other Interventions to Increase Comprehension of Cancer Trials ............... 1-4 
1.4. 
Summary of Background, Significance and Innovation .................................................. 1-5 
2. 
STUDY DESIGN ............................................................................................................... 2-1 
2.1. 
Randomized Study ............................................................................................................ 2-1 
2.1.1. 
Study Overview .................................................................................................................. 2-1 
2.1.2. 
Summary of the BMT CTN 1101 and 1301 Protocols .......................................................... 2-2 
2.1.2.1. 
BMT CTN 1101 Protocol (Double Cord vs. Haplo) ............................................................. 2-2 
2.1.2.2. 
BMT CTN 1203 (GVHD Prophylaxis) ................................... Error! Bookmark not defined. 
2.1.2.3. 
BMT CTN 1301 (CNI-Free) ................................................................................................ 2-3 
2.1.3. 
Rationale for Study Design .................................................................................................. 2-3 
2.1.4. 
Hypothesis and Study Objectives ........................................................................................ 2-3 
2.1.4.1. 
Primary Objective ............................................................................................................... 2-3 
2.1.4.2. 
Secondary Objectives .......................................................................................................... 2-4 
2.1.5. 
Patient Eligibility Criteria .................................................................................................... 2-4 
2.1.6. 
Study Interventions ............................................................................................................. 2-4 
2.1.7. 
Hematopoietic Cell Transplantation ..................................................................................... 2-4 
2.1.8. 
Study Risks and Benefits ..................................................................................................... 2-5 
2.1.9. 
Study Withdrawal ............................................................................................................... 2-5 
2.2. 
Evaluation Study ............................................................................................................... 2-5 
2.2.1. 
Study Overview .................................................................................................................. 2-5 
2.2.2. 
Center Selection Criteria ..................................................................................................... 2-6 
3. 
STUDY ENDPOINTS ....................................................................................................... 3-1 
3.1. 
Study Endpoints for Randomized Study .......................................................................... 3-1 
3.1.1. 
Primary Endpoint ................................................................................................................ 3-1 
3.1.2. 
Secondary Endpoints ........................................................................................................... 3-1 
3.2. 
Study Endpoints for Evaluation Study ............................................................................. 3-1 
4. 
PATIENT REGISTRATION AND ENROLLMENT FOR RANDOMIZED STUDY ... 4-1 
4.1. 
Approaching Patients, Eligibility Screening and Obtaining Consent ............................. 4-1 
4.2. 
Study Registration and Randomization ........................................................................... 4-3 
4.3. 
Consent .............................................................................................................................. 4-3 
4.4. 
Patient Assessment ............................................................................................................ 4-4 
4.4.1. 
Study Assessments .............................................................................................................. 4-4 
4.4.2. 
Choice of Study Instruments ............................................................................................... 4-5 
4.4.3. 
Timing of Study Assessments.............................................................................................. 4-6 
4.5. 
Study Monitoring .............................................................................................................. 4-8 
4.5.1. 
Case Report Forms .............................................................................................................. 4-8 
4.5.2. 
Reporting Patient Deaths ..................................................................................................... 4-8 
4.5.3. 
Reporting Serious Adverse Events....................................................................................... 4-8 
4.5.4. 
CIBMTR Data Reporting .................................................................................................... 4-8 

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5. 
STATISTICAL CONSIDERATIONS .............................................................................. 5-1 
5.1. 
Study Design for Randomized Study ................................................................................ 5-1 
5.1.1. 
Accrual ............................................................................................................................... 5-1 
5.1.2. 
Randomization .................................................................................................................... 5-1 
5.1.3. 
Study Endpoints .................................................................................................................. 5-1 
5.2. 
Sample Size and Power Calculations ................................................................................ 5-1 
5.3. 
Interim Analysis Plan ....................................................................................................... 5-2 
5.3.1. 
Interim Analysis for Efficacy .............................................................................................. 5-2 
5.3.2. 
Interim Analysis for Futility ................................................................................................ 5-2 
5.4. 
Demographics and Baseline Characteristics .................................................................... 5-2 
5.5. 
Analysis Plan ..................................................................................................................... 5-2 
5.6. 
Safety Analysis .................................................................................................................. 5-3 
5.7. 
Study Design for Evaluation Study .................................................................................. 5-3 
5.7.1. 
Center Accrual .................................................................................................................... 5-3 
5.7.2. 
Analysis Plan ...................................................................................................................... 5-3 
 
 
LIST OF APPENDICES 
 
APPENDIX A – HUMAN SUBJECTS 
APPENDIX B – REFERENCES 
APPENDIX C – LETTER TEMPLATE INTRODUCING STUDY TO PARTICIPATING 
SITE IRBS  
APPENDIX D – SCRIPT FOR INTRODUCING ETRIC STUDY TO PARTICIPANTS 
APPENDIX E – INFORMATION SHEET FOR ETRIC STUDY 
APPENDIX F – ETRIC FORM TEMPLATES FOR PARENT STUDIES 
APPENDIX G – BMT CTN 0901 & BMT CTN 1203 CLOSURE DETAILS AND ETRIC 
 
 

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1-1 
CHAPTER 1 
 
 
1. BACKGROUND AND RATIONALE 
 
Informed consent is essential to the ethical conduct of research. Research shows that participants 
who better comprehend the studies in which they participate have better protocol adherence and 
less attrition.1,2 However, many clinical trial participants have misconceptions about the trials in 
which they are participating, including overestimation of benefits, underestimation of the 
unproven nature of the study intervention, and failure to recognize the primary purpose of the 
trial.3-7 In a study of 207 adults who were queried shortly after cancer clinical trial enrollment, 
Joffe et al. found that 74% did not recognize non-standard treatment, 70% were not aware of the 
unproven nature of the treatment, 63% did not recognize the potential for incremental risk from 
participation, 29% did not recognize the uncertainty of benefits to self, and 25% did not 
understand that trials are done mainly to benefit future patients.5 
 
While consent is an ongoing process that includes more than just the written consent form, the 
form continues to be a key component of the process. Consent forms, especially for cancer 
clinical trials, have become longer and more complex which can compromise patient 
comprehension.8-10 This is described as a conflict between completeness and comprehensibility. 
As consent forms become longer and more complete, they also become less comprehensible.11 
Indeed, patient inability to understand complex treatment protocols is partly blamed for the very 
low accrual rates on cancer clinical trials.12,13 Patient comprehension of the consent form 
depends on many factors. Health literacy level may be a major determinant of patients’ ability to 
understand most informed consent forms and to participate in the decision-making process.14,15 
Federal requirements state that information must be understandable to participants, yet studies 
indicate that most informed consent forms are complicated to the point that the average person in 
the United States is likely to find them difficult to read.10 Failure to provide information in a way 
that is understandable precludes adherence to the principle of respect for persons, described in 
the Belmont Report as demanding that “subjects enter into the research voluntarily and with 
adequate information.”16  
 
1.1. 
Informed Consent in HCT Clinical Trials 
 
The informed consent process for clinical trials in hematopoietic cell transplantation (HCT) 
entails unique challenges. HCT is a highly specialized and sophisticated medical treatment. It is 
usually offered to patients with very high risk hematologic cancers (e.g., leukemia, lymphoma, 
and myeloma) and non-malignant disorders (e.g., aplastic anemia, inherited metabolic, and 
immune deficiency diseases), where the alternative is a high probability of mortality due to the 
underlying disease. These diseases themselves are not common and patients must cope with 
trying to understanding the esoteric and frightening disorder with which they are afflicted as well 
as understanding treatments (both on and off trials) that are outside the average person’s zone of 
medical familiarity. HCT increases the chances of survival, but at the same time can be 
associated with complications that by themselves cause significant morbidity and mortality. In 
fact, depending on the underlying disease and transplant type, treatment related mortality rates in 
the first 3 months after HCT range from 5-50%.17 The complexity of the transplantation 

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processes, procedures, and toxicities is difficult to explain at the “layperson level”, even without 
the added nuances of research and study specific details (e.g., randomization, multiple study 
arms). Patients often face the dilemma of being confronted by a life-threatening illness and 
having to rapidly assimilate a large amount of unfamiliar and highly complex medical 
information that is conveyed in the ambiguous language of risk and probability. Stress caused by 
disease severity, the urgency to move ahead with treatment, and persistent cognitive effects of 
illness and treatment may interfere with their ability to fully understand the information provided 
to them. Furthermore, a patient may be eligible for several different types of transplant 
treatments, each with a different toxicity profile, adding an additional level of complexity to their 
decision making process. Also, research advances have led to rapid changes in transplant 
technology and practice, and patients may find it challenging to weigh the risks and benefits of 
experimental innovative therapy in comparison to standard but relatively new transplant 
treatments. Finally, it is sometimes difficult to distinguish risk inherent to the HCT procedure 
itself, whether applied on or off trial, from the potential incremental risk associated with a 
particular trial. Patients may refuse participation in a trial because they may fear these risks, even 
though the risks will be present if they receive HCT as standard of care.  
 
Despite these known challenges, very little research has been done to address and increase 
patient comprehension and satisfaction with the informed consent process in HCT clinical 
trials.18,19 To study the complex ethical issues arising in this setting, Stevens and Pletsch 
interviewed 12 mothers whose children with leukemia had participated in HCT clinical trials to 
evaluate their experience with the informed consent process.19 The mothers identified four 
themes in explaining their experiences when faced with questions of enrolling their children in 
clinical research. First, the presence of a life-threatening disorder impacts the context in which 
consent is considered – mothers struggled with research consent when their children were 
desperately ill and could not adequately analyze the purpose, procedures, risks, and benefits of 
the proposed research or perceive alternatives available to them. The second theme was the 
effect of mothers’ own emotional trauma on their ability to absorb and understand information 
provided during the consent process. The third theme was the pressure of needing to make a 
quick decision because of the urgency to begin treatment. The last theme was the burden of 
responsibility after consenting to research involving their children. Although this study did not 
address issues specifically related to the consent form, the authors suggested simplifying the 
consent process as one intervention to increase parents’ comprehension of HCT clinical trials.  
 
It seems reasonable that improved presentation of risks and benefits in a more understandable 
fashion would improve that consent process for HCT trials. We propose a study of a novel, easy-
to-read informed consent (ETRIC) form to increase patient comprehension and satisfaction and 
decrease anxiety related to the consent process for participation in HCT clinical trials conducted 
through the BMT CTN. Better understanding of the clinical trial and the risks and benefits 
associated with participation will certainly allow better adherence to the ethical principle of 
respect for persons and may translate to higher consent and participation rates on BMT CTN 
clinical trials. Furthermore, conduct of this study within the BMT CTN, the largest cooperative 
network for HCT research in the country, will facilitate dissemination of the intervention if it is 
proven effective and therefore ensure that the intervention has a major impact on the conduct of 
HCT clinical trials.   
 

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1.2. 
Development of ETRIC Form for the BMT CTN 
 
Recognizing the need for shorter and less complicated informed consent documents, the NCI, 
along with the Office of Human Research Protections and the US Food and Drug 
Administration, presented “Recommendations for the Development of Informed Consent 
Documents for Cancer Clinical Trials” in 1998.20 The recommendations and suggested templates 
shortened and simplified the informed consent forms, made them easier to understand, and 
incorporated federally required elements of informed consent. However, they did not provide 
recommendations on best practices for legible document design. To improve comprehension, 
experts suggest that both readability (reading level) and processability (incorporation of explicit 
information, layout, mental images, and context) of informed consent documents must be 
improved.21,22 Furthermore, research shows that even 15 years since their publication, the 
guidelines are not followed universally and consent forms for a large proportion of cancer 
clinical trials continue to be lengthy, complex, and written at a higher than recommended grade 
level; both investigator- and IRB-level barriers contribute to this.8-10,23-25 
 
The BMT CTN has an established process to ensure that clinical trial informed consent forms 
meet the federal guidelines and include all required elements.20 The National Marrow Donor 
Program’s Patient Services department, which has expertise in health literacy, patient education, 
and patient advocacy, develops a template consent form for each trial in consultation with the 
protocol team and Data Coordinating Center staff. This template is distributed to participating 
centers for submission, with the protocol, to their IRBs. If a center must revise this form to meet 
local requirements (which is universally the case), the revised consent must be previewed by the 
Data Coordinating Center to ensure that all required elements are retained before submission to 
the local IRB. If the IRB requests additional changes, the final consent form must be again 
reviewed by the Data and Coordinating Center before it can be used. 
 
An ad hoc task force was convened by the BMT CTN to address concerns that trial consent 
forms continued to be long and deficient in clarity and readability, even though they met all 
federal guidelines. The aim was to evaluate the prevalent format of BMT CTN consent forms 
and to provide recommendations for an easier-to-read informed consent template that followed 
evidence-based recommendations for readability and processability but still included all federally 
required elements for informed consent. Areas of expertise among task force members included 
IRB participation, research ethics, clinical trial design and conduct, health services research, 
medically underserved populations, health literacy and education, and patient advocacy. The task 
force performed a comprehensive literature search on adult literacy, patient education and 
readability, and informed consent and pediatric assent development. Clinical trial consent and 
assent forms for previous BMT CTN clinical trials were reviewed for completeness, readability, 
length, and format. Feedback was obtained from BMT CTN investigators and trial sites and their 
IRBs. The task force created a template for the ETRIC form (published recommendations are 
summarized in Table 1-2).26 
 
 
 

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Table 1-2. Summary of BMT CTN task force recommendations for ETRIC form 
Layout 
- Use a two-column format 
- Limit characters/line 
- Balance white space with text and graphics 
- Keep headers as close to text as possible  
- Leave left margins justified and right margins 
ragged 
- Make headings 1-2 font size larger than the body 
text 
Organization 
- Sequence of information should mirror the reader’s 
mental process and concerns 
- Include important information near the beginning 
- Use simple headers to break up text 
Typography 
- Prefer serif fonts for text 
- Prefer sans-serif fonts for section headers 
- Use 11-13 point size; vary text size among fonts  
Plain Language 
- Reading level should be eighth-grade or lower 
- Keep paragraphs short; convey one idea per 
paragraph 
- Keep sentences short, simple and direct 
- Break up long sentences into bulleted lists 
- Use verbs in active voice 
- Use words that are familiar to the reader 
- Keep words and terminology consistent throughout 
the document 
- Use simple graphics that work with the text, are 
culturally relevant and reproduce well 
Avoid 
- Large blocks of print  
- Underlining or italicizing blocks of text 
- Stylized initial letters or all capitals 
- Professional jargon  
- Acronyms, symbols and abbreviations 
 
One innovative feature of the ETRIC form is the layout of the consent document. The ability to 
locate information within a text is an essential consideration in comprehension and requires a 
series of distinct cognitive operations that are dependent on text features and layout.15 A two-
column text layout was recommended as it is more familiar to readers (e.g., similar to newspaper 
articles) and can facilitate information location within a text as readers can more effectively 
identify target words.21,27-32 Based on studies of text legibility, layout, and design, 
recommendations were provided on the organization of text and typography and the use of plain 
language specifically targeting specialized terminology related to HCT.27  
 
Institutional barriers to the implementation of the ETRIC form exist. Some investigators and 
IRBs are not willing to deviate from their standard formats for consent documents. In some 
instances, investigators have been reluctant to even submit the new format to their IRBs for fear 
of delaying the IRB approval process. In others, the IRB has refused to accept the new format.  
A strength of ETRIC is that it is a method that provides flexibility for varying requests from 
different IRBs, instead of a static format.  
 
1.3. 
ETRIC vs. Other Interventions to Increase Comprehension of Cancer Trials 
 
Flory and Emanuel conducted a systematic review of interventions to improve research 
participants’ understanding in informed consent for biomedical research.33 Only a few studies 
have investigated enhanced consent form interventions (e.g., shortening length, revising content, 
improving formatting, adding graphics) and their results were mixed, with some trials showing 
gain in understanding and others not. Very few studies included multicenter cancer clinical trials 
and no studies included HCT recipients.27,34  
 
A study by the Eastern Cooperative Oncology Group randomized 44 clinical trial sites 
participating in lung and breast cancer trials (N=226 patients) to a standard consent form versus 

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an easy-to-read consent form with a modified layout where readability was adjusted to a 7th-8th 
grade level from a 12th-14th grade level.27 Even though a 2-column format was not utilized in 
their study, their easy-to-read consent document was associated with reduced patient consent 
anxiety and increased satisfaction with the consent form, but not with improved patient 
comprehension. Their study did not include many individuals with low literacy levels, which was 
not unexpected as patients recruited onto clinical research studies tend to have higher levels of 
education than the general population. However, their results showed that the use of simpler 
materials does not offend well-educated participants and reduces anxiety for the population in 
general.   
 
A second non-randomized study assessed comprehension after informed consent using either a 
standard Southwestern Oncology Group form (16th grade level) or a simplified booklet form (7th 
grade level) in 183 healthy participants and cancer patients.34 A significantly larger proportion of 
participants preferred the simplified form to the standard consent form (62% vs. 38%; P<0.01) 
and found the simplified form easier to read (97% vs. 75%; P<0.01). However, the degree to 
which the participants understood the information in the two forms was similar (58% vs. 56%).  
 
The available literature suggests that much more work is needed in improving the forms used for 
consenting patients for participation in cancer clinical trials. The current studies do not include 
the broad spectrum of patients being approached for such participation; there are no data in the 
multicenter HCT trial setting. The challenge will be to not only improve patient satisfaction, 
which the above two studies demonstrated to be possible, but also to improve understanding. We 
believe that the ETRIC form, with its novel readability and processability enhancements, has the 
potential to meet this important unmet need.  
 
1.4. 
Summary of Background, Significance and Innovation 
 
There is an urgent need to develop interventions that can increase patient comprehension of HCT 
clinical trials. This study hypothesizes that use of a novel evidence-based ETRIC form template 
with enhanced readability and processability components will be associated with higher levels of 
patient comprehension of BMT CTN treatment protocols than use of the existing standard 
institution-specific consent forms. Furthermore, the ETRIC form will be associated with lower 
anxiety and greater satisfaction with the consent process. Also, institutional barriers exist to the 
implementation of the ETRIC form and it is important to understand what these are so that they 
can be addressed effectively if this form is proved to be superior to standard forms. Using the 
platform of ongoing large, multicenter BMT CTN clinical trials, we propose a study of the 
effectiveness and acceptability of the ETRIC form that has the potential to change national 
consent practices in HCT clinical trials and to inform efforts to improve informed consent across 
the landscape of trials for cancer and other serious diseases. Also provided are important data to 
inform educational efforts at the institutional level to increase acceptance of new approaches to 
informed consent documents. 

BMT CLINICAL TRIALS NETWORK 
 
 
 
 
2. STUDY DESIGN 
 
The study has two parts: (1) Ran
Evaluation Study to understand
 
 
2.1. 
Randomized Study 
 
2.1.1. Study Overview 
 
Randomized, multicenter, prospe
improve patient comprehension o
 
A two-arm, randomized study w
for participation in a large, multi
this ETRIC study, they will go 
 
ETR
Version 5.0
2-1 
CHAPTER 2 
ndomized Study to evaluate the effectiveness o
d barriers to implementation of ETRIC (Figure 2
 
ective comparative study of ETRIC or standard
of HCT clinical trials.  
will be conducted in patients about to undergo co
icenter BMT CTN clinical trial. Once they agree
through the consent process for the parent tri
Figure 2-1. Study Schema 
RIC – Protocol 1205 
0 dated July 27, 2016 
f ETRIC, and (2) 
-1). 
 
d consent form to 
onsent discussion 
e to participate in 
ial using either a 

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2-2 
standard or the ETRIC form. Note that the BMT CTN 0901 trial was removed as a parent trial 
due to its closure on April 18, 2014. The content of both forms will be similar but the ETRIC 
form will incorporate a two-column format with specific attention towards enhanced readability 
and processability. Following the consent discussion for the parent trial, patients will complete 
assessments of health literacy, comprehension of the parent trial, and satisfaction and anxiety 
related to the consent process. These assessments will be completed within 7 business days of the 
consent discussion. The schema for the randomized study is shown in Figure 2-2.  
 
 
 
 
 
 
 
2.1.2. Summary of the BMT CTN 1101 and 1301 Protocols 
 
2.1.2.1. 
BMT CTN 1101 Protocol (Double Cord vs. Haplo) 
 
Figure 2-2. Schema for Randomized Study 

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BMT CTN 1101 study is a phase III, multicenter, randomized clinical trial investigating 
allogeneic HCT using one of two stem cell donor sources, unrelated double umbilical cord blood 
versus HLA-haploidentical related bone marrow, in patients with acute leukemia and lymphoma. 
The primary objective is to compare progression-free survival at 2 years between the two study 
arms. Overall survival, relapse, non-relapse mortality, complications, and quality of life are 
secondary endpoints. .  
 
 
2.1.2.2. 
BMT CTN 1301 (CNI-Free) 
 
BMT CTN 1301 study is a three arm randomized Phase III, multicenter trial comparing two 
calcineurin inhibitor (CNI)-free strategies for GVHD prophylaxis to standard calcineurin 
inhibitor tacrolimus and methotrexate (Tac/Mtx) in patients with acute leukemia or 
myelodysplasia undergoing myeloablative conditioning hematopoietic stem cell transplantation. 
The primary objective of the randomized trial is to compare chronic GVHD/relapse-free survival 
[CRFS] as a time to event endpoint after hematopoietic stem cell transplant (HSCT) between 
each of the CNI-free interventions and a Tac/Mtx control. Secondary objectives are: comparison 
of rates of grade II-IV and III-IV acute GVHD, chronic GVHD, chronic GVHD-free survival, 
immunosuppression-free survival at one year, neutrophil and platelet engraftment, disease 
relapse, transplant-related mortality, rates of Grade ≥ 3 toxicity; incidence of CMV and EBV 
reactivation, incidence of infections, immune reconstitution, quality of life and overall survival. 
 
2.1.3. Rationale for Study Design 
 
These BMT CTN multicenter clinical trials were selected based on their total accrual goal and 
current enrollment rates to use as a platform to conduct this randomized study. These trials were 
chosen to reflect common indications and/or complications of HCT and the diversity and 
complexity of transplant technologies and supportive care treatments. Random allocation to the 
two study arms will reduce selection bias and will ensure that socio-demographic factors 
(including education status and health literacy levels) and disease characteristics of patients are 
comparable. There is a potential that patients, if aware that they are on the ETRIC arm, may 
overestimate their comprehension and satisfaction scores and underestimate their anxiety levels.  
 
2.1.4. Hypothesis and Study Objectives 
 
The primary hypothesis is that the patients consenting using the ETRIC form will have higher 
levels of comprehension of BMT CTN transplant protocols and risks associated with 
participation in the trial compared to patients consented using standard consent forms. The 
secondary hypotheses are that patients using the ETRIC forms will have lower anxiety and 
greater satisfaction with the consent process. 
 
2.1.4.1. 
Primary Objective 
 
The primary objective of the study is to determine whether the ETRIC form increases patient 
comprehension of informed consent compared to the standard consent form for the BMT CTN 

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parent studies. This will be achieved by comparing patient comprehension scores on the Quality 
of Informed Consent (QuIC) Part A instrument between patients randomized to the two arms.  
 
2.1.4.2. 
Secondary Objectives 
 
The secondary objectives are to compare additional measures of comprehension and measures of 
patient anxiety, satisfaction, and information location between the two arms. Specifically, these 
will include subjective comprehension scores on the QuIC (Part B) instrument, comprehension 
scores on the modified Deaconess Informed Consent Comprehension Test (DICCT), state 
anxiety scores on the State Trait Anxiety Inventory (STAI), satisfaction scores, and time taken 
for information location. The study will also explore patient consent rates on parent clinical trials 
for the two arms.  
 
2.1.5. Patient Eligibility Criteria 
 
Inclusion and exclusion criteria for the ETRIC randomized study will be the same as the 
eligibility criteria for the BMT CTN parent studies. Additional inclusion criterion specific for the 
ETRIC study will include:  
1. Adult patients (≥ 18 years). 
2. Speaking and reading proficiency in English (as most of this study’s instruments have not 
been translated and validated in languages other than English). 
3. Willing and able to provide informed consent.  
4. Stated willingness to comply with study procedures and reporting requirements.   
 
2.1.6. Study Interventions 
 
Patients will be randomized to either the ETRIC arm or the standard consent arm. The ETRIC 
consent form was developed by NMDP’s Patient Services department, which has expertise in 
health literacy and in development of consent documents for clinical trials, in consultation with 
clinical trial protocol team. The ETRIC form has a two-column format with specific attention 
towards enhancing readability and processability including layout, organization of content, 
typography, and using plain language (Section 1.2). The standard consent form has a single 
column format and lacks the formatting and readability enhancements of the ETRIC form. For 
patients randomized to the standard consent arm, participating centers will be allowed to use the 
standard consent form they are presently using for consenting patients for the parent studies. The 
content of both forms are similar and both contain all federally required elements for informed 
consent. Individual clinical trial sites will be allowed to make modifications to the ETRIC and 
the standard consent forms to meet requirements of their local IRBs. The BMT CTN 1205 
protocol team will ensure that any such modifications to the ETRIC form conform to the easy-to-
read format.  
 
2.1.7. Hematopoietic Cell Transplantation 
 

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The BMT CTN 1205 study is a non-therapeutic ancillary study. Patients will receive HCT and/or 
its associated treatments and supportive care as outlined in the BMT CTN parent protocols. In 
the event that a patient does not consent for participation in the BMT CTN parent trial, he/she 
will receive standard HCT and/or its associated treatments as recommended by his/her treating 
physician.  
 
2.1.8. Study Risks and Benefits 
 
Risks of study participation are expected to be minimal. Similarly, the study interventions are not 
expected to impact clinical outcomes. It is unknown whether study participants will experience 
any benefits.   
 
2.1.9. Study Withdrawal 
 
Subjects may be withdrawn from study participation if the treating physician believes it is in the 
patient’s best interest.  
 
2.2. 
Evaluation Study 
 
2.2.1. Study Overview 
 
For the evaluation study, site visits will be scheduled to 9 transplant centers to understand 
barriers to the implementation of the ETRIC form. This will include visits to 5centers that are 
participating in the randomized consent form study as well as another 4 trial sites that are not 
participating in the consent study but are enrolling patients on the BMT CTN parent clinical 
trials. This approach will provide us with a wide spectrum of procedures related to the consent 
process that are followed by trial sites and their IRBs.  
 
At each site, we will conduct semi-structured interviews of IRB administrators, site protocol 
investigators, and study coordinators. Semi-structured interviews will last 30-45 minutes and will 
examine: (1) willingness to utilize and acceptability of ETRIC two-column format, (2) perceived 
barriers to implementation, (3) previous experience with alternative format informed consent 
forms or novel methods of obtaining consent, (4) perception of value of ETRIC, and (5) 
helpfulness of resources provided to facilitate implementation of ETRIC (e.g., quick reference 
resources for design and format elements, template with default settings for format and design, 
additional resources for design support, educational resources for IRB and protocol team 
members, BMT CTN recommendations). 
 
Qualitative analyses will be conducted to identify themes representing facilitators and barriers to 
the local implementation of the ETRIC form. Other methods to conduct interviews (e.g., 
telephone interviews) were considered. However, face-to-face interviews have certain 
advantages. First, high unit and item response rates, valid data and detailed information can be 
captured by face-to-face interviews because longer interviews can be conducted and support can 
be provided by interviewers as they observe non-verbal expressions of respondents.35,36 Also, we 
would like the interview participant to give feedback on specific elements of the ETRIC form 

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which would be easier with the face-to-face interview than a telephone interview given the 
length of the consent forms and range of familiarity with the ETRIC form.  
 
2.2.2. Center Selection Criteria 
 
All centers participating in the BMT CTN parent clinical trials will be eligible to participate in 
the evaluation study. The BMT CTN 1205 (ETRIC) study protocol team will invite centers to 
participate in this study based on center interest and accrual rates on the parent BMT CTN 
clinical trials.  
 

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CHAPTER 3 
 
 
3. STUDY ENDPOINTS 
 
3.1. 
Study Endpoints for Randomized Study 
 
The instruments that will be used for study assessments are described in Section 4.4. 
 
3.1.1. Primary Endpoint 
 
The primary endpoint objective of this study is to compare objective comprehension scores on 
the QuIC Part A instrument between patients randomized to the ETRIC and the standard consent 
arms. 
 
3.1.2. Secondary Endpoints 
 
The secondary endpoints will compare the following measures between the two arms: (1) 
subjective comprehension scores on the QuIC (part B) instrument and the modified DICCT 
instrument, (2) state anxiety scores on STAI instrument, (3) satisfaction scores, (4) time taken for 
information location, and (5) patient consent rates on parent clinical trials. 
 
3.2. 
Study Endpoints for Evaluation Study 
 
For the evaluation study, using qualitative research methods (semi-structured interviews), the 
study will determine: (1) willingness to utilize and acceptability of ETRIC two-column format, 
(2) perceived barriers to implementation, (3) previous experience with alternative format 
informed consent forms or novel methods of obtaining consent, (4) perception of value of 
ETRIC, and (5) helpfulness of resources provided to facilitate implementation of ETRIC (e.g., 
quick reference resources for design and format elements, template with default settings for 
format and design, additional resources for design support, educational resources for IRB and 
protocol team members, BMT CTN recommendations). 
 

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CHAPTER 4 
 
 
4. PATIENT REGISTRATION AND ENROLLMENT FOR RANDOMIZED STUDY 
 
4.1. 
Approaching Patients, Eligibility Screening and Obtaining Consent 
 
Subjects may be approached for enrollment on the ETRIC protocol once they have been 
identified as potential participants for the BMT CTN 1101 or 1301 studies. Note that the BMT 
CTN 0901 trial and BMT CTN 1203 trial were removed as parent trials due to their closure on 
April 18, 2014 and May 13, 2016, respectively, and no further patients will be enrolled from 
these studies. The following scenarios regarding eligibility/participation in the ETRIC study can 
occur (Figure 4-1):   
 

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1) Scenario 1: On patient assessment, he/she is not found to be eligible for the parent trial. 
In this case, the patient would not be approached for participation in the BMT CTN 1205 
(ETRIC) randomized study. He/she will proceed with HCT or other treatments as 
recommended by his/her physician.  
2) Scenario 2: On patient assessment, he/she is found to be potentially eligible for the parent 
trial. However, on approaching the patient for the study, he/she indicates no interest in 
participation or going through the consent process. He/she will proceed with HCT or 
other treatments as recommended by his/her physician.  
3) Scenario 3: On patient assessment, he/she is found to be potentially eligible for the parent 
trial and is interested in proceeding with the consent process for the study. Once patient 
expresses interest in the parent study, he/she will be approached for participating in the 
Figure 4-1. Possible Scenarios for Patient Registration 

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BMT CTN 1205 (ETRIC) study. In this case, patient declines participation in the BMT 
CTN 1205 (ETRIC) study, and he/she will proceed with the consent process for the 
parent trial using their standard consent form. 
4) Scenario 4: On patient assessment, he/she is found to be potentially eligible for the parent 
trial and is interested in proceeding with the consent process for the study. Once patient 
expresses interest in the parent study, he/she will be approached for participating in the 
BMT CTN 1205 (ETRIC) study. In this case, patient agrees to participate in the BMT 
CTN 1205 (ETRIC) study. He/she will be randomized and will undergo consent 
discussions for the parent study using either the ETRIC or the standard consent forms.  
 
In case a patient consents to and is enrolled on the BMT CTN 1205 (ETRIC) study, and then 
subsequently is found to not meet the eligibility criteria for the parent study (prior to the consent 
discussion for the study), he/she will be removed from the BMT CTN 1205 (ETRIC) study (this 
situation would be similar to Scenario 1 above). No ETRIC assessments will be conducted for 
such patients.   
 
Patients who agree to participate in the BMT CTN 1205 (ETRIC) study, and then go through the 
consent process for but decline participation in or are later found ineligible for the parent study, 
will continue on the BMT CTN 1205 (ETRIC) study. They will be asked to complete all the 
assessments for the BMT CTN 1205 (ETRIC) study even though they do not proceed onto the 
parent study.  
 
Transplant physicians or other center staff will evaluate patient eligibility for enrollment for the 
BMT CTN 1205 (ETRIC) study. Eligibility criteria will be verified and ineligible patients will 
proceed off study and no further study procedures will be conducted. Eligible patients willing to 
potentially participate in the BMT CTN 1205 (ETRIC) study will have a thorough discussion 
about the protocol with an investigator, a sub-investigator, clinical research nurse, or research 
coordinator. If necessary, this discussion may take place by telephone. During the discussion, the 
purpose of the study and study procedures will be presented as objectively as possible, and the 
potential benefits and risks of participation will be explained. Patients will be registered through 
EMMES AdvantageEDCSM (Electronic Data Capture, an Internet-based data entry system).  
 
4.2. 
Study Registration and Randomization 
 
Once the subject is deemed eligible, has given informed consent, and the transplant center has 
confirmed patient eligibility, randomization occurs. A subject may be randomized on to one of 
two arms: ETRIC vs. standard consent.  
 
4.3. 
Consent  
 
Given the number of consents and randomization conversations subjects will encounter, the 
randomized portion of the ETRIC study will seek a waiver of the requirement to document 
consent from the IRBs of participating sites according to the requirements of the Common Rule 
(Section 46.117(c)(2)) (also see Appendix A). This does not mean that informed consent will not 
occur but rather that informed consent process will be verbal and subjects will neither read nor 
sign an informed consent form. Specific items will still need to be addressed in the consent 

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conversation as required by the federal regulations, as shown in the consent script (Appendix D). 
Subjects will be given a written information sheet about the BMT CTN 1205 (ETRIC) study that 
addresses all required elements of informed consent (Appendix E). Additionally, a sample letter 
to the participating site’s IRB requesting a waiver from the requirement to document consent is 
attached as Appendix C. The Principal Investigator or his/her designee at each transplant center 
will contact the candidates to enroll them onto the study. The study coordinator at each center 
will provide the patient with information about the purpose of the study and obtain verbal 
consent, either in person or over the phone. The date of verbal consent will be recorded and 
saved in the patient’s study file. 
 
4.4. 
Patient Assessment 
 
4.4.1. Study Assessments 
 
Table 4-4-1 describes the patient reported assessments that will occur as part of the BMT CTN 
1205 (ETRIC) study. All assessments will occur at one time – within 7 business days of consent 
discussion for the parent trial. These assessments will be conducted in addition to other 
assessments being performed for the parent trials and any other ancillary studies in which the 
patient might be participating. (Note, there are no patient reported assessments for the 1203 
trial.) 
  
 

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Table 4-4-1: Summary of Study Assessments 
Instrument 
Description 
Administration 
Health Literacy 
 
 
- Rapid Estimate of 
Adult Literacy in 
Medicine 
(REALM)37 
Medical-word recognition and pronunciation test comprising 11 medical 
terms, arranged in order of complexity by the number of syllables and 
pronunciation difficulty; scores assigns health literacy skills into 4 
categories of grade-equivalent reading level 
Study coordinator, 
2 minutes 
- Newest Vital Sign 
(NVS)38 
Measures health literacy level using 1 scenario of an ice cream container 
nutrition label; 1 score (6 items) includes assessment of two main 
constructs, numeracy and reading comprehension  
Study coordinator, 
3 minutes 
Comprehension 
 
 
- Quality of Informed 
Consent (QuIC)4 
Measures subjects actual (objective - part A, 16 items) and perceived 
(subjective - part B, 14 items) understanding of cancer clinical trials to 
address 13 independent domains of informed consent; responses 
measured in a 3 item (part A) or 5 item (part B) Likert scale   
Self administered, 
7 minutes 
- Modified Deaconess 
Informed Consent 
Comprehension Test 
(DICCT)39-41  
Semi-structured interviews assess subjects understanding of 8 core 
elements of disclosure for the study they have agreed to participate in. 
Scores of 2,1 or 0 are assigned to responses that indicate complete, partial 
or no understanding of each element.  
Study coordinator, 
5 minutes 
Anxiety 
 
 
- State Trait Anxiety 
Inventory (STAI)42 
Measures anxiety and distinguishes it from depressive syndromes; 40 
items to assess state/trait anxiety; responses rated on a 4 point Likert scale  
Self administered, 
5 minutes 
Satisfaction 
 
 
- Study specific and 
QuIC Supplement43 
Short study specific questionnaire and selected questions from the QuIC 
supplement questionnaire will query participants about their overall 
satisfaction with the consent process, helpfulness of information provided, 
and comprehension of key study-specific elements of treatment 
Self administered,  
5 minutes 
Information location 
 
 
- Study specific 
Participants will be asked to identify 5  items of information within the 
consent document; time taken to locate items will be measured 
Study coordinator, 
5 minutes 
 
4.4.2. Choice of Study Instruments 
 
In choosing study instruments, two considerations were taken into account. First, instruments 
were sought that have been well-validated to assess the endpoints of interest, where available. 
Second, the study was tailored to be sensitive to the critical nature of these patients’ illnesses and 
the stressful climate in which their decisions are being made. Consequently, the selected 
instruments will minimize the burden of participation by keeping the patient time commitment 
required to a minimum.   
 
Although available tools are unable to completely capture the complexity of the construct of 
health literacy, the Rapid Estimate of Adult Literacy in Medicine (REALM) instrument is a 
validated and reliable instrument that has been extensively used in assessing health literacy, 
especially in the context of informed consent studies among cancer patients.14,15,27 The Newest 
Vital Sign (NVS) instrument consists of a single scenario, an ice cream container nutrition label, 

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and 6 questions measuring word comprehension and application and numeracy.38 The REALM 
and NVS were chosen over other literacy assessments such as the Test of Functional Health 
Literacy in Adults (TOFHLA) standard and short forms because collectively they require 
significantly less time to administer, measure both comprehension and numeracy and are more 
sensitive to marginal health literacy. 
 
The Quality of Informed Consent (QuIC) instrument will be used to measure comprehension.4,44 
QuIC incorporates the basic elements of informed consent specified in federal regulations, 
assesses therapeutic misconceptions, and measures actual (part A) and perceived (part B) 
understanding of cancer clinical trials. It has good test-retest reliability (interclass correlation 
coefficient 0.66-0.77).4 Part A consists of 16 statements to which subjects can respond “agree”, 
“disagree”, or “unsure.” Part B includes 14 questions with responses measured on a 5-point scale 
that ranges from “I didn’t understand this at all” to “I understood this very well.” Each section is 
scored on a normalized scale from 0 to 100. The QuIC was chosen over other instruments that 
measure subject comprehension of consent forms (e.g., Brief Informed Consent Evaluation 
Protocol [BICEP],45 Deaconess Informed Consent Comprehension Test [DICCT]41) as the QuIC 
has been developed specifically for cancer clinical trials, has been well validated in the literature, 
and measures both objective knowledge and self-reported subjective understanding of a subject 
undergoing the informed consent process in a clinical trial.4,8,44,46-49 As a secondary endpoint, the 
study will use a modification of the DICCT to evaluate subject comprehension of 8 core 
elements of disclosure for the study in which they are considering participation.39-41 The test uses 
semi-structured interviews to obtain open-ended responses to questions related to study purpose, 
protocol, risks, direct benefits, indirect benefits, freedom to withdraw, alternative treatments,  
and voluntariness. Responses are scored as 2, 1, or 0 to indicate complete, partial, or no 
understanding and a composite score is determined.  
 
Anxiety related to the consent process will be measured using the State Trait Anxiety Inventory 
(STAI), a commonly used and validated tool with good internal consistency, test-retest 
reliability.42 There are no validated instruments for measuring satisfaction with the informed 
consent process. A short questionnaire that can be self-administered by patients will be 
developed to measure satisfaction and understanding of key study-specific elements. In addition, 
selected questions will be used from the QuIC supplement to assess satisfaction.43 There are no 
validated instruments for measuring consent information location (text search ability). To 
measure information location and to differentiate it from comprehension, the time it takes for 
subjects to locate 5 important items of information in the consent form will be determined.   
 
4.4.3. Timing of Study Assessments 
 
For the BMT CTN 1205 (ETRIC) study, enrolled patients will complete assessments within 7 
business days of consent discussion for the parent trial. These will include assessments for health 
literacy and assessments for study endpoints (comprehension, anxiety, satisfaction, information 
location). These assessments will be conducted irrespective of whether the patient participates 
(and signs consent) or declines participation (and does not sign consent) for the parent study.  
 
 
 

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There are two sets of assessments: 
- 
Coordinator administered assessments: These include – (1) REALM (health literacy), (2) 
NVS (health literacy), (3) Modified DICCT (comprehension), and (4) assessment for 
information location. Preferably, these assessments should occur right after the consent 
discussion for the parent clinical trial. However, if that is not feasible, they could be 
completed in a separate visit within 7 business days.  
- 
Patient self-administered assessments: These will include – (1) QuIC (comprehension), 
(2) STAI (anxiety), and (3) assessment for satisfaction with the consent process. 
Preferably, these assessments should occur right after the consent discussion for the 
parent study. However, if that is not feasible, patients can be allowed to take them home 
and complete and return them by mail to the transplant center within 7 business days. 
 
All study assessments will be administered using paper-based forms. Table 4-4-3 shows the 
timing of the study assessments for this study and their relation to patient reported assessments 
for the parentstudies.  
 
 

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Table 4-4-3: Patient Reported Assessments in the BMT CTN 1205 and Parent Studies 
Study/Instrument 
Administered by 
# of 
items 
Within 7 
business days of 
post-consent* 
Pre-
HCT1 
100 
Days 
180 
Days 
12 
mos 
24 
mos 
Time 
required 
1205 
 
 
 
 
 
 
 
 
 
Health Literacy 
 
 
 
 
 
 
 
 
 
- REALM 
Coordinator 
11 
X 
 
 
 
 
 
2 minutes 
-  NVS 
Coordinator 
6 
X 
 
 
 
 
 
3 minutes 
Comprehension 
 
 
 
 
 
 
 
 
 
-  QuIC (A and B) 
Self 
30 
X 
 
 
 
 
 
7 minutes 
-  Modified DICCT 
Coordinator 
11 
X 
 
 
 
 
 
5 minutes 
Anxiety 
 
 
 
 
 
 
 
 
 
- STAI 
Self 
40 
X 
 
 
 
 
 
5 minutes 
Satisfaction 
 
 
 
 
 
 
 
 
 
- Satisfaction Survey 
Self 
7 
X 
 
 
 
 
 
5 minutes 
Information location 
 
 
 
 
 
 
 
 
 
-  Study specific 
Coordinator 
5 
X 
 
 
 
 
 
5 minutes 
1101 
 
 
 
 
 
 
 
 
 
-  FACT-BMT 
Self 
37 
 
X 
 
 
X 
X 
6 minutes 
-  MOS SF-36 
Self 
36 
 
X 
 
 
X 
X 
6 minutes 
-  Global HRQoL 
Self 
4 
 
X 
 
 
X 
X 
< 1 minute 
-  Occupational Functioning 
Self 
6 
 
X 
 
 
X 
X 
< 1 minute 
-  EQ-5D 
Self 
5 
 
X 
 
 
X 
X 
1 minute 
1301 
 
 
 
 
 
 
 
 
 
-  FACT-BMT 
Self 
37 
 
X 
X 
X 
X 
X 
6 minutes 
-  MOS SF-36 
Self 
36 
 
X 
X 
X 
X 
X 
6 minutes 
-  MDASI 
Self 
19 
 
X 
X 
X 
X 
X 
< 5 minutes 
1 Depending on a center’s processes, there is a possibility that the post-consent assessments for the 1205 study and the pre-transplant assessments for the 1101 or 1301 
study will occur at the same time. 
Note: There are no patient-reported assessments for the BMT CTN 1203. 
 

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4.5. 
Study Monitoring 
 
Monitoring for this study will follow the mechanisms already established for the parent trials, 
whichever trial the patient is being considered for. Given the minimal risks associated with the 
BMT CTN 1205 (ETRIC) study interventions and the subsequent short followup period, no 
additional monitoring will be conducted for the BMT CTN 1205 (ETRIC) study. Patients will be 
monitored clinically with laboratory assessments, physical exams, restaging studies, and other 
testing deemed to be standard practice and appropriate by the treating physician and the 
transplant center.  
 
4.5.1. Case Report Forms 
 
The procedures required for forms completion and timeliness of submission can be found in the 
AdvantageEDCSM User’s Guide. Assessments that are not completed in AdvantageEDCSM 
within 30 days of participant enrollment onto 1205 are considered delinquent. Transplant centers 
can view submitted past due and expected forms via AdvantageEDCSM. A missing form will 
continue to be requested either until the form is reported or until an exception is granted. 
 
4.5.2. Reporting Patient Deaths 
 
Patient deaths related to the BMT CTN 1205 (ETRIC) study are not anticipated. Reporting of 
patient death to the BMT CTN Data and Coordinating Center (DCC) will be conducted 
according to established procedures for the parent trials.  
  
4.5.3. Reporting Serious Adverse Events 
 
Reporting of patient serious adverse events (SAE) will be consistent with standard BMT CTN 
procedures but be limited to events which are possibly, probably, or definitely associated with 
participation in this study since this protocol does not involve any pharmacologic treatment or 
invasive procedures. Unexpected, grades 3-5 adverse events (AEs) will be reported through an 
expedited AE reporting system via the web-based electronic data capture system, 
AdvantageEDC. Unexpected, grades 4-5 AEs must be reported within 24 hours of the event. 
Unexpected, grade 3 AEs must be reported within three business days of knowledge of the event. 
Other SAEs will be tracked periodically as defined in the Form Submission Schedule, staged 
according to NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. 
The Data and Safety Monitoring Board will receive summary reports of all adverse experiences 
on at least an annual basis.  
 
4.5.4. CIBMTR Data Reporting 
 
Centers participating in BMT CTN trials must register and provide transplant outcome data on 
all consecutive hematopoietic stem cell transplants done at their institution during their time of 
BMT CTN participation to the Center for International Blood and Marrow Transplant Research 
(CIBMTR). Registration is done using procedure and forms developed by CIBMTR for the Stem 
Cell Transplant Outcomes Database (SCTOD). (Note: Federal legislation requires submission of 
these forms for all US allogenic transplant recipients.)  

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Patients enrolled in this trial will remain on pre selected form submission track (Transplant 
Essential Data track also known as “TED” track or Comprehensive Report From track also 
known as “CRF” track) that was originally assigned by the CIBMTR algorithm. CIBMTR forms 
will be submitted directly to the CIBMTR at the times specified on the Form Submission 
Schedule. 
 
 

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CHAPTER 5 
 
 
5. STATISTICAL CONSIDERATIONS 
 
5.1. 
Study Design for Randomized Study 
 
The randomized study will test two interventions – the ETRIC consent form vs. the standard 
consent form for patients participating in the BMT CTN 1101 and 1301 studies. The BMT CTN 
0901 trial and BMT CTN 1203 trial were removed as parent protocols for the BMT CTN 1205 
study due to their closure to accrual on April 18, 2014 and May 13, 2016, respectively. Those 
who enrolled in the BMT CTN 1205 prior to the BMT CTN 0901 and BMT CTN 1203 closures 
will be included in the analysis. 
 
5.1.1. Accrual 
 
It is estimated that 3 years of accrual will be necessary to enroll the targeted sample size of 198 
patients (99 in each arm). Accrual will be reported by race, ethnicity, and sex. Study assessments 
will be conducted after the consent process. No patient follow-up will be conducted for this 
study.  
  
5.1.2. Randomization 
 
Patients will be randomized at a ratio of 1:1 between the two consent arms. Randomization will 
be stratified by center and by parent BMT CTN treatment protocol. Study ID numbers will be 
randomized within strata. Study personnel will be blinded to randomization assignment until a 
study participant agrees to participate and is assigned a study ID number.  
 
5.1.3. Study Endpoints 
 
The primary endpoint of this study is to compare objective comprehension scores on the QuIC 
(part A) instrument between patients randomized to the ETRIC versus the standard consent arms. 
Secondary endpoints will compare the following measures between the two arms: (1) subjective 
comprehension scores on the QuIC (part B) instrument and the modified DICCT instrument, (2) 
state anxiety scores on STAI instrument, (3) satisfaction scores, (4) time taken for information 
location, and (5) patient consent rates on parent clinical trials.  
 
5.2. 
Sample Size and Power Calculations 
 
Based on previous studies in the literature,4,43,44 this study is designed to detect a 4-point 
difference in the mean QuIC part A comprehension scores between the two study arms. This 
difference represents a 0.5 standard deviation difference and has been considered to represent a 
clinically meaningful difference in comprehension scores in previous studies. The sample size 
for a two-sample t-test will require 64 participants per group to detect a 4-unit difference 
between group means (α=5%, power=80%, standard deviation=8). Asymptotic relative 
efficiency of the Mann-Whitney test to the 2-sample t-test is 0.864 under any symmetric 

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distribution, which means that 15% more subjects will need to be recruited, leading to 74 per 
group or 148 in total. Another 25% is added to account for possible dropouts (e.g., patients 
consent for this study, but are subsequently not able to participate in the consent process for the 
BMT CTN parent clinical trial [e.g., due to disease progression or determined ineligible to 
participate]). The study will need to enroll 198 subjects (approximately 99 in each arm). The 
stratified randomization will eliminate possible association between trial and center strata and 
consent group assignment, which potentially increases power properties.  
 
5.3. 
Interim Analysis Plan 
 
5.3.1. Interim Analysis for Efficacy 
 
No interim analysis for efficacy will be performed for several reasons. This study is a non-
therapeutic study with minimal risks to the study participants. Stopping enrollment to one of the 
intervention arms at an interim analysis would impact the ability to evaluate secondary endpoints 
for the study. 
 
5.3.2. Interim Analysis for Futility 
 
No interim analysis for futility will be performed. Both intervention arms are considered minimal 
risk to participants.   
 
5.4. 
Demographics and Baseline Characteristics 
 
Demographic and baseline characteristics will be summarized for all patients. Characteristics to 
be examined include: patient characteristics (age, sex, race/ethnicity, performance status, disease 
and disease risk, educational status, household income, as well as health literacy level); donor 
characteristics (donor type, HLA-match); and transplant characteristics (transplant type, 
conditioning). Characteristics will be recorded for all patients who enroll on the BMT CTN 1205 
(ETRIC) study, irrespective of whether they subsequently consent for the parent BMT CTN  
protocol. Between groups comparisons will be performed for continuous variables via a Kruskal-
Wallis test and for categorical variables, via the chi-square test. The study will also apply 
Mantel-Haenszel methods to account for stratification by center and protocol. We are not 
expecting that the strata effect will be strong enough to change our findings. However, if a 
Kruskal-Wallis and Mantel-Haenszel produce different conclusions the underlying assumptions 
will be investigated for each of the tests and proceed with a method more appropriate for a given 
situation. 
 
5.5. 
Analysis Plan 
 
The primary analysis will be performed using the intention-to-treat principle so that all 
randomized patients will be included in the analysis. The t-test or the Mann-Whitney test will be 
used if the t-test assumptions are violated. Secondary endpoints of subjective comprehension, 
anxiety, satisfaction, and information location will be analyzed with the Mann-Whitney test. The 
binary outcome of consent rates will be compared using the Fisher exact test. The above 
unadjusted analyses will be complemented by analyses that adjust for potentially confounding 

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variables in regression analyses. Generalized estimating equations (GEE)50 will be used to 
control for effect of confounding variables (e.g., patient demographics, health literacy level, 
strata) and a potential consenter effect (as more than one clinician could be involved in the 
consent process at a clinical trial site). GEE with identity link will be used for comprehension, 
anxiety and satisfaction analyses. Information location will be analyzed with LOG link and 
LOGIT link with accrual outcome. Variance will be estimated with the sandwich estimator if the 
number of consenters is > 30; otherwise the “leave-one-consenter-out” jackknife variance 
estimation will be used.51 Exact logistic regression will be used with accrual if the problem of 
small counts appears. Otherwise Wald tests will be used for significance testing. All two-way 
interactions between the group indicator (ETRIC vs. standard) and confounding variables will be 
tested and added to the model if significant. It is expected that all confounders will be analyzed 
as fixed effects except for the consenter which will be the repeated factor in the GEE. The form 
of continuous predictors will be either linear, quadratic, or categorized depending on the number 
of clusters observed in the dataset. Every category in categorical variables will have at least 10 
subjects otherwise we will consider merging with neighboring categories. The presence of 
missing data in excess of 10% will be addressed by developing an imputation model for missing 
components given the observed part. Then, the multiple imputations approach will be used to 
estimate regression parameters and their standard errors.52  
 
5.6. 
Safety Analysis 
 
The reporting of serious adverse events will be consistent with standard BMT CTN procedures.   
 
5.7. 
Study Design for Evaluation Study 
 
The evaluation study will use qualitative research methods to understand barriers and facilitators 
to the use of ETRIC consent form at BMT CTN clinical trial sites participating in the 
parentstudies.  
 
5.7.1. Center Accrual 
 
Assessments will be conducted at 9 transplant centers. This will include 5 centers that participate 
in and another 4 centers that are not participating in the ETRIC randomized study. During a one-
day visit at each site, semi-structured interviews will be conducted of: (1) IRB administrators, 
members, and other relevant personnel involved in the consent approval process, (2) site protocol 
investigators, and (3) study coordinators/research personnel who interact with patients during the 
consent process.  
 
5.7.2. Analysis Plan 
 
Assessments at each site will be conducted by two study team members with expertise in 
qualitative research methods and knowledge of transplantation and IRB processes as well as 
health literacy and readability concerns outlined in the literature. Interviews will be recorded and 
notes will be taken during the interviews to record nonverbal behavior of participants and to 
provide a back-up in case the recording fails. Evaluation study participants will not receive any 
incentives for participation.  

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For the semi-structured interviews, systematic, sequential, transcript-based analysis will be 
utilized concurrently with data collection to identify saturation of themes across the data.53 Two 
experienced reviewers familiar with the area of study and preliminary research will analyze the 
data to assess the reliability and validity of the coded data through inter- and intra-coder 
agreement measures.54 Inter-coder reliability refers to consistency among different coders while 
intra-coder reliability refers to consistency within a single coder. The qualitative analysis process 
includes four steps as outlined below.  
 
Step 1: The transcribed data will be organized by question in order to examine responses across 
all participants, looking for consistencies and differences. This step includes reassigning 
responses to an alternate question (asked earlier or later in the interview) rather than the original 
question posed if it better answers the alternate question. 
 
Step 2: The next major stage of qualitative data analysis will involve creating a codebook and 
coding the textual data line by line (i.e., segmenting the data into meaningful analytical units). 
This study will use inductive codes developed by the analysts through direct examination of the 
data. During coding, a master list (i.e., codebook) will be created consisting of six basic 
components: the code, a brief definition, a full definition, guidelines for when to use the code, 
guidelines for when not to use the code, and examples.55 The code is used to index text for 
retrieval and to assign values to text such as the frequency, amount, or presence/absence of 
information.56-58 Because initial coding instructions often yield poor agreement, two coders will 
independently code the text segments two times. The purpose of this first coding comparison is 
to pretest and remedy problems with the code book. Once problems are identified and fixed, the 
same two coders will use the amended code book to recode the same segments.  
 
Step 3: Validity and reliability of results will be assessed through: (1) a detailed review which 
assesses consistency of code application within segments and (2) inter-coder and intra-coder 
statistical analysis. In the first technique, the study will compare the sets of codes that each coder 
assigned to each of the text passages. A response is considered to be coded the same only if both 
coders use the identical set of codes. Presence of one or more disagreements will be counted as a 
coding discrepancy. Using this method, comparison of the code book pretest will demonstrate 
the level of reliability of text analysis.54 In the latter technique, a simple measure of agreement 
for how a code is assigned (the proportion of times that the two raters agree) will be used. To 
correct for the possibility that coders might agree by chance, calculations will use the kappa 
statistic.59 A kappa < 0.90 will indicate a problem with agreement in the way a code is being 
used.54 As a way to ensure consistency in subsequent analysis steps, one study team member will 
resolve any remaining inter-coder discrepancies in the text passages and assign codes for the rest 
of the data. 
 
Step 4: In the last step of qualitative analysis, coded textual data are explored inductively using 
content analysis to generate categories and explanations. This will identify hierarchical 
relationships among codes, creating families of codes that can be aggregated, reviewed, and 
analyzed at an increasingly general level.55 This process is referred to as content analysis for 
saturation of themes. The themes will be reported with quoted text included as support and 
context.  

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Computer assisted qualitative data analysis software (CAQDAS), NVivo, will be used to add 
rigor to the research through electronic search of the transcripts and to provide transparency on 
how the analysis process is carried out, increasing the ability to replicate the analysis methods.  
 
 

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APPENDIX A 
 
HUMAN SUBJECTS 
 

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APPENDIX A 
 
HUMAN SUBJECTS 
 
 
Waiver of the requirement to document informed consent: Given the number of consents and 
randomization conversations subjects will encounter, the randomized portion of this study will 
seek a waiver of the requirement to document consent from the IRBs of participating sites. We 
believe that our study meets the criteria for waiver of the requirement to obtain written informed 
consent (CFR §46.117 (c) (1): An IRB may waive the requirement for the investigator to obtain a 
signed consent form for some or all subjects if it finds either: … (2) That the research presents no 
more than minimal risk of harm to subjects and involves no procedures for which written consent 
is normally required outside of the research context.).  
 
This does not mean that informed consent will not occur but rather that informed consent process 
will be verbal and subjects will neither read nor sign an informed consent form. Subjects will be 
provided with a written statement regarding the research that includes all the required elements 
of informed consents. Specific items will still need to be addressed in the consent conversation as 
required by the federal regulations, as shown in the attached consent script (Appendix D). 
Additionally, a sample letter to the participating site’s IRB requesting a waiver from the 
requirement to document consent is attached as Appendix C. 
 
Subject consent: Candidates for the study will be identified as described in Chapter 4 of the 
protocol. The Principal Investigator or his/her designee at each transplant center will contact the 
candidates and provide the patient with information about the purpose of the study, obtain verbal 
consent, and enroll/randomize the patient on the BMT CTN 1205 trial. The Network will provide 
template consent forms (ETRIC and standard consent) to each center. Centers will be allowed to 
modify the standard consent form according to their local IRB requirements, if needed. IRB 
specific changes to the ETRIC consent will be allowed, as long as the easy-to-read format is 
maintained. Each center must provide evidence of IRB approval for the BMT CTN 1205 
(ETRIC) study as well as the BMT CTN parent studies.  
 
Additionally, there may be some concern that participants who are randomized to the ETRIC 
consent arm will consent to the parent BMT CTN trial using an experimental, untested consent. 
The content of the standard consent and the ETRIC consent will be the same, both containing all 
of the required elements for informed consent per federal regulations. The only difference in the 
ETRIC consent arm is enhanced formatting and a two-column layout. Furthermore, to ensure 
that participants have given truly informed consent, we will incorporate open ended (as opposed 
to yes/no) questions at the end of the consent process to ensure comprehension. These questions 
will address the voluntary nature of participation in research and the ability to withdraw from the 
study at any time without consequence, the purpose and nature of the study, the risks of the 
study, and alternative options. These questions will be asked of participants in both study arms. 
 
Table A-1 highlights various required components of informed consent that will be met by the 
ETRIC script (Appendix D) that will be provided to site investigators as guidance for obtaining 
consent and by the study information sheet (Appendix E). Hence, even though waiver of 

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requirement to document informed consent will be requested, the consent process for the BMT 
CTN 1205 (ETRIC) study will comply with all regulatory requirements for informed consent.  
Table A-1: Regulatory requirements met by ETRIC study consent materials 
Requirement 
Notes 
(a) Required regulatory elements for consent:  
 
(1) A statement that the study involves research, an explanation of the 
purposes of the research and the expected duration of the subject's 
participation, a description of the procedures to be followed, and 
identification of any procedures which are experimental  
Requirement met 
(2) A description of any reasonably foreseeable risks or discomforts to the 
subject 
Requirement met 
(3) A description of any benefits to the subject or to others which may 
reasonably be expected from the research 
Requirement met 
(4) A disclosure of appropriate alternative procedures or courses of 
treatment, if any, that might be advantageous to the subject 
Requirement met 
(5) A statement describing the extent, if any, to which confidentiality of 
records identifying the subject will be maintained 
Requirement met 
(6) For research involving more than minimal risk, an explanation as to 
whether any compensation and an explanation as to whether any 
medical treatments are available if injury occurs and, if so, what they 
consist of, or where further information may be obtained 
Not addressed as 
this is a minimal 
risk study 
(7) An explanation of whom to contact for answers to pertinent questions 
about the research and research subjects' rights, and whom to contact in 
the event of a research-related injury to the subject 
Requirement met 
(8) A statement that participation is voluntary, refusal to participate will 
involve no penalty or loss of benefits to which the subject is otherwise 
entitled, and the subject may discontinue participation at any time 
without penalty or loss of benefits to which the subject is otherwise 
entitled 
Requirement met 
(b) Additional elements of informed consent. When appropriate, one or 
more of the following elements of information shall also be provided to 
each subject: 
 
(1) A statement that the particular treatment or procedure may involve 
risks to the subject (or to the embryo or fetus, if the subject is or may 
become pregnant) which are currently unforeseeable  
Not applicable 
(2) Anticipated circumstances under which the subject's participation may 
be terminated by the investigator without regard to the subject's consent 
Not applicable 
(3) Any additional costs to the subject that may result from participation in 
the research 
Requirement met 
(4) The consequences of a subject's decision to withdraw from the research 
and procedures for orderly termination of participation by the subject 
Requirement met 
(5) A statement that significant new findings developed during the course 
of the research which may relate to the subject's willingness to continue 
participation will be provided to the subject 
Requirement met 
(6) The approximate number of subjects involved in the study 
Requirement met 

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Confidentiality: Confidentiality will be maintained by individual names being masked and 
assigned a patient identifier code. The code relaying the patient’s identity with the ID code will 
be kept separately at the center. The ID code will be transmitted to the network.   
 
Participation of women, children, minorities and other populations: Women and ethnic 
minorities will be included in this study. Children will not be included, as the study assessments 
for BMT CTN 1205 measure adult level comprehension. 
 
Accrual will be monitored within each center with the expectation that the enrolled patient 
population is representative of the transplanted patient population at each center. Representation 
will be examined by comparing gender, race, ethnicity, and age distributions. Accrual of 
minority patients will be expected to be in proportion to the number of minority patients 
transplanted at each center. The DCC and NHLBI will discuss enrollment anomalies with the 
centers. 
 

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APPENDIX B 
 
REFERENCES 
 

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APPENDIX B 
 
REFERENCES 
 
 
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Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent: a new 
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Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer 
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Beardsley E, Jefford M, Mileshkin L. Longer consent forms for clinical trials compromise 
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18. Massimo L. Ethical problems in bone marrow transplantation in children. Bone Marrow 
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36. Jackle A, Roberts C, Lynn P. Telephone versus face-to-face interviewing: mode effects on 
data quality and likely causes. Inst. for Social and Economic Research; 2006. Available at: 
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shortened screening instrument. Fam Med. 1993;25(6):391-395. 
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newest vital sign. Ann Fam Med. 2005;3(6):514-522. 
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children participating in clinical anesthesia and surgery research. Anesthesiology. 
2003;98(3):603-608. Prepublished on 2003/02/28 as DOI. 
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46. Bergenmar M, Johansson H, Wilking N. Levels of knowledge and perceived understanding 
among participants in cancer clinical trials - factors related to the informed consent 
procedure. Clin Trials. 2011;8(1):77-84. 
47. Ford ME, Kallen M, Richardson P, et al. Effect of social support on informed consent in 
older adults with Parkinson disease and their caregivers. J Med Ethics. 2008;34(1):41-47. 
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54. Carey JW, Morgan M, Oxtoby MJ. Carey JW, Morgan M, Oxtoby MJ. Intercoder 
agreement in analysis of responses to open-ended interview questions: Examples from 
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55. MacQueen KM, McLellan E, Kay K, Milstein B. Codebook development for team-based 
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59. Gorden RL. Basic Interviewing Skills. Waveland Press Inc., Long Grove, IL. 1998. 
 
 

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APPENDIX C 
 
LETTER TEMPLATE INTRODUCING STUDY TO 
PARTICIPATING SITE IRBS 
 

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Date: 
 
Dear IRB Chair, 
 
As part of the Easy-to-Read Informed Consent (ETRIC) study, we are asking for a waiver of the 
requirement for the documentation of informed consent for the randomized portion of the ETRIC 
study (Chapter 4 in the protocol). Please note, we are not requesting a waiver for the parent BMT 
study (BMT CTN protocols 1101 and 1301), as those studies will still document written 
informed consent, nor are we requesting a waiver for the interviews with IRB administrators, 
principal investigators, and study coordinators in the evaluation study.  
 
We are seeking a waiver of the requirement to document informed consent to reduce the number 
of written consent forms that participants must read and sign, a concern that was raised to us by 
blood and marrow transplant researchers. We believe that the randomized portion ETRIC study 
meets the second criterion for a waiver of documentation of consent at 45 CFR 46.117 (c), which 
states, “…the research presents no more than minimal risk of harm to subjects and involves no 
procedures for which written consent is normally required outside of the research context.” 
 
For the randomized portion of the ETRIC study, the procedures are reading the consent form, 
providing opinions regarding the consent form (e.g., Quality of Informed Consent, information 
location) and questionnaires that measure health literacy, comprehension, and anxiety. The 
questionnaires are similar to those that patients routinely undergo in a clinical setting with 
specific written consent for the questionnaire. Additionally, similar studies focused on informed 
consent assessing attitudes, preferences, and comprehension have been deemed exempt by 
IRBs,(1, 2) though we are seeking only a waiver to document informed consent. 
 
Additionally, please note that while the ETRIC is novel, to ensure that participants have given 
truly informed consent, we will incorporate open ended (as opposed to yes/no) questions at the 
end of the consent process to ensure comprehension. This will be done for both the standard 
consent arm and the ETRIC arm to ensure that participants understand the parent study to which 
they are consenting. 
 
While we are requesting a waiver of the requirement to document informed consent, we will still 
obtain fully informed consent verbally, including all of the eight required elements of informed 
consent at 45 CFR 46.116. We believe we will still meet the requirements of respect for persons, 
as consent will be verbally obtained.   
 
Sincerely,  
 
 
 
(Participating site Principal Investigator) 
 
 
 

BMT CLINICAL TRIALS NETWORK 
 
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C-3 
References  
1. Dresden GM, Levitt MA. Modifying a standard industry clinical trial consent form improves 
patient information retention as part of the informed consent process. Acad Emerg Med. 2008; 
8(3): 246-252.  
2. Davis TC, Berkel HJ, Holcombe RF, Pramanik S, Divers SG. Informed consent for clinical 
trials: A comparative study of standard versus simplified forms. J Natl Cancer Inst. 1998; 90(9): 
668-674.  
 

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APPENDIX D 
 
SCRIPT FOR INTRODUCING ETRIC STUDY TO 
PARTICIPANTS 
 

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D-2 
APPENDIX D 
 
SCRIPT FOR INTRODUCING ETRIC STUDY TO PARTICIPANTS 
 
 
Thank you for your interest in this consent form study. This research study seeks to learn 
whether a new alternate consent form is easier to comprehend or understand, creates greater 
satisfaction for participants, improves the ability to find information in the consent form, and 
creates less anxiety than traditional research consent forms, as well as learn the opinions of 
people like you about this new style of consent form as well as traditional research consent 
forms. If you do not want to participate in this consent study, you can still participate in the 
(insert appropriate parent BMT CTN trial here) with the traditional consent form.  
 
If you decide to participate, you will be randomized (like flipping a coin) to receive either the 
alternative consent form or the standard consent form. Both forms contain the same information, 
but are organized and formatted differently. Your participation for the study will take about 30 
minutes to read the consent form and complete some surveys that will measure your 
understanding of the information in the consent form, health literacy, and anxiety. These 
assessments might be done in one visit, or might be spaced out, depending on your schedule. 
 
The risks of the study are that your confidentiality could be compromised if the study records are 
accessed by unauthorized people. To prevent that, we will identify you with a code and we will 
mask your name. The code key that links your code with your name is kept in a separate, secure 
location. While we do not expect you to personally benefit from this study today, we hope to 
learn how to improve the informed consent process for research for people like you in the future. 
 
If you have any questions about the research, you can contact (insert site PI), or if you have any 
questions about your rights as a research participant, you can contact (insert site research subject 
advocate here). I will give you this paper so you have the contact information for both of these 
people in case you have questions later. 
 
Do you have any questions for me about the consent study? 
- If yes, ask your clinic personnel.  
- If no, proceed to next step. 
 
Great. Please remember that your participation in the consent study is voluntary. It is your choice 
to participate or not, and whether you participate or not will have no effect on your medical care 
or your participation in other studies. Also, you can stop participation in the consent study at any 
time without any penalties to you. Would you like to participate in the consent study? 
 
- If yes, notify your clinic personnel. 
- If no, proceed with standard consent for parent BMT CTN trial. 
 

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E-1 
APPENDIX E 
 
INFORMATION SHEET FOR ETRIC STUDY 
 

BMT CLINICAL TRIALS NETWORK 
 
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E-2 
BMT CTN 1205 Study 
Alternate Consent Form for Hematopoietic Cell  
Transplantation Clinical Trials 
Information Sheet 
1. Introduction 
Choosing to join a clinical trial or research study is an important personal decision. This 
information sheet has basic information about a study that is testing an alternate consent form to 
find out if it’s easier to understand than a standard consent form.   
This study does not treat your cancer or disease.  
This Information Sheet will tell you about the purpose of the study, the possible risks and 
benefits, other options available to you, and your rights as a participant in the study.  
Everyone who takes part in research at [insert facility name] should know that: 
 Being in any research study is voluntary.  
 You may or may not benefit from being in the study. Knowledge we gain from this study 
may benefit others.  
 If you join the study, you can quit the study at any time.  
 If you decide to quit the study, it will not affect your care at [insert name of facility or 
institution]. 
 Please ask the study staff questions about anything that you do not understand, or if you 
would like to have more information. 
 You can ask questions now or any time during the study. 
 
2. Study Sponsors 
The National Institutes of Health (NIH), through the Blood and Marrow Transplant Clinical 
Trials Network (BMT CTN), are providing staff support and money for this research study. The 
BMT CTN and the NIH will make decisions about how to manage the study. 
 
3. Study Purpose  
We invite you to join this research study because you have been asked to join 1 of these BMT 
CTN studies: 
 1101 - A Multi-Center, Phase III, Randomized Trial of Reduced Intensity Conditioning 
(RIC) and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus 

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HLA-Haploidentical Related Bone Marrow (Haplo) for Patients with Hematologic 
Malignancies   
 1301 - A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-Free 
Interventions for Prevention of Graft-versus-Host Disease 
Our main goal is to learn if an alternate consent form is easier to understand than a standard 
consent form. The other goals are to learn if the new consent helps you feel:  
 Less nervous about deciding to be part of a study (informed consent process), and  
 More satisfied with the informed consent process. 
 
4. Right to Ask Questions and Withdraw 
You have the right to ask questions about the study at any time. If you have questions about the 
study or you want to leave the study, please contact:  
[insert contact info for site PI] 
Being in this study is voluntary. You can choose not to be in this study or leave this study at any 
time. If you choose not to take part or leave this study, it will not affect your regular medical care 
in any way. It will also not affect your relationship with the BMT CTN. 
 
5. Study Information   
If you agree to join the study, we will randomize you to 1 of 2 groups. We will not assign you to 
a group. You will be put in one or other group by chance, just like flipping a coin (randomize). 
We will randomize you to get the alternate consent form or the standard consent form.  
After you finish talking about consent for the study, we will ask you to take 7 tests. These tests 
will take about 30 minutes to finish and will occur preferably in 1 day of consent but no more 
than 7 business days after the consent discussion for the transplant study.  
You will take some of the tests on your own, but a researcher will help you with the other tests.  
Keep in mind that if you also join the transplant research study, you will be taking more tests. 
Your study doctor and study staff will be available to discuss how long the transplant study tests 
will take to finish. 
Our goal is to have 198 people join the study. 
 
6. Risks and Discomforts 
There are no medical or physical risks to being part of this study.
 

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7. Possible Benefits 
Taking part in this study will not make your health better. The information from this study will 
help us know if the alternate consent form is easier to understand than a standard consent form. 
This information could improve the experience of being in a research study for future patients.
8. Privacy, Confidentiality and Use of Information 
We will do our best to make sure that the personal information in your medical record is kept 
private. However, we cannot guarantee total privacy. All your medical and demographic (such as 
race and ethnicity, gender and household income) information will be kept private and 
confidential. [insert name of Transplant Center] and the organizations listed below will not 
disclose your participation by any means of communication to any person or organization, except 
by your written request, or permission, or unless required by federal, state or local laws, or 
regulatory agencies.  
Individuals authorized by the organizations below will have access to your research and medical 
information. They may use this information for inspections or audits related to this research. We 
may give out your personal information if required by law. 
If information from this study is published or presented at scientific meetings, your name 
and other personal information will not be used.  
Information about your transplant from your original medical records may be seen or sent to: 
 /Institution/ 
 The National Institutes of Health (NIH) 
 The National Heart, Lung, and Blood Institute (NHLBI)  
 The National Cancer Institute (NCI) 
 Office of Human Research Protection (OHRP) 
 Institutional Review Boards (IRBs) responsible for this study 
 Data and Safety Monitoring Board (DSMB), not part of /Institution/ 
 Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 
 Study investigators 
Information that does not include personally identifiable information about this study has been or 
will be submitted, at the appropriate and required time, to the government-operated clinical trial 
registry data bank, which contains information about registered studies. This data bank can be 
accessed by you and the general public at: www.ClinicalTrials.gov. Federal law requires study 
information for certain studies to be submitted to the data bank. 
 

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9. Ending Your Participation 
The study doctor or the study sponsor may stop the study at any time, and we may ask you to 
leave the study. If we ask you to leave the study, the reasons will be discussed with you.  
We ask that you talk with the research doctor before you leave the study. Even if you leave the 
study, the information collected from your participation will be included in the study results, unless 
you specifically ask that it not be included. 
 
10. Physical Injury as a Result of Participation 
It’s not likely that you will be injured from this study. However, it is important to tell your study 
doctor, __________________ [investigator's name(s)] or study staff if you feel that you have 
been injured from taking part in this study. You can tell the doctor in person or call him/her at 
__________________ [telephone number]. 
 
11. Payment
You will not be paid for taking part in this study. 
 
12. Costs and Reimbursements 
It will not cost you anything to participate in this study. You will not be reimbursed for 
participating in this study. 
 
13. For More Information  
If you need more information about this study, or if you have problems while taking part in this 
study, you can contact the study doctor or his/her staff at the telephone numbers listed here:   
[Insert name and contact detail]
 
 
14. Contact Someone about Your Rights 
If you wish to speak to someone not directly involved in the study, or if you have any complaints 
about the project, or any questions about your rights as a research participant, then you may contact:  
[Insert appropriate contact details] 
The ethical aspects of this research study have been reviewed and approved by [name of IRB]. 
For questions about your rights while taking part in this study, call the __________[name of 
center] Institutional Review Board (a group of people who review the research to protect your 
rights) at __________________ (telephone number).  

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BMT CLINICAL TRIALS NETWORK 
 
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APPENDIX F 
 
ETRIC TEMPLATES FOR PARENT STUDIES 
 

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APPENDIX F 
 
ETRIC TEMPLATES FOR PARENT STUDIES 
 
 
Samples of the ETRIC templates for the parent studies are included as part of this appendix. For 
each participating site, the content of the ETRIC form will be similar to the standard consent 
forms that have already been approved by the site IRBs for the parent studies. To accomplish 
this, the version of the standard consent form that has been approved by each site’s IRB will be 
reformatted into the ETRIC format. The main difference between the two consents will be 
formatting and layout enhancements to present information about the study in an easy-to-read 
format in the ETRIC form. Note that the BMT CTN 0901 trial and BMT CTN 1203 trial were 
removed as parent trials due to their closure on April 18, 2014 and May 13, 2016, respectively. 
The BMT CTN 0901 ETRIC and BMT CTN 1203 ETRIC are in Appendix G.   
 
 

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Sample ETRIC Informed Consent Template for the BMT CTN 1101 Study 
 
BMT CTN 1101, v5.0 
 
A Multi-Center, Phase III, Randomized Trial of Reduced Intensity Conditioning (RIC) and 
Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-
Haploidentical Related Bone Marrow for Patients with Hematologic Malignancies  
 
Your Name:       ________________________________ 
Study Title:  
A Multi-Center, Phase III, Randomized Trial of Reduced Intensity Conditioning 
(RIC) and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) 
versus HLA-Haploidentical Related Bone Marrow for Patients with 
Hematologic Malignancies  
Protocol: 
      BMT CTN #1101 
Co-Investigator:  
Ephraim Fuchs, M.D. 
Johns Hopkins University 
488 Bunting-Blaustein Cancer Research Building, 1650 Orleans Street 
Baltimore, MD  21231 
Phone: 410- 955-8143  Email: fuchsep@jhmi.edu 
 
Co-Investigator:  
Paul O’Donnell, M.D., Ph.D. 
Fred Hutchinson Cancer Research Center 
1100 Fairview Avenue North/LM-200, Seattle, WA 98109-1023 
Phone: 206-667-1968  Email: podonnel@fhcrc.org 
 
Co-Investigator: 
Claudio Brunstein, M.D. 
University of Minnesota Medical Center 
420 Delaware Street SE, MMC 286, Minneapolis, MN 55455 
Phone: 612-624-5620  Email: bruns072@umn.edu 
 
Transplant Center 
Investigator:  
_____________________________________ 
 
Sponsor:   
The National Institutes of Health (NIH) is sponsoring this study by 
providing financial support through the Blood and Marrow Transplant 
Clinical Trials Network (BMT CTN).  
 
 

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F-4 
1.  Introduction 
We invite you to join this clinical trial, also 
known as a research study. We are doing 
this research because we want to learn more 
about reduced intensity transplants that use a 
mismatched donor. These results will help 
us understand if one kind of mismatched 
donor is better or if there is no difference at 
all. 
This study will take at least 4 years and will 
include about 400 participants. Your study 
participation will last for 3 years after your 
transplant.  
This Consent Form will tell you about the 
purpose of the study, the possible risks and 
benefits, other options available to you, and 
your rights as a participant in the study.  
Everyone who takes part in research at 
[insert facility name] should know that: 
 Being in any research study is voluntary.  
 You may or may not benefit from being 
in the study. Knowledge we gain from 
this study may benefit others.  
 If you join the study, you can quit the 
study at any time.  
 If you decide to quit the study, it will not 
affect your care at [insert name of 
facility or institution]. 
 Please ask the study staff questions 
about anything that you do not 
understand, or if you would like to have 
more information. 
 You can ask questions now or any time 
during the study. 
 Please take the time you need to talk 
about the study with your doctor, study 
staff, and your family and friends. It is 
your decision to be in the study. If you 
decide to join, please sign and date the 
end of the Consent Form. 
You and your doctor will discuss other 
treatment choices if you do not want to 
participate in this study.
2.  Study Background 
The National Institutes of Health (NIH), 
through the Blood and Marrow Transplant 
Clinical Trials Network (BMT CTN), are 
providing staff support and money for this 
research study. The BMT CTN will direct 
the research study. The BMT CTN and the 
NIH will make decisions about how to 
manage the study. 
A stem cell transplant is the only treatment 
at this time that may cure your disease. An 
allogeneic transplant uses blood-making 
cells from a family member or an unrelated 
donor to remove and replace your abnormal 
blood cells. Your doctor may recommend 
that you have a transplant that uses lower 
amounts of chemotherapy and radiation. 
This type of transplant is also called a 

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reduced intensity, non-myeloablative, or 
“mini” transplant. Because of your age or 
health problems and because you do not 
have a matched donor, you may have a 
higher chance of health problems from a 
standard stem cell transplant that uses high 
doses of chemotherapy and/or radiation. 
Recent studies by the BMT CTN suggest the 
results are very similar for reduced intensity 
transplants when they use either mismatched 
cord blood or use mismatched bone marrow 
from a family member.  
There is no guarantee or promise that this 
procedure will be successful.  
3.  Study Purpose  
We are inviting you to take part in this study 
because you have a cancer of the blood or 
lymph glands and a stem cell transplant is a 
treatment option.  
Tissue typing shows that you do not have a 
completely matched donor available in your 
family. You also do not have a matched 
donor outside of your family who can 
donate when you need them to. However, 
you do have two other donor choices 
available for a transplant: (1) partially 
matched units of unrelated cord blood, and 
(2) a family donor who is a partial match. 
We are doing this research to learn more 
about reduced intensity transplants that use a 
mismatched donor. We will use either cord 
blood from an unrelated donor or bone 
marrow from a family member, and then 
compare the transplant results.  
These results will help us understand if one 
kind of mismatched donor is better or if 
there is no difference at all. 
4.  Right to Ask Questions and/or Withdraw 
You have the right to ask questions about the 
study at any time. If you have questions about 
the study or you want to leave the study, 
please contact:  
[insert contact info for site PI] 
Being in this study is voluntary. You can 
choose not to be in this study or leave this 
study at any time. If you choose not to take  
part or leave this study, it will not affect 
your regular medical care in any way.  
Your study doctor and study staff will be 
available to answer any questions that you 
may have about taking part in or leaving this 
study.
 
 

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5.  Study Treatment and Tests 
We will check your health before you start 
treatment, while you receive treatment, and 
for several years after you finish your 
treatment. 
Before You Start Your Treatment 
We will ask you to take quality of life 
surveys.  The surveys will ask about: 
o Any side effects of your treatment 
o Any health problems 
o How well you can do things that are 
important to you 
o How you relate to other people  
o Your feelings.  
You may skip any questions you wish. 
 
We will also ask you to provide optional 
Blood Samples for Future Research (see 
Section 18: Optional Blood Samples for 
Future Research).  
Randomization 
We will use a computer to randomly assign 
you to 1 of 2 study groups. One group will 
receive partially matched cord blood from an 
unrelated donor, and one group will receive 
bone marrow from a partially matched family 
member. You will have an equal chance of 
being placed in either group. 
During Your Treatment 
 Conditioning Regimen Before 
Transplant (chemotherapy and 
radiation) 
You will be treated with a type of 
chemotherapy called fludarabine, which is 
given daily for 5 days. If you receive cord 
blood, you will also be given a type of 
chemotherapy called cyclophosphamide for 
1 day. If you receive bone marrow, you will 
be given cyclophosphamide for 2 days. 
After the chemotherapy is completed, you 
will receive a small dose of radiation to your 
whole body (Total Body Irradiation) in a 
single dose. The chemotherapy and radiation 
may cause side effects. Some of these side 
effects may be life-threatening (see Section 
6: Risks and Discomforts). 
If you receive cord blood, and have not had 
cytotoxic chemotherapy within the last 3 
months or an autologous transplant within the 
last 2 years, you will receive a slightly higher 
dose of radiation (300 cGy instead of 200 
cGy).  This slightly higher dose of radiation 
has shown hematopoietic recovery is 
comparable to that seen with low dose 
radiation for patients who have had 
chemotherapy in the last 3 months or an 
autologous transplant in the last 2 years. 
Reinfusion of Stem Cells (Transplant) 
On your transplant day, if you receive cord 
blood, it will be given to you through your 
catheter like a blood transfusion. If you 
receive bone marrow, your family donor 
will have his or her marrow collected in the 
operating room. The donated marrow may 
be taken to a laboratory where red cells will 
be removed. The donor cells will be given to 
you through your catheter and will travel to 

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your bone marrow where they will start to 
make healthy, new blood cells.  
If you receive cord blood you will start to 
take the immune suppressing drugs 
cyclosporine and mycophenolate mofetil 
(MMF) for 3 days before transplant. These 
drugs may help prevent a complication 
called graft-versus-host disease (GVHD; 
see Section 6: Risks and Discomforts).    
If you receive bone marrow, you will be 
given another dose of cyclophosphamide on 
days 3 and 4 after your transplant. You will 
start to take the immune suppressing drugs 
tacrolimus and MMF to help prevent 
GVHD on day 5 after your transplant. 
In both study groups (partially matched cord 
blood from an unrelated donor or bone 
marrow from a partially matched family 
member), you will continue to take MMF 
for about 5 weeks and cyclosporine or 
tacrolimus for up to 6 months.  
If you receive cord blood, you will be given 
filgrastim (G-CSF) through your catheter 
or by injection under your skin beginning on 
day 1 after your transplant. If you receive 
bone marrow, you will be given filgrastim 
(G-CSF) beginning on day 5 after your 
transplant. Filgrastim speeds up the recovery 
of white blood cells. In both study groups, 
you will receive filgrastim daily until your 
white blood cells have recovered.  
The immune suppressing drugs and filgrastim 
may cause side effects. These side effects 
may be life-threatening (see Section 6: Risks 
and Discomforts).  
If needed, you will receive blood transfusions 
to maintain normal blood cell levels and 
antibiotics to treat or prevent infection. You 
may also receive extra nutrients and pain 
drugs during or after your transplant. They 
will be given to you through your catheter.   
 Health Evaluations 
We will test (evaluate) your health during 
the study. These tests and how often they are 
scheduled are standard care for patients 
receiving an allogeneic transplant. They 
would be done even if you were not part of 
this study. You will be watched closely for 
any signs and symptoms of GVHD. 
 
Health evaluations after treatment:  
1) Physical exam to assess toxicities, and 
infections weekly until Day 56 and then 
at Days 180, 365, and 730. 
2) Physical exam to assess GVHD weekly 
until Day 90 and then at Days 180, 365, 
and 730. 
3) Routine blood tests (cell counts and liver 
and kidney function) weekly until Day 
56 and then at Days 180, 365, and 730. 
4) Blood or bone marrow tests to find the 
amount of donor cells in your body on 
Days 28 and 56.  This is also called 
chimerism. 
5) Restaging tests to see how much cancer 
you have after treatment on Day 730. 
6) A quality of life survey (see Before You 
Start Your Treatment) at Days 365 and 
730.  
7) Optional blood samples for future 
research (see Section 18: Optional 
Blood Samples for Future Research). 

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F-8 
 Long-term follow-up  
Data regarding your clinical situation after 2 
years may be obtained from the CIBMTR, 
which captures information on all US 
transplants.
 
6.  Risks and Discomforts 
You will have side effects while on the 
study. Side effects can range from mild to 
very serious.  
The risks and discomforts in participating in 
this study will be similar to what you may 
have with blood or marrow cell transplant if 
you do not participate in this trial. Other 
complications from transplants, such as 
graft-versus-host disease (GVHD) and 
infections happen equally in patients who 
have either type of regimen.  
 
Your health care team will give you 
medicines to help lower side effects such as 
feeling sick to your stomach (nausea). In 
some cases, side effects can be long lasting 
or may never go away.  
Risks Related to Medications or Total Body 
Irradiation Used in Conditioning Regimens  
All chemotherapy and radiation treatments 
used as conditioning regimens in this study 
are commonly used in allogeneic 
hematopoietic cell transplantation.  
TABLE 1 – Risks and Side Effects 
 
 
 
Likely 
What it means: This type of side effect is expected to occur in more than 
20% of patients. This means that 21 or more patients out of 100 might get 
this side effect. 
Less Likely 
What it means: This type of side effect is expected to occur in 20% of 
patients or fewer. This means that 20 patients or fewer out of 100 might get 
this side effect. 
Rare, but 
Serious 
What it means: This type of side effect does not occur very often – in fewer 
than 2% of patients – but is serious when it occurs. This means that 1 or 2 
patients (or fewer) out of 100 might get this side effect. 

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Cyclophosphamide (Cytoxan®) 
Likely  
Less Likely 
Rare, but Serious 
 Decreased white blood cell 
count with increased risk of 
infection 
 Temporary hair loss 
 Nausea 
 Vomiting 
 Loss of appetite 
 Sores in mouth or on lips 
 Diarrhea 
 Stopping of menstrual periods 
in women 
 Decreased sperm production 
in men 
 Decreased platelet count 
(mild) with increased risk of 
bleeding 
 Blood in urine 
 Anemia 
 Temporary tiredness 
 Damage to the fetus if 
you become pregnant 
while taking drug 
 
 Scarring of lung 
tissue, with cough and 
shortness of breath 
 Severe heart muscle 
injury and death at 
very high doses 
 New (secondary) 
cancers 
 
 
Fludarabine (Fludara®) 
Likely  
Less Likely 
Rare, but Serious 
 Decreased white blood cell 
count with risk of infection 
 Decreased platelet count 
with increased risk of 
bleeding 
 Anemia 
 Tiredness 
 Nausea 
 Vomiting 
 Diarrhea 
 Numbness and 
tingling in hands 
and/or feet related to 
irritation of nerves 
of the hand and/or 
feet 
 Changes in vision 
 Pneumonia 
 Agitation or 
nervousness 
 Confusion 
 Cough 
 Difficulty breathing 
 Weakness 
 Severe brain injury 
and death 
 
 
 

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Filgrastim  (G-CSF; Neupogen) 
Likely  
Less Likely 
Rare, but Serious 
 Ache or pain inside the bones 
 Increased levels of liver 
enzymes and uric acid in the 
blood 
 Low number of platelets in the 
blood 
 Headache 
 Tiredness 
 Local irritation (skin) 
at the injection site 
 Nausea 
 
 Allergic reaction 
 Low fever 
 Enlargement or 
rupture of the 
spleen 
 Worsening of pre-
existing skin rashes 
 
Mycophenolate mofetil (MMF; CellCept) 
Likely  
Less Likely 
Rare, but Serious 
 Miscarriage 
 Birth defects 
 Diarrhea 
 Damage to unborn baby 
 Limited effectiveness of birth 
control 
 Stomach pain 
 Upset stomach 
 Vomiting 
 Headache 
 Tremors 
 Low white blood cell count 
with increased risk of 
infection 
 Increased blood cholesterols 
 Swelling of the hands, feet, 
ankles, or lower legs 
 Anemia 
 Rash 
 Difficulty falling 
asleep or staying 
asleep 
 Dizziness 
 Uncontrollable hand 
shakes 
 Difficulty breathing 
 Unusual bruising 
 Fast heartbeat 
 Excessive tiredness 
 Weakness 
 Blood in stool 
 Bloody vomit 
 Change in vision 
 Secondary cancers, 
such as 
lymphoproliferative 
disease or lymphoma  
 Progressive Multifocal 
Leukoencephalopathy 
 
 
 

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Total Body Irradiation 
Likely 
Less Likely 
Rare, but Serious 
 Fatigue 
 Hair loss 
 Infertility 
 Loss of appetite 
 Mouth sores 
 Nausea 
 Vomiting 
 Cataracts 
 Inflammation of the 
parotid glands 
 Skin pigmentation 
(reversible) 
 Stunted growth  
 Low white blood cell 
count with increased risk 
of infection 
 Low platelet count with 
increased risk of 
bleeding 
 Anemia 
 Diarrhea 
 Lung fibrosis 
 Second cancers 
 
Tacrolimus (Prograf; FK-506)/Cyclosporine 
Likely 
Less Likely 
Rare, but Serious 
 Kidney problems 
 Loss of magnesium, calcium, 
potassium 
 High blood pressure 
 Tremors 
 Increases in cholesterol and 
triglyceride 
 
 Nausea 
 Vomiting 
 Liver problems 
 Changes in how 
clearly one can 
think 
 Insomnia 
 Unwanted hair 
growth 
 Confusion 
 Seizures 
 Changes in vision 
 Dizziness 
 Red blood cell 
destruction 
 
 
 

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It is very important that you do not eat 
grapefruit or drink grapefruit juice while 
taking Tacrolimus. Grapefruit has an 
ingredient called bergamottin, which can 
affect some of the treatment drugs used in 
this study. Common soft drinks that have 
bergamottin are Fresca, Squirt, and Sunny 
Delight.  
 
Risks and Toxicities Related to Transplant 
The following problems may occur as a 
result of cord blood or marrow transplant. 
These risks may occur whether a transplant 
was done as part of the study or not:  
1. Slow recovery of blood counts. The red 
blood cells, white blood cells, and platelets 
can be slow to recover after blood or 
marrow transplant. Until your blood counts 
recover, you will need blood and platelet 
transfusions, and will be at risk for bleeding 
and infections. To speed the recovery of the 
white cells as much as possible you will 
receive filgrastim.   
2. Graft failure. The cord blood or bone 
marrow stem cells (the “graft”) may fail to 
grow inside your body. Past experience 
suggests that there can be up to a 10-15% 
chance of graft failure. If graft failure occurs, 
this may result in low blood counts for a long 
period of time. If your counts do not recover, 
you may need to receive a second transplant. 
Graft failure can be fatal. 
3. Graft-versus-Host Disease (GVHD). 
GVHD results from the bone marrow or cord 
blood cells in the graft recognizing your body 
as foreign and attacking it. In most cases, 
GVHD can be successfully treated. 
Sometimes GVHD is severe or difficult to 
treat and may lead to death. You will be 
watched closely for this complication and 
given drugs to prevent and/or treat it.  
Acute GVHD may produce skin rash, nausea, 
vomiting, diarrhea, abdominal pain, 
abnormalities of liver function, and an 
increased risk of infection. Chronic GVHD 
may produce skin rashes, hair loss, thickened 
dry skin, dry eyes, dry mouth, liver disease, 
weight loss, diarrhea, and an increased risk of 
infection. To confirm the diagnosis of acute 
or chronic GVHD, you may be asked to have 
a biopsy (a small sample of your tissue to 
look at under the microscope) of your skin, 
gut, or, rarely, your liver.  
4. Other complications. Other complications 
may include: 
a. Damage to the vital organs in your 
body. The transplant could cause 
problems in any body organ such as the 
heart, lungs, liver, gut, kidneys and 
bladder, or brain. The kidneys and the 
liver are most likely to be damaged. Some 
patients will experience serious lung 
problems from infections or the 
chemotherapy and radiation.  
b. Serious infections. Full and complete 
recovery of your immune system may 
take many months. During this time, there 
is an increased risk of infections.  You 
will be prescribed certain drugs to reduce 
the chance of those infections. However, 
these treatments do not always work. If 
you have an infection, you may have to 
stay in the hospital longer or be re-
hospitalized after transplant. Although 
most infections can be successfully 
treated, some infections may result in 
death.  
c. Relapse of disease or a new blood 
cancer. Your leukemia or lymphoma may 
come back even if the transplant is 
initially successful. In rare cases, a new 
blood cancer may develop from the donor 
cells. Cyclophosphamide can cause 

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damage to blood cells, which may result 
in a blood cancer such as 
myelodysplastic syndrome (MDS) or 
acute myeloid leukemia (AML). The 
blood cancer usually develops 2-10 
years after treatment, or 6 years on 
average.  
The risk of developing a new blood 
cancer after allogeneic blood or marrow 
transplant is probably less than 2%. 
However, if you receive bone marrow, 
your donor’s marrow is exposed to the 
chemotherapy drug, cyclophosphamide, 
after the transplant. There is a risk that a 
blood cancer may develop in your 
donor’s blood cells. This risk is 
unknown, but it may be as high as 5%. If 
cancer develops in your donor’s blood 
cells, you may require additional 
treatment with chemotherapy or another 
blood or marrow transplant. 
d. Risk to the unborn. The treatments in 
this study have not been proven to be safe 
at any stage of pregnancy. Therefore, if 
you are pregnant or nursing, you are not 
eligible for this study. Women who can 
become pregnant must refrain from all 
acts of vaginal sex (abstinence) or use two 
forms of effective birth control while 
receiving chemotherapy, TBI, and drugs 
to prevent GVHD. Effective birth control 
is defined as the following: 
1. Consistent use of birth control pills 
2. Injectable birth control methods 
(Depo-Provera, Norplant) 
3. Tubal sterilization or male partner 
who has undergone a vasectomy 
4. Placement of an IUD (intrauterine 
device) 
5. Use of a diaphragm with 
contraceptive jelly and/or condoms 
with contraceptive foam every time 
you have sex. 
 
Reproductive Risks  
The drugs used in this research study may 
damage your reproductive organs, affect your 
ability to have children or possibly cause birth 
defects if you take them while you are 
pregnant. It is important that a woman is not 
pregnant or breast-feeding and does not 
become pregnant during the course of the 
study. 
If you are a woman and can become 
pregnant, you will need to take a pregnancy 
test before you start the study. You should 
discuss ways to prevent pregnancy while 
you are in the study. Women who have gone 
through puberty may find that their 
menstrual cycle becomes irregular or stops 
permanently. This does not mean that you 
cannot become pregnant. You must still use 
two effective methods of birth control or 
abstinence during your transplant and 
continue until you are finished with your 
GVHD prevention treatment. 
If you are a man, your body may not be able 
to produce sperm (become sterile). You 
should talk with your doctor about banking 
your sperm before having a transplant. 
Please check with your doctor to understand 
more about these risks. 
Unforeseen Risks  
New risks might appear at any time during 
the study. These risks might be different 
from what is listed in this Consent Form. 
We will promptly tell you about new 
information that may affect your decision to 
take part in the study. We may learn new 
things about reduced intensity transplants that 

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might make you want to stop being in the 
study. We will let you know if this happens 
and you can decide if you want to continue in 
the study.  
Additional Information about MMF 
 MMF could be damaging to an unborn 
baby if you are pregnant or become 
pregnant while receiving the drug.  
 MMF can make birth control pills less 
effective and increase your chances of 
becoming pregnant while you are taking 
it. 
 If you could become pregnant, you must 
use 2 effective forms of birth control or 
abstinence for 4 weeks before starting 
MMF, during treatment, and for 6 weeks 
after stopping MMF. 
 In this study, you will be assigned to 
receive MMF for about 5 weeks, so you 
should not become pregnant during that 
time. If you think you might be pregnant 
or could be become pregnant during the 
upcoming 5 weeks, you should not join 
the study. 
Other Treatments or Drugs  
Some drugs react with each other. It is 
important to tell the study doctor or staff 
about any other drugs or treatments you are 
taking. This includes over-the-counter drugs, 
vitamins and herbal treatments.  
It is also important that you tell the study 
staff about changes to any of your drugs 
during the study. 
For more information about risks and side 
effects, ask your study doctor. 
 
7.  Alternative Treatments
Participation in this study is optional. If you 
choose not to take part, you may still receive 
an allogeneic transplant to treat your disease. 
The treatment and evaluations you would 
receive could be very similar to what would 
receive if you join this study.  
Your study doctor will talk with you about 
your options. If you decide not to participate 
in this study, your medical care will not be 
affected in any way. 
Your other choices may include: 
 Treatment with other drugs, radiation, or 
a combination of drugs and radiation 
without a transplant  
 An allogeneic blood or marrow 
transplant that is not part of the study, or 
another type of transplant 
 Participation in another clinical trial, if 
available (check with your doctor) 
 No treatment for your blood cancer at 
this time 
 Comfort care. 
Every treatment option has benefits and 
risks. Talk with your doctor about your 
treatment choices before you decide if you 
will take part in this study. 
 
 
 
 

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8.  Possible Benefits
Taking part in this study may or may not 
make your health better. The information 
from this study will help doctors learn more 
about reduced intensity transplant as a 
treatment for people with a blood cancer and 
who have a mismatched donor. This 
information could help people with a blood 
cancer who may need a transplant in the 
future. 
 
9.  New Information Available During the Study 
During this study, the study doctors may learn 
new information about the study drug or the 
risks and benefits of the study. If this happens, 
they will tell you about the new information. 
The new information may mean that you can 
no longer take part in the study, or that you 
may not want to continue in the study.  
If this happens, the study doctor will stop 
your participation and will offer you all 
available care to meet your needs and 
medical conditions. 
 
 
10.  Privacy, Confidentiality and Use of Information 
Your confidentiality is one of our main 
concerns. We will do our best to make sure 
that the personal information in your 
medical record is kept private. However, we 
cannot guarantee total privacy. All your 
medical and demographic (such as race and 
ethnicity, gender and household income) 
information will be kept private and 
confidential. (Name of Transplant Center) 
and the organizations listed below will not 
disclose your participation by any means of 
communication to any person or 
organization, except by your written request, 
or permission, or unless required by federal, 
state or local laws, or regulatory agencies.  
Individuals authorized by the organizations 
below will have access to your research and 
medical information. They may use this 
information for inspections or audits to 
study the outcomes of your treatment. In 
agreeing to participate, you consent to such 
inspections and to the copying of parts of 
your records, if required by these 
organizations. 
We may give out your personal information 
if required by law. If information from this 
study is published or presented at scientific 
meetings, your name and other personal 
information will not be used.  
Information about your transplant from your 
original medical records may be seen or sent 
to national and international transplant 
registries, including: 
 

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 /Institution/ 
 The National Institutes of Health (NIH) 
 The National Heart, Lung, and Blood 
Institute (NHLBI)  
 The National Cancer Institute (NCI) 
 Office of Human Research Protection 
(OHRP) 
 The Food and Drug Administration (FDA)  
 Institutional Review Boards (IRBs) 
responsible for this study 
 Data and Safety Monitoring Board 
(DSMB), not part of /Institution/ 
 Blood and Marrow Transplant Clinical 
Trials Network (BMT CTN), including 
the Center for International Blood and 
Marrow Transplant Research (CIBMTR), 
the National Marrow Donor Program 
(NMDP) and the EMMES Corporation 
who are coordinating the studies of the 
BMT CTN 
 Study investigators 
A description of this clinical trial will be 
available on http://www.ClinicalTrials.gov, 
as required by U.S. Law. This Web site will 
not include information that can identify 
you. At most, the Web site will include a 
summary of the results. You can search this 
Web site at any time.   
For questions about access to your medical 
records, please contact /name/ at /number. 
 
 
 
 
 
 
11.  Ending Your Participation 
The study doctor or the study sponsor may 
stop the study at any time, and we may ask 
you to leave the study. If we ask you to 
leave the study, the reasons will be 
discussed with you. Possible reasons to end 
your participation in this study include: 
 You do not meet the study 
requirements.  
 You need a medical treatment not 
allowed in this study. 
 The study doctor decides that it 
would be harmful to you to stay in 
the study. 
 You are having serious side effects. 
 You become pregnant. 
 You cannot keep appointments or 
take study drugs as directed. 
 The study is stopped for any reason. 

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You could have serious health risks if 
you stop treatment during the 
conditioning process before you receive 
your transplant. If you stop taking the 
immune suppressing drugs (see Section 
6: Risks and Discomforts) too soon 
after transplant, your body could reject 
the donor stem cells or you could 
develop serious complications and 
possibly die.  
We ask that you talk with the research 
doctor and your regular doctor before 
you leave the study. Your doctors will 
tell you how to stop safely and talk with 
you about other treatment choices.  
 If you decide to leave this study after 
the start of treatment, or your doctor 
asks you to leave the study for 
medical reasons, you will need to 
come back to the doctor’s office for 
tests for your safety. Even if you 
leave the study, the information 
collected from your participation will 
be included in the study results, unless 
you specifically ask that it not be 
included. 
 
 
 
12.  Physical Injury as a Result of Participation 
It is important to tell your study doctor, 
__________________ [investigator's 
name(s)] or study staff if you feel that you 
have been injured from taking part in this 
study. You can tell the doctor in person or 
call him/her at __________________ 
[telephone number]. 
You will get all available medical treatment 
if you are injured from taking part in this 
study. You and/or your health plan will be 
charged for this treatment. The study will 
not pay for medical treatment.  
In case you are injured in this study, you do 
not lose any of your legal rights to receive 
payment by signing this Consent Form.
13.  Compensation or Payment
You will not be paid for taking part in this 
study. You will not be compensated or 
reimbursed for any extra costs (for example, 
travel and meals) from taking part in this 
study.
 
 
 

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14.  Costs and Reimbursements 
Most of the visits for this study are standard 
medical care for your allogeneic transplant 
and will be billed to your insurance company. 
You and/or your health plan/insurance 
company will need to pay for the costs of 
standard treatment in this study.  
Some health plans will not pay these costs 
for people taking part in studies. Check with 
your health plan or insurance company to 
find out if they will pay.  
You or your insurance will not be charged for 
tests that are only done for research on this 
study. 
 
For questions about your costs, financial 
responsibilities, and/or medical insurance 
coverage for your transplant and this study, 
please contact /Center/ Financial Counselor 
at /Number/. 
For more information on clinical trials and 
insurance coverage, you can visit the 
National Cancer Institute’s Web site at 
http://cancer.gov/clinicaltrials/understanding
/insurance-coverage. You can print a copy 
of the “Clinical Trials and Insurance 
Coverage” information from this Web site. 
Another way to get the information is to call 
1-800-4-CANCER (1-800-422-6237) and 
ask them to send you a free copy. 
15.  For More Information 
If you need more information about this 
study, or if you have problems while taking 
part in this study, you can contact the 
study doctor or his/her staff. They can be 
reached at the telephone numbers listed here:   
[Insert name and contact detail] 
 
16.  Contact Someone about Your Rights 
If you wish to speak to someone not directly 
involved in the study, or if you have any 
complaints about the project, or any questions 
about your rights as a research participant, 
then you may contact:  
[Insert appropriate contact details] 
The ethical aspects of this research study have 
been reviewed and approved by [name of 
IRB]. 
 
For questions about your rights while taking 
part in this study, call the __________[name 
of center] Institutional Review Board (a 
group of people who review the research to 
protect your rights) at __________________ 
(telephone number).  

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17.  Cost-effectiveness Research 
Study purpose: The study doctors want to 
learn more about the costs of the two types of 
transplant that are being tested in the larger 
transplant study: 1) partially matched units of 
unrelated cord blood and 2) family donors 
who are a partial match. This research will 
help doctors know which type of transplant is 
more cost effective.  
Lead study doctor: Scott Ramsey of the 
Fred Hutchinson Cancer Research Center in 
Seattle is the lead study doctor for the cost-
effectiveness research. Dr. Ramsey is a 
medical doctor and well-known health 
economist.  
Your health insurance and out-of-pocket 
medical costs: If you agree to join this study, 
we will ask for the following information 
about your health insurance: 
1) Type 
2) Provider 
3) Policy number 
4) Group number 
5) Policy holder’s name and date of birth. 
We will also want to know about your out-of-
pocket transplant costs (costs not covered by 
your insurance). The out-of-pocket costs you 
and your family have to cover are important 
in understanding the overall cost of 
transplant, so we want to collect information 
this information as well. For example, we 
want to know how much you spend on: 
1) Medical costs (for example, co-pays, 
prescriptions) 
2) Travel and lodging  
3) Cost of time away from work for both 
you and your caregivers (family and 
friends).  
Your health insurance and out-of-pocket 
information is called the ‘study data’ in this 
consent form. 
How we will use your health insurance 
information: After you have finished the 
transplant study, we will use your insurance 
information to learn about the 
reimbursements your health insurer made and 
calculate the cost of your transplant. Illness 
and transplant-related costs happen before the 
transplant and go on for many years after, so 
we want to collect reimbursement 
information for the 12 months before your 
transplant, and for the 2 years following.   
Privacy, confidentiality and use of 
information: Only the study doctors at the 
Fred Hutchinson Cancer Research Center 
will have access to your health insurance and 
out-of-pocket cost information (study data). 
To maintain your confidentiality, we will not 
link your name to the study data. Also, all of 
the study doctors signed a confidentiality 
agreement and promised to keep electronic 
data protected under passwords and physical 
data (paper or other media such as CDs) in 
secure facilities (for example, on-campus 
locked offices and locked filing cabinets).   

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Collecting the study data: We will collect 
your health insurance and out-of-pocket 
information using an online questionnaire 
and diary. You will get a user ID number and 
password to log on to the system. The system 
was designed to be very user friendly, but we 
will help you with the online questionnaire 
and diary over the phone if needed. We will 
also send email reminders. The option to 
complete a mail-out survey will also be 
available. 
As stated above, we will collect 
reimbursement information starting 12 
months before your transplant until 2 years 
after.    
We will collect out-of-pocket costs every 
month for the first 6 months after transplant 
and every 3 months after that until the end of 
the study (2-years). We think each online 
entry will take between 5 and 25 minutes, but 
this depends on how much information there 
is to enter.  
Help from your caregiver(s): We ask that 
you give us the name(s) and contact 
information of your main caregiver(s). This 
may be your spouse, partner, parent, adult 
child or sibling, and friends. You may not 
feel like using the online diary when you’re 
recovering from your transplant, so we ask 
that your caregiver(s) help enter this 
information.    
We also want to know the time your 
caregiver(s) spend caring for you after your 
transplant and the time they spend away from 
work or school.   
Be sure to talk to your caregiver(s) about this 
study and get their permission before giving 
us their name and contact information. If you 
give us the name of your caregiver(s), we 
will explain the study to them and what they 
would need to do. They will also get their 
own consent form to participate in this study.   
Risks to participating: The risks to 
participating in the cost-effectiveness study 
are small. We will make every effort to keep 
your health insurance and out-of-pocket cost 
information private. We will only use this 
data to get reimbursement information. A 
possible risk is the loss of confidentiality 
about your medical information, but the 
chance of this happening is very small.  
Payment and costs: You will not get paid 
for participating in this study. You will not 
be charged for taking part in this study.   
If you provide out-of-pocket costs, we will 
give you a summary of these costs at the end 
of the study. This may be helpful information 
for tax reporting.   
Right to ask questions and/or withdraw: 
You do not have to be part of the cost-
effectiveness research study. Your 
involvement is totally voluntary and 
deciding not to be part of this study will not 
affect the medical care or services you are 
receiving. You can also leave the study at 
any time.  
For more information:  Contact Lederle 
Tenney, Fred Hutchinson Cancer Research 
Center 
at 
(855) 
267-9045 
or 
email: 
ltenney@fhcrc.org. 

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18.  Blood Samples for Research (Optional) 
This section of the informed consent form is 
about future research studies that will use 
blood samples from people who are taking 
part in the main study. You may choose to 
give blood samples for these future research 
studies if you want to. You can still be a part 
of the main study even if you say 'no' to give 
blood samples for future research studies. 
There are no major risks associated with 
drawing blood.  Having your blood drawn 
can be uncomfortable and can sometimes 
cause a bruise.  In rare cases, a blood draw 
can cause fainting.  Only trained people will 
draw your blood. 
 
If you agree to provide blood samples, here is 
what will happen: 
a.) We will collect five extra blood samples 
at the same time you have routine blood 
tests done. The amount of blood 
collected from you is about 4 
tablespoons (50 ml) each time. If you 
weigh less than 50 kg, the amount of 
blood collected will be based on your 
weight (1 ml per kg).  
b.) We will collect samples at five different 
dates in the study: Prior to transplant, 
Day 28, Day 56, Day 180, and Day 365. 
c.) The blood samples will be sent to the 
BMT CTN Repository for processing 
and storage. A repository is a place that 
protects, stores and sends out samples 
for approved research studies. All 
research samples will be given a bar 
code that cannot be linked to your name 
or other identifying information by 
future researchers testing your samples. 
d.) Samples stored in the Repository will be 
used mainly by clinicians and 
researchers in the BMT CTN network. 
In the future, the unused research 
samples and clinical information will be 
made available outside of this network.  
e.) Researchers can apply to study the 
materials stored in the Repository. The 
BMT CTN Steering Committee and/or 
the BMT CTN Executive Committee 
must approve each request before they 
will share samples or information with 
researchers. This is to make sure that the 
investigators requesting the samples are 
qualified, and that the research is of high 
quality. 
f.) DNA from your stored blood samples 
might be used in genome-wide 
association (GWA) studies for a future 
project either done or supported by the 
National Institutes of Health (NIH). 
Genome-wide association studies are a 
way for scientists to find genes that have 
a role in human disease or treatment. 
Each study can look at hundreds of 
thousands of genetic changes at the same 
time. 
If your coded samples are used in 
such a study, the researcher is 
required to add your test results and 
sample information into a shared, 
public research database. This public 
database is called the NIH Genotype 

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and Phenotype Database and it is 
managed by the National Center for 
Biotechnology Information (NCBI). 
The NCBI will never have any 
information that would identify you, 
or link you to your information or 
research samples.  
Some general things you should know about 
letting us store your blood samples for 
research are: 
 We will only store samples from people 
who give us permission. 
 Research is meant to gain knowledge that 
my help people in the future. You will not 
get any direct benefit from taking part. 
Additionally, you or your doctor will not 
be given results and they will not be 
added to your medical record. 
 A possible risk is the loss of 
confidentiality about your medical 
information. We will use safety measures 
with both your samples and clinical 
information to make sure that your 
personal information will be kept private. 
The chance that this information will be 
given to someone else is extremely small.  
 Your blood will be used only for research 
and will not be sold. The research done 
with your blood may help to develop new 
products in the future. You will not get 
paid for any samples or for any products 
that may be developed from current or 
future research. 
You can change your mind at any time 
about allowing us to use your samples and 
health information for research.  
We ask that you contact [Principal 
Investigator] in writing and let him/her 
know you do not want us to use your 
research samples or health information for 
research. His/her mailing address is on the 
first page of this form. However, samples 
and information that have already been 
shared with other researchers cannot be 
taken back or destroyed.  
 

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Health Insurance Portability and 
Accountability Act 1 (HIPAA1) 
Authorization to use and disclose 
research purpose 
A. 
Purpose:   
As a research participant, I authorize the 
Principal Investigators and the researcher’s 
staff to use and disclose my individual health 
information for the purpose of conducting the 
research study:  
A Multi-Center, Phase III, Randomized 
Trial of Reduced Intensity Conditioning 
(RIC) and Transplantation of Double 
Unrelated Umbilical Cord Blood (dUCB) 
versus HLA-Haploidentical Related Bone 
Marrow for Patients with Hematologic 
Malignancies 
B. Individual Health Information to be 
Used or Disclosed:  
My individual health information that may 
be used or disclosed to do this research 
includes:  
 Demographic information (for example: 
date of birth, sex, weight).  
 Medical history (for example: diagnosis, 
complications with prior treatment). 
 Findings from physical exams. 
                                                 
1 HIPAA is the Health Insurance Portability and 
Accountability Act of 1996, a federal law related to 
privacy of health information 
 Laboratory test results obtained at the 
time of work up and after transplant (for 
example: blood tests, biopsy results).  
C. Parties Who May Disclose My Individual 
Health Information:  
The researcher and the researcher’s staff 
may collect my individual health 
information from: 
[List hospitals, clinics or providers from 
which health care information can be 
requested]. 
D. Parties Who May Receive or Use My 
Individual Health Information:  
The individual health information disclosed 
by parties listed in item c and information 
disclosed by me during the course of the 
research may be received and used by the 
following parties: 
Principal Investigator and the researcher’s 
staff 
Study Sponsors  
 National Heart, Lung, and Blood 
Institute (NHLBI) and the National 
Cancer Institute (NCI), both of the 
National Institutes of Health (NIH),  
 Blood and Marrow Transplant Clinical 
Trials Network (BMT CTN), Data 
Coordinating Center 
 U.S. government agencies that are 
responsible for overseeing research such 
as the Food and Drug Administration 

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(FDA) and the Office of Human 
Research Protections (OHRP) 
U.S. government agencies that are 
responsible for overseeing public health 
concerns such as the Centers for Disease 
Control (CDC) and federal, state and local 
health departments.  
E. Right to Refuse to Sign this 
Authorization:  
I do not have to sign this Authorization. If I 
decide not to sign the Authorization, I will 
not be allowed to participate in this study or 
receive any treatment related to research that 
is provided through the study.  
My decision not to sign this authorization 
will not affect any other treatment, payment, 
or enrollment in health plans or eligibility 
for benefits.  
F. Right to Revoke:   
I can change my mind and withdraw this 
authorization at any time by sending a written 
notice to the Principal Investigator to inform 
the researcher of my decision.  
If I withdraw this authorization, the 
researcher may only use and disclose the 
protected health information already 
collected for this research study. No further 
health information about me will be 
collected by or disclosed to the researcher 
for this study. 
G. Potential for Re-disclosure:  
My individual health information disclosed 
under this authorization may be subject to 
re-disclosure outside the research study and 
no longer protected. 
Examples include potential disclosures for 
law enforcement purposes, mandated 
reporting or abuse or neglect, judicial 
proceedings, health oversight activities and 
public health measures. 
H. Genetic Information 
Nondiscrimination Act (GINA)  
A new federal law (2009), called the Genetic 
Information Nondiscrimination Act (GINA) 
generally makes it illegal for health 
insurance companies, group health plans, 
and employers of 15 or more persons to 
discriminate against you based on your 
genetic information.  
Health insurance companies and group 
health plans may not request your genetic 
information that we get from this research. 
This means that they must not use your 
genetic information when making decisions 
regarding insurability. Be aware that this 
new federal law will not protect you against 
genetic discrimination by companies that 
sell life insurance, disability insurance, or 
long-term care insurance. 
I. This authorization does not have an 
expiration date. 
 
 

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TITLE: A Multi-Center, Phase III, Randomized Trial of Reduced Intensity Conditioning (RIC)  
and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-
Haploidentical Related Bone Marrow for Patients with Hematologic Malignancies 
PROTOCOL NUMBER: BMT CTN #1101 
CO-INVESTIGATOR: 
 
Ephraim Fuchs, M.D. 
Johns Hopkins University 
488 Bunting-Blaustein Cancer Research Bldg 
1650 Orleans Street, Baltimore, MD  21231 
Phone: 410- 955-8143   
Email: fuchsep@jhmi.edu 
CO-INVESTIGATOR: 
 
Paul O’Donnell, M.D., Ph.D. 
Fred Hutchinson Cancer Research Center 
1100 Fairview Avenue North/LM-200 
Seattle, WA  98109-1023 
Phone: 206-667-1968   
Email: podonnel@fhcrc.org 
CO-INVESTIGATOR: 
 
Claudio Brunstein, M.D. 
University of Minnesota Medical Center 
420 Delaware Street SE, MMC 286 
Minneapolis, MN  55455 
Phone: 612-624-5620  
Email: bruns072@umn.edu 
 
 
 I have read and understood this Consent 
Form.  The nature and purpose of the 
research study has been explained to me. 
 I understand that the treatment intensity 
will be randomly assigned to me. 
 I have had the chance to ask questions, 
and understand the answers I have been 
given.  I understand that I may ask 
questions at any time during the study. 
 I freely agree to be a participant in the 
study. 
 I understand that I may not directly 
benefit from taking part in the study. 
 I understand that, while information 
gained during the study may be 
published, I will not be identified and 
my personal results will stay 
confidential. 
 I have had the chance to discuss my 
participation in this research study with a 
family member or friend. 
 I understand that I can leave this study at 
any time, and doing so will not affect my 
current care or prevent me from 
receiving future treatment. 
 I understand that I will be given a copy 
of this signed Consent Form.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participant Name 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
 
Date 

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Statement of Consent for Cost Effectiveness Research 
The purpose of the cost effectiveness 
research, the procedures involved, and the 
risks and benefits have been explained to 
me. I have asked all the questions I have at 
this time and I have been told whom to 
contact if I have more questions. I have been 
told that I will be given a signed copy of this 
consent form to keep. 
I understand that I do not have to participate 
in the cost effectiveness research. If I decide 
to not participate, it will not affect my 
medical care in any way. 
 I agree to be part of the cost-effectiveness 
research.  
 I do not agree to be part of the cost-
effectiveness research.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
 
Date 
 
Statement of Consent for Research Samples 
The purpose of storing blood samples, the 
procedures involved, and the risks and 
benefits have been explained to me. I have 
asked all the questions I have at this time 
and I have been told whom to contact if I 
have more questions. I have been told that I 
will be given a signed copy of this consent 
form to keep. 
I understand that I do not have to allow the 
use of my blood for research. If I decide to 
not let you store research samples now or in 
the future, it will not affect my medical care 
in any way. 
I voluntarily agree that my blood and 
information can be stored indefinitely by the 
BMT CTN and/or NHLBI Repositories for 
research to learn about, prevent, or treat 
health problems. I also understand that my 
DNA and clinical information may or may 
not be used in genome-wide association 
studies. 
 I agree to allow my blood samples to be 
stored for research. 
 I do not agree to allow my blood samples 
to be stored for research. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
 
Date 
 
 
I certify that I have provided a verbal explanation of the details of the research study, including 
the procedures and risks. I believe the participant has understood the information provided. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name of Counseling Physician 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Counseling Physician 
 
 
 
 
Date 
 

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Sample ETRIC Informed Consent Template for the BMT CTN 1301 Study 
 
BMT CTN 1301, v3.0 
 
A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-Free 
Interventions for Prevention of Graft-versus Host-Disease 
 
 
 
Your Name:  
________________________________ 
 
Study Title:  
A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-Free 
Interventions for Prevention of Graft-versus Host-Disease  
 
Protocol: 
 
BMT CTN # 1301 
 
Principal 
Investigator:   
[Insert local PI name] 
 
 
Sponsor:   
The National Institutes of Health (NIH) is sponsoring this study by 
providing financial support through the Blood and Marrow Transplant 
Clinical Trials Network (BMT CTN).  
 
 
 
 
 

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1. Introduction 
We invite you to join this clinical trial, also 
known as a research study. We are doing 
this study because we want to compare 3 
types of treatment to see which one is best at 
preventing chronic Graft-versus-Host 
Disease (GVHD). You are being asked to 
join this study because: 
 
You have a disease that can be 
treated by an allogeneic stem cell 
transplant (using bone marrow or 
peripheral blood stem cells (PBSCs) 
from a donor) and 
 
Your doctor plans to use a standard 
intensity conditioning regimen for 
your transplant.   
See Section 2: Study Background for a 
definition of the bolded terms. 
Your study participation will last for 2 years 
after your transplant. This study will take 
at least 2 years total and will include 345 
participants. There will be 115 participants 
in each of the treatment groups.  
This Consent Form will tell you about the 
purpose of the study, the possible risks and 
benefits, other options available to you, and 
your rights as a participant in the study.  
Everyone who takes part in research at 
[insert facility name] should know that: 
 Being in any research study is 
voluntary. 
 You may or may not benefit from 
being in the study.  Knowledge we 
gain from this study may benefit 
others. 
 If you join the study, you can quit 
the study at any time.  
 If you decide to quit the study, it will 
not affect your care at [insert name 
of facility or institution]. 
 Please ask the study staff questions 
about anything that you do not 
understand, or if you would like to 
have more information. 
 You can ask questions now or any 
time during the study. 
 Please take the time you need to talk 
about the study with your doctor, 
study staff, and your family and 
friends. It is your decision to be in 
the study. If you decide to join, 
please sign and date the end of the 
Consent Form. 
You and your doctor will discuss other 
treatment choices if you do not want to 
participate in this study. 
 

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2. Study Background 
The National Institutes of Health (NIH), 
through the Blood and Marrow Transplant 
Clinical Trials Network (BMT CTN), are 
providing staff support and money for this 
research study. The BMT CTN and the NIH 
will make decisions about how to manage 
the study.  
The Miltenyi Biotec company is supporting 
this study with supplies and money. This 
company makes a tool that helps prepare the 
donated stem cells before giving them to 
patients. 
An allogeneic stem cell transplant 
(allogeneic transplant) is a standard 
treatment for blood cancers like acute 
leukemia and myelodysplastic disorder. An 
allogeneic transplant replaces your abnormal 
(or diseased) blood cells with blood cells 
from a donor. It requires a close tissue 
match between you and the donor. Your 
donor could be a family member, like a 
sister or brother, or it could be an unrelated 
person.  
An allogeneic transplant first uses 
chemotherapy and possibly radiation to 
destroy the abnormal blood cells or stop 
them from growing. Then, we replace the 
destroyed cells with the new cells from your 
donor.  
The chemotherapy and radiation you get to 
destroy the abnormal cells and prepare your 
body for transplant is called the 
conditioning regimen.  
A common problem after allogeneic 
transplant is a condition called Graft Versus 
Host Disease (GVHD). “Graft” is the donor 
blood cells that you will get during your 
transplant. “Host” is the person (in this case, 
you) who gets the donated cells.   
GVHD is a side effect where the donor cells 
(or graft) attack and damage some of your 
tissue. There are 2 kinds of GVHD: acute 
and chronic. Acute GVHD usually develops 
within the first 3 months after transplant. 
Chronic GVHD usually develops later and 
lasts longer.   
GVHD can cause:  
 Skin rash 
 Stomach (or intestinal) problems like 
nausea (feeling sick to your 
stomach), vomiting (throwing up), or 
diarrhea (loose stool)   
 Damage to your liver  
 Hepatitis or jaundice (yellowing of 
the skin)   
 Increased risk of infection 
Chronic GVHD can affect many organs and 
greatly impact your quality of life. 
(See Section 6: Risks and Discomforts for 
more information on the side effects of 
GVHD, and GVHD prevention drugs.)
 

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3. Study Purpose  
We are inviting you to take part in this study 
because you have acute leukemia or 
myelodysplasia, and an allogeneic transplant 
is a treatment option. We are doing this 
research to compare 3 different treatment 
combinations to see if 1 or more is better 
than the standard treatment for preventing 
chronic GVHD. The treatments are listed 
below (Table 1): 
 
Table 1: Treatment Groups 
Group A: 
CD34 Selected Peripheral Blood Stem Cells (new treatment) 
Group B: 
Bone Marrow Transplant followed by Post-Transplant 
Cyclophosphamide (new treatment) 
Group C: 
Bone Marrow Transplant with Tacrolimus and Methotrexate as 
GVHD Prevention (standard treatment) 
 
Doctors are mostly interested in learning 
how Groups A and B compare to Group C. 
The study will help doctors decide which 
treatment is best at preventing chronic 
GVHD. We also want to learn how much 
GVHD is affecting your quality of life, if at 
all.  
(See Section 5: Study Tests and 
Treatments for more information on the 
treatment groups.) 
 
 
4. Rights to Ask Questions and/or Withdraw 
You have the right to ask questions about the 
study at any time. If you have questions about 
your rights as a participant or you want to 
leave the study, please contact:  
[insert contact info] 
Being in this study is voluntary. You can 
choose not to be in this study or leave this 
study at any time. If you choose not to take 
part or leave this study, it will not affect 
your regular medical care in any way.  
Your study doctor and study staff will be 
available to answer any questions that you 
may have about taking part in or leaving this 
study.  

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5. Study Treatment and Tests 
We will check your health before you start 
treatment, during your treatment, and for 2 
years after transplant. All patients in this 
study need to have a matched donor. 
Before You Start Your Treatment 
Before you begin, you will need to have 
several exams (tests) and checkups to find 
out if you can be in the study. These exams 
and checkups are part of regular cancer care. 
They would be done even if you don’t join 
the study.  The exams include: 
 Medical history 
 Physical exam, including height and 
weight 
 Blood and urine tests 
 Heart function tests, including EKG 
and ejection fraction 
 Lung (pulmonary) function tests 
 Tests to see how much cancer is in 
your body (cancer re-staging). This 
might include a bone marrow 
aspirate or biopsy. This is where 
samples of your bone marrow are 
taken from your hip bone with a 
large needle.  
 Chest X-ray or chest CT 
 A pregnancy test if you are a woman 
and able to have children. If you are 
pregnant, you will not be able to take 
part in this study. 
 Health quality of life surveys 
We will also talk with you about providing 
extra blood samples for future research (see 
Section 17: Blood Samples for Future 
Research). This is completely optional.  
The quality of life surveys are for study 
participants who are: 
 
Children and teenagers, 8 – 18 years 
old, who speak English, and 
 
Adults, 18 or older, who speak English 
or Spanish 
The survey will ask about: 
o Any side effects of your treatment 
o Any health problems 
o How well you can do things that are 
important to you 
o How you relate to other people  
o Your feelings.  
We will ask you to fill out paper surveys at 
the clinic or hospital. The surveys will take 
less than 30 minutes to finish. If you need to 
take the survey by phone, an interviewer 
will contact you before your transplant. You 
may skip any questions you wish.  
Randomization  
We will use a computer to randomly assign 
you to 1 of 3 treatment groups (A, B, or C). 
You will have an equal chance of being 

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placed in 1 of the 3 groups. You, your doctor, 
and the study researcher won’t have any 
control over which treatment group you’re 
assigned.  
During Your Treatment 
The tables below describe the 3 treatment 
groups that will be used in this study. Each 
treatment includes a conditioning regimen 
(chemotherapy and/or radiation), allogeneic 
transplant, and GVHD prevention. Your 
doctor will decide on the conditioning 
regimen. You will be given the 
chemotherapy drugs by mouth or by IV 
(through your vein). The amount of 
chemotherapy drugs you receive will be 
based on your weight. The chemotherapy 
and radiation may cause side effects. Some 
of these side effects may be life-threatening 
(see Section 6: Risks and Discomforts). 
Some of the treatment groups include a 
medicine called Mesna. Mesna helps prevent 
bladder discomfort and hemorrhaging 
(bleeding). 
 
 

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Group A: CD34 Selected Peripheral Blood Stem Cells 
Your doctor will choose 1 of 2 conditioning regimens 
before transplant: 
Graft (source 
of donor cells) 
for transplant: 
GVHD prevention 
treatment:  
1. Total Body Irradiation (TBI), Chemotherapy 
drugs (3), and Mesna: 
 TBI, given 3 times a day for 4 days (11 doses 
total), starting 9 days before transplant 
 Thiotepa, given once daily for 2 days, starting 5 
days before transplant 
 Anti-Thymocyte Globulin (rATG), given over 
6-8 hours, once daily for 2 days, starting 4 days 
before transplant 
 Cyclophosphamide (Cy), given once daily for 2 
days, starting 3 days before transplant 
 Mesna – your doctor will decide how many 
doses based on Cy dose        
Peripheral 
blood stem 
cells 
The donor cells will 
be put through a 
device, CliniMACS, 
that removes the 
immune cells 
responsible for 
causing GVHD. 
2. Chemotherapy drugs (4): 
 Busulfan, given over 2 hours, 4 times each day 
for 3 days, starting 9 days before transplant 
 Melphalan, given over 30 minutes, once daily 
for 2 days, starting 6 days before transplant 
 Fludarabine, given over 30 minutes, 5 times a 
day for 5 days, starting 6 days before transplant 
 Anti-Thymocyte Globulin (rATG), given once 
daily for 2 days, starting 3 days before transplant  
 

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Group B: Post-Transplant Cyclophosphamide (Cy) 
We’ll give you medicines to kill the donor cells that are attacking your body after your transplant. 
 
Your doctor will choose 1 of 3 conditioning regimens 
before transplant: 
Graft source 
for transplant: 
GVHD prevention 
drugs:  
1. Chemotherapy drugs (Busulfan and Cy) and 
Mesna:  
 Busulfan, given for 4 days. Your doctor will 
decide when you will start taking this drug and 
how many doses you will get every day.   
 Cyclophosphamide (Cy), given once daily for 2 
days, starting 3 days before transplant    
 Mesna – your doctor will decide when you will 
start taking this drug and how many doses you 
will get every day.   
Bone marrow 
Cyclophosphamide 
will be given by IV 
(through your vein), 
over 1-2 hours, on 
Days 3 and 4 after 
your transplant. 
 
2. Chemotherapy drugs (Busulfan and 
Fludarabine): 
 Busulfan,  given for 4 days. Your doctor will 
decide when you will start taking this drug and 
how many doses you will get every day.   
 Fludarabine, given 4 times a day for 4 days, 
starting 5 days before transplant. Each dose will 
take about 30 minutes. 
3. Total Body Irradiation (TBI) and 
Chemotherapy drugs (Cy):  
 TBI – your doctor will decide how many doses, 
for 4 days, starting 7 days before transplant 
 Cyclophosphamide (Cy), given once daily for 2 
days, starting 3 days before transplant 
 Mesna – your doctor will decide when you will 
start taking this drug and how many doses you 
will get every day.   

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Group C: Tacrolimus and Methotrexate (standard treatment) 
We’ll give you medicines to prevent the donor cells from attacking your body before your 
transplant.  
 
Your doctor will choose 1 of 4 conditioning regimens 
before transplant: 
Graft source 
for transplant: 
GVHD prevention 
drugs:  
1. Chemotherapy drugs (Busulfan and Cy) and 
Mesna  
a. Busulfan, your doctor will decide when you 
will start taking this drug and how many doses 
you will get every day.   
 
Cyclophosphamide (Cy), given over 1-2 hours, 
once daily for 2 days, starting 3 days before 
transplant  
 
Mesna – your doctor will decide when you will 
start taking this drug and how many doses you 
will get every day.   
Bone marrow 
Before your transplant: 
Tacrolimus will be 
given as a pill by 
mouth or by IV 
(through your vein) 2 
times every day, 
starting 3 days before 
transplant. The amount 
will slowly be lowered 
and eventually stopped. 
This process will take 
place over several 
months. 
After your transplant: 
Methotrexate will be 
given by IV (through 
your vein) on Days 1, 
3, 6 and 11 after your 
transplant. 
2. Chemotherapy drugs (Busulfan and 
Fludarabine): 
a. Busulfan, your doctor will decide when you 
will start taking this drug and how many doses 
you will get every day.   
b. Fludarabine, given 4 times a day for 4 days, 
starting 5 days before transplant. Each dose will 
take about 30 minutes. 
3. Total Body Irradiation (TBI) and 
Chemotherapy drugs (Cy) and Mesna:  
a. TBI – your doctor will decide how many doses, 
for 4 days, starting 7 days before transplant 
 
Cyclophosphamide (Cy), given once daily for 
2 days, starting 3 days before transplant  
 
Mesna – your doctor will decide when you will 

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start taking this drug and how many doses you 
will get every day.   
4. Total Body Irradiation (TBI) and 
Chemotherapy drugs (Etoposide): 
a. TBI – your doctor will decide how many doses, 
for 4 days, starting 7 days before transplant 
 
Etoposide, given one time, 3 days before 
transplant 
 
Treatment Groups A and B don’t require 
long-term use of GVHD prevention drugs. If 
you’re assigned to Treatment Group A or B 
and you develop GVHD, your doctor will 
give you drugs to treat the GVHD. Your 
doctor will determine your treatment (drugs) 
and the amount based on your signs and 
symptoms.  
Your Transplant (Peripheral blood stem 
cells (PBSCs) or bone marrow) 
On your transplant day, we will give you the 
donated PBSCs or bone marrow through 
your catheter. It works just like a blood 
transfusion. The cells will travel to your 
bone marrow where they will start to make 
healthy, new blood cells after several weeks.  
After Your Transplant 
We’ll evaluate (test) your health after your 
transplant. These tests and how often they 
are scheduled are standard care for patients 
receiving an allogeneic transplant. They 
would be done even if you were not part of 
this study. You will be watched closely for 
any signs and symptoms of GVHD.  
Health evaluations after transplant: 
See Table 1: Timeline of Exams After Your 
Transplant for a schedule of when we will 
give you these exams.  
Quality of life surveys (see Before You Start 
Your Treatment earlier in this section). We 
will ask you about your general health and 
how well you feel while you’re in this study. 
Even though different treatments may treat a 
disease equally well, there might be 
differences in how patients feel or the side 
effects they have after their treatment. This is 
important information for when we evaluate 
the treatments in this study. You will take the 
surveys at the clinic or hospital on Days 100, 
180, 365 and 730.   
1) Optional blood samples for future 
research (see Section 17: Blood 
Samples for Future Research).
 
 
 

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Table 1: Timeline of Exams After Your Transplant 
Exams 
Day After Transplant 
Weekly 
until 
Day 63 
 
100 
150 
180 
270 
365 
 
730 
 
Tests for toxicities, and 
infections 
 
 
 
 
 
 
 
Monitoring for CMV, 
EBV 
 
  
 
 
 
(Weekly 
until Day 
100) 
 
 
 
 
 
 
 
 
 
 
Tests for  GVHD 
 
 
 
 
 
 
 
Blood tests for cell 
counts, liver and kidney 
function 
 
 
 
 
 
 
 
Tests to see how much 
cancer you still have 
 
 
 
 
 
 
 
Quality of life surveys  
 
 
 
 
 
 
 
Optional blood samples 
for research (if you 
consent) 
(Day 35 
only) 
  
 
 
 
 
 
 
 
 
 

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6. Risks and Discomforts 
You will have side effects while on the 
study. Side effects can range from mild to 
serious.  
The risks and discomforts of allogeneic 
transplant are the same if you join this study, 
or if you don’t join this study. You might do 
better or worse with a standard transplant. 
Your healthcare team may give you 
medicines to help with side effects like 
nausea (feeling sick to your stomach). In 
some cases, side effects can last a long time 
or may never go away.  
Risks of Medications 
The risks of the chemotherapy drugs, and/or 
radiation you get as part of the treatment are 
listed below. How often patients get each of 
side effects are shown in Table 2. 
 
Table 2: Risks And Side Effects 
Likely 
What it means: This type of side effect is expected in more than 20% of 
patients. This means that 21 or more patients out of 100 might get this side 
effect. 
Less Likely 
What it means: This type of side effect is expected in 20% of patients or 
fewer. This means that 20 or fewer patients out of 100 might get this side 
effect. 
Rare, but Serious 
What it means: This type of side effect is expected in fewer than 2% of 
patients. This means that 1 or 2 patients (or fewer) out of 100 might get this 
side effect. It doesn’t happen very often, but is serious when it does. 
 
 
 

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Busulfan (Chemotherapy drug) 
Likely  
 (May happen in more than 20% 
of patients) 
Less Likely 
(May happen in fewer than 
20% of patients) 
Rare, but Serious  
(May happen in fewer than 
2% of patients) 
 Upset stomach or pain in the 
belly 
 Constipation  
 Diarrhea (loose stool) 
 Feeling dizzy 
 Water retention (storing 
extra water) 
 Headache 
 Heartburn 
 Insomnia (not able to sleep) 
 Loss of appetite 
 Mouth sores (mucositis) 
 Nausea (feeling sick to your 
stomach) 
 Vomiting (throwing up) 
 Runny nose 
 Skin rashes 
 Irregular or no menstrual 
periods in women 
 Tachycardia (fast heart beat) 
 Cough 
 Hepatic Veno-occlusive 
disease (type of liver 
disease)  
 High blood pressure 
 High magnesium and 
phosphorus levels in the 
blood 
 High sugar levels in the 
blood 
 Infertility 
 Low blood pressure 
 Seizures  
 Dyspnea (shortness of 
breath) 
 
 Cataracts 
 Lung fibrosis (scarring of 
lungs) 
 

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Cyclophosphamide (Cytoxan®) (Chemotherapy drug) 
Likely  
(May happen in more than 
20% of patients) 
Less Likely  
(May happen in less than 20% 
of patients) 
Rare, but Serious  
(May happen in less than 2% 
of patients) 
 Sores in mouth or on lips 
  Loss of appetite  
 Nausea (feeling sick to 
stomach) 
 Vomiting (throwing up) 
 Diarrhea (loose stool) 
 Water retention 
 Temporary hair loss 
 Damage to male (testes) 
and female (ovaries) sex 
glands 
 Infertility (inability to have 
children) 
 Irregular or no menstrual 
periods in women 
 Neutropenia (low white 
blood cell count and 
increased risk of infection) 
 Thrombocyotpenia (low 
platelet count and increased 
risk of bleeding) 
 Bleeding in bladder 
 Anemia (low red blood 
cell count) 
 Damage to the fetus if you 
become pregnant while 
taking drug 
 Stomach pain 
 Skin rash 
 Allergic reaction 
 Scarring of lung tissue 
with cough and shortness 
of breath 
 Serious skin rash 
 Severe heart muscle injury 
and death (at very high 
doses) 
 Second (new) cancers  
 
 
If you are taking cyclophosphamide, your doctor may also prescribe you a medicine called 
Mesna. Mesna helps prevent bladder discomfort and bleeding that can occur from taking 
cyclophosphamide. 
 

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Etoposide (Chemotherapy drug) 
Likely  
(May happen in more than 
20% of patients) 
Less Likely  
(May happen in less than 20% 
of patients) 
Rare, but Serious  
(May happen in less than 2% 
of patients) 
 Diarrhea 
 Hair loss 
 Nausea (feeling sick to 
stomach) 
 Vomiting (throwing up) 
 
 Mouth sores (mucositis) 
 Constipation  
 Upset stomach or pain in 
the belly 
 Allergic reaction 
 Peripheral neuropathy 
(numbness and tingling in 
hands and/or feet) 
 
Fludarabine (Chemotherapy drug) 
Likely  
(May happen in more than 
20% of patients) 
Less Likely  
(May happen in less than 20% 
of patients) 
Rare, but Serious  
(May happen in less than 2% 
of patients) 
 Diarrhea (loose stool) 
 Mouth sores  
 Nausea (feeling sick to 
stomach) 
 Vomiting (throwing up) 
 Suppressed immune 
system (immune system 
not able to fight off 
infection as normal) 
 Fever 
 Numbness and tingling in 
the hands and/or feet 
 Feeling sleepy or tired 
 Changes in vision  
 Weakness 
 Coma 
 Cough 
 Inflammation (swelling) 
of the lungs 
 Interstitial Pneumonia 
(type of lung disease)  
 Skin rash 

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Melphalan (Chemotherapy drug) 
Likely  
(May happen in more than 
20% of patients) 
Less Likely  
(May happen in less than 20% 
of patients) 
Rare, but Serious  
(May happen in less than 2% 
of patients) 
 Constipation 
 Diarrhea(loose stool) 
 Temporary hair loss 
 Mouth sores (mucositis) 
 Nausea (feeling sick to 
stomach) 
 Vomiting (throwing up) 
 Abnormal heart beat 
 Increased risk of Hepatitis 
 Kidney failure 
 Allergic reaction 
 Interstitial Pneumonia 
(type of lung disease) 
 Seizure 
 Scarring of lung tissue  

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Total Body Irradiation (TBI) 
Likely 
(May happen in more than 
20% of patients) 
Less Likely  
(May happen in less than 20% 
of patients) 
Rare, but Serious  
(May happen in less than 
2% of patients) 
 
Diarrhea 
 
Nausea (feeling sick to 
stomatch) 
 
Vomiting (throwing up) 
 
Stomach cramps 
 
Temporary hair loss  
 
Cataracts 
 
Stunted growth  
 
Low platelet count with 
increased risk of bleeding 
 
Low white blood cell count 
with increased risk of 
infection 
 
Pain and swelling of the 
parotid gland (salivary 
glands under the ears) 
 
Anemia 
 
Infertility (inability to have 
children)  
 
Endocrinopathies (such as 
thyroid disease or diabetes) 
 
Mouth sores (mucositis) 
 
Lung inflammation and 
pneumonia 
 
Redness of the skin 
 
Liver problems 
 
 
Second (new) cancers 
 
Difficulty swallowing 
 
Back problems 
 
Kidney problems 
 
 

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Thiotepa (Chemotherapy drug) 
Likely 
(May happen in more than 
20% of patients) 
Less Likely  
(May happen in less than 20% 
of patients) 
Rare , but Serious 
(May happen in less than 
2% of patients) 
 
Low  white blood cell count 
with increased risk of 
infection 
 
Diarrhea (loose stool) 
 
Nausea (feeling sick to 
stomach) 
 
Vomiting (throwing up)  
 
Liver damage 
 
Low sperm production in 
men 
 
Temporary hair loss 
 
Loss of appetite 
 
Missing or no menstrual 
period in women 
 
Mouth and throat sores 
 
Infertility (inability to have 
children)  
 
Liver abnormalities 
 
Skin rash 
 
Change in skin coloring 
 
Low platelet count with 
increased risk of bleeding  
 
 
 
Confusion 
 Disorientation 
 
 
 
 
 

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Rabbit Anti-Thymocyte Globulin (rATG) 
 
Likely 
(May happen in more than 
20% of patients) 
Less Likely  
(May happen in less than 20% 
of patients) 
Rare , but Serious 
(May happen in less than 
2% of patients) 
 Fever 
 Shaking chills 
 Low blood pressure 
 Skin rash 
 Itching 
 Decreased  platelet 
counts 
 Decreased white blood 
cell counts 
Serum sickness, consisting of : 
 Severe skin rashes 
 Mouth sores 
 Vaginal sores 
 Pain/swelling of joints 
 Kidney damage  
 
 
Severe allergic reaction 
which may cause: 
 
 Life-threatening drop 
in blood pressure 
 Wheezing 
 Difficulty breathing 
 Severe hives 
 
 

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Risks of Drugs Used to Prevent GVHD 
If you’re assigned to Treatment Group C 
you will get medicines to help prevent 
GVHD after your transplant. The side 
effects of the GVHD drugs usually stop 
when you’re done taking them. 
  
Cyclosporine (Gengraf® or Neoral®) (GVHD prevention drug) 
Likely 
(May happen in more than 
20% of patients) 
Less Likely  
(May happen in less than 20% 
of patients) 
Rare, but Serious  
(May happen in less than 2% 
of patients) 
 
Kidney problems 
 
Loss of magnesium, calcium, 
and potassium 
 
High blood pressure 
 
Liver problems 
 
Unwanted hair growth 
 
Growth of extra tissue on the 
gums (inside mouth) 
 
Burning, tingling or 
numbness in the hands, arms, 
feet or legs 
 
Seizures 
 
Changes in vision 
 
Formation of very small 
blood clots 
 
 

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Methotrexate (GVHD prevention drug) 
Likely 
(May happen in more than 
20% of patients) 
Less Likely  
(May happen in less than 20% 
of patients) 
Rare  
(May happen in less than 2% 
of patients) 
 Low white blood cell 
count with increased risk 
of infection 
 Feeling tired 
 Infections 
 
 Nausea(feeling sick to 
stomach) 
 Vomiting (throwing up) 
 Irritation or sores in the 
throat or mouth (mucositis) 
 Diarrhea (loose stool) 
 Upset stomach or pain in 
the belly 
 Fever 
 Chills 
 Anemia (low red blood cell 
count) 
 Abnormal liver tests 
 Kidney failure 
 Feeling dizzy 
 Lung fibrosis (scarring of 
the lungs) 
 

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Tacrolimus (FK506, Prograf®) (GVHD prevention drug) 
Likely 
(May happen in more than 20% of 
patients) 
Less Likely  
(May happen in less than 
20% of patients) 
Rare  
(May happen in less than 
2% of patients) 
 Kidney problems 
 Loss of magnesium, calcium, 
potassium 
 High blood pressure 
 Tremors (shaking) 
 High cholesterol and 
triglyceride 
 Low blood platelet count with 
increased risk of bleeding 
 Infections 
 Nausea (feeling sick 
to stomach) 
 Vomiting (throwing 
up) 
 Unwanted hair growth 
 Liver problems 
 Insomnia (not able to 
sleep) 
 Foggy thinking 
 Confusion 
 Seizures 
 Changes in vision 
 Feeling dizzy 
 Red blood cell damage 
 
 
It is very important that you do not eat 
grapefruit or drink grapefruit juice while 
taking Tacrolimus. Grapefruit has an 
ingredient called bergamottin, which can 
affect some of the treatment drugs used in 
this study. Common soft drinks that have 
bergamottin are Fresca, Squirt, and Sunny 
Delight.  
Risks of Transplant 
The following problems may happen after 
transplant. These problems might happen if 
you have a transplant as part of the study or 
as standard care:  
Graft-Versus-Host Disease (GVHD)  
GVHD develops when the donor’s white 
blood cells attack your body. White blood 
cells are also called T cells. You are more 
likely to get GVHD if your donor’s tissue 
type does not closely match your tissue type. 
There are 2 kinds of GVHD: acute and 
chronic.  
Acute GVHD 
Acute GVHD usually develops within the 
first 3 months after transplant.You may 
experience these side effects with acute 
GVHD:  

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 
Skin rash 
 
Nausea (feeling sick to your stomach) 
 
Vomiting (throwing up) 
 
Diarrhea 
 
Abdominal (stomach area) pain 
 
Problems with your liver (your doctor 
will run tests for this) 
 
Infection 
Chronic GVHD 
Chronic GVHD usually develops later and 
lasts longer. You may experience these side 
effects with chronic GVHD:  
 
Skin rashes 
 
Hair loss 
 
Thickened skin 
 
Dry eyes 
 
Dry mouth 
 
Liver disease (your doctor will run tests 
for this) 
 
Weight loss 
 
Diarrhea 
 
Infection 
We don’t know for sure if you will develop 
acute or chronic GVHD. Your doctor will 
watch you closely for GVHD and treat it if it 
happens.  
To know for sure if you have acute or 
chronic GVHD, we may do a biopsy of your 
skin. A biopsy involves taking a small piece 
of your skin to look at it under a microscope. 
There’s a small chance that we might also 
do a biopsy of your intestine and liver. Risks 
of biopsy may include pain, infection, or 
bleeding. 
In most cases, GVHD can be treated with 
drugs. In some cases, GVHD  can be very 
hard to treat. It might also cause death.  
Slow recovery of blood counts  
The red blood cells, white blood cells, and 
platelets can be slow to recover after 
transplant. Until your blood counts recover, 
you will need blood and platelet 
transfusions. You’ll be at risk for bleeding 
and infections. We might give you a drug 
called Filgrastim (G-CSF; Neupogen®) to 
speed up the recovery of the white blood 
cells as much as possible and lower the 
chance of bleeding and infections. 
Graft (donor cells) failure or rejection  
The PBSCs or bone marrow (the “graft”) 
might not grow inside your body. There can 
be a 10 - 15% chance of graft failure. If graft 
failure happens, this may result in low blood 
counts for a long period of time. If your 
counts don’t recover, you may need to get a 
second transplant. Graft failure can be fatal. 
Damage to the vital organs in your body 
Your vital organs include your heart, lungs, 
liver, intestines, kidneys, bladder and brain. 
The chemotherapy and GVHD drugs may 
hurt these organs. You may develop lung 

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problems from chemotherapy or an 
infection.  
If there is serious damage to your vital 
organs, you may have to stay in the hospital 
longer or return to the hospital after your 
transplant. Many patients get better, but 
these complications can cause permanent 
damage to your organs or death. 
Serious infections 
It may take many months for your immune 
system to recover from the chemotherapy 
and the transplant. There is an increased risk 
of infection during this time when your body 
is healing. We will give you drugs to reduce 
the chance of infection, but they may not 
work. If you have an infection, you may 
have to stay in the hospital longer or return 
to the hospital after transplant.  Many 
patients get better, but some infections can 
cause death. 
Return (relapse) of disease or a new blood 
cancer 
Your disease may come back even if the 
transplant is successful at first. In rare cases, a 
new blood cancer may develop from the 
donor cells.  
Cyclophosphamide can cause damage to 
blood cells, which may result in a blood 
cancer such as myelodysplastic syndrome 
(MDS) or acute myeloid leukemia (AML). 
The blood cancer usually develops 2-10 
years after treatment, or 6 years on average. 
The risk of developing a new blood cancer 
after allogeneic transplant is less than 2% (1 
or 2 patients (or fewer) out of 100). If cancer 
develops in your donor’s blood cells, you 
may need more chemotherapy or another 
transplant. 
Lymphoproliferative Syndrome 
Patients in treatment Treatment Group A 
(CD34 Selected Peripheral Blood Stem Cell 
Graft) have an increased risk of developing 
post-transplant lymphoproliferative disorder 
(PTLD) or lymphoma caused by a virus 
called EBV.  They can develop symptoms 
like fevers and enlarged lymph nodes.  Your 
doctor may use scans and biopsies to 
confirm the diagnosis.  Your blood will be 
monitored to check if you have signs of 
EBV in the blood.  In many patients EBV 
can be treated at that stage before it ever 
progresses to lymphoma.  EBV in the blood 
or EBV lymphoma often responds to 
treatment with rituximab, a drug commonly 
used in other lymphomas.   
Risk to the Unborn 
The treatments in this study have not been 
proven safe at any stage of pregnancy. If you 
are pregnant or nursing, you can’t join this 
study. Women who can become pregnant 
must use effective birth control while 
receiving chemotherapy, TBI, and drugs to 
prevent GVHD, and for 1 year after 
transplant. Effective birth control is defined as 
the following: 
1. Refraining from all acts of vaginal 
sex (abstinence)  
2. Consistent use of birth control pills 
3. Injectable birth control methods 
(Depo-Provera, Norplant) 

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4. Tubal sterilization or male partner 
who has undergone a vasectomy 
5. Placement of an IUD (intrauterine 
device) 
6. Use of a diaphragm with 
contraceptive jelly and/or condoms 
with contraceptive foam every time 
you have sex. 
Reproductive Risks  
The drugs used in this research study may 
damage your reproductive organs, affect 
your ability to have children, or cause birth 
defects if you take them while you are 
pregnant. It is important that females who 
aren’t pregnant or breast-feeding don’t 
become pregnant while part of the study.  
Both women who can become pregnant 
and their male partners should use birth 
control for 1 year after transplant while 
on this study. 
 
Females who join the study 
If you are female and can become 
pregnant, you will need to take a 
pregnancy test before you start the study. 
You should discuss ways to prevent 
pregnancy while you’re in the study. 
Women who have gone through puberty 
might experience irregular menstrual 
cycles or their cycle might stop forever. 
This doesn’t mean that you can’t become 
pregnant. You must still use an effective 
form of birth control during your 
transplant and continue with it until you 
are finished with GVHD prevention 
treatment.  
Be sure to talk with your doctor about 
options for fertility planning, like storing 
your eggs, before starting chemotherapy and 
radiation treatment. 
 
Males who join the study 
If you are male, your body may not be 
able to produce sperm (become sterile). 
Be sure to talk with your doctor about 
options for fertility planning, like 
banking your sperm, before starting 
chemotherapy and radiation treatment. 
Unforeseen Risks  
New risks might appear at any time during 
the study. These risks might be different 
from what is listed in this Consent Form. 
We will promptly tell you about new 
information that may affect your decision to 
take part in the study. We may learn new 
things that might make you want to stop being 
in the study. If this happens, we will let you 
know so you can decide if you want to 
continue in the study.  
Other Treatments or Medicines 
Some medicines react with each other, and it 
is important that you tell the study doctor or 
staff about any other drugs, treatments, or 
medicines you are taking.  This includes 
non-prescription or over-the-counter 
medicines, vitamins, and herbal treatments.  
It is also important that you tell the study 
staff about any changes to your medicines 
while you’re in the study. For more 
information about risks and side effects, ask 
your study doctor.

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7. Alternative Treatments 
Participation in this study is optional. If you 
choose not to take part, you can still receive 
an allogeneic transplant to treat your 
disease. The treatment and tests could be 
very similar to what you’d receive if you’re 
part of the study.  
Your study doctor will talk with you about 
your options. If you decide not to participate 
in this study, your medical care will not be 
affected in any way. 
Your other choices may include: 
 Treatment with other drugs, 
radiation, or a combination of drugs 
and radiation without a transplant. 
 An allogeneic transplant that is not 
part of the study, or another type of 
transplant 
 Participation in another research 
study, if available (check with your 
doctor) 
 No treatment for your blood cancer 
at this time 
 Comfort care 
Every treatment option has benefits and 
risks. Talk with your doctor about your 
treatment choices before you decide if you 
will take part in this study. 
 
8. Possible Benefits 
We don’t know if taking part in this study will 
make your health better. The information 
from this study will help doctors learn more 
about drugs used to prevent GVHD. This 
information could help people with a blood 
cancer who may need a transplant in the 
future. 
 
9. New Information Available During the Study 
During this research study, the study doctors 
may learn new information about the study 
drugs or the risks and benefits of the study.  If 
this happens, they will tell you about the new 
information. The new information may mean 
that you can no longer participate in the study, 
or that you may not want to continue in the 
study.  
If this happens, the study doctor will stop 
your participation in the study and will offer 
you all available care to suit your needs and 
medical conditions. 
 
 

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10. Privacy, Confidentiality and Use of Information
Your confidentiality is one of our main 
concerns. We will do our best to make sure 
that the personal information in your 
medical record is kept private. However, we 
cannot guarantee total privacy. All your 
medical and demographic (such as race and 
ethnicity, gender and household income) 
information will be kept private and 
confidential. [Name of Transplant Center] 
and the organizations listed below will not 
disclose your participation by any means of 
communication to any person or 
organization, except by your written request, 
or permission, or unless required by federal, 
state or local laws, or regulatory agencies.  
 
Individuals authorized by the organizations 
below will have access to your research and 
medical information. They may use this 
information for inspections or audits to 
study the outcomes of your treatment. In 
agreeing to participate, you consent to such 
inspections and to the copying of parts of 
your 
records, 
if 
required 
by 
these 
organizations. 
We may give out your personal information 
if required by law. If information from this 
study is published or presented at scientific 
meetings, your name and other personal 
information will not be used.  
Information about your transplant from your 
original medical records may be seen or sent 
to these agencies or organizations:  
 The Center for International Blood and 
Marrow Transplant Research (CIBMTR) 
 The National Marrow Donor Program 
(NMDP) 
 The Food and Drug Administration 
(FDA) 
 The National Institutes of Health (NIH), 
which include the National Heart, Lung, 
and Blood Institute (NHLBI) and the 
National Cancer Institute (NCI) 
 Data and Coordinating Center of the 
Blood and Marrow Transplant Clinical 
Trials Network (BMT CTN DCC), 
including The Emmes Corporation 
 BMT CTN Data and Safety Monitoring 
Board (DSMB) 
 Miltenyi Biotec, makers of the device 
that removes cells that are associated 
with the development of GVHD (used in 
Treatment Group A) 
 Study investigators 
We will not identify you by name in any 
publications or reports that come from these 
organizations or groups. 
Information that does not include personally 
identifiable information about this study has 
been or will be submitted, at the appropriate 
and required time, to the government-
operated clinical trial registry data bank, 
which contains registration, results, and 
other information about registered studies.   
This data bank can be accessed by you and 
the general public at 

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www.ClinicalTrials.gov. Federal law 
requires clinical trial information for certain 
studies to be submitted to the data bank.For 
questions about access to your medical 
records, please contact /name/ at /number. 
 
11.  Ending Your Participation 
Being in this study is voluntary.  You can 
choose to not be in this study, or leave this 
study at any time.  If you choose not to take 
part or leave this study, your regular medical 
care will not be affected in any way. 
The study doctor or the study sponsor may 
stop the study at any time, and we may ask 
you to leave the study.  If we ask you to 
leave the study, the reasons will be 
discussed with you. Possible reasons to end 
your participation in this study include: 
 You do not meet the study 
requirements.  
 You need a medical treatment not 
allowed in this study. 
 The study doctor decides that it 
would be harmful to you to stay in 
the study. 
 You are having serious side effects. 
 You become pregnant. 
 You cannot keep appointments or 
take study drugs as directed. 
 The study is stopped for any reason. 
You could have serious health risks if you 
stop treatment during the conditioning 
process before you receive your transplant. 
If you stop taking the immune suppressing 
drugs too soon after transplant (see Section 
6: Risks and Discomforts), your body 
could reject the donor stem cells or you 
could develop serious complications and 
possibly die.  
We ask that you talk with the research 
doctor and your regular doctor before you 
leave the study. Your doctors will tell you 
how to stop safely and talk with you about 
other treatment choices.  
If you decide to leave this study after getting 
the study treatment, or are asked to leave by 
your doctor for medical reasons, you will 
need to come back to the doctor’s office for 
tests for your safety. Even if you leave the 
study, the information collected from your 
participation will be included in the study 
evaluation. 
 
 
 
 
 

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12.  Physical Injury as a Result of Participation  
It is important that you tell your doctor, 
[investigator's name(s)] or study staff if you 
feel that you have been injured because of 
taking part in this study.  You can tell the 
doctor in person or call him/her at  
[telephone number]. 
You will get medical treatment if you are 
injured as a result of taking part in this 
study.  You and/or your health plan will be 
charged for this treatment.  The study will 
not pay for medical treatment.  
In case you are injured in this study, you do 
not lose any of your legal rights to seek 
payment by signing this Consent Form. 
 
13.  Compensation or Payment 
You will not be paid for taking part in this 
study. You will not be  compensated or 
reimbursed for any extra costs (for example, 
travel and meals) from taking part in this 
study. 
 
14.  Costs and Reimbursements 
Most of the visits for this study are standard 
medical care for your allogeneic transplants 
and will be billed to your insurance company. 
You and/or your health plan/insurance 
company will need to pay for some or all of 
the costs of standard treatment in this study.   
You or your insurance will not be charged for 
optional blood samples for research on this 
study. You will not pay for any extra tests that 
are being done for the study. 
Some health plans will not pay the costs for 
people taking part in studies. Check with 
your health plan or insurance company to 
find out if they will pay.  
For questions about your costs, financial 
responsibilities, and/or medical insurance 
coverage for your transplant and this study, 
please contact /Center/ Financial Counselor 
at /Number/. 
For more information on clinical trials and 
insurance coverage, you can visit the 
National Cancer Institute’s Web site at 
http://cancer.gov/clinicaltrials/understanding
/insurance-coverage. You can print a copy 
of the “Clinical Trials and Insurance 
Coverage” information from this Web site. 
Another way to get the information is to call 
1-800-4-CANCER (1-800-422-6237) and 
ask them to send you a free copy. 
 
 
 

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15.  For More Information  
If you need more information about this 
study, or if you have problems while taking 
part in this study, you can contact the study 
doctor or his/her staff.  They can be reached 
at the telephone numbers listed here: 
[Insert name and contact details] 
 
16.  Contact Someone about Your Rights 
If you wish to speak to someone not directly 
involved in the study, or if you have any 
complaints about any aspect of the project, 
the way it is being conducted or any questions 
about your rights as a research participant, 
then you may contact:  
[Insert appropriate contact details] 
The ethical aspects of this study have been 
reviewed and approved by [name of IRB]. 
For questions about your rights while taking 
part in this study, call the [name of center] 
Institutional Review Board (a group of 
people who review the research to protect 
your rights) at (telephone number). 
 
17.  Blood Samples for Future Research (Optional) 
This section of the Consent Form is about 
future research studies.  This research will 
use blood samples from people who are 
taking part in the main study. You may 
choose to give blood samples for these 
research studies if you want to. You can still 
be a part of the main study even if you say 
'no' to give blood samples for immune 
recovery research studies. 
Researchers are trying to learn more about 
why patients develop side effects after 
transplant, such as infections and graft-
versus-host-disease (GVHD).This research 
is meant to gain knowledge that may help 
people in the future and make transplants 
even more successful.  
If you agree to provide blood samples, here 
is what will happen: 
 
a.) We’ll collect 5 blood samples from 
your catheter or a vein in your arm. 
These samples will probably be 
collected at the same time as your 
other blood draws. We’ll take about 
2 teaspoons (or 6 mL) before you 
begin the conditioning regimen for 
your transplant, and about 20 
teaspoons (or 86 mL) at each time: 
35 days, 100 days, 6 months, and 1 
year after your transplant.  
 
These samples will only be 
collected from patients who are 
more than 66 pounds (30 kg).   

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b.) The blood samples for future 
research will be sent to the BMT 
CTN Repository for processing and 
storage. A repository is a place that 
protects, stores and sends out 
samples for approved research 
studies. All research samples will be 
given a bar code that cannot be 
linked to you by future researchers 
testing your samples. A link to this 
code does exist.  The link is stored at 
the Data and Coordinating Center for 
the BMT CTN DCC.  The staff at the 
repository where your samples are 
being stored does not have a link to 
this code.  Your research samples 
will continue to be stored at the 
BMT CTN Repository until they are 
used up for research. 
c.) Materials stored in the Repository 
will be used mainly by clinicians and 
researchers in the BMT CTN 
network. In the future, the unused 
research samples and clinical data 
will be made available outside of this 
network.  
d.) Researchers can apply to study the 
materials stored in the Repository. 
The BMT CTN Steering Committee 
and/or the BMT CTN Executive 
Committee must approve each 
request before they will share 
samples or information with 
researchers. This is to make sure that 
the investigators requesting the 
samples are qualified, and that the 
research is of high quality. 
e.) DNA from your stored blood 
samples might be used in genome-
wide association (GWA) studies for 
a future project either done or 
supported by the National Institutes 
of Health (NIH). Genome-wide 
association studies are a way for 
scientists to find genes that have a 
role in human disease or treatment. 
Each study can look at hundreds of 
thousands of genetic changes at the 
same time 
If your coded samples are used in 
such a study, the researcher is 
required to add your test results and 
sample information into a shared, 
public research database. This public 
database is called the NIH Genotype 
and Phenotype Database and it is 
managed by the National Center for 
Biotechnology Information (NCBI). 
The NCBI will never have any 
information that would identify you, 
or link you to your information or 
research samples, although the 
results of genetic studies could 
theoretically include identifying 
information about you. 
Things to Think About:  
 
 The choice to let us have blood 
samples for future research is up to 
you.  No matter what you decide to 
do, it will not affect your care.  
 
 If you decide now that your blood 
can be kept for future research, you 
can change your mind at any time.  
Just contact your study doctor and let 

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him or her know that you do not 
want us to use your blood sample.  
Then any blood that remains will no 
longer be used for research.  
 
 In the future, people who do research 
on these blood samples may need to 
know more about your health.  While 
the study doctor or others involved in 
running this study may give the 
researchers reports about your 
health, it will not give them your 
name, address, phone number, or any 
other information that will let the 
researchers know who you are.  
 
 Your blood will be used only for 
research and will not be sold.  The 
research done with your blood may 
help to develop new products in the 
future. 
 
Genetic Information Nondiscrimination 
Act: 
 A new federal law (2009), called the 
Genetic Information Nondiscrimination 
Act (GINA), generally makes it illegal 
for health insurance companies, group 
health plans, and employers of 15 or 
more persons to discriminate against 
you based on your genetic information. 
Health insurance companies and group 
health plans may not request your 
genetic information that we get from 
this research.  
 
 This means that they must not use your 
genetic information when making 
decisions about your insurance. Be 
aware that this new federal law will not 
protect you against genetic 
discrimination by companies that sell 
life insurance, disability insurance, or 
long-term care insurance. 
Benefits: 
The benefits of research using blood include 
learning more about how your body’s 
immune system recovers after a transplant, 
as well as why certain complications like 
graft-versus-host 
disease 
or 
infections 
develop.  
 
Risks: 
There is a small risk of an infection or 
fainting from the blood draw.  
The greatest risk to you is the release of 
information from your health records.  We 
will do our best to make sure that your 
personal information will be kept private.  
The chance that this information will be 
given to someone else is very small.  
Making Your Choice  
Please read each sentence below and think 
about your choice. After reading each 
sentence, please indicate your choice below. 
If you have any questions, please talk to 
your doctor or nurse, or call our research 
review board at [contact information].  
No matter what you decide to do, it will not 
affect your care.

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Statement of Consent for Blood Samples for Future Research (Optional)
The purpose of storing blood samples, the 
procedures involved, and the risks and 
benefits have been explained to me. I have 
asked all the questions I have at this time 
and I have been told whom to contact if I 
have more questions. I have been told that I 
will be given a signed copy of this Consent 
Form to keep. I understand that I do not 
have to allow the use of my blood and for 
research. If I decide not to let you store 
research samples now or in the future, it will 
not affect my medical care in any way. 
I voluntarily agree that my blood and 
information can be stored indefinitely by the 
BMT CTN and/or NHLBI Repositories for 
research to learn about, prevent, or treat 
health problems. I also understand that my 
DNA and health information may or may 
not be used in genome-wide association 
studies. 
 I agree to allow my blood samples to be stored for research. 
 I do not agree to allow my blood samples to be stored for research. 
 
______________________________________ 
__________________  
 
Signature 
 
 
 
 
 
Date 
 
 
 
 

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Health Insurance Portability and 
Accountability Act 1 (HIPAA2) 
Authorization to use and disclose 
individual health information for 
research purposes 
 
A. Purpose:   
As a research participant, I authorize the 
Principal Investigators and the 
researcher’s staff to use and disclose my 
individual health information for the 
purpose of conducting the research 
study:  
A Multi-Center Phase II Trial of 
Randomized Novel Approaches for 
Graft-versus-Host Disease 
Prevention Compared to 
Contemporary Controls 
 
B. Individual Health Information to be 
Used or Disclosed:  
My individual health information that 
may be used or disclosed to do this 
research includes:  
 Demographic information (for 
example: date of birth, sex, weight).  
 Medical history (for example: 
diagnosis, complications with prior 
treatment). 
 Findings from physical exams. 
 Laboratory test results obtained at 
the time of work up and after 
transplant (for example: blood tests, 
biopsy results).  
 
                                                 
2 HIPAA is the Health Insurance Portability and 
Accountability Act of 1996, a federal law related to 
privacy of health information 
C. Parties Who May Disclose My 
Individual Health Information:  
The researcher and the researcher’s staff 
may collect my individual health 
information from: 
[List hospitals, clinics or providers from 
which health care information can be 
requested]. 
 
D. Parties Who May Receive or Use My 
Individual Health Information:  
The individual health information 
disclosed by parties listed in item c and 
information disclosed by me during the 
course of the research may be received 
and used by the following parties: 
 
Study Sponsors  
 National Heart, Lung, and Blood 
Institute (NHLBI) and the 
National Cancer Institute (NCI), 
both of the National Institutes of 
Health (NIH) 
 Blood and Marrow Transplant 
Clinical Trials Network Data and 
Coordinating Center (BMT CTN 
DCC) , including the Center for 
International Blood and Marrow 
Transplant Research (CIBMTR), 
the National Marrow Donor 
Program (NMDP), and the 
EMMES Corporation. 
 BMT CTN 1301 Co-Principal 
Investigators: Dr. Leo Luznik, 
Dr. Marcelo Pasquini, and Dr. 
Miguel Angel Perales. 
 
Other Organizations 
 U.S. government agencies that 
are responsible for overseeing 

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research such as the Food and 
Drug Administration (FDA) and 
the Office of Human Research 
Protections (OHRP) 
 U.S. government agencies that 
are responsible for overseeing 
public health concerns such as 
the Centers for Disease Control 
(CDC) and federal, state and 
local health departments. 
 Miltenyi Biotec, makers of the 
device that removes cells that are 
associated with the development 
of GVHD (used in Treatment 
Group A) 
 
E. Right to Refuse to Sign this 
Authorization:  
I do not have to sign this Authorization.  
If I decide not to sign the Authorization, 
I will not be allowed to participate in this 
study or receive any treatment related to 
research that is provided through the 
study.   
My decision not to sign this 
authorization will not affect any other 
treatment, payment, or enrollment in 
health plans or eligibility for benefits.   
 
F. Right to Revoke:   
I can change my mind and withdraw this 
authorization at any time by sending a 
written notice to the Principal 
Investigator to inform the researcher of 
my decision.  
If I withdraw this authorization, t he 
researcher may only use and disclose the 
protected health information already 
collected for this research study.  No 
further health information about me will 
be collected by or disclosed to the 
researcher for this study. 
 
G. Potential for Re-disclosure:  
My individual health information 
disclosed under this authorization may 
be subject to re-disclosure outside the 
research study and no longer protected. 
Examples include potential disclosures 
for law enforcement purposes, mandated 
reporting or abuse or neglect, judicial 
proceedings, health oversight activities 
and public health measures. 
 
H. This authorization does not have an 
expiration date. 
 
 
 

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Title: BMT CTN #1301: A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-
Free Interventions for Prevention of Graft-Versus-Host-Disease 
Principle Investigator: 
Name:  
 
Address: 
 
Email:  
Phone:  
Fax: 
 
 I have had the chance to ask questions, 
and understand the answers I have been 
given. I understand that I may ask 
questions at any time during the study. 
 I freely agree to be a participant in the 
study. 
 I understand that I may not directly 
benefit from taking part in the study. 
 I understand that, while information 
gained during the study may be published, 
I will not be identified and my personal 
results will stay confidential. 
 I have had the chance to discuss my 
participation in this research study with a 
family member or friend. 
 I understand that I can leave this study at 
any time, and doing so will not affect my 
current care or prevent me from receiving 
future treatment. 
 I understand that I will be given a copy of 
this signed consent form. 
 
 
 
 
______ 
               
Participant Name 
___________________________________ 
Date 
I certify that I have provided a verbal explanation of the details of the research study, including 
the procedures and risks. I believe the participant has understood the information provided. 
___________________________________ 
Name of Counseling Physician
___________________________________ 
Date
___________________________ 
Signature of Counseling Physician 
_______________________________ 
Date 
 

BMT CLINICAL TRIALS NETWORK 
 
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G-1 
APPENDIX G 
 
BMT CTN 0901 & BMT CTN 1203 CLOSURE DETAILS AND 
ETRIC 
 

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G-2 
APPENDIX G 
 
BMT CTN 0901 CLOSURE DETAILS AND ETRIC 
 
 
The BMT CTN 0901 study was a phase III, multicenter, randomized clinical trial investigating 
allogeneic HCT using standard high dose versus reduced intensity preparative chemotherapy 
regimens in patients with acute myeloid leukemia or myelodysplastic syndromes. The primary 
objective was comparison of overall survival at 18-months between the two study arms. Disease-
free survival, relapse, non-relapse mortality, complications and toxicities and quality of life were 
secondary endpoints. The trial opened for enrollment on June 2, 2011 and closed to accrual on 
April 18, 2014. Approximately 19 potentially eligible 0901 patients enrolled onto the BMT CTN 
1205 study between December 2013 and April 2014. Table G-1 outlines the patient reported 
assessments for the 1205 and 0901 studies.  
Table G-1: Patient Assessments in the BMT CTN 1205 and 0901 Studies 
Study/Instrument Administered 
by 
# of 
items 
TIME POINTS (pre and post) 
Time 
Required 
Within 
7 
business 
days 
post-
consent* 
Pre-
HCT* 
100 
days 
12 
mos 
18 
mos 
24 
mos 
5 
yrs 
1205 
 
 
 
 
 
 
 
 
 
 
Health Literacy 
 
 
 
 
 
 
 
 
 
 
- REALM 
Coordinator 
11 
X 
 
 
 
 
 
 
2 minutes 
- NVS 
Coordinator 
6 
X 
 
 
 
 
 
 
3 minutes 
Comprehension 
 
 
 
 
 
 
 
 
 
 
- QuIC (A and B) 
Self 
30 
X 
 
 
 
 
 
 
7 minutes 
- Modified DICCT 
Coordinator 
11 
X 
 
 
 
 
 
 
5 minutes 
Anxiety 
 
 
 
 
 
 
 
 
 
 
- STAI 
Self 
40 
X 
 
 
 
 
 
 
5 minutes 
Satisfaction 
 
 
 
 
 
 
 
 
 
 
- Satisfaction 
Survey 
Self 
7 
X 
 
 
 
 
 
 
5 minutes 
Information 
location 
 
 
 
 
 
 
 
 
 
 
-  Study specific 
Coordinator 
5 
X 
 
 
 
 
 
 
5 minutes 
0901 
 
 
 
 
 
 
 
 
 
 
- FACT-BMT 
Self 
37 
 
X 
X 
X 
X 
 
X 
6 minutes 
- MOS SF-36 
Self 
36 
 
X 
X 
X 
X 
 
X 
6 minutes 
- MDASI 
Self 
19 
 
X 
X 
X 
X 
 
X 
< 5 minutes 
- Global HRQoL 
Self 
4 
 
X 
X 
X 
X 
 
X 
< 1 minute 
- Occupational 
Functioning 
Self 
6 
 
X 
X 
X 
X 
 
X 
< 1 minute 
- EQ-5D 
Self 
5 
 
X 
X 
X 
X 
 
X 
1 minute 
 

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G-3 
Sample ETRIC Informed Consent Template for BMT CTN 0901 Study 
 
BMT CTN 0901 v5.0  
 
A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation 
Comparing Regimen Intensity in Patients with Myelodysplastic Syndrome or Acute 
Myeloid Leukemia 
 
 
 
 
Your Name:   
__________________________________________________ 
 
Study Title: 
BMT CTN 0901: A Randomized, Multi-Center, Phase III Study of 
Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in 
Patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia 
 
Protocol:  
 
BMT CTN #0901, version 5.0  
 
Co-Investigator: 
Bart Scott, MD 
 
 
 
Fred Hutchinson Cancer Research Center 
 
  
1100 Fairview Ave North, D1-100 
 
Seattle, WA 98109-1023 
Phone: (206) 667-1990 
 
Co-Investigator: 
Mitchell Horwitz, MD 
 
 
 
Duke University 
2400 Pratt St. DUMC 3961 
Durham, NC 27710 
Phone: (919) 668-1045 
 
Transplant Center 
Investigator:  
__________________________________________________ 
 
Sponsor: 
The National Institutes of Health (NIH) gave financial support for this 
research study through the Blood and Marrow Transplant Clinical Trials 
Network (BMT CTN).  
 
 

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G-4 
1. Introduction 
We invite you to join this clinical trial, also 
known as a research study. The main goals 
of the study are to:  
1. Compare 2 kinds of treatments used 
to destroy diseased cells and prepare 
your body for transplant. This 
process is also called a conditioning 
regimen. 
2. Measure how well your disease 
(acute myeloid leukemia or 
myelodysplastic syndrome) responds 
to the treatment.  
Combinations of chemotherapy and 
sometimes radiation are used as a treatment 
to destroy cancer cells and help donor cells 
start to grow in your bone marrow. 
Depending on the combination used, each 
treatment (or conditioning regimen) can 
have a different intensity or strength.  
 High intensity treatment uses high 
doses of chemotherapy or radiation.  
 Reduced intensity treatment uses 
lower doses of chemotherapy or 
radiation.  
Both kinds of treatments are used by stem 
cell transplant doctors around the world and 
are not experimental. Our goal is to see if 
one kind of treatment is better than the other 
for people who have a stem cell transplant to 
treat either their acute myeloid leukemia 
(AML) or myelodysplastic syndromes 
(MDS). 
If you volunteer to join this study, we will 
randomly assign you to receive either a high 
intensity or a reduced intensity treatment 
before you receive the stem cells from your 
donor.   
We believe this study will last about 18 
months for most patients who decide to 
join. About 356 patients will take part in the 
study at transplant centers around the United 
States.  
We will explain the 2 different treatments in 
this consent form. Every participating clinic 
will report their results, so we can compare 
and share the results at the end of the study. 
This consent form tells you about the study, 
its possible risks and benefits, other options 
available to you, and your rights as a 
participant in the study. Please take your 
time to make your decision.  
Everyone who takes part in research at 
[insert facility name] should know that: 
 Being in any research study is 
voluntary. 
 You may or may not benefit from 
being in the study.  Knowledge we 
gain from this study may benefit 
others. 
 If you join the study, you can quit 
the study at any time.   
 If you decide to quit the study, it will 
not affect your care at [insert name 
of facility or institution]. 
 Please ask the study staff questions 
about anything that you do not 
understand, or if you would like to 
have more information. 
 You can ask questions now or any 
time during the study. 
 Please take the time you need to talk 
about the study with your doctor, 
study staff, and your family and 

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G-5 
friends.  It is your decision to be in 
the study.  If you decide to take part, 
please sign and date the end of the 
Consent Form. 
You and your doctor will discuss other 
treatment choices if you do not want to 
participate in this study.
2.  Study Background   
This research study is sponsored by The 
National Institutes of Health (NIH) through 
the Blood and Marrow Transplant Clinical 
Trials Network (BMT CTN).  
Conditioning Regimen 
The conditioning regimen is a combination 
of chemotherapy and/or radiation given to 
patients before the donor cells are infused. 
This treatment allows donor cells to engraft 
and start growing in your bone marrow. The 
treatment also helps to kill cancer cells that 
might not be detectable.  
Different chemotherapy drugs can be used 
as part of the conditioning regimen. Some 
common combinations of chemotherapy 
drugs used for transplant are: 
 Busulfan + cyclophosphamide or 
fludarabine 
 Fludarabine + melphalan 
 Radiation + cyclophosphamide  
Each combination of chemotherapy drugs or 
radiation has a different strength. This 
strength can also be described as the 
treatment “intensity”.  
Stem cell transplant destroys cancer in two 
ways:  
1. The treatment (or conditioning 
regimen) destroys cancer cells. 
2. The immune cells from the donor 
can recognize cancer cells and kill 
them.  
High intensity treatments are also known as 
myeloablative conditioning (MAC) 
regimens. These treatments work well to 
destroy cancer cells because they use very 
high amounts of chemotherapy or radiation. 
High intensity treatments can also have 
more side effects during and after transplant.  
Using a lower or “reduced” intensity 
treatment before transplant can have fewer 
serious problems from the chemotherapy 
drugs. While the cancer killing effects may 
also be lower, studies show that immune 
cells given during the transplant can help 
destroy remaining cancer cells. Transplants 
with reduced intensity conditioning (RIC) 
regimens are often used for people who 
cannot have high doses of chemotherapy or 
radiation because of their age or other 
medical problems.  
This study will compare high intensity and 
reduced intensity treatments used to destroy 
cancer cells and prepare bone marrow for 
transplant. Our goal is to see if one kind of 
treatment is better than the other for people 
who have a stem cell transplant to treat 
either their AML or MDS. 
 
 
 

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G-6 
3.  Study Purpose  
You are invited to join this research study 
because you have AML or MDS and are 
currently being evaluated for an allogeneic 
transplant. The main goal of this study is to 
see if patients with AML or MDS have 
better results with transplants using reduced 
intensity treatment compared to high 
intensity treatment. 
4.  Right to ask Questions and/or Withdraw  
You have the right to ask questions about 
the study at any time.  If you have questions 
about your rights as a participant or you 
want to leave the study, please contact: 
[insert contact info]. 
Being in this study is voluntary.  You can 
choose to not be in this study, or leave this 
study at any time.   
If you choose to not take part or to leave this 
study, your regular medical care will not be 
affected in any way.  The conditioning 
regimen of your transplant will be the 
standard of care. If you decide to leave this 
study after taking the study treatment, or are 
asked to leave by your doctor for medical 
reasons, you will be asked to come back to 
the doctor’s office for tests for your safety 
and as part of your routine medical care.   
 Even if you withdraw from the study, the 
information collected from your 
participation will be included in the study 
evaluation, unless you specifically ask 
that it not be included. 
 Your study doctor and study staff will be 
available to answer any questions that you 
may have about your participation in, or 
your withdrawal from this study. 
 
5.  Study Treatment and Tests   
Before you join the study, we will evaluate 
your general health, medical history, and 
your current medications. 
Study Participation 
You will need to go to the clinic at least 
once before the study begins. Your 
participation in the study starts after you 
sign this consent form. After your transplant 
you will have weekly evaluations for the 
first 3 months of this study. After 3 months, 
you will have an evaluation at 6, 12 and 18 
months after your transplant.  
These evaluations will be done if you are in 
the hospital ward or clinic, or if your disease 
becomes active again after the transplant.  
Before You Start Your Treatment 
You will have at least one clinic visit before 
you begin the study. This visit will collect 
information about your: 
 Physical health (including history, 
height, weight and temperature) 
 Heart, lung and kidney function  
 Chest x-ray 
 Bone marrow biopsy and aspirate 

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G-7 
 Routine blood tests, including cell 
counts, liver and kidney function  
 Routine markers of infectious 
diseases, including hepatitis, herpes, 
HIV, syphilis, varicella zoster 
(shingles) among others 
 Pregnancy test (if it applies to you) 
 HLA type from you and your donor 
 Health quality of life for English 
speaking patients (see below) 
Randomization 
We selected 5 different treatment options 
based on the ones that are most often used 
by transplant centers. The treatment options 
are listed in Table 1.  
Your doctor will choose 1 reduced intensity 
treatment (A or B in the table below) and 1 
high intensity treatment (C, D or E in the 
table below) to use for this study. These are 
often the most commonly used at [insert 
Institution name]. A computer program will 
then assign you by chance to either the 
reduced intensity or the high intensity 
treatment option.  
You will have an equal chance of being 
placed in either group. This means that half 
of the people in the study will be in the 
reduced intensity group and half will be in 
the high intensity group.
TABLE 1: TREATMENT OPTIONS (CONDITIONING REGIMENS) 
Reduced Intensity Treatments  
 
High Intensity Treatments 
A 
Fludarabine + Busulfan (Flu/Bu) 
 
C 
Busulfan  + Fludarabine (Bu/Flu) 
B 
Fludarabine + Melphalan (Flu/Mel) 
 
D 
Busulfana + Cyclophosphamide (Bu/Cy) 
 
 
 
E 
Cyclophosphamide + Total Body 
Irradiation (Cy/TBI) 
 
__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Study Evaluations 
We will measure your health at specific 
times during your study participation. These 
tests and how often they are scheduled are 
standard for what we do for all patients 
receiving an allogeneic transplant. We 
would do them even if you were not part of 
this study. 
a.) History, physical exam and weight: 
weekly for 3 months, 6, 12 and 18 
months. 
b.) Routine blood tests, including cell 
counts, liver and kidney function: 
weekly for 3 months, 6, 12 and 18 
months.  
c.) Bone marrow biopsy and/or aspirate: at 
Day 100 and 18 months. 
d.) Graft-versus-host disease (GVHD) and 
infections monitoring: weekly for 3 
months, 6, 12 and 18 months. 
e.) Side effects or toxicity: monthly for the 
first 3 months, then at 6, 12 and 18 
months. 
f.) Blood or bone marrow tests to find out 
the proportion of donor cells present in 

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the recipient (chimerism): at 1, 3 and 18 
months.  
g.) Health quality of life for English 
speaking patients (see below): at 3, 12 
and 18 months. 
Blood Samples for Busulfan 
Pharmacokinetics 
Some transplant centers may be 
participating in this ancillary study.  
Researchers are trying to learn more about 
how your body breaks down one of the 
drugs (busulfan) given as part of the 
conditioning regimen in this study. Samples 
for this test will be collected from you only 
if you receive this drug and your transplant 
center is participating in this ancillary 
study. These tests measure how much 
busulfan is concentrated in the blood. 
Busulfan levels are already done routinely 
in some settings in order to avoid too high 
levels. Every patient can have different 
levels of this drug after receiving the same 
dose of busulfan.  
The goal of this study is to see if these 
levels can be tied to the success of the 
transplant. This study will explore the levels 
of busulfan in these 2 treatment intensities 
and compare with what happens after 
transplant.  
This study will collect up to several blood 
samples within 6 to 8 hours after a dose of 
busulfan was given to you. Each blood 
sample volume is 3mL (1/2 teaspoon). Once 
all several blood samples are collected from 
you, they will be sent to a laboratory for 
testing. None of your personal information 
will be shared with the laboratory.  
Busulfan blood tests are part of this clinical 
trial at select centers, but your center may 
repeat these as part the routine transplant 
procedure. If this happens, your doctor will 
either collect 6mL (1 teaspoon) each time as 
described above, or collect 3mL for 
research tests on another day that busulfan 
is given.  
Health Quality of Life 
We will ask you about your general health 
and how well you feel while you participate 
in this study. Even though different 
treatments may treat a disease equally well, 
there might be a difference in how patients 
feel or the side effects they have after their 
treatment. This is important information for 
when we evaluate the treatments in this 
study. 
We will collect information by using 
surveys. The surveys will ask about: 
 How you feel 
 What symptoms you might have and 
how they affect you 
 How well can you do regular daily 
activities  
You will need to fill out the surveys and 
each survey should take about 30 minutes to 
finish. Your answers will help us understand 
how your transplant treatment affects how 
you feel, what you can do, and your general 
quality of life.
   
 
 
 

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6.  Alternative Treatment 
It is your choice to join this study. If you 
decide you do not want to participate, you 
may still receive a transplant for treatment 
of your disease. It is possible that you may 
have a treatment and evaluations that are 
very similar to what would be if you joined 
this study.  
Your study doctor will discuss these choices 
with you. If you decide you do not want to 
join this research study, your medical care 
will not be affected in any way.
 
7.  Risks and Discomforts   
The risks and discomforts of stem cell 
transplant are the same if you join this study, 
or if you do not join this study. The 
differences in side effects from medications 
are because of the different levels of 
treatment strength.  
High intensity treatments usually have more 
side effects early after transplant compared 
to reduced intensity treatments. Other 
problems with transplant, such as graft-
versus-host disease (GVHD) and infections 
happen equally in patients who have high 
intensity or reduced intensity treatments.  
Risks Related to Medications or Irradiation 
Used in Conditioning Regimens  
All chemotherapy and radiation treatments 
used as conditioning in this study are 
commonly used in allogeneic stem cell 
transplantation. The side effects can 
change based on the amount of drug given. 
This is true for busulfan, which is used for 
reduced 
intensity 
and 
high 
intensity 
treatments 
but 
in 
different 
amounts.
 
 

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TABLE B-2 – ADVERSE EVENTS  
 
Cyclophosphamide 
Likely Side Effects (May 
happen in more than 20% 
of patients) 
Less Likely  
(May happen in less 
than 20% of 
patients) 
Rare  
(May happen in less 
than 2% of patients) 
 
 Damage to male 
(testes) and female 
(ovaries) sex glands 
 Diarrhea 
 Fluid retention 
 Hair loss 
 Infertility 
 Irregular or no 
menstrual cycles 
 Loss of appetite  
 Nausea, Vomiting 
 Suppression of the 
immune system 
 Bleeding in the 
bladder 
 Inflammation 
of the heart 
muscle (heart 
failure) 
 Shortness of 
breath 
 Allergic reaction 
 Lung fibrosis 
 Serious skin 
rashes 
 
Fludarabine 
Likely Side Effects (May 
happen in more than 20% 
of patients) 
Less Likely  
(May happen in less 
than 20% of 
patients) 
Rare  
(May happen in less 
than 2% of patients) 
 
 Diarrhea 
 Mouth sores  
 Nausea and vomiting 
 Suppression of the 
immune system 
 Fever 
 Numbness in 
the extremities 
 Sleepiness 
 Visual changes 
 Weakness 
 Coma 
 Cough 
 Inflammation of 
the lung 
 Interstitial 
Pneumonia 
 Skin rash 
 
 
 

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Busulfan 
Likely Side Effects (May 
happen in more than 20% 
of patients) 
Less Likely  
(May happen in less 
than 20% of 
patients) 
Rare  
(May happen in less 
than 2% of patients) 
 
 Abdominal 
discomfort 
 Constipation 
 Diarrhea 
 Dizziness 
 Fluid retention 
 Headache 
 Heartburn 
 Insomnia 
 Lack of appetite 
 Mouth sores  
 Nausea and vomiting 
 Running nose 
 Skin rashes 
 Irregular or no 
menstrual cycles 
 Tachycardia 
 Cough 
 Hepatic Veno-
occlusive 
Disease  
 High blood 
pressure 
 High 
magnesium 
and 
phosphorus 
levels in the 
blood 
 High sugar 
levels in the 
blood 
 Infertility 
 Low blood 
pressure 
 Seizures 
 Cataracts 
 Lung fibrosis 
 
 
Melphalan 
Likely Side Effects (May 
happen in more than 20% 
of patients) 
Less Likely  
(May happen in less 
than 20% of 
patients) 
Rare  
(May happen in less 
than 2% of patients) 
 
 Constipation 
 Diarrhea 
 Hair loss 
 Mucositis 
 Nausea and vomiting 
 Heart rhythm 
abnormalities 
 Hepatitis 
 Kidney failure 
 Allergic reaction 
 Interstitial 
Pneumonia 
 Seizure 
 Lung fibrosis 
 
 
 

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Total Body Irradiation (TBI) 
 
Likely 
(“Likely” refers to a side effect that 
is expected to occur in more than 
20% of patients) 
Less Likely 
(“Less likely” refers to 
a side effect that is 
expected to occur in 
20% or fewer patients) 
Rare 
(These possible risks have 
been reported in rare 
occurrences, typically less 
than 2% of patients. They may 
be serious if they occur) 
 Diarrhea 
 Nausea 
 Stomach cramps 
 Vomiting (throwing up) 
 Painful swelling of the salivary 
glands under the ears for a few 
days 
 Short-term hair loss 
 Anemia 
 Infection 
 Bleeding 
 Cataracts 
 Sterility (inability to have 
children) 
 Slow growth 
 Hormone problems (such as 
thyroid disease or diabetes) 
 Mouth sores  
 Lung 
inflammation  
 Pneumonia 
 Redness of the 
skin 
 Serious liver 
problems 
 Risk of developing other 
cancers in the future 
 Difficulty swallowing 
 Back problems  
 Kidney problems 
 Learning problems 
 
Risks Related to the Medication Used to 
Help Prevent Graft-versus-Host Disease 
(GVHD) 
Graft-versus-Host Disease (GVHD) is a 
medical condition that can become serious 
enough to cause death. GVHD is a common 
development after allogeneic stem cell 
transplant. It happens when the donor cells 
attack and damage your organ tissues after 
transplant. GVHD can cause:  
 Skin rashes  
 Feeling sick to your stomach 
(nausea) 
 Throwing up (vomiting) 
 Abdominal pain 
 Diarrhea  
 Liver damage or jaundice (yellowing 
of the skin or eyes)   
Your doctor will prescribe medication to 
prevent GVHD. You will start GVHD 
prevention around the time you get your 
donor cells, and it can last many months 
after the transplant. These medications do 

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not completely prevent GVHD and more 
drugs might be needed to manage this 
complication.  
Your doctor will decide which GVHD 
prevention treatment is the best choice for 
you. This decision is not part of the research 
study. Your doctor will also decide your 
medications based on what is regularly used 
for transplant in this hospital or clinic. 
Below is a list of commonly-used drugs 
used to prevent GVHD. Your doctor may 
choose to use other medications than what is 
listed here.  
a) Tacrolimus:  This drug is used to try 
to prevent GVHD. Early side effects 
you may have include: feeling sick to 
your stomach (nausea) or throwing 
up (vomiting) after you swallow. 
Other side effects include high blood 
pressure (hypertension), shaking 
hands (tremor), increased hair 
growth and possibly how clearly you 
can think or make decisions (mental 
function).   
If you have these effects, they 
generally go away if your doctor 
lowers the amount of medication you 
take.  A few patients have had a 
seizure while on these medications.   
Your liver or kidneys might not work 
as well as they did before. If this 
happens, your doctor may lower the 
amount of drug you take or stop 
giving the drug completely. You 
might be more likely to have kidney 
problems if you need to take other 
medications at the same time. This is 
especially true for drugs that we 
know might cause kidney problems, 
such as antibiotics.  Sometimes, the 
kidney damage caused is serious 
enough for you to need an artificial 
kidney machine (hemodialysis). 
Some patients given tacrolimus 
develop diabetes and must take 
insulin while taking tacrolimus. 
It is very important that you do 
not eat grapefruit or drink 
grapefruit juice. Grapefruit has an 
ingredient called begamottin, 
which can affect some the 
treatment drugs, including 
tacrolimus, used in this study. 
Common soft drinks that have 
bergamottin are Fresca, Squirt, and 
Sunny Delight.  
b.) Methotrexate:  This is also a 
medication used to try to prevent 
GVHD.  Methotrexate causes 
damage to cells and can affect many 
different parts of your body.  It may 
cause mouth sores or mouth 
inflammation. Or if you already have 
these problems from your treatments 
and other medications, they can get 
worse.   
Methotrexate may slow down the 
recovery of blood cells after 
transplantation.  Methotrexate can 
also cause kidney damage. If your 
kidneys are already damaged for 
other reasons, it can make your 
kidneys worse. If kidney damage 
does happen, your doctor might give 
you a lower dose of methotrexate, or 
stop giving it completely. 
c.) Tacrolimus and Methotrexate:  
These medications can affect your 
body’s immune system and make it 

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easier for you to get infections.  Even 
simple infections can become very 
serious and even life-threatening. As 
a result, you might have more 
infections for several months after 
transplant, especially viral infections 
and pneumonia. 
Risks Related to the Transplant 
Procedure 
The following risks are part of the transplant 
process and not connected to any one 
medication or the transplanted donor cells. 
a) Bleeding: Platelets help your blood 
to clot. When you have low amounts 
of platelets, you may have bleeding 
problems. Once your new bone 
marrow starts to grow, your platelets 
will increase and your blood will 
start to clot normally again.  
Bleeding problems can range from 
minor bleeding, such as nosebleeds 
or bruising, to more serious bleeding 
in your brain and lungs. Serious 
bleeding can be very dangerous and 
can happen if your platelet levels 
stay low. Usually, we can prevent 
major bleeding problems with 
transfusions of platelets.  However, 
if your body does not respond well to 
transfused platelets, you may be at 
serious risk for bleeding.  
b) Veno-occlusive Disease (VOD): 
High dose chemotherapy, irradiation 
therapy and medications used to 
prevent GVHD can cause Veno-
occlusive Disease (VOD). VOD 
causes severe damage to the liver.  
Symptoms include jaundice 
(yellowing of the skin and eyes), 
weight gain, and extra fluid build-up 
in the belly (abdominal cavity) and 
other parts of the body. We can 
usually manage veno-occlusive 
disease very well, to the point where 
it goes away. However, 
complications can happen with VOD 
that may put your life in danger. 
c) Mouth Sores and Diarrhea: The 
large doses of chemotherapy and 
radiation cause irritation in the lining 
of the mouth and intestines. This can 
result in painful mouth sores and 
diarrhea.  If you have severe mouth 
sores, we will give you medicine to 
help control the pain. If your mouth 
sores are very bad, you may not be 
able to eat normally until the sores 
are healed. Mouth sores get better 
when your white blood count starts 
to rise, and your donor cells start to 
grow (also called engraftment). 
d) Capillary Leak Syndrome: This 
can happen from your chemotherapy 
and radiation treatments.  The blood 
vessels may become ‘leaky’ and 
fluid enters your abdomen, lungs, 
and other tissues.  You may gain 
water weight and not go to the 
bathroom as often as you normally 
do. Capillary leak syndrome can be 
difficult to manage if extra fluid 
enters your lungs and makes it hard 
to breathe. You may die if fluid 
continues to build up in your lungs.  
e) Unexpected Organ Damage and 
Other Side Effects: You might have 
unexpected, life-threatening heart, 
lung, kidney, or liver damage as a 
result of your transplant. High doses 

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of chemotherapy and radiation can 
cause very bad lung damage that 
may not get better with time or 
medications. If this happens, you 
may need to use oxygen or even a 
respirator. The lung damage may get 
worse and be life-threatening. 
Rarely, multiple organ failure (such 
as lung and kidney failure) can 
happen, which can lead to death. 
f) Fluid Build-up: We will give you 
intravenous (IV) fluids during the 
transplant process and it can be hard 
for your body to eliminate this fluid. 
We will also give you Furosamide, 
which is a medication that can help 
your body get rid of the extra fluid. 
One risk of Furosamide is hearing 
loss. Some side effects may be loss 
of body chemicals such as potassium 
and sodium. 
g) Late Effects: You may have side 
effects happen a few months to many 
years after your transplant.   
 You may have problems with 
your thyroid gland that require 
you to take thyroid medication.   
 You may get cataracts earlier in 
life compared to a person who 
has not had a transplant.  If you 
develop cataracts (cloudiness in 
the eyes) they may need 
treatment.  
 Your kidneys could be affected 
and cause anemia (low red blood 
cell count) or high blood 
pressure.   
 You may develop a second 
cancer as a result of the 
chemotherapy, radiation and/or 
underlying disease. If secondary 
cancers happen they generally do 
not develop until 10 to15 years 
after your transplant.   
 We do not know the long-term 
effects of transplant on your 
heart, lungs and brain. 
Unforeseen Risks 
New risks might appear at any time during 
the study that are different from the risks 
listed in this Consent Form. We will 
promptly tell you of any new information 
that may affect your decision to participate. 
Risk to the unborn: 
The treatments in this study have NOT been 
proven to be safe at any stage of pregnancy. 
Therefore, if you are pregnant or nursing, 
you are not eligible for this study. Women 
who have the potential of becoming 
pregnant must use some form of effective 
birth control while receiving chemotherapy, 
TBI, and GVHD prophylaxis. Effective birth 
control is defined as the following: 
  Refraining from all acts of vaginal 
intercourse (abstinence) 
  Consistent use of birth control pills 
   Injectable birth control methods 
(Depo-Provera, Norplant) 
   Tubal sterilization or male partner 
who has undergone a vasectomy 
   Placement of an IUD (intrauterine 
device) 
   Use, with every act of intercourse, 
of a diaphragm with contraceptive 
jelly and/or condoms with 
contraceptive foam.  

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Sterility and future child bearing 
potential for men and women.  
Chemotherapy and/or sterility or irradiation 
may affect your ability to have children. 
Male patients may become sterile (unable to 
produce sperm) and should discuss with 
their doctor regarding sperm banking prior 
to transplantation. Female patients who have 
attained puberty may find that their 
menstrual cycle become irregular or stops 
permanently. However, this DOES NOT 
MEAN THAT YOU CANNOT BECOME 
PREGNANT, and you must use some 
effective method of birth control during 
transplant and afterwards until you are off 
GVHD prophylaxis. Damage to 
reproductive tissue may result in infertility 
(inability to have children). It is not known 
if the damage could result in birth defects. 
You should discuss these risks and options 
in detail with your doctor before entering 
this study.  
 
 
 
 
8.  Possible Benefits  
Taking part in this study may or may not 
make your health better compared to 
receiving the transplant through your routine 
medical care. We do know that the 
information from this study will help doctors 
learn more about selection of conditioning 
regimen intensities. This information could 
help patients in the future who are in need of 
an allogeneic transplant. 
 
9.  What if I Change my Mind  
You can change your mind at any time about 
allowing us to use your samples and health 
information for research. We ask that you 
contact [Principal Investigator] in writing 
and let him/her know you do not want us to 
use your research samples or health 
information for research. His/her mailing 
address is on the first page of this form.   
 
If you withdraw yourself from this protocol, 
even if you allowed your samples to be used 
for research, your samples will not be used 
from that point and they will be discarded. 
However, samples and information that have 
already been shared with other researchers 
cannot be taken back or destroyed.  
 
10.  New Information Available During the Study  
During this research study, new information 
about the study drug or the risks and benefits 
of the study may become known to the study 
doctors.  If this happens, they will tell you 
about the new information.   
The new information may mean that you can 
no longer participate in the study, or that you 
may not want to continue in the study.  If this 
happens, the study doctor will stop your 
participation in the study and you will be 

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G-17 
offered all available care to suit your needs 
and medical conditions. 
 
 
11.  Privacy, Confidentiality and Use of Information   
Your confidentiality is one of our main 
concerns. We will do our best to make sure 
that the personal information in your medical 
record and research records remains 
confidential. We will not discuss or publish 
information about your health with any 
unauthorized person or persons. However, we 
cannot guarantee total privacy.   
Your personal information may be given out 
if required by law. If information from this 
study is published or presented at scientific 
meetings, your name and other personal 
information will not be used. Your study 
number is not related to your name, social 
security number or medical record number at 
[insert facility name]. 
A description of this clinical trial will be 
available on http://www.clinicaltrials.gov/, as 
required by U.S. Law. This Web site will not 
include information that can identify you. At 
most, the Web site will include a summary of 
the results. You can search this Web site at 
any time.  
Information about your transplant from your 
original medical records may be seen or sent 
to national and international transplant 
registries, including:  
 The Center for International Blood and 
Marrow Transplant Research (CIBMTR) 
 The National Marrow Donor Program 
(NMDP) 
 The Food and Drug Administration 
(FDA) 
 The National Institutes of Health (NIH), 
which include the National Heart, Lung, 
and Blood Institute (NHLBI) and the 
National Cancer Institute (NCI) 
 Data Coordinating Center of the Blood 
and Marrow Transplant Clinical Trials 
Network (BMT CTN) and  
 Other authorized study organizations.   
We will not identify you by name in any 
publications or reports that come from these 
organizations or groups. 
 
12.  Ending Your Participation   
The study doctor or the study sponsor may 
stop the study at any time, and you may be 
asked to leave the study. We may ask you to 
leave the study if you do not follow 
directions or if you suffer from side effects 
of the treatment.   
The study sponsor may decide to end the 
study at any time. If you are asked to leave 
the study, the reasons will be discussed with 
you. 
Possible reasons to end your participation in 
this study include: 
 You do not meet the study requirements.   
 You need a medical treatment not 
allowed in this study. 

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G-18 
 The study doctor decides that it would 
be harmful to you to stay in the study. 
 You are having serious side effects. 
 You become pregnant. 
 You cannot keep appointments or take 
study drugs as directed. 
 The study is stopped for any reason. 
 
13.  Physical Injury as a Result of Participation
It is important to tell your study doctor, 
__________________ [investigator's 
name(s)] or study staff if you feel that you 
have been injured from taking part in this 
study. You can tell the doctor in person or call 
him/her at __________________ [telephone 
number].  
You will get medical treatment if you are 
injured as a result of taking part in this study.  
You and/or your health plan will be charged for 
this treatment.   
This study will not pay for medical treatment. 
In case of injury resulting from this study, you 
do not lose any of your legal rights to seek 
payment by signing this form.
 
14.  Compensation or Payment
You will not be paid for your participation in 
the research study. You will not get 
compensation or reimbursement for any extra 
expenses (travel, meals, etc.) you may have 
through your participation on this trial.
 
15.  Costs and Reimbursement
Most of the visits for this research study are 
standard medical care for patients undergoing 
allogeneic transplants and will be billed to 
your insurance company.  You and/or your 
health plan/insurance company will need to 
pay for some or all of the costs of standard 
treatment in this study.   
You or your insurance will not be charged for 
the busulfan blood samples required for the 
study or the optional blood sample for 
research on this study.
16.  Ethical Review 
The ethical aspects of this research study have been reviewed and approved by [name of IRB]. 

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G-19 
17.  Further Information 
If you need any information about this study, or 
if you have any problems while you are 
participating in this study you can contact the 
study doctor or his/her staff.  They may be 
contacted at the telephone numbers listed 
below. 
[Insert name and contact details].
 
 
Independent Contact 
If you wish to speak to someone not directly 
involved in the study, or if you have any 
complaints about any aspect of the project, the 
way it is being conducted or any questions 
about your rights as a research participant, then 
you may contact:  
[Insert appropriate contact details].
_
Health Insurance Portability and 
Accountability Act 1 (HIPAA3) 
Authorization to use and disclose 
individual health information for research 
purposes 
A. Purpose:   
As a research participant, I authorize the 
Principal Investigators and the 
researcher’s staff to use and disclose my 
individual health information for the 
purpose of conducting the research study:  
A Randomized, Multi-Center, Phase III 
Study of Allogeneic Stem Cell 
Transplantation Comparing Regimen 
Intensity in Patients with Myelodysplastic 
Syndrome or Acute Myeloid Leukemia 
B. Individual Health Information to be 
Used or Disclosed:  
                                                 
3 HIPAA is the Health Insurance Portability and 
Accountability Act of 1996, a federal law related to 
privacy of health information 
My individual health information that may 
be used or disclosed to do this research 
includes:  
 Demographic information (for 
example: date of birth, sex, weight).  
 Medical history (for example: 
diagnosis, complications with prior 
treatment). 
 Findings from physical exams. 
 Laboratory test results obtained at the 
time of work up and after transplant 
(for example: blood tests, biopsy 
results).  
C. Parties Who May Disclose My 
Individual Health Information:  
The researcher and the researcher’s staff 
may collect my individual health 
information from: 
[List hospitals, clinics or providers from 
which health care information can be 
requested]. 

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D. Parties Who May Receive or Use My 
Individual Health Information:  
The individual health information 
disclosed by parties listed in item C and 
information disclosed by me during the 
course of the research may be received 
and used by the following parties: 
 Principal Investigator and the 
researcher’s staff 
Dr. Bart Scott, Co-Principal 
Investigator  
Dr. Mitchell Horwitz, Co-Principal 
Investigator  
 National Heart, Lung, and Blood 
Institute (NHLBI) and the National 
Cancer Institute (NCI), both of the 
National Institutes of Health (NIH),  
 Study sponsors  
Blood and Marrow Transplant Clinical 
Trials Network (BMT CTN), Data 
Coordinating Center 
 U.S. government agencies that are 
responsible for overseeing research 
such as the Food and Drug 
Administration (FDA) and the Office 
of Human Research Protections 
(OHRP) 
 U.S. government agencies that are 
responsible for overseeing public 
health concerns such as the Centers 
for Disease Control (CDC) and 
federal, state and local health 
departments. 
E. Right to Refuse to Sign this 
Authorization:  
I do not have to sign this Authorization.  
If I decide not to sign the Authorization, I 
will not be allowed to participate in this 
study or receive any treatment related to 
research that is provided through the 
study.   
My decision not to sign this authorization 
will not affect any other treatment, 
payment, or enrollment in health plans or 
eligibility for benefits.   
F. Right to Revoke:   
I can change my mind and withdraw this 
authorization at any time by sending a 
written notice to the Principal Investigator 
to inform the researcher of my decision. 
If I withdraw this authorization, the 
researcher may only use and disclose the 
protected health information already 
collected for this research study.  No 
further health information about me will 
be collected by or disclosed to the 
researcher for this study. 
G. Potential for Re-disclosure:  
My individual health information 
disclosed under this authorization may be 
subject to re-disclosure outside the 
research study and no longer protected. 
Examples include potential disclosures for 
law enforcement purposes, mandated 
reporting or abuse or neglect, judicial 
proceedings, health oversight activities 
and public health measures. 
H. This authorization does not have an 
expiration date.

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G-21 
18.  Blood Samples for Future Research (Optional)
Researchers also want to learn how to better 
predict possible health problems and how to 
make transplants more successful.  Much of 
this research is done using human tissue or 
blood.   
We would like to store a sample of your 
blood for use in future research studies.  
Your blood would be collected at your 
transplant center before your transplant.  We 
would keep the sample at a central place 
called the BMT CTN Research Sample 
Repository (this will be called the 
“Repository” in the rest of the consent 
form).  A Repository is a place that protects, 
stores and sends out samples for approved 
research studies.   
Some general things you should know about 
letting us store your blood samples for 
research are: 
 We will only store samples from 
people who give us permission.  You 
should feel free to talk over your 
decision with your family, friends, 
doctor, and health care team.  If you 
decide to not let us store research 
samples now or in the future, it will 
not affect your medical care.  
 Research is meant to gain knowledge 
that may help people in the future.  
You will not get any direct benefit 
from taking part.  
 All testing done on your blood is for 
research purposes.  You or your 
doctor will not be given results and 
they will not be added to your 
medical record. 
 You will not get paid for any 
samples or for any products that may 
be developed from current or future 
research. 
If you agree to provide a blood sample, here 
is what will happen: 
 
1. A single 6 mL sample of your blood 
(approximately 1 teaspoon) will be 
collected before your transplant and 
stored solely for research purposes.  
The collection will be done at the 
same time as the routine blood 
collection done for the study. 
2. The research sample will be given 
unique bar code designation that 
cannot be linked to you by the 
researcher testing your samples.  
3. Researchers can apply to study the 
materials stored in the Repository.  
4. Materials stored in the Repository 
will be used mainly by clinicians and 
researchers in the BMT CTN 
network.  In the future, the remaining 
research samples and clinical data 
will be made available outside of this 
network.  Researchers from other 
universities, the government, and 
drug or health-related companies can 
apply to use the samples and 
information.  Only skilled 
researchers will be allowed to use the 
samples and information. 

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G-22 
5. The BMT CTN Steering Committee 
or the BMT CTN Biomarkers 
Committee must approve each study 
application before they will share 
samples or information with 
researchers.  This kind of review is 
to make sure that the investigators 
requesting the samples are qualified, 
and that the research they propose 
has a high potential of success and 
for contribution of scientific 
knowledge. 
6. DNA from your stored blood sample 
might be used in genome-wide 
association (GWA) or 
pharmacogenomics studies for a 
future project either done or 
supported by the National Institutes 
of Health (NIH). Genome-wide 
association studies are a way for 
scientists to identify genes involved 
in human disease.  This method 
searches the genome for small 
genetic changes that are more 
common in people with a particular 
disease than in people without the 
disease. Each study can look at 
hundreds of thousands of genetic 
changes at the same time. 
Researchers use data from this type 
of study to find genes that may add 
to a person’s risk of developing a 
certain disease.  Pharmacogenomics 
studies are similar genetic tests but 
look specifically at genes related to 
how the body breaks down 
medications.  
If your coded samples are used in 
such a study, the researcher is 
required to add your test results and 
sample information into a shared, 
public research database.  This 
public database is called the NIH 
Genotype and Phenotype Database 
and it is managed by the National 
Center for Biotechnology 
Information (NCBI).  The NCBI will 
never have any information that 
would identify you, or link you to 
your information or research 
samples.  
7. A new federal law (2009), called the 
Genetic Information 
Nondiscrimination Act (GINA) 
generally makes it illegal for health 
insurance companies, group health 
plans, and employers of 15 or more 
persons to discriminate against you 
based on your genetic information.  
Health insurance companies and 
group health plans may not request 
your genetic information that we get 
from this research.  This means that 
they must not use your genetic 
information when making decisions 
regarding insurability.  Be aware that 
this new federal law will not protect 
you against genetic discrimination by 
companies that sell life insurance, 
disability insurance, or long-term 
care insurance. 
 

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Statement of consent 
The purpose of storing blood samples, the 
procedures involved, and the risks and 
benefits have been explained to me.  I have 
asked all the questions I have at this time 
and I have been told whom to contact if I 
have more questions.  I have been told that 
I will be given a signed copy of this consent 
form to keep. 
I understand that I do not have to allow the 
use of my blood for research.  If I decide to 
not let you store research samples now or 
in the future, it will not affect my medical 
care in any way. 
 
 
 
 
 
I voluntarily agree that my blood, tissue 
and information can be stored indefinitely 
by the BMT CTN and/or NHLBI 
Repositories for research to learn about, 
prevent, or treat health problems.  I also 
understand that my DNA and health 
information may or may not be used in 
genome-wide association studies. 
 
 I agree to allow my blood samples to be 
stored for research. 
 I do not agree to allow my blood 
samples to be stored for research. 
 
 
 
 
 
 
 
 
Signature 
 
 
Date

BMT CLINICAL TRIALS NETWORK 
 
ETRIC – Protocol 1205 
Version 5.0 dated July 27, 2016 
 
 
G-24 
 
TITLE: 
A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell 
 
Transplantation Comparing Regimen Intensity in Patients with Myelodysplastic 
 
Syndrome or Acute Myeloid Leukemia 
PROTOCOL NUMBER: BMT CTN #0901 
CO-INVESTIGATOR: 
 
Bart Scott, MD 
Fred Hutchinson Cancer Research Center 
1100 Fairview Ave North, D1-100 
 
Seattle, WA 98109-1023 
Phone: (206)  
CO-INVESTIGATOR: 
 
Mitchell Horwitz, MD 
Duke University 
2400 Pratt St. DUMC 3961 
Durham, NC 27710 
Phone: (919) 668-1045 
 
 I have read and understood this Consent 
Form.  The nature and purpose of the 
research study has been explained to me. 
 I understand that the treatment intensity 
will be randomly assigned to me. 
 I have had the chance to ask questions, 
and understand the answers I have been 
given.  I understand that I may ask 
questions at any time during the study. 
 I freely agree to be a participant in the 
study. 
 I understand that I may not directly 
benefit from taking part in the study. 
 I understand that, while information 
gained during the study may be 
published, I will not be identified and 
my personal results will stay 
confidential. 
 I have had the chance to discuss my 
participation in this research study with a 
family member or friend. 
 I understand that I can leave this study at 
any time, and doing so will not affect my 
current care or prevent me from 
receiving future treatment. 
 I understand that I will be given a copy 
of this signed Consent Form. 
 
________________________ 
 
 
 
 
 
 
 
 
Participant Signature  
 
Print Name 
 
 
 
Date 
 
I certify that I have provided a verbal explanation of the details of the research study, including 
the procedures and risks.  I believe the participant has understood the information provided. 
______________________________________________________ 
Signature of Counseling Physician 
 
       
Date 
 
 
 
 
 
 
                               
    
Signature of Interpreter 
 
 
 
Date 
 

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G-28 
BMT CTN 1203 CLOSURE DETAILS AND ETRIC 
The BMT CTN 1203 study was a phase II, multicenter, randomized clinical trial investigating 
whether any of three new GVHD prophylaxis approaches improved the rate of GVHD and 
relapse free survival at one year after allogeneic transplant in patients with acute leukemia, 
chronic myelogenous leukemia, myelodysplasia, chronic lymphocytic leukemia/small 
lymphocytic lymphoma, follicular lymphoma, marginal zone lymphoma, Hodgkin’s Lymphoma, 
diffuse large B cell lymphoma, or mantle cell lymphoma. The primary objective was comparison 
of one year GVHD/relapse or progression-free survival (GRFS) after hematopoietic stem cell 
transplantation (HSCT) between each of three novel GVHD prophylaxis approaches and a 
contemporary control from the Center for International Blood and Marrow Transplant Research 
(CIBMTR) database. Rates of grade II-IV and III-IV acute GVHD, visceral acute GVHD, 
chronic GVHD, immunosuppression-free survival at one year, hematologic recovery (neutrophil 
and platelet), donor cell engraftment, disease relapse or progression, transplant-related mortality, 
rates of Grade > 3 toxicity according to the Common Terminology Criteria for Adverse Events 
(CTCAE) Version 4.0, incidence of infections, immune reconstitution, and overall survival were 
secondary endpoints. The trial opened for enrollment on September 17, 2014 and closed to 
accrual on May 13, 2016. Approximately 100 potentially eligible 1203 patients enrolled onto the 
BMT CTN 1205 study between November 2014 and May 2016. Table G-2 outlines the patient 
reported assessments for the 1205 and 1203 studies.  
Table G-2: Patient Assessments in the BMT CTN 1205 and 1203 Studies 
Study/Instrument Administered 
by 
# of 
items 
TIME POINTS (pre and post) 
Time 
Required 
Within 
7 
business 
days 
post-
consent* 
Pre-
HCT* 
100 
days 
12 
mos 
18 
mos 
24 
mos 
5 
yrs 
1205 
 
 
 
 
 
 
 
 
 
 
Health Literacy 
 
 
 
 
 
 
 
 
 
 
- REALM 
Coordinator 
11 
X 
 
 
 
 
 
 
2 minutes 
- NVS 
Coordinator 
6 
X 
 
 
 
 
 
 
3 minutes 
Comprehension 
 
 
 
 
 
 
 
 
 
 
- QuIC (A and B) 
Self 
30 
X 
 
 
 
 
 
 
7 minutes 
- Modified DICCT 
Coordinator 
11 
X 
 
 
 
 
 
 
5 minutes 
Anxiety 
 
 
 
 
 
 
 
 
 
 
- STAI 
Self 
40 
X 
 
 
 
 
 
 
5 minutes 
Satisfaction 
 
 
 
 
 
 
 
 
 
 
- Satisfaction 
Survey 
Self 
7 
X 
 
 
 
 
 
 
5 minutes 
Information 
location 
 
 
 
 
 
 
 
 
 
 
-  Study specific 
Coordinator 
5 
X 
 
 
 
 
 
 
5 minutes 

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G-29 
Sample ETRIC Informed Consent Template for the BMT CTN 1203 Study 
 
BMT CTN 1203, v3.0 
 
A Multi-center Phase II Trial Randomizing Novel Approaches for Graft-
versus-Host Disease Prevention Compared to Contemporary Controls 
 
 
 
Your Name:  
________________________________ 
 
 
Study Title:  
A Multi-center Phase II Trial Randomizing Novel Approaches for Graft-
versus-Host Disease Prevention Compared to Contemporary Controls 
 
Protocol: 
 
BMT CTN #1203 
 
Principal 
Investigator:   
Insert local PI information 
 
 
Sponsor:   
The National Institutes of Health (NIH) is sponsoring this study by 
providing financial support through the Blood and Marrow Transplant 
Clinical Trials Network (BMT CTN).  
 
 
 

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1. Introduction 
We invite you to join this clinical trial, also 
known as a research study. You are being 
asked to join because you have a disease that 
can be treated with an allogeneic transplant 
and you have a matched related or unrelated 
peripheral blood stem cell donor.  
We are doing this study to find a way to 
prevent Graft-versus-Host-Disease 
(GVHD). GVHD is a possible side effect of 
allogeneic transplant and can be very 
serious. 
For this study, the type of allogeneic 
transplant you will get is called a peripheral 
blood stem cell (PBSC) transplant. Your 
doctor also wants to use a reduced-intensity 
or non-myeloablative conditioning 
regimen for your transplant. 
(See section 2: Study Background for a 
definition of the bolded terms.) 
We will use 3 drug combinations to see 
which one, if any, is better at preventing 
GVHD than the current standard of care. 
The 3 drug combinations are:   
 Tacrolimus, methotrexate, and 
bortezomib 
 Tacrolimus, methotrexate and 
maraviroc  
 Tacrolimus, mycophenolate mofetil 
and cyclophosphamide  
This study will take at least 2 years and will 
include 270 participants. Your participation 
will last about 1 year.  
This Consent Form will tell you about the 
purpose of the study, the possible risks and 
benefits, other options available to you, and 
your rights as a participant in the study.  
Everyone who takes part in research at 
[insert facility name] should know that: 
 Being in any research study is 
voluntary. 
 You may or may not benefit from 
being in the study.  Knowledge we 
gain from this study may benefit 
others. 
 If you join the study, you can quit 
the study at any time.  
 If you decide to quit the study, it will 
not affect your care at [insert name 
of facility or institution]. 
 Please ask the study staff questions 
about anything that you do not 
understand, or if you would like to 
have more information. 
 You can ask questions now or any 
time during the study. 
 Please take the time you need to talk 
about the study with your doctor, 
study staff, and your family and 
friends. It is your decision to be in 
the study. If you decide to join, 

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please sign and date the end of the 
Consent Form. 
You and your doctor will discuss other 
treatment choices if you do not want to 
participate in this study.  
 
2. Study Background 
The National Institutes of Health (NIH), 
through the Blood and Marrow Transplant 
Clinical Trials Network (BMT CTN), are 
providing staff support and money for this 
research study. The BMT CTN and the NIH 
will make decisions about how to manage 
the study.  
For this study, you will receive a type of 
allogeneic transplant called peripheral blood 
stem cell (PBSC) transplant. Your doctor 
also wants to use a reduced-intensity or non-
myeloablative conditioning regimen for your 
transplant. 
An allogeneic transplant uses blood-
making cells from a family member or an 
unrelated donor to remove and replace your 
abnormal blood cells. With a peripheral 
blood stem cell (PBSC) transplant, the 
donor cells come from his or her blood 
stream.  
The conditioning regimen is the 
chemotherapy and radiation used to destroy 
the diseased cells before you get your donor 
cells. A reduced-intensity or non-
myeloablative conditioning regimen uses 
lower doses of chemotherapy or radiation.  
Graft-versus-Host-Disease (GVHD) is a 
common side effect of allogeneic transplant. 
It is a medical condition that can become 
very serious.   
GVHD happens because of differences 
between your own immune cells (host) and 
the immune cells from your donor (graft). 
Your new immune system, or the donated 
cells, might see your cells as foreign and 
attack them.  
GVHD can cause:  
 Skin rashes 
 Nausea (feeling sick to your 
stomach) 
 Vomiting (throwing up) 
 Diarrhea 
 Liver damage 
 Hepatitis or jaundice  
 Increased risk of infection
 
 

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3. Study Purpose  
We are inviting you to take part in this study 
because you have a cancer of the blood or 
lymph glands and an allogeneic transplant is 
a treatment option for you. We are doing 
this study to learn more about preventing 
GVHD. 
We will use 3 drug combinations to see 
which one, if any, is better at preventing 
GVHD than the current standard of care 
(Table 1). The current standard of care is a 
combination of drugs called tacrolimus and 
methotrexate.  
Table 1: Treatment Groups (Study Drug Combinations) 
Treatment Group A 
Treatment Group B 
Treatment Group C 
 Tacrolimus 
 Methotrexate 
 Bortezomib 
 Tacrolimus 
 Methotrexate  
 Maraviroc 
 
 Tacrolimus, 
 Mycophenolate Mofetil 
 Cyclophosphamide 
 
The current standard of care for preventing 
GVHD (tacrolimus and methotrexate) is not 
available on this study. If you want the 
current standard of care, be sure to let your 
doctor know (see Section 7: Alternative 
Treatments).  
The study results will be compared to the 
standard of care. This study will help 
doctors make the best choices about which 
drugs work best to prevent GVHD. 
 
4. Rights to Ask Questions and/or Withdraw 
You have the right to ask questions about the 
study at any time. If you have questions about 
your rights as a participant or you want to 
leave the study, please contact:  
[insert contact info] 
Being in this study is voluntary. You can 
choose not to be in this study or leave this 
study at any time. If you choose not to take 
part or leave this study, it will not affect 
your regular medical care in any way.  
Your study doctor and study staff will be 
available to answer any questions that you 
may have about taking part in or leaving this 
study.  

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5. Study Treatment and Tests 
We will check your health before you start 
treatment, while you receive treatment, and 
for 1 year after transplant.   
Before You Start Your Treatment  
You will need to have several check-ups and 
tests to see if you can be in the study. These 
check-ups and tests are part of your regular 
cancer care. They would be done even if you 
were not part of this study. These tests 
include: 
 Medical history 
 Physical exam, height and weight 
 Blood and urine tests 
 Heart function tests 
 Lung (pulmonary) function tests 
 Cancer re-staging test to see how 
much cancer you have (if needed) 
 Bone marrow tests if you have acute 
leukemia, chronic myelogenous 
leukemia, or myelodysplastic 
syndrome. These tests are called 
aspirates or biopsies. Samples of 
your marrow will be taken from your 
hip bone with a large needle.  
 Imaging studies if you have 
lymphoma   
 Chest X-ray or chest CT 
 A pregnancy test (if you are a woman 
able to have children) 
Randomization  
We will use a computer program to assign 
you by chance to 1 of 3 treatment groups. 
You won’t be able to choose your group. 
Once you are assigned to a group, you can’t 
change to the other groups. The study doctor 
can’t change your group either. You will have 
an equal chance of being placed in 1 of the 3 
groups.  
During Your Treatment   
Conditioning Regimen Before Transplant 
The conditioning regimen is the 
combination of chemotherapy and radiation 
you will receive before you get your donor 
cells. This helps the donor cells start to grow 
and make new cells in your bone marrow 
(engraft). It also helps to kill cancer cells. 
Your doctor will choose from 1 of several 
conditioning regimens to prepare your body 
for transplant. The regimens are:  
 Fludarabine and busulfan 
 Fludarabine and melphalan 
 Fludarabine and cyclophosphamide 
 Fludarabine and Total Body Irradiation 
(TBI), or 
 Fludarabine, cyclophosphamide, and 
TBI 

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Your doctor will decide which conditioning 
regimen you will receive before you are 
assigned to one of the three (3) treatment 
groups (study drug combinations).  
Reinfusion of Peripheral Blood Stem Cells 
(Transplant) 
On your transplant day (Day 0), the donor 
cells (stem cells) will be given to you 
through your catheter, like a blood 
transfusion. The cells will travel to your 
bone marrow where they will start to make 
healthy, new blood cells. 
GVHD Prevention Drugs 
You will be given different combinations of 
drugs to prevent GVHD. Some drugs will be 
given to you before your transplant and some 
after. You will be randomized (assigned by 
chance) to 1 of 3 treatment groups. 
Treatment Group A: Tacrolimus, 
methotrexate and bortezomib 
If you are assigned to Treatment Group A, 
we will give you tacrolimus as a pill or by 
intravenous infusion (IV) beginning 3 days 
before your transplant. We will give you less 
and less until we stop it completely. This 
can take several months. 
After your transplant, we will give you 
methotrexate by IV on Days 1, 3, 6, and 11. 
We will give you bortezomib as a shot (or 
IV push) on Days 1, 4 and 7 after your 
transplant. 
Treatment Group B: Tacrolimus, 
methotrexate and maraviroc group 
If you are assigned to Treatment Group B, 
we will give you tacrolimus as a pill or by 
IV beginning 3 days before your transplant. 
We will give you less and less until we stop 
it completely. This can take several months. 
After your transplant, we will give you 
methotrexate by IV on Days 1, 3, 6, and 11. 
We will give you maraviroc beginning 3 
days before your transplant. It will be given 
to you as a pill to take 2 times a day. You 
will continue to take it 2 times every day for 
30 days after your transplant. 
Treatment Group C: Tacrolimus, 
mycophenolate mofetil and 
cyclophosphamide group 
If you are assigned to Treatment Group C, 
we will give you tacrolimus beginning Day 
5. It will be given as a pill or by IV. We will 
give you less and less until we stop it 
completely. This can take several months.  
We will give you mycophenolate mofetil 
beginning Day 5. It will be given as a pill or 
by IV 3 times a day. You will continue to 
take it 3 times a day for 30 days. Your 
doctor might decide that you have to 
continue taking this drug if you have signs 
of GVHD.  
On Days 3 and 4 after your transplant, we 
will give you cyclophosphamide by IV. It 
will take about 1-2 hours.  
Health Evaluations 
We will test (evaluate) your health during 
the study. These tests and how often they are 
scheduled are standard care for patients 
receiving an allogeneic transplant. They 

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would be done even if you were not part of 
this study. You will be watched closely for 
any signs and symptoms of GVHD.  
Health Evaluations After Transplant 
 Physical exam to look for toxicities, 
and infections weekly until Day 63 
and then at Days 100, 120, 150, 180, 
270 and 365. 
 Physical exam to assess GVHD 
weekly starting Day 7 until Day 63, 
and then at Days 100, 120, 150, 180, 
270 and 365. 
 Routine blood tests (cell counts, liver 
and kidney function) weekly until 
Day 63 and then at Days 100, 180, 
270 and 365. 
 Blood or bone marrow tests to find 
the amount of donor cells in your 
body on Days 28 and 100. This is 
also called chimerism. 
 Disease evaluation tests to see how 
much cancer you have after 
treatment on Day 100, 180 and 365. 
 Lung (pulmonary) function tests on 
Day 365. 
 Optional blood samples for future 
research on Days 35, 100, 180 and 
365  (see Section 18: Blood 
Samples for Future Research). 
6. Risks and Discomforts 
The risks and discomforts of stem cell 
transplant are the same if you join this study, 
or if you don’t join this study. Your health 
care team may give you drugs to help ease 
side effects, such as feeling sick to your 
stomach (nausea). In some cases, side 
effects can be long-lasting or never go away.  
Risks and Toxicities Related to Medications  
All immune suppressive drugs, except for 
bortezomib and maraviroc, are commonly 
used in allogeneic transplant. 
Table 1- Risks and Side Effects 
Likely 
What it means: This type of side effect is expected to occur in more than 
20% of patients. This means that 21 or more patients out of 100 might get 
this side effect. 
Less Likely 
What it means: This type of side effect is expected to occur in 20% of 
patients or fewer. This means that 20 patients or fewer out of 100 might 
get this side effect. 
Rare, but 
Serious 
What it means: This type of side effect does not occur very often – in 
fewer than 2% of patients – but is serious when it occurs. This means that 
1 or 2 patients (or fewer) out of 100 might get this side effect. 

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Bortezomib (Velcade®) – GVHD prevention drug 
 
Likely 
Less Likely 
Rare, but Serious 
 Anemia (low red blood 
cell count) 
 Thrombocytopenia (low 
platelet count and 
increased risk of 
bleeding) 
 Feeling weak and 
uncomfortable  
 Feeling tired 
Fever, with shaking 
chills 
 Weight loss because of 
loss of appetite (not 
feeling hungry) 
 Constipation  
 Diarrhea 
 Nausea (feeling sick to 
your stomach) 
 Vomiting (throwing up) 
 Stomach pain 
 Pain , numbness and 
tingling in hands and 
feet 
 Neutropenia (low white 
blood cell count and risk of 
infection) 
 Insomnia (trouble sleeping) 
 Skin rash 
 Low blood pressure 
 Arrhythmia (changes in 
heart beat) that causes you 
to feel light-headed, dizzy, 
faint, or short of breath 
 Chest pain 
 Heartburn 
 Bleeding in stomach or 
lungs 
 Blood in urine 
 Pneumonia and bronchitis 
(lung infection) 
 Confusion  
 Anxiety (feeling worried 
and nervous) 
 Painful sores in the mouth 
or throat 
 Changes in the way things 
taste 
 Abnormal liver tests 
 Blurred vision 
 
 Redness and swelling in the 
eye 
 Aches and pain and 
 Coughing up blood 
 Posterior reversible 
encephalopathy syndrome 
(PRES) (Headache, 
confusion, seizures and 
vision loss caused by very 
high blood pressure that 
comes on quickly) 
 Hepatitis (swelling of the 
liver) and liver failure 
 Pancreatitis (swelling of the 
intestines, stomach, or 
pancreas) 
 Pleural effusion (swelling 
and fluid build-up in and 
around the lungs) 
 Pericarditis (swelling or 
fluid build-up in and around 
the heart)  
 Hearing loss  
 Bleeding in the brain 
 Loss of some or all vision in 
one or both eyes 
 Encephalopathy (brain 
disorder that can lead to death 
 Allergic reactions that cause 
swelling of the skin, face or 
throat 
 Rash with skin peeling and 
mouth sores that can lead to 
death 
 Pain, redness, swelling and 

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Likely 
Less Likely 
Rare, but Serious 
weakness in arms and legs 
muscles, joints and the bone 
in the arms and legs 
 Muscle weakness 
 Cough 
 Shortness of breath 
 Headache 
 Nose bleeds 
 Changes in blood sugar 
 Low potassium and sodium 
in your blood 
 Increase in calcium in your 
blood 
 Flu-like symptoms such as 
chills, sore throat, runny 
nose and sinus and throat 
infections 
 Edema (swelling or fluid 
build-up in the arms and 
legs, feeling dizzy and 
gaining weight) 
 Shingles (Herpes virus)  
 New or worsening heart 
failure 
 Infections of the bladder, 
sinuses, throat, stomach and 
intestines and skin 
 Fungal infections in the 
mouth and throat 
 
Life-threatening infections 
in the blood 
infection at the injection site 
for bortezomib  
 Pain in the mouth and throat 
when swallowing 
 Intestinal obstruction  
 Fast death of cancer cells. 
This might let toxins 
(poisons) into the blood and 
hurt organs such as the 
kidneys 
 
Severe muscle weakness and 
paralysis 
 
 
 

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Cyclophosphamide (Cytoxan®) – GVHD prevention drug 
 
Likely 
Less Likely 
Rare, but Serious 
 Neutropenia (low white blood 
cell count and increased risk of 
infection) 
 Temporary hair loss 
 Nausea (feeling sick to your 
stomach) 
 Vomiting (throwing up) 
 Loss of appetite 
 Sores in mouth or on lips 
 Diarrhea 
 Stopping of menstrual periods 
in women 
 Low sperm production in men 
 Thrombocytopenia (low platelet 
count and increased risk of 
bleeding) 
 Anemia (low red blood 
cell count) 
 Temporary tiredness 
 Damage to the fetus if 
you become pregnant 
while taking drug 
 Stomach pain 
 Skin rash 
 Bleeding in bladder 
 
 Scarring of lung tissue, 
with cough and 
shortness of breath 
 Severe heart muscle 
injury and death (at 
very high doses) 
 Second cancers 
 
 
 
 

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Maraviroc (Selzentry®) – GVHD prevention drug 
 
Likely 
Less Likely 
Rare, but Serious 
 Fever, cough and 
flu-like symptoms 
 Rash and redness 
of the skin 
 Upper respiratory 
(lung) infections 
 
 Fever 
 Feeling dizzy 
 Insomnia (trouble sleeping) 
 Anxiety (feeling worried and 
nervous) 
 Depression  
 Itching 
 Benign (not cancer) skin tumors 
 High blood pressure 
 Loss of appetite 
 Constipation 
 Neutropenia (low white blood counts 
and increased risk of infections) 
 Joint pain 
 Sweating a lot 
 Nerve damage (causing numbness, 
tingling, and burning) 
 Muscle pain 
 Bladder discomfort 
 Acne 
 Abnormal liver tests 
 Herpes infections 
 Eye infections or inflammation 
(redness and swelling) 
 Trouble breathing  
 Genital warts 
 Change in body fat  
 Loss of consciousness 
(fainting) 
 Rash covering the whole 
body 
 Allergic reactions that 
can cause liver damage 
and jaundice (yellow 
skin) 
 
 
 

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Methotrexate – GVHD prevention drug 
 
Likely 
Less Likely 
Rare, but Serious 
 Neutropenia (low white 
blood cell count and 
increased risk of infection) 
 Feeling tired 
 Infections 
 
 Nausea (feeling sick to your 
stomach) 
 Vomiting (throwing up) 
 Irritation or sores in the 
throat or mouth 
 Diarrhea 
 Stomach pain  
 Fever 
 Chills 
 Anemia (low red blood cell 
count) 
 Abnormal liver tests 
 Kidney failure 
 Feeling dizzy 
 Scarring of the lungs 
 
 
 
 

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Mycophenolate Mofetil (MMF, Cellcept®) – GVHD prevention drug 
 
Likely 
Less Likely 
Rare, but Serious 
 Miscarriage (unborn baby dies in 
uterus) 
 Birth defects 
 Damage to unborn baby 
 Less effective birth control pills 
(you could get pregnant while 
taking your birth control pills) 
 Diarrhea 
 Stomach pain 
 Nausea (feeling stick to your 
stomach)  
 Vomiting (throwing up) 
 Headache 
 Tremors (shaking) 
 Neutropenia (low white blood 
cell count and increased risk of 
infection) 
 High cholesterol 
 Thrombocytopenia (low platelet 
count and increased risk of 
bleeding) 
 Swelling of the hands, feet, 
ankles, or lower legs 
 Anemia (low red 
blood cell count) 
 Body rash 
 Insomnia (trouble 
sleeping)  
 Feeling dizzy 
 Trouble breathing 
 Abnormal bruising 
 Fast heartbeat 
 Feeling very tired 
 Weakness 
 Blood in stool  
 Blood in vomit 
 Change in vision 
 Encephalopathy (brain 
disorder  that can lead to 
death) 
 Second cancers 
 
 
 
 
 

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Tacrolimus (FK506, Prograf®) – GVHD prevention drug 
 
Likely 
Less Likely 
Rare, but Serious 
 Kidney problems 
 Loss of magnesium, calcium, 
potassium 
 High blood pressure 
 Tremors (shaking) 
 High cholesterol and 
triglyceride 
 Thrombocytopenia (low platelet 
count and increased risk of 
bleeding) 
 Infections 
 
 Nausea (feeling sick to 
your stomach) 
 Vomiting (throwing up) 
 Liver problems 
 Foggy thinking 
 Insomnia (trouble 
sleeping) 
 Unwanted hair growth 
 Confusion 
 Seizures 
 Changes in vision 
 Feeling dizzy 
 Pure red cell aplasia. 
(Your body stops 
making red blood cells. 
This could lead to 
anemia.)  
 
It is very important that you do not eat 
grapefruit or drink grapefruit juice while 
taking Tacrolimus. Grapefruit has an 
ingredient called bergamottin, which can 
affect some of the treatment drugs used in 
this study. Common soft drinks that have 
bergamottin are Fresca, Squirt, and Sunny 
Delight.  
Risks and Toxicities Related to Transplant 
The following problems may happen 
because of your transplant. These risks may 
happen if a transplant was done as part of 
the study or not. The risks are:  
Slow recovery of blood counts. The red 
blood cells, white blood cells, and platelets 
can be slow to recover after blood or 
marrow transplant. Until your blood counts 
recover, you will need blood and platelet 
transfusions, and will be at risk for bleeding 
and infections. To speed the recovery of the 
white cells as much as possible you will 
receive Filgrastim.   
Graft failure. The stem cells (the “graft”) 
may fail to grow inside your body. Past 
experience suggests that there can be up to a 
10-15% chance of graft failure. If graft failure 
occurs, this may result in low blood counts for 
a long period of time. If your counts do not 
recover, you may need to receive a second 
transplant. Graft failure can be fatal. 
Graft-Versus-Host Disease (GVHD). 
GVHD results from cells in the graft 
recognizing your body as foreign and 
attacking it. In most cases, GVHD can be 
successfully treated. Sometimes GVHD is 

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severe or difficult to treat and may lead to 
death. You will be watched closely for this 
complication and given drugs to prevent 
and/or treat it.  
Acute GVHD may produce skin rash, nausea, 
vomiting, diarrhea, abdominal pain, 
abnormalities of liver function, and an 
increased risk of infection. Chronic GVHD 
may produce skin rashes, hair loss, thickened 
dry skin, dry eyes, dry mouth, liver disease, 
weight loss, diarrhea, and an increased risk of 
infection. To confirm the diagnosis of acute 
or chronic GVHD, you may be asked to have 
a biopsy (a small sample of your tissue to 
look at under the microscope) of your skin, 
gut, or, rarely, your liver.  
Other complications may include: 
a. Damage to the vital organs in your 
body. The transplant could cause 
problems in any body organ such as the 
heart, lungs, liver, gut, kidneys and 
bladder, or brain. The kidneys and the 
liver are most likely to be damaged. Some 
patients will experience serious lung 
problems from infections or the 
chemotherapy and radiation.  
b. Serious infections. Full and complete 
recovery of your immune system may 
take many months. During this time, there 
is an increased risk of infections.  You 
will be prescribed certain drugs to reduce 
the chance of those infections. However, 
these treatments do not always work. If 
you have an infection, you may have to 
stay in the hospital longer or be re-
hospitalized after transplant. Although 
most infections can be successfully 
treated, some infections may result in 
death.  
c. Relapse of disease or a new blood 
cancer. Your leukemia or lymphoma may 
come back even if the transplant is 
initially successful. In rare cases, a new 
blood cancer may develop from the donor 
cells. Cyclophosphamide can cause 
damage to blood cells, which may result 
in a blood cancer such as 
myelodysplastic syndrome (MDS) or 
acute myeloid leukemia (AML). The 
blood cancer usually develops 2-10 
years after treatment, or 6 years on 
average. The risk of developing a new 
blood cancer after allogeneic blood or 
marrow transplant is probably less than 
2%. If cancer develops in your donor’s 
blood cells, you may require additional 
treatment with chemotherapy or another 
blood or marrow transplant. 
d. Risk to the unborn. The treatments in 
this study have not been proven to be safe 
at any stage of pregnancy. Therefore, if 
you are pregnant or nursing, you are not 
eligible for this study. Women who can 
become pregnant must use effective birth 
control while receiving chemotherapy, 
TBI, and drugs to prevent GVHD, and for 
1 year after transplant. Effective birth 
control is defined as the following:  
1. Refraining from all acts of vaginal sex 
(abstinence) 
2. Consistent use of birth control pills 
3. Injectable birth control methods  
(Depo-Provera, Norplant) 

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4. Tubal sterilization or male partner 
who has undergone a vasectomy 
5. Placement of an IUD (intrauterine 
device) 
6. Use of a diaphragm with contraceptive 
jelly and/or condoms with contraceptive 
foam every time you have sex. 
Reproductive Risks 
The drugs used in this research study may 
damage your reproductive organs, affect your 
ability to have children or possibly cause birth 
defects if you take them while you are 
pregnant. It is important that a woman is not 
pregnant or breast-feeding and does not 
become pregnant during the course of the 
study.  
It is important that both women who can 
become pregnant and their male partners 
use birth control for 1 year after transplant 
while on this study. 
If you are a woman and can become 
pregnant, you will need to take a pregnancy 
test before you start the study. You should 
discuss ways to prevent pregnancy while 
you are in the study. Women who have gone 
through puberty may find that their 
menstrual cycle becomes irregular or stops 
permanently. This does not mean that you 
cannot become pregnant. You must still use 
an effective method of birth control during 
your transplant and continue until you are 
finished with your GVHD prevention 
treatment.  
If you are a man, your body may not be able 
to produce sperm (become sterile). You 
should talk with your doctor about banking 
your sperm before having a transplant.  
Please check with your doctor to understand 
more about these risks. 
Additional Information about Bortezomib 
(Velcade®) 
 The effect of Velcade® on reproduction 
and its safety in pregnancy are unknown. 
If you are a woman capable of becoming 
pregnant [anyone who has not 
undergone a hysterectomy (removal of 
the womb), has not had both ovaries 
removed or has not been post-
menopausal (stopped menstrual periods) 
for more than 24 months in a row], you 
must have a negative pregnancy test 
before beginning treatment. In addition, 
you must not be breastfeeding a baby 
during this study. 
 
 If you think that you have become 
pregnant or may have fathered a child 
while taking part in this study you must 
tell the study doctor immediately. The 
study doctor will advise you of the 
possible risks to your unborn baby and 
discuss options for managing the 
pregnancy with you. You should also 
notify the doctor managing your 
pregnancy that the mother/father 
received a study drug called Velcade®. 
 
 If you are a woman and you become 
pregnant during your participation in this 
study, your treatment with Velcade® will 

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be stopped and you may be withdrawn 
from some of the study procedures but 
not from follow-up by your study doctor. 
The study doctor will ask for your 
permission to stay in contact with you 
throughout the length of the pregnancy. 
 
 If you are a man and your partner 
becomes pregnant, the study doctor will 
ask for your partner’s permission to 
collect information about her pregnancy 
and the health of the baby. 
 
 Laboratory tests show that Velcade® 
may damage DNA. Based on this 
information, it is possible that Velcade® 
may cause infertility in men and women. 
Additional Information about MMF 
 MMF could be damaging to an unborn 
baby if you are pregnant or become 
pregnant while receiving the drug.  
 MMF can make birth control pills less 
effective and increase your chances of 
becoming pregnant while you are taking 
it. 
 If you could become pregnant, you must 
use 2 effective forms of birth control for 
4 weeks before starting MMF, during 
treatment, and for 1 year after transplant. 
 If you think you might be pregnant or 
could be become pregnant prior to 
enrollment, you should not join this 
study. 
Unforeseen Risks  
New risks might appear at any time during 
the study. These risks might be different 
from what is listed in this Consent Form. 
We will promptly tell you about new 
information that may affect your decision to 
take part in the study. We may learn new 
things about reduced-intensity transplants that 
might make you want to stop being in the 
study. We will let you know if this happens 
and you can decide if you want to continue in 
the study.  
Other Treatments or Medications 
Some medicines react with each other, and it 
is important that you tell the study doctor or 
staff about any other drugs, treatments, or 
medicines you are taking. This includes 
over-the-counter drugs, vitamins and herbal 
treatments.  
It is also important that you tell the study 
staff about any changes to these medications 
during your participation in the study. 
For more information about risks and side 
effects, ask your study doctor. 
 
 
 

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7. Alternative Treatments
Participation in this study is optional. If you 
choose not to take part, you may still receive 
an allogeneic transplant to treat your disease. 
The treatment and evaluations you would 
receive could be very similar to what would 
receive if you join this study.  
Your study doctor will talk with you about 
your options. If you decide not to participate 
in this study, your medical care will not be 
affected in any way. 
Your other choices may include: 
 An allogeneic transplant, including the 
standard drugs that are used to prevent 
GVHD (standard of care) 
 Treatment with other drugs, radiation, or 
a combination of drugs and radiation 
without a transplant 
 An allogeneic transplant that is not part 
of the study, or another type of 
transplant 
 Participation in another clinical trial, if 
available (check with your doctor) 
 No treatment for your blood cancer at 
this time 
 Comfort care. 
Every treatment option has benefits and 
risks. Talk with your doctor about your 
treatment choices before you decide if you 
will take part in this study.
8. Possible Benefits 
Taking part in this study may or may not 
make your health better. The information 
from this study will help doctors learn more 
about drugs used to prevent GVHD. It could 
also help people with a blood cancer that may 
need a transplant in the future.
9. New Information Available During the Study 
 
During this research study, the study doctors 
may learn about new information about the 
study drugs or the risks and benefits of the 
study. If this happens, they will tell you about 
the new information. The new information 
may mean that you can no longer participate 
in the study, or that you may not want to 
continue in the study.  
If this happens, the study doctor will stop 
your participation in the study and will offer 
you all available care to meet your needs  
and medical conditions. 
 
 

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10. Privacy, Confidentiality and Use of Information 
Your confidentiality is one of our main 
concerns. We will do our best to make sure 
that the personal information in your 
medical record is kept private. However, we 
cannot guarantee total privacy.  
All your medical and demographic (such as 
race and ethnicity, gender and household 
income) information will be kept private and 
confidential.  
[Name of Transplant Center] and the 
organizations listed below will not disclose 
your participation by any means of 
communication to any person or 
organization, except by your written request, 
or permission, or unless required by federal, 
state or local laws, or regulatory agencies.  
Individuals authorized by the organizations 
below will have access to your research and 
medical information. They may use this 
information for inspections or audits to 
study the outcomes of your treatment, or for 
required reporting to regulatory authorities 
(such as to the FDA for serious adverse 
events). In agreeing to participate, you 
consent to such inspections and to the 
copying of parts of your records, if required 
by these organizations 
 The Center for International Blood 
and Marrow Transplant Research 
(CIBMTR) 
 The National Marrow Donor Program 
(NMDP) 
 The Food and Drug Administration 
(FDA) 
 The National Institutes of Health 
(NIH), which include the National 
Heart, Lung, and Blood Institute 
(NHLBI) and the National Cancer 
Institute (NCI) 
 Data and Coordinating Center of the 
Blood and Marrow Transplant 
Clinical Trials Network (BMT CTN)  
 Millennium Pharmaceuticals, Inc., 
supplier of bortezomib 
We will not identify you by name in any 
publications or reports that come from these 
organizations or groups. 
Information that does not include personally 
identifiable information about this clinical 
trial has been or will be submitted, at the 
appropriate and required time, to the 
government-operated clinical trial registry 
data bank, which contains registration, 
results, and other information about 
registered studies.   
This data bank can be accessed by you and 
the general public at 
www.ClinicalTrials.gov.  Federal law 
requires clinical trial information for certain 
clinical trials to be submitted to the data 
bank. 
For questions about access to your medical 
records, please contact: 
[Insert name and phone number]. 

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11.  Ending Your Participation 
Being in this study is voluntary. You can 
choose to not be in this study, or leave this 
study at any time. If you choose not to take 
part or leave this study, your regular medical 
care will not be affected in any way. Tell 
your doctor if you are thinking about 
stopping or decide to stop. He or she will tell 
you how to stop safely. 
The study doctor or the study sponsor may 
stop the study at any time, and we may ask 
you to leave the study.  We may ask you to 
leave the study if you do not follow 
directions or if you suffer from side effects 
of the treatment.  If we ask you to leave the 
study, the reasons will be discussed with 
you.  Possible reasons to end your 
participation in this study include: 
 You do not meet the study 
requirements.  
 You need a medical treatment not 
allowed in this study. 
 The study doctor decides that it 
would be harmful to you to stay in 
the study. 
 You are having serious side effects. 
 You become pregnant. 
 You cannot keep appointments or 
take study drugs as directed. 
 The study is stopped for any reason. 
If you decide to leave this study after taking 
the study treatment, or are asked to leave by 
your doctor for medical reason, you will 
need to come back to the doctor’s office for 
tests for your safety. Even if you leave the 
study, the information collected from your 
participation will be included in the study 
evaluation, unless you specifically ask that it 
not be included. 
12.  Physical Injury as a Result of Participation  
  
It is important that you tell your doctor, 
[investigator's name(s)] or study staff if you 
feel that you have been injured because of 
taking part in this study.  You can tell the 
doctor in person or call him/her at  [telephone 
number]. 
You will get medical treatment if you are 
injured as a result of taking part in this 
study. You and/or your health plan will be 
charged for this treatment. The study will 
not pay for medical treatment.  
In case of injury resulting from this study, you 
do not lose any of your legal rights to seek 
payment by signing this form. 
 
 
 

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13.  Compensation or Payment 
 
You will not be paid for your participation in 
the research study. You will not be 
compensated or reimbursed for any extra 
costs (travel, meals, etc.) from taking part in 
this study. Taking part in this study might 
help researchers make products to sell. 
Millennium Pharmaceuticals, Inc. 
(manufacturer of bortezomib) or others may 
profit from these products. You will not 
have any rights to the patents or discoveries 
that could happen from this research, and 
you will not receive any payments from it. 
 
 
14.  Costs and Reimbursements 
 
Most of the visits for this research study are 
standard medical care for your allogeneic 
transplant and will be billed to your insurance 
company. You and/or your health 
plan/insurance company will need to pay for 
some or all of the costs of standard treatment 
in this study.   
You or your insurance will not be charged for 
tests that are only done for research on this 
study. 
The drug bortezomib is being provided by the 
manufacturer (Millennium Pharmaceuticals, 
Inc.), free of charge. The drug maraviroc is 
being provided by the study, free of charge. 
Some health plans will not pay these costs for 
people taking part in studies. Check with your 
health plan or insurance to find out if they 
will pay.  
For questions about your costs, financial 
responsibilities, and/or medical insurance 
coverage for your transplant and this study, 
please contact /Center/Financial Counselor at 
/Number/. 
For more information on clinical trials and 
insurance coverage, you can visit the 
National Cancer Institute’s Web site at 
http://cancer.gov/clinicaltrials/understanding
/insurance-coverage.  You can print a copy 
of the “Clinical Trials and Insurance 
Coverage” information from this Web site. 
Another way to get the information is to call 
1-800-4-CANCER (1-800-422-6237) and 
ask them to send you a free copy. 
 
 

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15.  Ethical Review 
The ethical aspects of this research study have 
been reviewed and approved by [name of 
IRB]. 
 
 
 
 
 
 
16.  For More Information  
 
If you need more information about this 
study, or if you have problems while taking 
part in this study, you can contact the study 
doctor or his/her staff.  They can be reached 
at the telephone numbers listed here: 
[Insert name and contact details] 
 
 
17.  Contact Someone about Your Rights 
 
If you wish to speak to someone not directly 
involved in the study, or if you have any 
complaints about any aspect of the project, 
the way it is being conducted or any questions 
about your rights as a research participant, 
then you may contact:  
[Insert appropriate contact details] 
For questions about your rights while taking 
part in this study, call the __________[name 
of center] Institutional Review Board (a 
group of people who review the research to 
protect your rights) at __________________ 
(telephone number). 
 
 
 

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18.  Blood Samples for Future Research (Optional) 
 
This section of the Consent Form is about 
future research studies that will use blood 
samples from people who are taking part 
in the main study.  
You can choose to give blood samples for 
the future research studies if you want to. 
You can still be a part of the main study 
even if you say “no” to giving blood 
samples for future research studies. Please 
mark your choice at the end of this section. 
Researchers are trying to learn more about 
how the human body processes the drugs 
used for transplant and how the body 
recovers after transplant. This research is 
meant to gain knowledge that may help 
people in the future and make transplants 
even more successful.  
If you agree to provide blood samples, here 
is what will happen: 
a) We would like to have five (5) small 
blood samples for future research.  If 
you agree, these samples will be 
drawn before you begin the 
conditioning regimen for your 
transplant (3 teaspoons or 16 mL), 
and at 4 different times after your 
transplant: on Days 35, 100, 180 and 
365 (10 teaspoons or 40 mL each). 
These samples will be kept and may 
be used in research to learn more 
about immune reconstitution, 
GVHD, cancer and other diseases.   
 
b) The blood samples will be sent to the 
BMT CTN Repository for processing 
and storage. A repository is a place 
that protects, stores and sends out 
samples for approved research 
studies. All research samples will be 
given a bar code that cannot be 
linked to you by future researchers 
testing your samples. A link to this 
code does exist. The link is stored at 
the Data and Coordinating Center for 
the Blood and Marrow Transplant 
Clinical Trials Network (BMT CTN 
DCC). The staff at the Repository 
where your sample is being stored 
does not have a link to this code. 
Your research samples will continue 
to be stored at the BMT CTN 
Repository until they are used up for 
approved research. 
c) These samples will be kept and may 
be used in research to learn more 
about immune recovery, GVHD, 
cancer and other diseases. When the 
samples are given to investigators for 
research, no information about your 
name, address, phone number or 
other information that will let the 
researcher know who you are will be 
provided. 
 
DNA from your stored blood 
samples might be used in genome-
wide association (GWA) studies for 
a future project either done or 
supported by the National Institutes 

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of Health (NIH).  Genome-wide 
association studies are a way for 
scientists to find genes that have a 
role in human disease or treatment. 
Each study can look at hundreds of 
thousands of genetic changes at the 
same time. 
 
If your coded samples are used in 
such a study, the research is required 
to add your test results and sample 
information into a public research 
database. This public database is 
called the NIH Genotype and 
Phenotype Database and it is 
managed by the National Center for 
Biotechnology Information (NCBI).  
The NCBI will never have any 
information that would identify you, 
or link you to your information or 
research samples, although the 
results of genetic studies could 
theoretically include identifying 
information about you.  
Benefits: 
The research that may be done with your 
blood is not designed specifically to help 
you. The benefits of research using blood 
include learning more about what causes 
GVHD, cancer and other diseases, how to 
prevent them, and how to treat them.  
Risks: 
There is a small risk of an infection or 
fainting from the blood draw.  
A possible risk is the loss of confidentiality 
about your medical information. We will do 
our best to make sure that your personal 
information will be kept private. The chance 
that this information will be given to 
someone else is very small.  
Some general things to think about when 
letting us store your blood samples for 
research are:  
1. The choice to let us have blood 
samples for future research is up to 
you. No matter what you decide to 
do, it will not affect your care.  
 
If you decide now that your blood 
can be kept for research, you can 
change your mind at any time. Just 
contact your study doctor and let him 
or her know that you do not want us 
to use your blood sample. Then any 
blood that remains will no longer be 
used for research.  
 
2. In the future, people who do research 
on these blood samples may need to 
know more about your health. While 
the study doctor or others involved in 
running this study may give the 
researchers reports about your 
health, it will not give them your 
name, address, phone number, or any 
other information that will let the 
researchers know who you are.  
 
Sometimes blood is used for genetic 
research (about diseases that are 
passed on in families). Even if your 
blood is used for this kind of 
research, the results will not be put in 
your health records.  

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3. Your blood will be used only for 
research and will not be sold. The 
research done with your blood may 
help to develop new products in the 
future. Reports about research done 
with your blood will not be given to 
you or your doctor.  These reports 
will not be put in your health record. 
The research will not have an effect 
on your care.  
Genetic Information Nondiscrimination 
Act: 
A new federal law (2009), called the Genetic 
Information Nondiscrimination Act (GINA), 
generally makes it illegal for health 
insurance companies, group health plans, 
and employers of 15 or more persons to 
discriminate against you based on your 
genetic information. Health insurance 
companies and group health plans may not 
request your genetic information that we get 
from this research.  
This means that they must not use your 
genetic information when making decisions 
about your insurance. Be aware that this new 
federal law will not protect you against 
genetic discrimination by companies that 
sell life insurance, disability insurance, or 
long-term care insurance. 
We ask that you contact [Principal 
Investigator] in writing and let him/her 
know you do not want us to use your 
research samples or health information for 
research. His/her mailing address is on the 
first page of this form. However, samples 
and information that have already been 
shared with other researchers cannot be 
taken back or destroyed.  
Making Your Choice:  
Please read each sentence below and think 
about your choice. After reading each 
sentence, please indicate your choice below. 
If you have any questions, please talk to 
your doctor or nurse, or call our research 
review board at ___________________.  
No matter what you decide to do, it will not 
affect your care. 
You can change your mind at any time 
about allowing us to use your samples and 
health information for research. 
 
 

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Statement of Consent for Blood Samples for Future Research (Optional)
The purpose of storing blood samples, the 
procedures involved, and the risks and 
benefits have been explained to me. I have 
asked all the questions I have at this time and 
I have been told whom to contact if I have 
more questions. I have been told that I will be 
given a signed copy of this consent form to 
keep. I understand that I do not have to allow 
the use of my blood and for research. If I 
decide to not let you store research samples 
now or in the future, it will not affect my 
medical care in any way.
I voluntarily agree that a blood samples may 
be collected and that my blood and related 
information can be stored indefinitely by the 
BMT CTN Repository for research to learn 
about, prevent, or treat GVHD, cancer, or 
other health problems. I also understand that 
my DNA and health information may or may 
not be used in genome-wide association 
studies.  
 
 
 
 I do agree to give blood samples for future research. 
 I do not agree to give blood samples for future research. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
 
Date 
 
 

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Health Insurance Portability and 
Accountability Act 1 (HIPAA1) 
Authorization to use and disclose 
individual health information for 
research purposes 
A. Purpose:   
As a research participant, I authorize the 
Principal Investigators and the 
researcher’s staff to use and disclose my 
individual health information for the 
purpose of conducting the research 
study:  
A Multi-Center Phase II Trial 
Randomizing Novel Approaches for 
Graft-versus-Host Disease 
Prevention Compared to 
Contemporary Controls 
B. Individual Health Information to be 
Used or Disclosed:  
My individual health information that 
may be used or disclosed to do this 
research includes:  
 Demographic information (for 
example: date of birth, sex, weight).  
 Medical history (for example: 
diagnosis, complications with prior 
treatment). 
 Findings from physical exams. 
 Laboratory test results obtained at 
the time of work up and after 
transplant (for example: blood tests, 
biopsy results).  
C. Parties Who May Disclose My 
Individual Health Information:  
The researcher and the researcher’s staff 
may collect my individual health 
information from: 
[List hospitals, clinics or providers from 
which health care information can be 
requested]. 
D. Parties Who May Receive or Use My 
Individual Health Information:  
The individual health information 
disclosed by parties listed in item c and 
information disclosed by me during the 
course of the research may be received 
and used by the following parties: 
Principal Investigator and the 
researcher’s staff: 
Dr. Javier Bolaños-Meade  
Dr. John Koreth  
Dr. Ran Reshef 
 
Study Sponsors:  
 National Heart, Lung, and Blood 
Institute (NHLBI) and the 
National Cancer Institute (NCI), 
both of the National Institutes of 
Health (NIH),  
 Blood and Marrow Transplant 
Clinical Trials Network (BMT 
CTN), Data and Coordinating 
Center 
 U.S. government agencies that 
are responsible for overseeing 

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research such as the Food and 
Drug Administration (FDA) and 
the Office of Human Research 
Protections (OHRP) 
 U.S. government agencies that 
are responsible for overseeing 
public health concerns such as 
the Centers for Disease Control 
(CDC) and federal, state and 
local health departments. 
 Millennium Pharmaceuticals, Inc., 
supplier of bortezomib. 
E. Right to Refuse to Sign this 
Authorization:  
I do not have to sign this Authorization.  
If I decide not to sign the Authorization, 
I will not be allowed to participate in this 
study or receive any treatment related to 
research that is provided through the 
study.   
My decision not to sign this 
authorization will not affect any other 
treatment, payment, or enrollment in 
health plans or eligibility for benefits.   
 
F. Right to Revoke:   
I can change my mind and withdraw this 
authorization at any time by sending a 
written notice to the Principal 
Investigator to inform the researcher of 
my decision.  
If I withdraw this authorization, t he 
researcher may only use and disclose the 
protected health information already 
collected for this research study.  No 
further health information about me will 
be collected by or disclosed to the 
researcher for this study. 
G. Potential for Re-disclosure:  
My individual health information 
disclosed under this authorization may 
be subject to re-disclosure outside the 
research study and no longer protected. 
Examples include potential disclosures 
for law enforcement purposes, mandated 
reporting or abuse or neglect, judicial 
proceedings, health oversight activities 
and public health measures. 
H. This authorization does not have an 
expiration date. 
 
 

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TITLE: BMT CTN #1203: A Multi-center Phase II Trial Randomizing Novel Approaches for 
Graft-versus-Host Disease Prevention Compared to Contemporary Controls 
PRINCIPAL INVESTIGATOR(S):  
Name:  
 
Address 
Email:  
Phone:  
Fax: 
 
 
 
 I have read and understood this Consent 
Form. The nature and purpose of the 
research study has been explained to me. 
 I have had the chance to ask questions, 
and understand the answers I have been 
given. I understand that I may ask 
questions at any time during the study. 
 I freely agree to be a participant in the 
study. 
 I understand that I may not directly 
benefit from taking part in the study. 
 I understand that, while information 
gained during the study may be 
published, I will not be identified and 
my personal results will stay 
confidential. 
 I have had the chance to discuss my 
participation in this research study with a 
family member or friend. 
 I understand that I can leave this study at 
any time, and doing so will not affect my 
current care or prevent me from 
receiving future treatment. 
 I understand that I will be given a copy 
of this signed consent form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participant Name 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
 
 
Date 
 
I certify that I have provided a verbal explanation of the details of the research study, including 
the procedures and risks.  I believe the participant has understood the information provided. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NAme of Counseling Physician 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Counseling Physician 
 
 
 
 
Date