Conditions: Leukemia, Myeloid, Acute
Keywords: Acute Myeloid Leukemia Outpatient CPX-351 Vyxeos® Leukemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

Brief summary:
This is a single-arm, single-site run-in phase (six subjects) followed by a multicenter continuation phase (114 subjects), Phase IV study. Eligible subjects will be receiving CPX-351 as their usual medical care administered according to FDA approval, as a condition for participation.

Detailed description:
This is an open-label, non-randomized study of a non-drug intervention in subjects receiving CPX-351 as their usual medical care administered according to its FDA approval. The study intervention is the application of a prescribed outpatient care model, including a nurse teacher educational program and quality of life surveys for both subjects and caregivers, in subjects who meet medical and logistical criteria. Induction therapy and medical follow-up are performed without prophylactic admission to an inpatient facility.

Arms:
arm 1: The study intervention is the application of a prescribed outpatient care model including a nurse teacher educational program and quality of life surveys for both subjects and caregivers. Induction therapy and medical follow up are performed without prophylactic admission to an inpatient facility. Subjects will also receive CPX-351 according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.

Interventions: intervention 1: Outpatient Care Model intervention 2: CPX-351
Intervention descriptions: intervention 1: Outpatient care model includes a nurse teacher educational program, scheduled outpatient visit protocol, and quality of life surveys for both subjects and caregivers. intervention 2: CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.

Protocol document:
ICF_002.pdf: 
Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Trial Partner Template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 1 of 9 
Version: MCW v 8-2-19 
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Medical College of Wisconsin and Froedtert Hospital 
INTRODUCTION TO THE INFORMED CONSENT 
 
Name of Subject: ____________________________ 
 
IIT-Michaelis: A multi-institutional, phase IV project to study the feasibility of safely managing 
patients receiving induction with liposomal daunorubicin and cytarabine (CPX-351) for acute 
myeloid leukemia (AML) in an outpatient environment 
 
Caregiver Consent 
 
Laura Michaelis, M.D. 
Department of Medicine 
Division of Hematology and Oncology 
Medical College of Wisconsin & Froedtert Hospital 
9200 W Wisconsin Ave 
Milwaukee WI 53226 
414-805-6700 
 
 
You are invited to take part in this research. You can decide whether to take part in this project 
or not. You are free to say yes or no. If there is anything that you do not understand, please ask 
questions. 
 
 
Definitions 
 
CPX-351 – also called Vyxeos, an FDA approved induction therapy for AML 
 
Induction Therapy – the first treatment given for a disease 
 
Inpatient/Outpatient – describes the location where you stay after receiving your 
treatment, in the hospital (inpatient) or at home (outpatient) 
 
Count Recovery – when the blood cell counts, including your infection-fighting cells 
and bleeding-prevention cells, return to safe levels 
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Trial Partner Template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 2 of 9 
Version: MCW v 8-2-19 
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Purpose 
This project is being done to study the drug 
CPX-351 when given in an outpatient setting 
and to assess the quality of life and 
management of health-related issues for you 
and the individual you provide care for.  
Length 
 You will be in this research project for 
about 3 months. 
My Other Options 
You do not have to join this project. You are 
free to say yes or no. 
 
Risks 
This is a brief list of the most commonly seen 
side effects/risks. The full consent form after 
this introduction contains a more complete list 
of potential research risks. 
 
Questionnaire risks: 
 
You may feel uncomfortable answering 
some questions. 
 
Your answers are confidential, but there 
is a risk that your answers could be read 
by people who should not read your 
personal information. 
 
Benefits 
This project will not help you, but we hope the 
information from this project will help us 
develop a better treatment strategy for 
individuals with AML and their caregivers. 
 
Procedures or Activities 
 
List of visits: 
 
You will need to come with the patient 
to all of their visits.  For a full list of 
visits for the individual you provide care 
for, please see the full list included later 
in this document. 
 
Questionnaire visits (these will take 
place during the patient visits listed 
above) 
- Total Number: 4 visits 
- Total Time: 15-30 minutes per visit 
 
 
 
Procedures/Activities that will occur at 
various visits: 
 
 
Non-invasive Procedures/Activities 
- 
Questionnaires 
 
 
If you have more questions about this project at any time, you can call Dr. Michaelis at  
414-805-6700. 
 
If you have questions about your rights as a participant, want to report any problems or 
complaints, or offer input, you can call the MCW/Froedtert Hospital Research Subject 
Advocate at 414-955-8844. 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Trial Partner Template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 3 of 9 
Version: MCW v 8-2-19 
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CONSENT TO PARTICIPATE IN RESEARCH 
A1. INTRODUCTION – WHY ARE WE ASKING YOU TO PARTICIPATE? 
You are invited to participate in this research because you provide care for an individual who 
has been newly diagnosed with acute myeloid leukemia (AML) or AML with myelodysplastic-
related changes and is eligible for treatment with CPX-351 therapy. 
 
A total of about 120 participants and 120 or more of their caregivers are expected to participate 
in this research nationally including about 20 participants and 20 or more of their caregivers at 
the Medical College of Wisconsin/Froedtert Hospital. 
 
The Director of the project is Laura Michaelis, MD in the Department of Medicine. A research 
team works with Dr. Michaelis. You can ask who these people are.  
 
Jazz Pharmaceuticals, a drug company, is funding the research. 
 
A2. DO I HAVE TO PARTICIPATE? 
You can decide whether to take part in this research or not. You are free to say yes or no. Even 
if you join this project, you do not have to stay in it. You may stop at any time.  
 
A3. WHY IS THIS PROJECT BEING DONE? 
CPX-351, an induction treatment for AML is approved by the U.S. Food and Drug 
Administration. Traditionally, treatment is provided in an inpatient environment where patients 
stay in the hospital for between three to five weeks. This study is designed to assess CPX-351 
given in an outpatient setting where treatment is given in the hospital, but the patient goes home 
every day after the treatment is completed. Patients continue in that setting as long as they 
respond well and are considered safe to be treated as an outpatient.  
 
The purpose of this project is to study the feasibility of giving CPX-351 to adult patients with 
AML as an outpatient therapy. This study will also monitor the experiences of both you and the 
individual you provide care for on the management of side effects and their quality of life.  
 
B1. WHAT WILL HAPPEN IF I PARTICIPATE? 
Before any study tests or procedures are done, you will be asked to sign this consent form. The 
study doctor will discuss the study with you and answer your questions. 
 
Screening procedures:  
The screening procedures and assessments must be completed prior to starting the study 
treatment to confirm that you are eligible for this study. 
 
Nurse Teacher Program 
You and the individual you provide care for will be enrolled in an education program, Nurse 
Teacher training. This must be completed 7 days prior to treatment. The Nurse Teacher training 
will provide education on the outpatient management program including the completion of 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Trial Partner Template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 4 of 9 
Version: MCW v 8-2-19 
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subject diaries that will allow patients to keep track of their symptoms and temperature on a 
daily basis. 
If the screening information, including the completion and understanding of the Nurse Teacher 
Program shows that you meet the requirements of the study, then you will be able to start the 
study. If the screening information shows that you cannot be in the research study, the study 
doctors will discuss other options with you. 
 
Clinic Visits 
You must come with the patient to all study visits. 
 
During treatment: days 1, 3, 5, and 6 
 
Then three times a week until count recovery or until day 60 (whichever is first) 
 
Then monthly at day 30, 60 and 90. 
 
If the patient experiences any side effects, they may need to come to the clinic for additional 
visits. 
 
You must reside with the patient for the length of this study, which is until the patient has their 
cell counts recover or 90 days after treatment, whichever comes first.   
 
Study Questionnaires 
You will be asked to complete questionnaires with a member of the study team asking about the 
symptoms and health of the patient you care for at the following time points: 
 
The first day of treatment for the individual you provide care for; this will be done with a 
member of the study team (Day 1) 
 
Once between Days 7-10 
 
Day 30 
Day 60 
 
B2. HOW LONG WILL I BE IN THE PROJECT? 
You will be in this research project for about 3 months. 
 
B3. CAN I STOP BEING IN THE PROJECT?   
You may stop at any time. If you decide to leave the project, please let the research team know.  
 
If you decide to leave the project, the research subject will need to select a new caregiver in 
order to continue in the project. 
 
The research investigator may stop your participation in the project at any time for any reason 
without your consent.  Your doctor will tell you if this happens. 
 
C1. WHAT HEALTH RISKS OR PROBLEMS CAN I EXPECT FROM THE PROJECT? 
You may feel that some of the questions we ask are stressful or upsetting. If you do not wish to 
answer a question, you may skip it and go to the next question, or you may stop immediately.  
(If you become upset, please let us know and we can give you information about individuals 
who may be able to help you.) 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Trial Partner Template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 5 of 9 
Version: MCW v 8-2-19 
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5/25/2021 
 
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Another risk may be loss of confidentiality. Every effort will be made to keep your research 
records confidential but we cannot guarantee it. Depending on the kind of information being 
collected, if your research information were accidentally seen, it might be used in a way that 
could embarrass you or affect your ability to get insurance. If you have questions, you can talk 
to the project director about whether this could apply to you.  
 
C2. ARE THERE ANY BENEFITS TO TAKING PART IN THE PROJECT? 
This project will not help you, but we hope the information from this project will help us develop 
a better treatment for patients with AML and provide better health services for their caregivers. 
 
D1. ARE THERE ANY COSTS TO BEING IN THE PROJECT? 
There are no costs to you for any of the visits or services you receive in this project. If you have 
questions regarding costs, please contact Dr. Michaelis.  
 
D2. WILL I BE PAID FOR PARTICIPATING IN THE PROJECT? 
You will not be paid for participating in this project. 
 
D4. WILL I BE GIVEN NEW INFORMATION ABOUT THE PROJECT? 
 
If we learn any important new information about CPX-351 that might change your mind about 
being in the project, we will tell you about it right away. You can then decide if you want to stay 
in the project. 
  
When research data is collected and analyzed , there is the chance of finding something 
clinically relevant. There may be benefits to learning such results (such as early detection and 
treatment of a medical condition), but there are risks as well (such as feeling worried about a 
finding for which no treatment is required or appropriate).   
 
In this study, you will be informed of any findings of possible clinical significance that may be 
discovered during review of results from your research data. The results of your research data 
will be placed in your medical record.  
 
The results from the data we collect in this research study are the same quality as what you 
would receive as part of your health care. The data will be reviewed by a physician who 
normally reads such results. We will provide you with this information so that you may discuss it 
with your primary care physician.  
 
D5. WHO CAN ANSWER MY QUESTIONS ABOUT THE PROJECT? 
 
If you have more questions about this project at any time, you can call Dr. Michaelis, 414-
805-6700. 
 
If you have questions about your rights as a research participant, want to report any 
problems or complaints, or offer input, you can call the MCW/Froedtert Hospital Research 
Subject Advocate at 414-955-8844. 
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Trial Partner Template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 6 of 9 
Version: MCW v 8-2-19 
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E. PERMISSION TO COLLECT, USE AND SHARE HEALTH INFORMATION 
E1. What health information will be collected and used for this project? 
To be in this research project, the research team needs your permission to access, collect and 
use some of your health information. If you say no, you cannot be in the project. This 
information may come from questions we ask, forms we ask you to fill out, or your medical 
record, as described below. We will only collect and use information needed for the project. 
 
The protected health information (PHI) originates from services you will or have received at one 
or more of the following locations: the Medical College of Wisconsin (MCW); BloodCenter of 
Wisconsin (BCW); Children’s Hospital of Wisconsin (CHW); any Froedtert Health Affiliate- 
Froedtert Memorial Lutheran Hospital (FMLH), Inc.; Community Memorial Hospital (CMH) 
Menomonee Falls, Inc.;  St. Joseph’s Community Hospital (SJH) West Bend, Inc.;  Froedtert & 
The Medical College of Wisconsin Community Physicians Clinics, Inc. (FMCWCP); the West 
Bend Surgery Center, LLC; and the Froedtert Surgery Center, LLC.  
 
The health information to be collected and used for this project is:  
 
Health information collected during this project, such as questionnaires 
 
E2. Who will see the health information collected for this project? 
The only MCW/Froedtert Hospital employees allowed to handle your health information are 
those on the research team, those on the Institutional Review Board (IRB) and those who check 
on the research activities to make sure the hospital’s rules are followed. 
 
If the costs of any necessary emergency medical treatment in the event of a research-related 
injury are billed to your health insurance, your health information may need to be disclosed to 
the insurer for billing purposes. 
 
The research team may share your information with people who don’t work at MCW/Froedtert 
Hospital because they planned, pay for, or work with us on this project. The federal Privacy Rule 
may no longer protect your health information once it leaves MCW/Froedtert Hospital.  For this 
project, we plan to share information with those doctors, researchers or government 
representatives working with us on this project at the institutions or companies listed here: 
 
The U.S. Department of Health & Human Services (DHHS) 
 
Jazz Pharmaceuticals and its affiliates, representatives, contractors, collaborators and 
licensees  
 
The Office for Human Research Protections (OHRP) 
 
Other government agencies in this or other countries 
 
The designated Data Safety Monitoring board and Institutional Review Board which is a 
committee that has reviewed this research study to help ensure that your rights and 
welfare as a research participant are protected and that the research study is carried out 
in an ethical manner, and Privacy Boards and their related staff that have oversight 
responsibilities for this study.  
 
Personnel from the study site that provide study related treatment, procedures, or audits 
 
Those required by law 
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Trial Partner Template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 7 of 9 
Version: MCW v 8-2-19 
EFFECTIVE 
 
5/25/2021 
 
MCW/FH IRB
Because this project involves the use of drugs and/or devices, the FDA also has the right to 
inspect all project records. 
 
We will not use your personal health information for a different project without your permission 
or the permission of a hospital research review board (IRB). Once all personal identification is 
removed from your health information, the information may be used for future research or 
distributed to another investigator for future research without additional informed consent from 
you or your legally authorized representative. The information might also be used or released 
for other purposes without asking you. Results of the project may be presented in public talks or 
written articles, but no information will be presented that identifies you. 
 
E3. What are the risks of sharing this health information? 
One risk of taking part in a research project is that more people will handle your personal health 
information collected for this project. The research team will make every effort to protect the 
information and keep it confidential, but it is possible that an unauthorized person might see it. 
Depending on the kind of information being collected, it might be used in a way that could 
embarrass you or affect your ability to get insurance. If you have questions, you can talk to the 
research doctor about whether this could apply to you.  
 
E4. How long will you keep the health information for this project? 
If you sign this form, we plan to keep your information without any end-date in case we need to 
check it again for this project. 
 
E5. Can I cancel my permission to share this health information? 
If you change your mind later and do not want us to collect or share your health information, you 
need to send a letter to: 
Laura Michaelis, MD 
Froedtert Hospital & the Medical College of Wisconsin 
Division of Hematology and Oncology, 
9200 W Wisconsin Avenue 
Milwaukee, WI 53226 
The letter must say that you have changed your mind and do not want the researcher to collect 
and share your health information. At that time, we may decide that you cannot continue to be 
part of the project. We may still use the information we have already collected. 
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Trial Partner Template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 8 of 9 
Version: MCW v 8-2-19 
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CONSENT TO PARTICIPATE 
 
By signing my name below, I confirm the following: 
 
I have read (or had read to me) this entire consent document, including Appendix 1. All of 
my questions have been answered to my satisfaction. 
 
The project’s purpose, procedures, risks and possible benefits have been explained to me.   
 
I agree to let the research team use and share the health information and other information 
gathered for this project. 
 
I voluntarily agree to participate in this research project. I agree to follow the procedures as 
directed.  I have been told that I can stop at any time. 
 
IMPORTANT: You will receive a signed and dated copy of this consent form.  Please keep it 
where you can find it easily.  It will help you remember what we discussed today. 
 
 
 
 
Subject's Name please print  
Subject's Signature 
Date    
 
 
 
Name of Witness please print 
Signature of Witness 
 
Date 
Rationale for Use of Witness 
 Subject has limited/no literacy 
 Subject has limited English proficiency 
 Subject has limited/no vision 
 
 Sponsor requirement 
 Other ____________________ 
 
 
 
* Name of person discussing/ 
obtaining consent please print  
Signature of person 
discussing/obtaining consent 
Date 
* A member of the research team trained and authorized by the Principal Investigator to act on 
her/his behalf in obtaining informed consent according to the protocol.  The Principal 
Investigator is responsible and accountable for the research project. 
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Trial Partner Template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 9 of 9 
Version: MCW v 8-2-19 
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Appendix 1: Example of Visit Schedule 
MONDAY 
TUESDAY 
WEDNESDAY 
THURSDAY 
FRIDAY 
SATURDAY 
SUNDAY 
 
LABS/Vitals 
 
Visit with MD or APP 
 
Day 1: TREATMENT 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Physical Assessment by MD 
or APP 
 
TREATMENT 
PHONE 
ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Physical Assessment 
by MD or APP 
 
TREATMENT 
LABS/Vitals 
 
Assessment by 
Oncology Nurse in 
Day Hospital or 
Clinic 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
 
Visit with MD or APP; 
Quality of Life Surveys 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
 
LABS/Vitals 
 
Assessment by 
Oncology Nurse in 
Day Hospital or 
Clinic 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
 
Visit with MD or APP 
 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
PHONE 
ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by 
Oncology Nurse in 
Day Hospital or Clinic 
 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
Bone Marrow biopsy 
 
 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
 
Visit with MD or APP 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
 
 
LABS/Vitals 
 
Assessment by 
Oncology Nurse in 
Day Hospital or 
Clinic 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
 
Visit with MD or APP 
 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
PHONE 
ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by 
Oncology Nurse in 
Day Hospital or Clinic 
 
 

Prot_SAP_000.pdf: 

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ICF_001.pdf: 
Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 1 of 16 
Version: MCW v 8-27-19 
 
EFFECTIVE 
 
5/25/2021 
 
MCW/FH IRB
 
Medical College of Wisconsin and Froedtert Hospital 
INTRODUCTION TO THE INFORMED CONSENT 
 
Name of Subject: ____________________________ 
 
IIT-Michaelis: A multi-institutional, phase IV project to study the feasibility of safely managing 
patients receiving induction with liposomal daunorubicin and cytarabine (CPX-351) for acute 
myeloid leukemia (AML) in an outpatient environment 
 
Subject Consent 
 
Laura Michaelis, M.D. 
Department of Medicine 
Division of Hematology and Oncology 
Medical College of Wisconsin & Froedtert Hospital 
9200 W Wisconsin Ave 
Milwaukee WI 53226 
414-805-6700 
 
 
You are invited to take part in this research. You can decide whether to take part in this project 
or not. You are free to say yes or no. If there is anything that you do not understand, please ask 
questions. 
 
 
Definitions 
 
CPX-351 – also called Vyxeos, an FDA approved induction therapy for AML 
 
Induction Therapy – the first treatment given for a disease 
 
Inpatient/Outpatient – describes the location where you stay after receiving your 
treatment, in the hospital (inpatient) or at home (outpatient) 
 
Count Recovery – when the blood cell counts, including your infection-fighting cells 
and bleeding-prevention cells, return to safe levels 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 2 of 16 
Version: MCW v 8-27-19 
 
EFFECTIVE 
 
5/25/2021 
 
MCW/FH IRB
 
Purpose 
This project is being done to study the drug 
CPX-351 when given in an outpatient setting 
and to assess the quality of life and 
management of health-related issues for you 
and your caregiver. 
 
Length 
1. You will be in this research project for 
about 3 months.  
 
Risks 
This is a brief list of the most commonly seen 
side effects. The full consent form after this 
introduction contains a more complete list of 
potential research risks. 
 
CPX-351 risks: 
 
Bleeding 
 
Fever 
 
Rash 
 
Swelling 
 
Nausea 
 
Sores in the mouth or throat 
 
Diarrhea 
 
Constipation 
 
Muscle pain 
 
Tiredness 
 
Stomach Pain 
 
Difficulty breathing 
 
Headache 
 
Cough 
 
Decreased appetite 
 
Irregular heartbeat 
 
Pneumonia 
 
Blood infection 
 
Chills 
 
Sleep disorders 
 
Vomiting 
Procedures 
 
List of visits: 
 
Screening Visit  
- Total Number: 1 
- Total Time: 2-4 hours 
 
Treatment visits 
- Total Number: 4-6 
- Total Time: 2-5 hours per visit 
 
Study Visits until Count Recovery  
- Total Number: about 15 
- Total Time: about 1-3 hours per visit 
 
Follow-up 
- 
Total Number:  1-2 
- 
Total Time:  1-2 hours each 
 
 
Procedures that will occur at various 
visits: 
 
Invasive Procedures 
- Bone marrow biopsy 
- Routine blood tests 
- Drug infusion 
- Echo/MUGA 
 
Non-invasive Procedures 
- Medical history 
- Physical exam 
- ECG 
- Urinalysis 
- Questionnaires 
 
 
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 3 of 16 
Version: MCW v 8-27-19 
 
EFFECTIVE 
 
5/25/2021 
 
MCW/FH IRB
 
My Other Options 
You do not have to join this project. Your other 
options may include: 
1. Joining a different project 
2. Getting no treatment for this condition 
 
Benefits 
We don’t know if this project will help you. Your 
condition may get better but it could stay the 
same or even get worse. 
If you have more questions about this project at any time, you can call Dr. Michaelis at  
414-805-6700. 
 
If you have questions about your rights as a participant, want to report any problems or 
complaints, or offer input, you can call the MCW/Froedtert Hospital Research Subject 
Advocate at 414-955-8844. 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 4 of 16 
Version: MCW v 8-27-19 
 
EFFECTIVE 
 
5/25/2021 
 
MCW/FH IRB
CONSENT TO PARTICIPATE IN RESEARCH 
A1. INTRODUCTION – WHY ARE WE ASKING YOU TO PARTICIPATE? 
You are being invited to participate in this research because you have been newly diagnosed 
with acute myeloid leukemia (AML) and are eligible for treatment with CPX-351 therapy. 
 
A total of about 120 participants and 120 or more of their caregivers are expected to participate 
in this research nationally including about 20 participants and 20 or more of their caregivers at 
the Medical College of Wisconsin/Froedtert Hospital. 
 
The Director of the project is Laura Michaelis, MD in the Department of Medicine. A research 
team works with Dr. Michaelis. You can ask who these people are.  
 
Jazz Pharmaceuticals, a drug company, is funding the research. 
 
A2. DO I HAVE TO PARTICIPATE? 
You can decide whether to take part in this research or not. You are free to say yes or no. If you 
say no, your regular medical care will not change. Even if you join this project, you do not have 
to stay in it. You may stop at any time.  
 
A research project is different from routine medical care in three ways: 1) there are extra risks 
that we will tell you about in this form; 2) you may have some extra medical tests and visits; 3) 
the research procedures, tests and visits follow a set plan that must be kept. 
 
A3. WHY IS THIS PROJECT BEING DONE? 
CPX-351, an induction treatment for AML is approved by the U.S. Food and Drug 
Administration. Traditionally, treatment is provided in an inpatient environment where patients 
stay in the hospital for between three to five weeks. This study is designed to assess CPX-351 
given in an outpatient setting where treatment is given in the hospital, but the patient goes home 
every day after the treatment is completed. Patients continue in that setting as long as they 
respond well and are considered safe to be treated as an outpatient.  
 
The purpose of this project is to study the feasibility of giving CPX-351 to adult patients with 
AML as an outpatient therapy. This study will also monitor the experiences of both you and your 
caregiver on the management of side effects and your quality of life.  
 
B1. WHAT WILL HAPPEN IF I PARTICIPATE? 
Before any study tests or procedures are done, you will be asked to sign this consent form. The 
study staff will discuss the study with you and answer your questions. If you decide to join the 
study, some screening tests will be done first to see if you are eligible. 
 
All of these tests and procedures are considered “standard of care” which means that they 
would be done even if you do not take part in the research study. If you have had some of these 
tests or procedures recently, they may not have to be repeated. 
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 5 of 16 
Version: MCW v 8-27-19 
 
EFFECTIVE 
 
5/25/2021 
 
MCW/FH IRB
 
Screening procedures:  
 
The screening procedures and assessments must be completed prior to starting the study 
treatment to confirm that you are eligible for this study. 
 
Completed within 14 days prior to treatment 
 
Bone marrow biopsy 
 
ECHO/MUGA (cardiac assessment) 
 
Completed within 7 days prior to treatment 
 
Medical History which includes questions about your health, and current medications 
 
Physical Exam which includes your vital signs 
 
Your performance status that evaluates how you are able to carry on with your usual 
daily activities 
 
Routine blood tests 
 
Urinalysis 
 
Serum or urine pregnancy tests for women of child bearing potential 
 
Nurse Teacher Education Program 
You and your caregiver will be enrolled in an education program. This must be completed within 
7 days prior to treatment. This program will provide education on the outpatient monitoring and 
reporting requirements including the completion of subject diaries that will allow you to keep 
track of your symptoms, medication use, and temperature on a daily basis. You will also be 
provided additional educational materials to guide you with this monitoring. 
 
If all above criteria are met, then you will be able to start the study. If the screening information 
shows that you cannot be in the research study, your study doctor will discuss other options with 
you. 
 
Summary of Treatment Procedures  
 
Week 1 - Induction Therapy: 
You will come to the clinic for days 1 through 6 the first week of the study.  
 
Days 1, 3 and 5: 
Prior to your infusion of CPX-351, you will have the following: 
 
Physical exam which includes your vital signs 
 
Routine blood tests 
 
Review of any side effects that you may be experiencing 
 
Completion of questionnaires asking about your symptoms and your health with a 
member of the study team (Day 1) 
 
Review of your study diary 
 
Once these tests and assessments are completed, you will receive your infusion of CPX-
351. The infusion should take approximately 90 minutes.  
 
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
Page 6 of 16 
Version: MCW v 8-27-19 
 
EFFECTIVE 
 
5/25/2021 
 
MCW/FH IRB
 
Days 2, 4 and 6: 
On days 2, 4 and 6 you will not receive an infusion. For these visits you will have the 
following: 
 
An Oncology Nurse will complete an assessment  
o This will be done on the phone on days 2 and 4 
o On day 6 you will come to the clinic to have blood drawn for routine 
testing, to see the nurse and have vitals taken 
 
Review of any side effects that you may be experiencing 
 
Review of your study diary 
 
Weekly, Beginning with Week 2 Until Count Recovery 
Until your cell count recovers, you will come to the clinic three times a week. On two of the days 
between these clinic visits, you will receive phone calls from your oncology nurse. 
 
Three times per week you will have the following at the clinic: 
 
An Oncology Nurse will meet with you and complete an assessment 
 
Review of vital signs 
 
Review of any side effects that you may be experiencing 
 
Routine blood tests 
 
Review of your study diary 
 
Completion of questionnaires asking about your symptoms and your health 
(once only between day 7-10) 
 
Once per week (may occur during one of the above visits) you will have the following at 
the clinic: 
 
Physical exam which includes your vital signs  
 
Review of any side effects that you may be experiencing 
 
Review of your study diary 
 
Two times per week you will have the following: 
You will be called by the Oncology Nurse. During the phone call the Oncology Nurse will 
review your study diary with you and see if any needs or concerns arise. This may 
continue until your blood counts recover or until 90 days after the first infusion of CPX-
351 (whichever comes first). 
 
30, 60, and 90 Days from Day 1 of CPX-351 Induction 
You will come to the clinic for the following: 
 
Recent medical history which includes questions about your health, and current 
medications 
 
Physical Exam which includes your vital signs 
 
Your performance status which evaluates how you are able to carry on with your usual 
daily activities 
 
Review of any side effects that you may be experiencing (only on day 30 and day 60) 
 
Completion of questionnaires asking about your symptoms and your health (only on day 
30 and day 60) 
 
Review of your study diary (until count recovery or day 60, whichever occurs first) 
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
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At any time when you or your doctor don’t feel that it is safe for you to be an outpatient, then you 
will be admitted to the inpatient service. If your doctor finds any concerning medical information 
or findings, then they will recommend admission to the hospital for treatment.  
 
If you are admitted to the hospital and improve and your doctor feels that it is safe to discharge 
you, you may remain on study and be cared for, again, in the outpatient environment. 
 
B2. HOW LONG WILL I BE IN THE PROJECT? 
You will be in this research project for about 3 months. 
 
You will take the CPX-351 for 1 week. After you have finished treatment, we will follow you until 
90 days after the first day of CPX-351 treatment to monitor your health. 
 
B3. CAN I STOP BEING IN THE PROJECT?  
You are free to withdraw from the project at any time. If you leave, your regular medical care will 
not change. If you are thinking about leaving, please tell the research doctor.  
 
The research doctor can tell you about the effects of stopping, and you and the research 
doctor can talk about what follow-up care would help you the most. 
 
You might be asked to come back for one more visit to check your health. 
 
The research doctor may take you out of this project at any time. This would happen if: 
 
They think it is in your best interest. 
 
You do not follow the project rules. 
 
The whole project is stopped. 
If this happens, the research doctor will tell you. 
 
B4. ARE THERE ANY SPECIAL INSTRUCTIONS WHILE I AM IN THE PROJECT?  
 
You must bring your study diary to each clinic visit. 
 
You must live within 45 minutes from the clinic  
 
You must have a reliable caregiver who signs a separate caregiver consent 
 
You must have reliable, working telephone access 
 
C1. WHAT HEALTH RISKS OR PROBLEMS CAN I EXPECT FROM THE PROJECT? 
There are risks to taking part in any research project. There is a risk that you may get a drug 
that does not help your condition or may make it worse.  There also may be problems (side 
effects) we do not know about yet, from CPX-351 itself, or how it combines with other drugs you 
are taking. If we learn about new important side effects, we will tell you.  
 
We watch everyone in the project for problems (side effects). You need to tell the research 
doctor or a member of the research team immediately if you experience any problems, 
side effects, or changes in your health. If you have severe side effects, call Dr. Michaelis 
immediately at 414-805-6700. In an emergency, call 911. 
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
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Version: MCW v 8-27-19 
 
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C2. RISKS OF CPX-351 
The CPX-351 itself may cause problems (side effects).  Side effects may be mild or very 
serious.  Some can last a long time or never go away.  
 
Drugs can affect individuals in different ways. Complications of some of the side effects below 
may lead to life-threatening events and possibly death. 
 
The most common side effects related to CPX-351 include: 
 
Bleeding 
 
Fever 
 
Rash 
 
Swelling 
 
Nausea 
 
Sores in the mouth or throat 
 
Diarrhea 
 
Constipation 
 
Muscle pain 
 
Tiredness 
 
Stomach Pain 
 
Difficulty breathing 
 
Headache 
 
Cough 
 
Decreased appetite 
 
Irregular heartbeat 
 
Pneumonia 
 
Blood infection 
 
Chills 
 
Sleep disorders 
 
Vomiting 
 
There is increased risk by joining this study because this drug is usually given while inpatient 
and you will receive this drug while outpatient.  Medical staff will not be able to observe you at 
all times like in the inpatient hospital setting. To help decrease this risk, the study has a few 
additional requirements:  
 
Nurse assessments will be done over the telephone on days you don’t see your doctor 
 
You need to live close to the hospital, so you can come in for more checks if needed 
 
You need to have a caregiver who is qualified to help you as needed 
 
You will participate in a study-specific education program  
 
C3. OTHER RISKS OF THIS RESEARCH PROJECT 
Other procedures that are part of the research also involve some risks: 
 
Risks of Outpatient Treatment: 
The most important health risk from this study is that something could happen while you are an 
outpatient, i.e. a severe infection or bleeding event, that needs immediate care or treatment. 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
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Everything will be done to protect you from such a risk, but as you will not be an inpatient, care 
may be delayed compared to patients who are inpatients. 
 
Questionnaires:  
You may feel that some of the questions we ask are stressful or upsetting. If you do not wish to 
answer a question, you may skip it and go to the next question, or you may stop immediately.  
(If you become upset, please let us know and we can give you information about individuals 
who may be able to help you.) 
 
Risks of Bone Marrow Aspirate/Biopsy Collection:  
Bone marrow is collected using a needle under local anesthesia to aspirate (draw out) marrow 
tissue from the inside of your bone marrow aspirate (usually pelvic or hipbone). Biopsy refers to 
removal of a piece of tissue that does not cause any serious problems. The risks on bone 
marrow biopsy and aspirate include pain, bleeding, bruising, and/or discomfort at the biopsy 
site. Infection is also possible but rare. 
 
Risks of an Echocardiograms (ECHO): 
For the ECHO, an ultrasound probe is pressed against your chest to look at the structure and 
function of your heart.  You may have some discomfort when the wand is pressed against your 
chest in order to take pictures of your heart.  
 
Risks of a Multiple Gated Acquisition Scan (MUGA): 
A MUGA Scan takes images of the beating heart to see how well your heart is pumping blood. A 
small amount of radioactive material will be injected into your vein and bind to your red blood 
cells (blood cells that carry oxygen throughout your body) in order for the special camera to take 
pictures of how the blood moves through your heart. You will be asked to lie very still during this 
scan, because any movement can cause the images to be blurry. There may be some 
discomfort from having to lie still during the length of the procedure. Allergic reactions to the 
radioactive material are rare but may occur. The injection of the radioactive material may cause 
some slight discomfort.   
 
Risks of IV Injections: 
For an IV injection, a needle is inserted into your vein. For most people, needle sticks for IV 
injections do not cause any serious problems. The use of an IV may cause discomfort, irritation, 
mild bruising, bleeding, and rarely infection, nausea (stomach upset), and lightheadedness 
(feeling faint). 
 
Risks of Blood Tests: 
For most people, needle punctures for blood draws do not cause any problems. However, 
sometimes they may cause discomfort, irritation, mild bruising, bleeding, and rarely infection, 
nausea (stomach upset), and lightheadedness (feeling faint). 
 
C4. REPRODUCTIVE RISKS 
Risks to women who could become pregnant 
The drug in this project might affect a baby, before or after the baby is born. We do not know if 
the drug cause(s) harm to a baby, so we do not want anyone who might be pregnant to enter 
the project. You should not become pregnant or nurse a baby while in this project. You must tell 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
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the research doctor right away if you think you are pregnant. You will be asked to have a 
pregnancy test to be sure you are not pregnant at the start of the project.  
 
If you become pregnant during the project, you will be withdrawn from treatment for safety 
reasons. If you become pregnant while you are taking this experimental drug or within 3 months 
after you have stopped taking it, we ask that you inform the research doctor immediately. The 
research doctor will ask you for written permission to obtain information from you or your 
obstetrician on your pregnancy and the health of the baby. 
 
Risks of fathering a child 
You should not father a baby while taking part in this project because it is unknown if the drug 
could affect a baby. If your partner is able to become pregnant, one or both of you must use 
some form of effective birth control.  You must tell the research doctor right away if you think 
your partner is pregnant. 
 
If you think that you have fathered a baby while you are taking this experimental drug or within 3 
months after you have stopped taking it, we ask that you inform the research doctor 
immediately. At that time, the research doctor will ask permission of your partner for the use and 
disclosure of her health information regarding the pregnancy. She will be asked to sign a 
separate consent form. She can choose to do this or not. She will be asked to sign this form to 
allow your research doctor to contact her obstetrician to collect information on the progress of 
the pregnancy and its outcome. The research doctor will make this information available to the 
sponsor for safety monitoring. 
 
Birth control methods for all subjects 
Check with the research doctor about the birth control methods needed for this project and how 
long to use them. Some methods might not be good enough for this project. If you are having 
sex that could lead to pregnancy, you should use birth control while you are in this project.  
 
You must agree to use two acceptable methods of birth control. This may include the following: 
 
Not having vaginal sex (abstinence) 
 
Taking birth control pills orally 
 
Having birth control shots or patches such as Depo-Provera 
 
Use of an intrauterine device (IUD) 
 
Use of diaphragm with contraceptive jelly 
 
Use of condoms with contraceptive foam 
 
Use of cervical cap with spermicide 
 
Contraceptive sponge 
 
You should continue using birth control for 3 months after the last infusion of CPX-351. 
 
C5. ARE THERE ANY BENEFITS TO TAKING PART IN THE PROJECT? 
This study may or may not help you, but we hope the information from this study will help us 
develop better treatments for AML. 
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
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Version: MCW v 8-27-19 
 
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D1. ARE THERE ANY COSTS TO BEING IN THE PROJECT? 
Most of the medical care that you will receive in this project is considered routine care for your 
condition and would be recommended whether or not you join the project. Costs for routine care 
will be billed to you or your insurance carrier.  
 
Activities / costs that are part of the project will not be billed to you or your insurance company. 
These are: the study questionnaires and the study-specific Nurse Teacher Education Program. 
 
Some insurers will not pay for drugs, tests or hospitalization that are part of research, so check 
with your insurer before you join this project. If you have questions regarding costs, please 
contact Dr. Michaelis. 
 
If you participate in this research, the costs of any necessary emergency medical treatment in 
the event of a research-related injury will be billed to you or your health insurance. 
 
D2. WILL I BE PAID FOR PARTICIPATING IN THE PROJECT? 
There is no payment for being in this project  
 
D3. WHAT OTHER HEALTHCARE CHOICES DO I HAVE? 
You do not have to join this project. You are free to say yes or no. If you do not join this project, 
your research doctor can discuss other healthcare choices with you.  
 
Your other choices may include: 
 
Joining a different research project 
 
The procedure or drug offered to you may also be available without being in any 
research project. 
 
Receiving no treatment 
 
The research doctor can explain both the possible benefits and the risks of other options that 
are available to you. 
 
D4. WILL I BE GIVEN NEW INFORMATION ABOUT THE PROJECT? 
If we learn any important new information about CPX-351 that might change your mind about 
being in the project, we will tell you about it right away.  You can then decide if you want to stay 
in the project. 
 
When research data is collected and analyzed , there is the chance of finding something 
clinically relevant. There may be benefits to learning such results (such as early detection and 
treatment of a medical condition), but there are risks as well (such as feeling worried about a 
finding for which no treatment is required or appropriate).   
 
In this study, you will be informed of any findings of possible clinical significance that may be 
discovered during review of results from your research data. The results of your research data 
will be placed in your medical record.  
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
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Version: MCW v 8-27-19 
 
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The results from the data we collect in this research study are the same quality as what you 
would receive as part of your health care. The data will be reviewed by a physician who 
normally reads such results. We will provide you with this information so that you may discuss it 
with your primary care physician.  
 
D5. WHAT HAPPENS IF I AM INJURED BECAUSE I TOOK PART IN THE PROJECT?  
Emergency medical treatment for injuries directly related to your participation in this research 
project will be provided to you. You or your health insurance will be billed for the costs of this 
emergency treatment.  MCW will decide on a case by case basis if they will reimburse you or 
your insurer for emergency treatment costs.  If your research-related injury requires medical 
care beyond this emergency treatment, you or your insurer will be responsible for the costs of 
this follow-up care.  
 
At this time, there is no plan for any additional financial payments. 
 
If you believe that you have been injured because of your participation in this project, contact 
the research doctors right away.  Contact information: Dr. Michaelis, 414-805-6700.  
 
Nothing in this consent form affects any legal rights you may have nor does it release the 
investigator, the sponsor, the institution, or its agents from liability for negligence. 
D6. WHO CAN ANSWER MY QUESTIONS ABOUT THE PROJECT? 
- 
If you have more questions about this project at any time, you can call Dr. Michaelis at 
414-805-6700. 
- 
If you have questions about your rights as a research participant, want to report any 
problems or complaints, or offer input, you can call the MCW/Froedtert Hospital Research 
Subject Advocate at 414-955-8844. 
 
E. PERMISSION TO COLLECT, USE AND SHARE HEALTH INFORMATION 
E1. What health information will be collected and used for this project? 
To be in this research project, the research team needs your permission to access, collect and 
use some of your health information. If you say no, you cannot be in the project. This 
information may come from questions we ask, forms we ask you to fill out, or your medical 
record, as described below. We will only collect and use information needed for the project. 
 
The protected health information (PHI) originates from services you will or have received at one 
or more of the following locations: the Medical College of Wisconsin (MCW); BloodCenter of 
Wisconsin (BCW); Children’s Hospital of Wisconsin (CHW); any Froedtert Health Affiliate- 
Froedtert Memorial Lutheran Hospital (FMLH), Inc.; Community Memorial Hospital (CMH) 
Menomonee Falls, Inc.;  St. Joseph’s Community Hospital (SJH) West Bend, Inc.;  Froedtert & 
The Medical College of Wisconsin Community Physicians Clinics, Inc. (FMCWCP); the West 
Bend Surgery Center, LLC; and the Froedtert Surgery Center, LLC.  
 
The health information to be collected and used for this project is:  
 Hospital/Medical Records 
 Physician/Clinical Records 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
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Version: MCW v 8-27-19 
 
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 Lab and/or Pathology Reports 
 Radiology Reports 
 Biological Samples 
 
E2. Who will see the health information collected for this project? 
The only MCW/Froedtert Hospital employees allowed to handle your health information are 
those on the research team, those on the Institutional Review Board (IRB) and those who check 
on the research activities to make sure the hospital’s rules are followed. 
 
If the costs of any necessary emergency medical treatment in the event of a research-related 
injury are billed to your health insurance, your health information may need to be disclosed to 
the insurer for billing purposes. 
 
The research team may share your information with people who don’t work at MCW/Froedtert 
Hospital because they planned, pay for, or work with us on this project.  The federal Privacy 
Rule may no longer protect your health information once it leaves MCW/Froedtert Hospital. For 
this project, we plan to share information with those doctors, researchers or government 
representatives working with us on this project at the institutions or companies listed here: 
 
 
The U.S. Department of Health & Human Services (DHHS) 
 
Jazz Pharmaceuticals and its affiliates, representatives, contractors, collaborators and 
licensees  
 
The Office for Human Research Protections (OHRP) 
 
Other government agencies in this or other countries 
 
The designated Data Safety Monitoring board and Institutional Review Board which is a 
committee that has reviewed this research study to help ensure that your rights and 
welfare as a research participant are protected and that the research study is carried out 
in an ethical manner, and Privacy Boards and their related staff that have oversight 
responsibilities for this study.  
 
Personnel from the study site that provide study related treatment, procedures, or audits 
 
Those required by law 
 
Because this project involves the use of drugs and/or devices, the FDA also has the right to 
inspect all project records. 
 
We may record your research information, including results of tests and procedures done for 
research, in your Froedtert Hospital and/or Medical College of Wisconsin medical record. As a 
result, this research information may be seen by people allowed to see your medical records for 
healthcare operations or treatment, by those you allow to see your medical records by giving 
written permission, and by others when required by law. 
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
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Version: MCW v 8-27-19 
 
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We will not use your personal health information for a different project without your permission 
or the permission of a hospital research review board (IRB). Once all personal identification is 
removed from your health information, the information may be used for future research or 
distributed to another investigator for future research without additional informed consent from 
you or your legally authorized representative. The information might also be used or released 
for other purposes without asking you. Results of the project may be presented in public talks or 
written articles, but no information will be presented that identifies you. 
  
E3. What are the risks of sharing this health information? 
One risk of taking part in a research project is that more people will handle your personal health 
information collected for this project. The research team will make every effort to protect the 
information and keep it confidential, but it is possible that an unauthorized person might see it. 
Depending on the kind of information being collected, it might be used in a way that could 
embarrass you or affect your ability to get insurance. If you have questions, you can talk to the 
research doctor about whether this could apply to you.  
 
E4. How long will you keep the health information for this project? 
If you sign this form, we plan to keep your information without any end-date in case we need to 
check it again for this project. 
 
E5. Can I cancel my permission to share this health information? 
If you change your mind later and do not want us to collect or share your health information, you 
need to send a letter to  
Laura Michaelis, MD 
Froedtert Hospital & the Medical College of Wisconsin 
Division of Hematology and Oncology, 
9200 W Wisconsin Avenue 
Milwaukee, WI 53226 
 
The letter must say that you have changed your mind and do not want the researcher to collect 
and share your health information. At that time, we may decide that you cannot continue to be 
part of the project. We may still use the information we have already collected.  
 
F1. FOR MORE INFORMATION ABOUT THE PROJECT 
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. 
 
You can look up this project by referring to the ClinicalTrials.gov number (NCT03988205) or by 
asking the research team for a printed copy.   
 
 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
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Version: MCW v 8-27-19 
 
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CONSENT TO PARTICIPATE 
 
By signing my name below, I confirm the following: 
 
I have read (or had read to me) this entire consent document, including Appendix 1.  
All of my questions have been answered to my satisfaction. 
 
The project’s purpose, procedures, risks and possible benefits have been explained to me.  
 
I agree to let the research team use and share the health information and other information 
gathered for this project. 
 
I voluntarily agree to participate in this research project. I agree to follow the procedures as 
directed. I have been told that I can stop at any time. 
 
IMPORTANT: You will receive a signed and dated copy of this consent form. Please keep it 
where you can find it easily. It will help you remember what we discussed today. 
 
 
 
 
Subject's Name please print  
Subject's Signature 
Date   
 
 
 
Name of Witness (if applicable) 
please print (for short form consent 
process, or consent of blind or 
illiterate subject) 
Signature of Witness 
 
Date 
Rationale for Use of Witness 
 Subject has limited/no literacy 
 Subject has limited English 
proficiency 
 Subject has limited/no vision 
 
 Sponsor requirement 
 Other ____________________ 
 
 
 
 
 
* Name of person discussing/ 
obtaining consent please print  
Signature of person 
discussing/obtaining consent 
Date 
* A member of the research team trained and authorized by the Principal Investigator to act on 
her/his behalf in obtaining informed consent according to the protocol. The Principal Investigator 
is responsible and accountable for the research project. 


Medical College of Wisconsin & Froedtert Hospital 
Informed Consent for Research 
Clinical Interventions template - Version: March 30, 2018 
 
IRB Protocol Number: 34597 
IRB Approval Period: 5/25/2021 – 5/24/2022 
 
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Appendix 1: Example of Visit Schedule 
MONDAY 
TUESDAY 
WEDNESDAY 
THURSDAY 
FRIDAY 
SATURDAY 
SUNDAY 
 
LABS/Vitals 
 
Visit with MD or APP 
 
Day 1: TREATMENT 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Physical Assessment by MD 
or APP 
 
TREATMENT 
PHONE 
ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Physical Assessment 
by MD or APP 
 
TREATMENT 
LABS/Vitals 
 
Assessment by 
Oncology Nurse in 
Day Hospital or 
Clinic 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
 
Visit with MD or APP; 
Quality of Life Surveys 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
 
LABS/Vitals 
 
Assessment by 
Oncology Nurse in 
Day Hospital or 
Clinic 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
 
Visit with MD or APP 
 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
PHONE 
ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by 
Oncology Nurse in 
Day Hospital or Clinic 
 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
Bone Marrow biopsy 
 
 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
 
Visit with MD or APP 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
 
 
LABS/Vitals 
 
Assessment by 
Oncology Nurse in 
Day Hospital or 
Clinic 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
 
Visit with MD or APP 
 
PHONE ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by Oncology 
Nurse in Day Hospital or 
Clinic 
PHONE 
ASSESSMENT: 
Oncology Nurse 
LABS/Vitals 
 
Assessment by 
Oncology Nurse in 
Day Hospital or Clinic