Clinical trial NCT01203020
Conditions: Hodgkin's Lymphoma Non-Hodgkin's Lymphoma
Keywords: Hodgkin's non-Hodgkin's lymphomas allogeneic hematopoietic progenitor cell transplant HPCT busulfex fludarabine reduced-toxicity conditioning reduced-intensity conditioning
Sponsor: West Virginia University
Start date: 2010-10-12; Completion date: 2021-09-27
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study of allogeneic hematopoietic progenitor cell transplantation (HPCT) followed reduced toxicity conditioning with once daily intravenous Busulfex and fludarabine in patients with relapsed/chemotherapy refractory Hodgkin's and non-Hodgkin's lymphomas.

Detailed description:
This study hopes to learn if giving intravenous (IV) busulfan with fludarabine before (as a conditioning regimen) allogeneic hematopoietic progenitor cell transplantation (HPC) is safe and helps patients with Non-Hodgkin´s Lymphoma (NHL) and Hodgkin´s Lymphoma (HL). An HPC transplant takes cells from a donor´s bone marrow and, after chemotherapy treatment with a conditioning regimen, infuses the donor´s cells into the patient´s body. Busulfan is a strong drug that suppresses the immune system and fludarabine is a chemotherapy (cancer fighting) drug. These drugs can stop the growth of cancer cells by breaking the Deoxyribonucleic acid (DNA) or genetic material which is necessary for the growth of both healthy and cancer cells. The use of IV busulfan with fludarabine as a conditioning regimen prior to HPC transplant is investigational (not approved by the Food and Drug Administration \[FDA\]).

Busulfan is only given once daily by IV in this study, which is also not approved by the FDA. Patients in this study will go through standard procedures for their disease like medical history, physical exam, blood tests, Multi Gated Acquisition Scan (MUGA) scan or echocardiogram, bone marrow aspirate or biopsy, and lung functions test. Patients will be asked to donate additional blood and bone marrow for this study and for potential future research on their blood related to this study. Because of the normal procedures for HPC transplants patients in this study will be hospitalized for 4 to 6 weeks or longer and will make frequent trips to the clinic to visit the study doctor for supervision for at least one year. Each patient will also have to have a central venous catheter inserted into a large vein above the heart. This is used to give the drugs and to take blood samples.

Participation in this study will last about two years. The study expects to enroll 32 patients and will open to at least two collaborating institutions in the future. Upon initial Institutional Review Board (IRB) approval enrollment will only occur at West Virginia University (WVU). The IRB will be notified before enrollment occurs at other institutions.

Arms: arm 1: Intravenous busulfex 130mg/m2 on days -6 to -3 before transplant
Interventions: intervention 1: Busulfan intervention 2: Fludarabine
Intervention descriptions: intervention 1: Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6 intervention 2: Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)

Protocol documents:
Prot_SAP_000.pdf: 
NCT01203020
Once daily intravenous Busulf ex as part of reduced-toxicity conditioning for 
patients with relapsed/refractory Hodgkin's and non-Hodgkin's lymphomas 
undergoing allogeneic hematopoietic progenitor cell transplantation - A 
multicenter phase II study. 
11Oct2013






Protocol WVU 11310 
Version Date: Amendment 711OCT2013 
Schema 
Once daily intravenous Busulf ex as part of reduced-toxicity 
conditioning for patients with relapsed/refractory Hodgkin's 
and non-Hodgkin's lymphomas undergoing allogeneic 
hematopoietic progenitor cell transplantation - A 
multicenter phase II study. 
PRIMARY OBJECTIVES: 
1.
To assess 1-year PFS of patients with chemotherapy refractory Hodgkin and NHL
undergoing reduced-toxicity conditioning (RTC) with once daily intravenous Busulfex
and fludarabine.
SECONDARY OBJECTIVES: 
1.
To record 1 and 2 year overall survival following transplantation.
2.
To record 2 year PFS.
3.
To assess NRM following RTC transplantation at day+ 100 and 1-year.
4.
To assess relapse rate following transplantation at day+ 100 and 1-year.
5.
To assess disease response rate following transplantation at day+ 100 and at 1-year.
6.
To correlate OS, PFS, RR, NRM following HSCT with systemic busulfan exposure.
7.
To assess rates of acute and chronic GVHD.
8.
Time to successful neutrophil engraftment.
9.
Time to successful platelet engraftment.
10. To assess rates of primary and secondary graft failure.
11. To assess rates of primary and secondary graft rejection.
12. To assess rates of pulmonary toxicity and VOD post transplantation, and assess
correlation with Busulfex exposure levels.
13. To assess lineage specific chimerism kinetics of donor cells following once daily IV
Busulfex based RTC at days +30, +100, +180 and +365.
14. To correlate chimerism kinetics following transplantation with Busulfex exposure levels.
15. To determine immune reconstitution pattern at days +30, + 100, + 180, and +365.
16. To evaluate biologic & genetic markers associated with the malignancy, GVHD and/or
the treatment.
STUDY DESIGN: 
This is a phase II study of allogeneic hematopoietic progenitor cell transplantation (HPCT) 
following reduced toxicity conditioning with once daily intravenous Busulfex and fludarabine in 
patients with relapsed/chemotherapy refractory Hodgkin's and non-Hodgkin's lymphomas. 
3 

















































































































ICF_001.pdf: 
Once daily intravenous Busulfex as part of reduced—toxicity conditioning for 
patients with relapsed/refractory Hodgkin´s and non—Hodgkin´s lymphomas 
undergoing allogeneic hematopoietic progenitor cell transplantation — A 
multicenter 
 
 
NCT01203020 
10Jan2018 


WVU11310 
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Principal Investigator 
Department 
Protocol Number 
Study Title 
 
 
Co-Investigator(s) 
Sponsor (if any) 
More Than Minimal Risk Consent and HIPAA Form 
Abraham Kanate, MD 
Hematology/Oncology 
WVU11310- IRB Number:  1503612611 
Once daily intravenous Busulfex as part of reduced-toxicity conditioning for 
patients with relapsed/refractory Hodgkin's and non-Hodgkin's lymphomas 
undergoing allogeneic hematopoietic progenitor cell transplantation - A multicenter 
phase II study 
Michael Craig, MD; Aaron Cumpston, PharmD; Nilay Shah, MD; Kelly Ross, MD; 
Lauren Veltri, MD 
West Virginia University - Mary Babb Randolph Cancer Center 
 
Contact Persons 
Principal Investigator: Abraham Kanate, MD Address: West Virginia University, Department of Medicine - 
Hematology/Oncology, PO Box 9162, Morgantown, WV 26506 Telephone: (304) 598-4520 
In the event you experience any side effects or injury related to this research, you should contact Dr. Kanate at 
(304) 598-4520. After hours, please contact the Hematology/Oncology doctor on call at (304) 598-4000. 
For more information about this research and about research-related risks or injury, you can contact Dr. Kanate 
at (304) 598-4520. 
For information regarding your rights as a research subject, to discuss problems, concerns, or suggestions 
related to the research, to obtain information or offer input about the research, contact the Office of Research 
Compliance at (304) 293-7073. 
In addition if you would like to discuss problems, concerns, have suggestions related to research, or would like 
to offer input about the research, contact the Office of Research Integrity and Compliance at 304-293-7073. 
Introduction 
You,  
_, are a patient that has relapsed/refractory Hodgkin's or non-Hodgkin's lymphoma 
and you are undergoing an allogeneic hematopoietic progenitor cell (HPC) transplantation. This research study has 
been explained to you by  
 
. Before agreeing to be in this research study, it is important 
that you read and understand this form. It describes the purpose, procedures, benefits, risks, discomforts and 
precautions of the study. It also describes the alternative procedures that are available to you and your right to 
withdraw from the study at any time. Your participation in this study is expected to last for about two years. 
"Informed consent" includes: 


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• 
Reading this consent form, 
• 
Having the study doctor or staff explain the research study to you, 
• 
Asking questions about anything that is not clear, and 
• 
Taking home an unsigned copy of this consent form. This gives you time to think about it and to talk to family or 
friends before you make your decision. 
 
You should not join this research study until all of your questions are answered. 
Things to know before deciding to take part in a research study: 
• 
No one can promise that a research study will help you. 
• 
Taking part in a research study is entirely voluntary. No one can make you take part. 
• 
If you decide to take part, you can change your mind later on and withdraw from the research study. 
• 
The decision to join or not join the research study will not cause you to lose any medical benefits. If you decide 
not to take part in this study, your doctor will continue to treat you. 
• 
Parts of this study may involve standard medical care. Standard care is the treatment normally given for a certain 
condition or illness. 
• 
Other parts of this study may involve experimental (investigational) drugs that are being tested for a certain 
condition or illness. An investigational drug is one that has not been approved by the U.S. Food & Drug 
Administration (FDA). 
• 
Your medical records may become part of the research record. If that happens, your medical records may be 
looked at and/or copied by the sponsor of this study and government agencies or other groups associated with the 
study. 
• 
 Your medical insurance may be billed for any standard medical care you receive during the research study. If 
your insurance company is billed then it may have access to the research records. Insurance companies may not 
pay for treatment that is part of a research study. Taking part in a research study could affect your current or 
future insurance coverage. 
• 
This study includes optional blood samples for research, including genetic testing described later in this 
form. You do not have to participate in the optional research to be in the main part of the study. 
 
 
Purpose(s) of the Study 
We are studying an investigational use of a drug called BUSULFEX® (busulfan) Injection, also known as IV 
(intravenous or given in the vein) busulfan. The US Food and Drug Administration (FDA) has approved the use 
ofBUSULFEX in combination with another drug called cyclophosphamide as a conditioning regimen before 
allogeneic hematopoietic progenitor cell transplantation (HPC) for chronic myelogenous leukemia (CML). 
CML is a type of cancer of the blood. 
Although the FDA has approved the use of BUSULFEX in combination with cyclophosphamide as a 
conditioning regimen prior to HPC for CML, the purpose of this study is to find out the potential benefits and 
safety of giving IV busulfan in combination with fludarabine as a conditioning regimen before allogeneic 
hematopoietic progenitor cell transplantation (HPC) for the treatment ofrelapsed/refractory Non-Hodgkin's 
Lymphoma (NHL) and Hodgkin's Lymphoma (HL). Hematopoietic progenitor cells are the cells in the bone 
marrow from which all types of blood cells develop. An allogeneic HPC transplantation is the process of 
extracting progenitor cells from a donor's bone marrow and, after chemotherapy treatment with a conditioning 


WVU11310 
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regimen, infusion of the donor's progenitor cells into your body. 
Busulfan is a strong cytotoxic (harmful to cells) drug that suppresses the immune system and fludarabine is a 
chemotherapy (cancer fighting) drug. These drugs prevent the growth of cancer cells by breaking the DNA or 
genetic material which is necessary for the growth of both healthy and cancer cells. The use of IV busulfan in 
combination with fludarabine as a conditioning regimen prior to allogeneic HPC is investigational and has not 
been approved by the FDA. 
We also will be giving busulfan by IV only once a day, which is not approved by the FDA. Most patients 
normally get busulfan every 6 hours. We want to see if using busulfan once a day and in combination with 
fludarabine is safe and effective for your cancer. 
West Virginia University expects to enroll 32 subjects into this study. 
Description of Procedures 
The doctor in charge of this study or a member of the study staff has discussed with you the requirements for 
being in this study. A healthcare professional will evaluate your ability to be in the study. 
Before you begin the study: 
You will have the following exams, tests or procedures to find out if you can be in the study and are healthy 
enough to undergo a transplant. These exams, tests, or procedures are part of standard pre-transplant work-up 
and would be done even if you do not join the study. If you have had some of them recently, they may not need 
to be repeated. This will be up to your study doctor. 
Standard tests include: 
• 
Medical history and physical examination (includes vital signs, height, weight, and current medications) 
• 
Blood tests to check your blood counts, kidney and liver function, and HIV status. 
• 
A blood test to check for pregnancy for women of childbearing potential 
• 
Kamofsky Performance Status to see how well you perform daily activities 
• 
A MUGA scan or echocardiogram to test your heart function 
• 
Bone marrow aspirate or biopsy to check your disease status 
• 
A test to check your lung function 
• 
A CT scan or PET/CT of your chest, abdomen, and pelvis to check on your disease 
Tests needed for this study: 
We will also ask you to donate a sample of blood and bone marrow (if done for standard of care) for future 
research (explained later in this consent form) if you consent to this portion of the study. 
During the study: 
If the exams, tests and procedures show that you can be in the study, and you choose to take part, then you will 
need the following tests and procedures. Most all these tests are standard of care and would be done even if you 
did not take part in this study. 
You may be hospitalized for approximately 4-6 weeks or longer if necessary. You will need to remain in the 


WVU11310 
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Morgantown area or nearby for approximately 100 days following your transplant in order for your condition to 
be monitored. After Day 100, you will need to make frequent visits back to Morgantown to see your transplant 
doctor for continued close medical care supervision for at least one year following your transplant. 
Before treatment begins you will have central venous catheters (a small, flexible plastic tube inserted into a 
large vein above the heart, through which drugs and blood products can be given and samples withdrawn 
painlessly) placed. 
Conditioning Phase (Day-7 to Day O (day of transplant)): This period will take 7 days. During this period you 
will receive the busulfan and fludarabine conditioning regimen. You will also be started on a graft vs. host 
disease (GVHD) prevention treatment that is normally done at WVU. This treatment includes drugs called 
tacrolimus, methotrexate, and anti-thymocyte globulin (ATG). You may only need ATG as determined by your 
doctor if your donor is unrelated. During this time you will be monitored closely daily for any changes in your 
general health that you may experience. 
Day-7 
The following procedures will be performed: 
• 
Vital signs (blood pressure, heart rate and temperature) will be measured. 
• 
You will be given medication to prevent seizures (convulsions or fits). It is standard of care to give anti- 
seizure medication with busulfex (the study drug) when it is combined with other drugs like in this 
study. The risks of the drugs are listed later in this form. 
• 
You will have approximately 2 teaspoons of blood taken for routine laboratory tests including a 
complete blood count and blood chemistry to check on your general health. 
Day -6 to Day -3 
• 
Vital signs (blood pressure, heart rate and temperature) will be taken. 
• 
You will have approximately 2 teaspoons of blood taken each day for routine laboratory tests including 
a complete blood count and blood chemistry to check on your general health. 
• 
You will receive fludarabine through your vein for one hour (60 minutes) daily for four days (Days -6 
through -3). 
• 
 After your dose of fludarabine you will receive busulfex through your vein for three hours (180 minutes) 
for four days (Days -6 through -3). 
• 
On Day -6 only, (first day ofbusulfan), we will check the levels of busulfan in your blood after the 
infusion. The dose ofbusulfan may be changed on Day -4 and Day -3 if your blood levels are too high 
or too low. You will have a total of 6 teaspoons of blood taken at six various times after the completion 
of busulfan with the last sample drawn 8 hours after the start of the infusion. This blood is in addition to 
the 2 teaspoons we need for routine tests on Day -6. 


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Rest (Day -2 and -1) 
 
There are no study procedures scheduled on these days. The study doctor or staff member will call you to ask how 
you are feeling and discuss the medications you are taking. 
 
HPC Transplant (Day 0) 
 
• 
Vital signs (blood pressure, heart rate, and temperature) will be taken. 
• 
You will have approximately 2 teaspoons of blood taken to count your blood cells prior to your 
transplantation procedure. 
• 
You will receive your donor's hematopoietic progenitor cells through an IV infusion. 
• 
We will also ask you to donate a sample of blood for future research (explained later in this consent form) if 
you consent to this portion of the study. 
 
Follow-up (Day O through Day 28) 
• 
You will have approximately 2 teaspoons of blood taken to count your blood cells and perform routine 
laboratory tests. You will have blood drawn daily while you are in the hospital and then at least weekly after 
discharge until 28 days after your transplant (Day 0). 
• 
Vital signs (blood pressure, heart rate, and temperature) will be taken 
• 
You will have a complete physical examination including body weight measurements on Day 28. 
• 
You will be asked questions about how you are feeling and your daily activities to determine your general 
health at Day 28. 
• 
We will also ask you to donate a sample of blood for future research (explained later in this consent form) on 
Day 28 if you consent. 
Follow-Up Clinic Visit (Day 63) 
• 
Vital signs (blood pressure, heart rate, and temperature) will be taken. 
• 
You will have a complete physical examination including body weight measurements. 
• 
You will be asked questions about your daily activities to determine your general health. 
• 
You will have approximately 3 teaspoons of blood taken to count your blood cells and perform 
routine laboratory tests. 
• 
Your study doctor and study staff will ask you about how you are feeling and discuss the medications 
you are currently taking. 
• 
We will also ask you to donate a sample of blood and bone marrow (if one was done as standard of 
care) for future research (explained later in this consent form). 
 
Follow-Up Clinic Visit (Day 100, Day 180, Day 365 and Day 730) 
• 
Vital signs (blood pressure, heart rate, and temperature) will be taken. 
• 
You will have a complete physical examination including body weight measurements. 
• 
You will be asked questions about your daily activities to determine your general health. 
• 
You will have approximately 3 teaspoons of blood taken to count your blood cells and perform 
routine laboratory tests. 
• 
You will have a CT scan or PET/CT of your chest, abdomen and pelvis to check on your disease. 
• 
Your study doctor and study staff will ask you about how you are feeling and discuss the medications 
you are currently taking. 


WVU11310 
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• 
We will also ask you to donate a sample of blood and bone marrow (if one was done as standard of 
care) for future research (explained later in this consent form). 
 
We will talk to you about any side effects you may have experienced during this study at your normal clinic 
visits or hospital stays. 
 
We will probably need about 39 teaspoons (13 tablespoons) of your blood for this research study. You will 
be in this study for about two years. 
 
Optional Samples for Research 
Throughout the study we would like to draw some of your blood and store it to do future research related to 
this study. In addition, if you have a bone marrow biopsy as standard of care, we would also like to have 1-2 
ml of your bone marrow sample for future research. This blood and bone marrow will be stored in a 
laboratory at West Virginia University in the Mary Babb Randolph Cancer Center. We will keep these 
samples for as long as we need to complete the potential future research. We will do tests on the samples to 
look at parts of your blood that may help us learn more about your disease and/or response to treatment. This 
lab testing of your samples could involve both genetic and non-genetic tests; however the genetic tests do not 
involve research about diseases being passed on in families. Approximately 6 tablespoons will be collected 
during the two years you are in the study for the optional research samples. 
 
You do not have to agree to store your blood or bone marrow for future research if you want to be in the 
main part of this study. You can make your choice about future research and storing your blood at the end of 
this consent form. 
 
 
Risks and Discomforts 
You may have side effects while on the study. 
 
Everyone taking part in the study will be watched carefully for any side effects. However, doctors do not 
know all the side effects that may happen. Side effects may be mild or very serious. Your health care team 
may give you medicines to help lessen the side effects. Many side effects go away soon after you stop taking 
the study drugs. In some cases, side effects can be serious, long lasting, or may never go away. There is also 
a risk of death. 
 
If you have any injury, adverse effect, or any other unusual health experience during this study, make sure 
that you immediately tell the nurses or the doctor You can call any time to tell us about your health 
expenences. 
 
Busulfan Side Effects (the study drug) 
 
Common Side Effects (reported in greater than 20% of patients) 
 
Decreased blood counts 
Severe decreases in bone marrow function; causing severely decreased blood cell counts (white and red 
blood cells as well as platelets). This effect may be prolonged for unknown reasons and may result in severe 
problems such as serious infection, neutropenic fever (fever due to low white blood cell counts) or anemia 


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(low red blood cells). Due to a decrease in your platelet count, your risk of bleeding may be increased. 
 
Blood laboratory levels 
The levels of electrolytes (examples include potassium/calcium/magnesium) in your blood may 
decrease. You may have high blood sugar. 
 
Increased risk of infection 
Due to the reduced production of white blood cells by the bone marrow, you may be temporarily more 
prone to infection. In some cases, these infections can be serious and rarely, fatal. You should avoid contact 
with people who have contagious infections and tell your doctor if you begin to notice the signs of an 
infection such as fever or chills. 
 
General well-being 
You may feel very tired. It is important to allow yourself plenty of time to rest. You may experience 
fever, chills, generalized pain, chest and back pain. 
 
Gastrointestinal system 
Most patients feel sick (nausea and vomiting) beginning a few hours after the treatment is given and this 
could last for some days. You may experience a loss of appetite. You may have heartburn and poor 
digestion. You may develop diarrhea, constipation (infrequent bowel movements), hard stools or straining 
during bowel movements and rectal discomfort. You may experience pain in your abdomen and bloating. 
 
Respiratory system 
You may develop a lung disorder or abnormal breath sounds. You may develop a cough, shortness of 
breath and nose bleeds. 
 
Cardiovascular system 
You may develop a fast heartbeat or abnormal heart rhythms. Many patients develop edema (abnormal 
collection of fluid under the skin or in body cavities), an abnormal increase in blood volume or weight 
increase. You are at risk to experience hypertension (high blood pressure) and development of a blood clot. 
 
Liver and kidney systems 
You may develop a decrease in liver functioning. Several liver enzymes (alkaline phosphatase, SGOT and 
SGPT) may increase. An increase ofbilirubin and liver enzymes may represent a decrease in liver 
function. You may experience a decrease in kidney function (renal insufficiency). 
 
Nervous system and mental disorders 
You may experience headache, dizziness, anxiety, depression or difficulty falling asleep. 
 
Ear, Nose and Throat 
You may develop very painful ulcers or sores in your mouth and other mucous membranes. These may affect 
your ability to drink and eat. You may develop a runny nose. 
 
Skin changes 
You may develop a rash, which may or may not be itchy. 


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Less Common (reported in 5% to 20% of patients) 
Gastrointestinal system effects 
You may experience hiccups and loss of gastrointestinal propulsive activity (ileus). This means that 
your intestines slow down or stop the movement that moves food and digestive fluids through your 
digestive system. 
 
Respiratory system 
You may experience asthma, or inflammation of the lung (pneumonitis ). 
 
Cardiovascular system 
You may experience a rapid or very slow heart beat, changes in the rhythm of the heart beat, low blood 
pressure, widening of blood vessels (hot flashes or flushing). When a central catheter is used, occlusion of 
blood vessels might occur. You may also experience enlargement of the heart (cardiomegaly). 
 
Liver and kidney function 
Enlargement of the liver (hepatomegaly) may also occur. A severe form of this liver disorder can affect the 
blood vessels in your liver, which in rare cases, can be fatal. Symptoms of this may include increased liver 
enzymes, weight gain and enlargement of the liver. Weight gain may be caused by fluid retention (edema) as 
well. Kidney function tests may be abnormal. You may experience frequency in urination, inability to urinate 
and blood in your urine. 
 
Skin changes 
You may also experience itch (with or without a rash), acne, yellowing of the skin or eyes (jaundice) or 
changes in skin color (skin discoloration). 
 
Musculoskeletal system 
You may experience pain including joint pain (arthralgia), back pain or muscle pain (myalgia). 
 
Bruising, bleeding and clotting 
The production of platelets (which help the blood to clot) will be reduced with this treatment. Let your doctor 
know if you have any unexplained bruising or bleeding, such as nosebleeds, blood spots or rashes on the 
skin, bleeding gums, blood in the urine or stools, or cuts that won't stop bleeding. You may also develop 
blood clots. 
 
Rare (reported in less than 5% of patients) 
 
Gastrointestinal system 
You may experience inflammation of the esophagus (esophagitis), inflammation of the pancreas 
(pancreatitis), bleeding in the stomach and intestines (gastrointestinal bleeding), vomiting of blood 
(hematemesis). 
 
Respiratory system 
You may experience an infection of the lungs (pneumonia),coughing up blood, or a collapse oflung tissue 
(atelactasis), breathing faster than nonnal (hyperventilation), decreased oxygen in the blood (hypoxia), 


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accumulation of fluid in the space around the lungs (pleural effusion), bleeding in the lung (pulmonary 
alveolar hemorrhage) or failure of the lungs to work properly (respiratory failure). Years after treatment 
with IV busulfan, some patients developed some type of scar tissue formation in the lungs (pulmonary 
fibrosis). 
 
Cardiovascular system 
You may develop a decrease of the fraction of blood pumped out of the heart with each beat (decreased 
ejection fraction), decrease of the heart's function as a pump (left-sided heart failure), not enough oxygen 
in body tissues due to impaired heart function (cardiogenic shock), the presence of fluid in the sac around the 
heart (pericardia! effusion) or inflammation of the sac around the heart (pericarditis). You may also 
experience an increased blood volume. 
 
Nervous system and mental disorders 
Symptoms you may experience may include agitation, bleeding in the brain (cerebral hemorrhage), coma, 
confusion, nervousness, delusions, hallucinations, diseases of the brain (encephalopathy) and drowsiness 
(somnolence). When high doses ofbusulfan are given in combination with cyclophosphamide there is a risk 
of seizure. Your doctor can discuss this with you and will give you medication to help prevent them. 
 
Ear, Nose and Throat 
You may develop an ear disorder. You may develop sinus inflammation (sinusitis). 
 
Skin changes 
You may also develop an inflammation of fat cells under the skin (erythema nodosum), redness (erythema) 
and scaling under the entire skin (exfoliative dermatitis). 
 
Second cancer 
With long-term use of these drugs over many years, there is a very small risk of developing a second 
cancer. In this study, you will not receive these drugs over many years. 
 
Other 
Your body may lose the function of many organs. This is called multi-organ failure and can be fatal. Your 
doctor will discuss with you this condition and the medications that are used to control it. 
 
Other side effects besides the ones listed above have been reported less frequently, so make sure that you 
discuss these other side effects with your study doctor. 
 
Allergic Reactions 
 
Allergic reactions can vary in degrees of severity. They may cause death in rare cases. When a severe 
allergic reaction develops, it usually occurs at the time the medicine is entering the body (during drug 
infusion). Allergic reactions may cause trouble breathing, very low blood pressure, sudden swelling, and/or 
hives or rash. 
 
Additional Risks and Toxicities Related to the Standard Transplant Procedure 


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There are certain risks related to a HPC transplant. There are risks from the medications and/or irradiation 
therapy you will receive as part of the conditioning for the transplant and risks related to the transplant 
itself. Most of these risks and side effects are listed below, but they will vary from person to person. Your 
doctor will give you medications to lessen some of the side effects. Some of these complications can be 
serious and may be fatal in some instances. The risk of death may be as high as 40% depending on individual 
patient related factors. You will be monitored closely during the transplant for any complications that may 
occur. 
Risks Related to the Transplant Conditioning Regimen 
 
Fludarabine: This medication is used in HPC transplants to reduce the risk of rejecting the donor's 
transplanted cells. This therapy will cause the lowering of your white blood cell counts (making you 
susceptible to infections), platelets (making you susceptible to bleeding), and red blood cell count (causing 
anemia and making you tired). Fludarabine may cause nausea, vomiting, loss of appetite and diarrhea, 
reversible hair loss, mouth sores/ulcers, headache, skin rash, fever, chills, tiredness, weakness, damage to 
the heart and lungs, shortness of breath, high blood sugar, blurred vision, fluid retention (swelling) and 
hearing loss. 
 
Reproduction: The conditioning regimens discussed above are likely to cause women to enter pre-mature 
menopause. Men who receive these conditioning regimens are unlikely to be able to father 
children. However, there is no guarantee that this will happen to you, so you should discuss the need for 
birth control with your doctor. In any case, you are not protected from sexually transmitted diseases as a 
result of having these treatments. 
 
Graft-versus-Host Disease (GVHD) 
After the graft begins to function, there is a further risk of a reaction of the graft against your tissues. This 
reaction is called GVHD and may cause a skin rash, or abnormalities of the liver, or stomach. GVHD may 
cause nausea (feeling sick to your stomach), vomiting (throwing up), lack of appetite, stomach cramps, 
diarrhea (loose stools), and bleeding of the gut. Chronic GVHD may occur later after transplantation and 
may involve problems with the eyes, mouth, lips, throat and liver. Early (acute) or late (chronic) GVHD 
may become severe enough to result in death. GVHD is treated with drugs that weaken the immune system, 
and therefore make you more susceptible to infections. 
 
Risks Related to the Medications Used to Help Prevent GVHD 
NOTE: These drugs also decrease the risk ofrejection of the donor cells. 
 
Tacrolimus: This medication is used to try to prevent GVHD. The immediate side effects you may 
experience include nausea (feeling sick to your stomach) or vomiting (throwing up) when the medications 
are given orally. Other side effects you may experience include high blood pressure (hypertension), shaking 
of the hands (tremor), increased hair growth and possibly an effect on mental function. If you experience 
these effects they generally go away when the dose of the medication is decreased. A few patients have had a 
seizure while taking these medications. You may experience a change ofliver or kidney function, in which 
case the medication dose will be reduced or possibly even withheld. In rare cases, the kidney damage caused 
may require the use of an artificial kidney machine (hemodialysis). 


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Some patients given tacrolimus develop diabetes and must take insulin while taking tacrolimus. 
 
Methotrexate: This is also a medication used to try to prevent GVHD. Methotrexate causes damage to cells, 
and therefore can affect many different tissues of your body. It may cause or can worsen the mouth sores or 
inflammation of the mouth which you may have already developed from the procedures and medications 
used to prepare you for the transplant. It may also cause nausea (feeling sick to your stomach) and vomiting 
(throwing up). Methotrexate may slow down the recovery of blood cells after transplantation. Methotrexate 
can cause kidney damage. If your kidney is already damaged for other reasons, it can worsen kidney 
function. If kidney damage does occur, the methotrexate dose may be reduced or the medication may not be 
given at all. 
 
Anti-thymocyte Globulin (ATG): This medicine is used to try to prevent GVHD. It can cause infusion 
reactions such as fever and chills. This drug may also cause allergic reactions (some could be severe) and it 
could weaken your immune system, which can cause you to get infections easily. 
 
Tacrolimus, Methotrexate, and ATG: These medications interfere with the body's defense system (the 
immune system). This may cause you to have more infections (especially viral infections and pneumonia) 
for several months after transplant. 
 
Risks and Procedures Related to the Transplant Procedure 
 
The following risks are not specifically related to any one drug or the transplanted donor cells, but they are 
risks that are a part of the transplant procedure. The following applies to ALL patients. 
 
Venipuncture: Although you may require a central venous catheter to donate cells, there may be an 
occasional need to have an intravenous catheter placed in your arm(s) or you may need to have blood 
withdrawn from the veins of your arm(s). Drawing blood from the arm may be associated with bleeding into 
the skin and may very rarely result in an infection. 
 
Central Venous Catheter: A central venous catheter is a flexible sterile tube that can be placed into a large 
vein either under the collar bone or in your groin area so that blood can be withdrawn. Complications include 
blood clots and infection. Clotting may necessitate removal of the catheter or treatment of the clot by 
injecting a medicine that dissolves blood clots. If you develop an infection, you will require treatment with 
antibiotics. If the catheter is placed under the collarbone, other uncommon side effects may include swelling 
of the face and arm and/or lung collapse. If the lung collapses, it may be necessary to place a tube between 
the ribs to allow the lung to re-expand. 
 
Bleeding: Platelets help your blood to clot. Your platelets will be low until the new bone marrow 
grows and, as a result, bleeding may occur. This can be minor bleeding, such as nosebleeds or bruising, 
but more serious, life-threatening bleeding in the lungs, brain and other organs can occur if the platelet 
count remains low. Usually, there is success in preventing major bleeding problems with transfusions 
of platelets. However, some patients may not respond well to transfused platelets and may be at serious 
risk for bleeding. 
 
Mouth Sores and Diarrhea: The chemotherapy causes irritation in the lining of the mouth and 


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intestines. This can result in painful mouth sores and diarrhea and you may need medication to help control 
the pain. If your mouth sores are severe you may not be able to eat normally until the sores are 
healed. Mouth sores get better when the white blood count starts to rise. 
 
Capillary Leak Syndrome: This may occur as a result of chemotherapy and radiation therapy. The blood 
vessels may become 'leaky' and fluid enters the abdominal cavity, 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 the lungs and causes difficulty breathing. You may die if there is 
continued fluid collection in the lungs. 
 
Unexpected Organ Damage and Other Side Effects: Although your major organs function well, it is possible 
you may experience unexpected, life-threatening heart, lung, kidney, or liver damage as a result of the 
transplant. Occasionally, the high doses of chemotherapy cause severe lung damage that cannot always be 
treated. If this happens, you may need to use oxygen or even a respirator. The lung damage can be life 
threatening. Rarely, multi-organ failure (such as lung and kidney failure) may occur, which is often fatal. 
 
Late Effects: You may experience side effects that occur several months to many years after your 
transplant. You may experience poor function of the thyroid gland, requiring you to take thyroid 
medication. It is rare, but your kidneys could be affected, causing anemia or high blood pressure. There is 
also a risk you may develop a second cancer including leukemia as a result of the chemotherapy, and/or 
your lymphoma. If secondary cancers occur they generally do not occur until 10 to 15 years after the 
transplant but can occur sometimes within five years after transplant. The long-term effects upon heart, 
lung, and brain are unknown. 
 
Fluid Build-up: You will receive intravenous fluids during the transplant process and you may have 
difficulty eliminating this fluid. Furosemide is a drug that is often given to help eliminate this excess 
fluid. This drug may cause hearing loss and loss of body chemicals such as potassium and sodium. 
 
Bone Marrow Aspirate/Biopsy: You may feel a sharp sting and bum when the anesthetic numbs your skin 
over the aspiration or biopsy site. You may hear a crunching sound and feel pressure and some pain when 
the needle enters the bone. The pain usually lasts for only a few seconds. During an aspiration, you may 
feel a quick, shooting pain down your leg as the sample is taken. This pain stops as soon as the sample is 
removed. The biopsy site may feel stiff or sore for 1 or 2 days after the biopsy. You may have a bruise on 
the site. 
 
Risk to the Unborn 
 
The treatment that you are undertaking has 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. 
 
Sterility and Future Childbearing Potential for Men and Women 
 
Chemotherapy may cause lasting effects on the reproductive potential of both men and women treated in 
this manner. It should be emphasized that your cancer treatment/therapy may cause your menstrual periods 
 
 
Phone: 304-293-7073 
Fax: 304-293-3098 
http://oric.research.wvu.edu 
 
Chestnut Ridge Research Building 
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to become irregular or cease altogether. However, this DOES NOT MEAN THAT YOU CANNOT 
BECOME PREGNANT, and you must use birth control. It is important that both men and women use birth 
control while on this study. 
 
Risks Related to the Infusion ofHematopoietic Progenitor Cells 
 
The HPC infusion is given similar to a blood transfusion. The infusion of HPC usually has few side 
effects. Rarely the infusion may cause a headache, chest pain or trouble breathing, a slight fever, or blood in 
the urine. You will be given pre-medications just prior to the infusion to decrease the risk of a 
reaction. Common, less serious reactions for patients include mild wheezing, mild shortness of breath, back 
or chest pain or lightheadedness. In rare instances, a severe allergic reaction can occur called anaphylaxis, 
which could cause a drop in blood pressure or extreme difficulty in breathing. You will be monitored very 
closely. 
The amount of radiation (x-rays and scans to assess your disease) that you are exposed to in this study is 
considered standard of care for your disease. The risks of these procedures will be explained to you by your 
doctor and staff involved in your care. Risks from radiation exposure are cumulative (they increase) over 
time. 
 
Alternatives 
You do not have to participate in this study. 
 
You do not have to take part in this study. Alternatives that could be considered in your case include: 
• 
Taking part in another study 
• 
Receiving other treatment or combination of treatments 
• 
Receiving no further treatment 
• 
 Receiving comfort care (palliative care). This treatment helps reduce symptoms associated with 
cancer (pain, fatigue, appetite). It does not treat the cancer directly, but tries to improve the way 
that you feel and keep active. 
• 
Your treating physician can discuss your treatment options with you. 
 
 
Benefits 
There is no guarantee that you will receive any medical benefit from taking part in this study. The potential 
benefit of this treatment is to help control/treat your disease. Information obtained from this study may 
benefit other patients with the same disease in the future. 
 
Financial Considerations 
You are strongly encouraged to contact your insurance company if you have one before you agree to be in 
this study. 
 
You or your insurance company will be responsible for paying for procedures, tests and possibly 
medications that are standard treatment for patients undergoing HPC transplants. Some examples of 
standard procedures include routine laboratory blood tests, x-rays, MRls, scans, surgeries, blood 
transfusions, physicians' charges and routine medical care. Examples of medications you could possibly 


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require in addition to the study medications include antibiotics or other medications to manage side 
effects of treatment. Your insurance company may not pay for costs associated with research studies like 
this one. You are responsible for any charges your insurance company does not pay. You may have to pay 
for some expenses related to this study, such as transportation, parking, meals, or others. 
 
You will not be paid for taking part in this study. 
 
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/insurancecoverage. 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 l-800-4-CANCER (l-800-422-6237) and ask them to send 
you a free copy of this information. 
 
Voluntary Compensation 
In the event of a research-related injury, necessary medical treatment will be provided to assist your recovery 
from the injury. This agreement to provide treatment does not include treatment for any injury/illness, which 
is not the result of the research. 
 
There is no money set aside to help treat you if you get hurt or sick in this study. The study doctor and WVU 
or its partners do not have special funds to pay for research study injuries if they occur. Signing this form 
does not take away your legal rights. 
 
Confidentiality 
Any information about you that is obtained as a result of your participation in this research will be kept as 
confidential as legally possible. Your research records and test results, just like hospital records, may be 
subpoenaed by court order or may be inspected by the study sponsor or federal regulatory authorities 
(including the FDA) without your additional consent. 
 
If any publications result from this research, neither your name nor any information from which you 
might be identified will be published without your consent. 
 
Authorization (Permission) to Use or Disclose (Release) Identifiable Health Information for Research at 
West Virginia University 
 
If you sign this form you are letting us use or give out your health information for research. This 
means the information we use or give out can be used to identify you. 
 
We want to keep your health information private. That is why we need you to agree to let us use or give out 
your information or you cannot be in this research study. We will not use information to identify you unless 
we ask you first. This means we will not use your name or other information about you to write papers or 
talk about our research unless you let us. 
 
Who do we need this information from? You (Patient/West Virginia University Hospitals/Mary Babb 


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Randolph Cancer Center) 
 
Who needs this information for this study? 
 
• 
 The research site(s) carrying out this study. This includes UHA or UHA Affiliated, WVU, WVU 
Hospitals. It also includes each site's research staff and medical staff. 
• 
Health care providers who provide services to you as part of this research study. 
• 
Laboratories that are used for this study. 
• 
The United States Department of Health and Human Services (which includes the National Institutes 
of Health, Food and Drug Administration (FDA)) and other regulatory groups 
• 
Foreign regulatory agencies 
• 
Dr. Kanate and the people and companies that are used to oversee, manage, or conduct the research 
• 
The members and staff of any Institutional Review Board (IRB) that oversees this research study. 
• 
West Virginia University Office of Research Compliance and Office of Sponsored Programs. 
• 
West Virginia University Clinical Trials Research Unit 
 
What information will we use? 
 
• 
Your medical records and research study records 
• 
New infonnation collected during this study like physical exams; visit notes from the research staff; 
lab results; and other test results like x-rays or ECG results. 
 
The information is being disclosed for the following reasons: 
 
• 
Review of your data for quality assurance purposes 
• 
Publication of study results (without identifying you) 
• 
Other research purposes such as reviewing the safety or effectiveness of the study drug and other 
products or therapies; conducting performance reviews of the study drug; evaluating other products 
or therapies for patients; developing a better understanding of disease; improving the design of future 
clinical trials 
 
You may cancel this permission at any time by writing to the study doctor at the address on the first page of 
this document. Your permission will not expire unless you cancel it. 
 
If you cancel this permission any information that we already have can still be used. If we already have 
information about you we can still give it out after you cancel your permission. 
 
You have a right to see and make copies of your medical records, but not until the study is done. When 
the study is done you can see your records and correct anything that is wrong. 
 
Voluntary Participation 
Participation in this study is voluntary. You are free to withdraw your consent to participate in this study at 
any time. 
The study doctor may stop you from taking part in this study at any time if he/she believes it is in your best 


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interest; if you do not follow the study rules; or if the study is stopped for any reason. If you stop being part 
of this study, the study doctor or one of the staff members will talk to you about any medical issues 
regarding the stopping of your participation. Your decision to stop being in this study will not affect your 
care here or your relationship with your doctor. Your study doctor may take you out of this study at any 
time without your consent. You could be removed from this study if: 
 
• 
Your disease gets worse, 
• 
You have unacceptable side effects, 
• 
You do not follow the study instructions, 
• 
The study is stopped, 
• 
If it is in your best interest to stop taking part in the study. 
 
In the event new information becomes available that may affect your willingness to take part in this study, 
this information will be given to you so that you can make an informed decision about whether or not to 
continue your participation. 
 
You have been given the opportunity to ask questions about the research, and you have received 
answers concerning areas you did not understand. 
 
Signature 
 
Making your choice: 
 
Please initial beside your choice about storing your blood and bone marrow for future research: 
 
 
Yes, I give the researchers permission to store my blood and bone marrow at 
West Virginia University to do future research. 
 
No, I do not give the researchers permission to store my blood and bone 
marrow at West Virginia University to do future research. 
 
By signing agreeing to take part in this study, you are confirming the following: 
 
 
• 
You have read all of the information in this Consent and Information Form, and you have had time to 
think about it. 
• 
All of your questions have been answered to your satisfaction. 
• 
You voluntarily agree to be part of this research study, to follow the study procedures, and to provide 
necessary information to the doctor, nurses, or other staff members, as requested. 
• 
You may freely choose to stop being a part of this study at any time. 
• 
You have received a copy of this Consent and Infonnation Form to keep for yourself. 


 
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Upon signing this form, you will receive a copy. I willingly consent to participate in this research. 
 
 
 
 
Signature of Subject or 
Subject's Legal 
Representative 
Printed Name 
Date 
Time 
 
 
 
The participant has had the opportunity to have questions addressed. The participant willingly 
agrees to be in the study. 
 
 
 
 
Signature of Investigator 
or Co-Investigator 
Printed Name 
Date 
Time 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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