Clinical trial NCT04083170
Conditions: Acute Erythroid Leukemia Acute Lymphoblastic Leukemia Acute Megakaryoblastic Leukemia Acute Myeloid Leukemia Chronic Myelogenous Leukemia, BCR-ABL1 Positive Hematopoietic and Lymphoid Cell Neoplasm HIV Infection Myelodysplastic Syndrome Myelodysplastic Syndrome With Excess Blasts Non-Hodgkin Lymphoma Refractory Anemia
Sponsor: Fred Hutchinson Cancer Center
Start date: 2022-10-06; Completion date: 2022-11-30
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial studies the side effects of a cord blood transplant using dilanubicel and to see how well it works in treating patients with human immunodeficiency virus (HIV) positive hematologic (blood) cancers. After a cord blood transplant, the immune cells, including white blood cells, can take a while to recover, putting the patient at increased risk of infection. Dilanubicel consists of blood stem cells that help to produce mature blood cells, including immune cells. Drugs used in chemotherapy, such as fludarabine, cyclophosphamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Total body irradiation is a type of whole-body radiation. Giving chemotherapy and total-body irradiation before a cord blood transplant with dilanubicel may help to kill any cancer cells that are in the body and make room in the patient's bone marrow for new stem cells to grow and reduce the risk of infection.

Detailed description:
OUTLINE: Patients are assigned to 1 of 2 regimens.

REGIMEN A: Patients receive fludarabine intravenously (IV) over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo total body irradiation (TBI) twice daily (BID) on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity.

REGIMEN B: Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI once daily (QD) on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 28, 80, and 180 days, and then at 1 and 2 years.

Arms: arm 1: Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Fludarabine intervention 2: Cyclophosphamide intervention 3: Thiotepa intervention 4: Total-Body Irradiation intervention 5: Umbilical Cord Blood Transplantation intervention 6: Dilanubicel
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Undergo TBI intervention 5: Undergo UCBT intervention 6: Given IV

Protocol documents:
Prot_SAP_001.pdf: 


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ICF_000.pdf: 
 
 
Official Title: 
Infusion of off-the-shelf ex vivo expanded cryopreserved 
progenitor cells to facilitate the engraftment of a single 
CCR5Δ32 homozygous or heterozygous cord blood unit in 
patients with HIV and hematological malignancies 
NCT Number: 
NCT04083170 
Document Type:  
Informed Consent Form 
Date of the 
Document: 
09.28.2022 
 
 


Protocol RG1004070 Consent Form A 
Page 1 of 21  
Fred Hutchinson Cancer Center 
University of Washington 
Seattle Children’s Hospital 
Consent to take part in a research study: 
Infusion of off-the-shelf ex vivo expanded cryopreserved progenitor cells to facilitate 
the engraftment of a single CCR5Δ32 homozygous or heterozygous cord blood unit 
in patients with HIV and hematological malignancies 
 
Local Principal Investigator: 
Filippo Milano, MD, PhD, Associate Professor,  
Fred Hutchinson Cancer Center. 206-667-5925 
 
Emergency number (24 hours): (206) 598-8902 
 
If you are serving as a legally authorized representative, a guardian, or are providing 
parental permission for a child in this study, the terms “participant”, "you", and "your" 
refer to the person for whom you are providing consent or parental permission.  
Important things to know about this study. 
You are invited to participate in a research study. The purpose of this study is to find out 
whether it is safe and effective to give patients with both a hematologic malignancy (cancer 
that affects blood, bone marrow and lymph nodes) and HIV (human immunodeficiency 
virus) infection one unit of cord blood followed by a unit of the off-the-shelf product 
(dilanubicel or expanded cord blood cells) in stem cell transplant. This research also aims 
to look at what happens to the HIV cells in your body in cord blood stem cell 
transplantation. 
The only well-established cure of HIV was in an individual (the Berlin patient) who received 
hematopoietic stem cell transplant from an unrelated adult donor who had a rare genetic 
mutation known as CCR5Δ32 that protects from HIV infection. Due to the rarity of finding a 
matched adult donor carrying the mutation, we will use a cord blood unit prescreened at a 
cord blood bank for CCR5Δ32 mutation. It is possible that use of this cord blood product to 
treat your hematologic malignancy may also improve or cure your HIV.  
Taking part in this study does not require you to discontinue your current highly active 
antiretroviral therapy (HAART) and other studies have shown no elevated risk of continuing 
HAART through transplant. If you and your clinical care provider choose to discontinue 
HAART post-transplant, the study will follow you to collect clinical information to better 
understand the effects of this therapy.  
You may not benefit from being in this study.  Knowledge that we may gain from this study 
may benefit others. Your participation in this study is completely voluntary. You do not have 
to participate in this study. You can choose to receive standard methods of stem cell 
transplant instead of participating in this study. We will give you details about the purposes, 
procedures, risks and possible benefits related to this study. We will explain other treatment 
choices available to you, and your rights as a participant in this study.   
Please read this consent form carefully. Please ask the study staff questions about 
anything that you do not understand in this consent form or any questions that you have 


Protocol RG1004070 Consent Form A 
Page 2 of 21  
that will help you decide whether to join the study. If you choose to join this study, we will 
give you a signed copy of this form to keep for future reference. 
We invite you to join this research study. 
We invite you to join this research study because you have been diagnosed with a 
hematologic malignancy and HIV and are eligible for a cord blood transplant. Up to 10 
people will join this study. Doctors at the Fred Hutchinson Cancer Center (Fred Hutch), 
University of Washington, Seattle Children’s Hospital, Case Western Reserve University 
Hospitals, Children’s National Medical Center, and the University of California San 
Francisco are conducting this research study. The Fred Hutch is the main center for this 
research study.   
Research is not the same as treatment or medical care. The purpose of a research study is 
to answer scientific questions.  
You do not have to be in the study. You are free to say “yes” or “no”, or to drop out after 
joining. If you say “no,” you would have no penalty or loss of benefits. Whatever you 
decide, your regular medical care would not change.  
Why are we doing this study? 
In this study, we want to learn what side effects, good or bad, dilanubicel has on people 
with hematologic malignancy and HIV. If you join this study, we would give you dilanubicel 
and watch carefully for any side effects. 
Cord blood stem cell transplant is a standard therapy in many transplant hospitals around 
the world. Previous experience with cord blood stem cell transplant has led to extended 
disease-free survival or cure for some patients with hematologic malignancies. 
One disadvantage of cord blood transplant is that it takes longer for blood counts to recover 
in patients treated with cord blood than for patients who receive other types of transplant. 
Studies have shown that this is because of the small number of cells (“cell dose”) in one 
unit of cord blood. The most common way to give a patient more cells is to use two units of 
cord blood. This has been done since 2000 and has been shown to improve the survival of 
cord blood transplant patients.  
Even with the use of two units of cord blood, studies have shown that it takes longer for 
cord blood transplant patients to recover blood counts than in patients receiving other types 
of transplant. When blood counts are very low for a long period of time, there is an 
increased risk of bleeding and infection. This may lead to more time in the hospital, and for 
some people the complications may be fatal.  
In a laboratory at Fred Hutch, researchers have developed a way of growing or “expanding” 
the number of cord blood cells in the lab to provide a temporary source of cells (especially 
neutrophils, white blood cells that fight infection) while patients are waiting to recover their 
blood counts after cord blood transplant. The expanded cells are called dilanubicel. 
dilanubicel is still being studied and government agencies, such as the U.S. Food and Drug 
Administration (FDA), do not allow this therapy as a standard of care treatment and it can 
only be used as part of a research study. 


Protocol RG1004070 Consent Form A 
Page 3 of 21  
We have completed one study using dilanubicel with cord blood transplant at Fred Hutch. 
Fifteen patients received dilanubicel along with unexpanded cord blood. This was mainly a 
safety study and there were no safety problems reported. Researchers also compared time 
to blood count recovery (“engraftment”) with a group of patients receiving cord blood 
transplant without dilanubicel, and the patients who received dilanubicel recovered their 
neutrophils and platelets (blood cells that prevent bleeding by helping the blood to clot) 
more quickly than those who did not receive dilanubicel. A larger multicenter study is 
ongoing to study whether the results from the first study can be repeated with more 
patients, and 160 patients have received dilanubicel in that study.  
Patients in the studies described above received either one or two cord blood units 
depending on their weight and the cell dose of the unexpanded cord blood. In this study, all 
patients will receive a single unexpanded cord blood unit with an infusion of dilanubicel. 
The main question is whether a single cord blood unit is enough for engraftment when 
combined with dilanubicel in patients with a hematologic malignancy and HIV. 
Dilanubicel is made ahead of time and then frozen for use and can be used for any patient 
without need for matching with the patient’s HLA type. A person’s HLA type is a set of 
proteins on the cells that help the immune system to recognize “self” from “other” (like 
bacteria or viruses). It is possible to use dilanubicel without HLA matching because the 
immune cells (T cells) in cord blood that could react against the patient are removed before 
the expanded cells are made.  
 
The unexpanded cord blood unit will be selected for patients as usual for cord blood 
transplant. 
 
We are also interested in looking at what happens to your HIV infection after cord blood 
transplantation. Since there haven’t been many studies that include patients with both a 
hematologic malignancy and HIV infection, we hope that the cord blood transplant will 
potentially control the hematologic disease while also eliminating the HIV cells in your body. 
What research tests, procedures, and treatments are done in this study? 
Most of the tests, procedures, and treatments you will have in this study are part of the 
standard care for your disease. However, there are some extra blood tests and procedures 
you will need to have if you participate in this study. Before any study-related tests and 
procedures are performed, you will be asked to read and sign this consent form. If you 
have any questions about the tests mentioned in this section, you should ask the study 
doctor or study staff. 
Study visits may happen at the same time as your visits for routine care either while you 
are in the hospital or coming into the clinic for scheduled appointments. 
Screening: 
Before you begin the study, you will need to have tests and procedures done to see if you 
can be in this study. Some of these procedures would be done for your routine care 
whether you participate in this study or not.  
• 
Medical history and physical exam 
• 
Disease staging, which may include a bone marrow aspirate and/or biopsy 


Protocol RG1004070 Consent Form A 
Page 4 of 21  
• 
MUGA or ECHO to look at your heart function 
• 
Pulmonary function tests 
• 
Pregnancy test 
• 
Blood tests for safety including complete blood counts, blood chemistry (kidney and 
liver function), panel reactive antibody 
• 
Blood tests for research (prior to conditioning) 
 
If you meet all study requirements and choose to take part, you will be allowed to 
participate in this study.  
Conditioning (pre-transplant chemotherapy and radiation): 
The day you receive the unexpanded cord blood unit and dilanubicel is considered “Day 0.” 
Prior to receiving the cord blood unit and dilanubicel, you will undergo “conditioning,” where 
you will receive chemotherapy and radiation. 
There are two types of conditioning regimens used in this study: high intensity regimen and 
middle intensity regimen. The type of transplant conditioning regimen you receive will be 
chosen by your doctor and will depend on your age, details of your disease, and your 
overall health. These conditioning regimens are standard treatments and are not 
experimental.   
Prior to conditioning, a research blood sample will be obtained. This blood sample will be 
used to establish a baseline measure prior to receiving dilanubicel.  
 
If you are receiving the High Intensity Regimen, it will involve the following:  
 
• 
Eight days before the transplant, you will start conditioning. You will be admitted to 
the hospital on the bone marrow transplant unit. Your doctor will let you know where 
you will start treatment. You will also need a central venous catheter for transplant, 
so if you do not already have one, one will be placed. 
 
• 
Chemotherapy (cyclophosphamide and fludarabine) and total body radiation (TBI) 
are given with the intent of helping to kill cancer cells and to prepare your body for 
the cord blood stem cells by suppressing your immune system. These procedures 
are summarized in a table below. 
 
High Intensity Regimen  
(High Dose TBI total 1320 cGy (165 cGy BID, total 8 fractions, days -4 to -1)) 
 
Day 
Conditioning 
Supportive 
Care/Other 
8 days prior to transplant 
Fludarabine 
 
7 days prior to transplant 
Fludarabine 
Cyclophosphamide 
 
6 days prior to transplant 
Fludarabine 
Cyclophosphamide 
 
5 days prior to transplant 
Rest 
4 days prior to transplant 
TBI twice daily 
 
3 days prior to transplant 
TBI twice daily 
Begin CSA  
2 days prior to transplant 
TBI twice daily 
 


Protocol RG1004070 Consent Form A 
Page 5 of 21  
1 day prior to transplant 
TBI twice daily 
 
0 (TRANSPLANT DAY) 
Unexpanded cord blood unit,  
followed by dilanubicel 
Begin MMF   
1 day after transplant 
 
Begin G-CSF (daily 
until recovery of 
white blood cell 
count) 
 
If you are receiving the Middle Intensity Regimen, it will involve the following:  
 
• 
Six days before the transplant, you will start conditioning. You will be admitted to the 
hospital on the bone marrow transplant unit. You will also need a central venous 
catheter for transplant, so if you do not already have one, one will be placed. 
 
• 
Chemotherapy (fludarabine, thiotepa, and cyclophosphamide) and TBI are given with 
the intent of helping to kill cancer cells and to prepare your body for the cord blood 
stem cells by suppressing your immune system. These procedures are described in 
a table below.  
 
Middle Intensity Regimen  
(TBI total 400 cGy (200 cGy/day x 2 days, -2 to -1)) 
 
Day 
Conditioning 
Supportive Care/Other 
6 days prior to transplant 
Fludarabine 
Cyclophosphamide 
 
5 days prior to transplant 
Fludarabine 
Thiotepa 
 
4 days prior to transplant 
Fludarabine 
Thiotepa 
 
3 days prior to transplant 
                           Fludarabine  
Begin CSA Begin MMF 
2 days prior to transplant 
Fludarabine 
TBI once daily  
 
1 days prior to transplant 
TBI once daily 
 
0 (TRANSPLANT DAY) 
Unexpanded cord blood unit,  
followed by dilanubicel 
 
1 day after transplant 
 
Begin G-CSF (daily until 
recovery of white blood 
cell count) 
Transplant Day:  
On Day 0, the transplant day, the cord blood stem cells are given intravenously through the 
central venous catheter. The unmanipulated cord blood unit will be infused first, followed by 
dilanubicel approximately 4 hours later. The time interval between the two infusions of cells 
allows us to better follow side effects that might occur with infusion of dilanubicel.  
 
You will receive dilanubicel intravenously (IV; through a vein). The infusion will last about 5-
10 minutes. The following procedures will be done several times after the infusion: 


Protocol RG1004070 Consent Form A 
Page 6 of 21  
• You will be asked how you are feeling and be monitored closely for any side effects 
from the infusion. 
• You will have your vital signs checked, including your heart rate, blood pressure, 
respiration rate (number of breaths), and temperature. 
Immunosuppression Therapy: 
As part of the transplant procedure, you will be given two drugs to reduce the risk of graft 
versus host disease (GVHD), a complication that occurs when the cord blood stem cells 
recognize the patient's body as foreign and attack it. Both drugs will initially be given 
through your central venous catheter and then changed to a pill form when you can take 
medication orally. The first drug is called Cyclosporine A (CSA). CSA will be started three 
days before the cord blood unit is given (day -3) and continued at full dose for at least 100 
days. The second drug is called Mycophenolate Mofetil (MMF). MMF will be started three 
days before the cord blood unit is given (day -3) or on Day 0 after your cord blood unit 
infusion, depending on which regimen you receive, and will continue at full dose for at least 
30 days.    
G-CSF: 
To help your blood cells recover as quickly as possible, you will receive granulocyte-colony-
stimulating factor (G-CSF or Neupogen). G-CSF signals the bone marrow to make white 
blood cells, which are needed to fight and prevent infections.  You will start receiving G-
CSF through your central line or as an injection under the skin the day after transplant (day 
1). You will continue to receive it daily until your white blood cell count recovers.   
Follow-up: 
In order to measure how your new marrow is developing, how your immune system is 
recovering after your transplant, and how long dilanubicel is in your blood, you will have 
blood drawn and/or bone marrow biopsies (“chimerism tests”) at specific time points.  
Blood draws will be scheduled for Days 28, 80, 6 months, 1 year, and 2 years after your 
transplant. Bone marrow biopsies are scheduled for Days 28 and 80 and 1-year post-
transplant. 
You will be discharged from the inpatient bone marrow transplant unit when you are ready 
to be cared for as an outpatient. Initially, it will be necessary for you to have frequent visits 
at the outpatient transplant clinic, and then at specific times as determined by your 
physician. Follow-up care beyond Day 80 will be according to your specific type of disease. 
Your physician will likely want to see you at 6 months, 1 year, and 2 years after the 
transplant.  In addition to the tests mentioned above, your physician may order other 
procedures or tests based on your diagnosis and your progress after transplant.  
You will be followed in the study for 2 years. After you have recovered from any immediate 
transplant related complications, follow-up will be routine and according to your specific 
disease type, but we will continue to collect data on how your marrow is functioning at 
these follow-up visits. 
As part of follow-up, we would like to contact you and/or your referring physician around 6 
months, 1 year and 2 years after transplant to see how you are doing. We may contact your 
physician to request copies of blood test results and other tests and procedures done as 


Protocol RG1004070 Consent Form A 
Page 7 of 21  
standard post-transplant follow-up. This will help us learn about the long-term effects of the 
study.  
How long would you stay in this study? 
You will be followed in the study for 2 years.  
 
The study doctor or your doctor may take you out of this study at any time, for any reason, 
and without your consent. This would happen if: 
• 
They think it is in your best interest not to continue in the study. 
• 
You are unable or unwilling to follow study procedures. 
• 
The whole study is stopped. 
You can decide to stop at any time. It is important to tell the study doctor if you are thinking 
about stopping or decide to stop. He or she will tell you how to stop safely. If you stop the 
study after receiving the chemotherapy and radiation, but before you receive the cord blood 
cells, there is a significant increase in the risk of death or life-threatening infection. Another 
reason to tell your doctor that you are thinking about stopping is to discuss what follow-up 
care and testing could be most helpful for you. 
We would like to do long-term follow-up. 
 
Long-term follow-up means keeping track of someone’s medical condition for the rest of 
his/her life to look at the long-term effects of the study. You will be asked to sign another 
consent form to allow Fred Hutch to keep getting information from your referring physician 
and sending you annual questionnaires about your health after you finish this study. This is 
done by the Long-Term Follow-Up Department, but some of the information will also be 
used for this study.  
 
You do not have to be in long-term follow-up. You could say “yes” or “no”. Either way, you 
could still join this study.  
 
If you choose not to join long-term follow-up, you would not be contacted regularly, and we 
would not ask your doctor to send medical records, but we might still need to contact you 
for some other reason. 
What are the side effects (risks)? 
The side effects associated with transplant can be uncomfortable, and in some cases 
dangerous, life-threatening, or fatal. Because this is a research study there may be 
additional side effects which are not known at this time. The known or possible side effects 
of the treatments you will receive as part of this study are listed below. The risks of the 
conditioning regimen, immunosuppression and supportive drugs are the same as they 
would be for a transplant without dilanubicel. If we learn about other side effects, we will tell 
you. 
 
Risks of Conditioning, Immunosuppression and Supportive Drugs 
1. Fludarabine: 
Likely (Over 10%) 
Less Likely (1-10%) 
Rare (Less than 1%) 


Protocol RG1004070 Consent Form A 
Page 8 of 21  
• 
Low white blood cell count with increased 
risk of infection  
• 
Low platelet count with increased risk of 
bleeding 
• 
Anemia 
• 
Nausea  
• 
Vomiting  
• 
Diarrhea  
• 
Fever 
• 
Pain 
• 
Cough 
• 
Increased risk of unusual infections lasting 
more than 6 months 
• 
Fatigue  
• 
Numbness and 
tingling in hands or 
feet 
• 
Visual changes 
• 
Damage to organs 
(brain, lungs, others) 
which may cause 
tiredness 
• 
Changes in thinking 
or shortness of 
breath 
• 
Rash 
• 
Severe problems 
with brain (coma at 
high-doses, 
confusion) 
• 
Pneumonia 
• 
Irregular heart beats 
• 
Kidney damage 
which may require 
dialysis 
 
 
2. Cyclophosphamide: 
Likely (Over 10%) 
Less Likely (1-10%) 
Rare (Less than 1%) 
• 
Nausea/vomiting  
• 
Diarrhea  
• 
Loss of appetite  
• 
Low white blood cell count with increased 
risk of infection 
• 
Low platelet count with increased risk of 
bleeding 
• 
Sores in mouth or on lips  
• 
Fatigue  
• 
Blood in urine 
• 
Lower sperm production in men 
• 
Hair loss 
• 
Missing or stopping of menstrual periods in 
women 
• 
Skin changes 
• 
Rash 
• 
Pain in belly 
• 
Anemia 
• 
Liver problems 
• 
Damage to the bone 
marrow (irreversible) 
which may cause 
infection 
• 
Bleeding 
• 
May require 
transfusions 
• 
Allergic reaction 
• 
Fluid around heart 
• 
Lung damage 
• 
Heart failure with 
high doses 
• 
Liver failure 
• 
Secondary cancers 
• 
Severe skin rash 
• 
Swelling of the body 
including the brain 
which may cause 
dizziness 
• 
Confusion 
 
3. Thiotepa 
Likely (Over 10%) 
Less Likely (1-10%) 
Rare (Less than 1%) 
• 
Low white blood cell count with an 
increased risk of infection (from bacteria, 
fungi or viruses) 
• 
Low platelet count with increased risk of 
bleeding 
• 
Anemia 
• 
Nausea/vomiting  
• 
Diarrhea  
• 
Anorexia (loss of appetite) 
• 
Mouth ulcers  
• 
Sores in mouth or on lips  
• 
Missing or stopping of menstrual periods in 
women 
• 
Hair loss 
• 
Skin rash 
• 
Change in skin 
coloring 
• 
Fatigue, weakness 
• 
Dizziness 
• 
Headache 
• 
Permanent sterility 
(inability to have 
children) 
• 
Blurred vision 
• 
Blood in urine 
• 
Swelling of feet or 
lower legs 
• 
Allergic reactions 
during infusion 
(fever, chills, itching, 
hives, flushing, rash, 
shortness of breath, 
wheezing, chest 
tightness, muscle 
stiffening)  
• 
Confusion 
• 
Seizures 
• 
Liver damage 
• 
Secondary cancers  
4. Total body irradiation (TBI):  
Likely (over 10%) 
Less Likely Side 
Effects (1- 10%) 
Rare (Less than 1%) 


Protocol RG1004070 Consent Form A 
Page 9 of 21  
• 
Nausea  
• 
Fatigue (feeling tired) 
• 
The irradiation dose used may result in 
sterility, and there is a risk of major genetic 
damage to any children conceived after 
transplant 
• 
Growth failure 
• 
Intestinal cramps 
• 
Painful swelling of 
the parotid gland (a 
gland under the 
chin) for a few days   
• 
Mucositis  
• 
Liver problems 
• 
Cataracts (an 
opacity or whitening 
of the lens) may 
develop in the eye 
• 
Decreased 
production of saliva 
and tear fluid 
• 
Decreased function 
of thyroid gland 
• 
Decreased 
production of other 
hormones 
• 
Temporary hair loss    
• 
Vomiting  
• 
Diarrhea  
• 
Lung damage 
• 
Kidney damage 
• 
Secondary cancers 
• 
Reddening of the 
skin 
• 
Liver failure 
• 
Brain injury 
• 
Difficulty swallowing 
• 
Vertebral 
deformities 
 
5. Granulocyte Colony Stimulating Factor (G-CSF): 
Likely (Over 10%) 
Less Likely (1-10%) 
• 
Muscle aches or pain  
• 
Bone pain 
• 
Itching  
• 
Skin rashes   
• 
Headache 
• 
Dyspnea (shortness of breath) 
• 
Edema (puffiness caused by excess fluid 
trapped in the body's tissues) 
• 
Insomnia 
• 
Blood vessel inflammation (vasculitis) 
• 
Ruptured spleen 
 
6. Cyclosporine: 
Likely (Over 10%) 
Less Likely (1-10%) 
Rare (Less than 1%) 
• 
Kidney problems 
• 
High blood pressure 
• 
Tremor  
• 
Increased or unwanted hair growth 
• 
Increased risk of relapse 
• 
Thrombotic thrombocytopenic purpura (disorder
that can lead to easy or excessive bruising and 
bleeding) 
• 
Electrolyte imbalances 
• 
Gingival hyperplasia (overgrowth of gum tissue 
around the teeth) 
• 
Increased risk of infection 
• 
Pain in the hands  
and/or feet when 
administered 
intravenously.  
• 
Nausea  
• 
Vomiting  
• 
Liver problems 
• 
Kidney damage 
• 
Increases in  
cholesterol and 
triglyceride 
• 
Confusion 
• 
Seizures  
• 
Vision changes 
• 
Dizziness 


Protocol RG1004070 Consent Form A 
Page 10 of 21  
 
7. Mycophenolate Mofetil (MMF):  
Likely (Over 10%) 
Less Likely (1-10%) 
Rare (Less than 1%) 
• 
Nausea (feeling sick to stomach) 
• 
Miscarriage or birth defects if become 
pregnant while taking and within 6 weeks 
after stopping MMF  
• 
Headache 
• 
Insomnia 
• 
Electrolyte imbalances 
• 
Leg cramps/bone pain 
• 
Hypertension 
• 
Dizziness 
• 
Hyperglycemia 
• 
Rash 
• 
Vomiting (throwing 
up)  
• 
Diarrhea (loose 
stools) and 
abdominal discomfort 
• 
Lower red blood cell 
count that is 
reversible 
• 
Lower white blood 
cell count with 
increased risk of 
infection 
• 
Stomach and bowel 
bleeding (blood in 
stools) 
• 
Secondary cancers 
• 
Progressive multifocal 
leukoencephalopathy (a 
serious brain infection 
that can cause 
weakness, clumsiness 
and confusion and can 
lead to death) 
 
The above tables list the side effects of the drugs individually. When used in combination (as 
they will be here for pre-transplant chemotherapy/radiation), the side effects may be more 
severe. For example, sores in the mouth (mucositis) are likely with this combination 
(cyclophosphamide, fludarabine and TBI) and may be severe. 
Risks of Transplant 
The following side effects may occur as a result of transplant and are not specific to cord 
blood as a donor or dilanubicel. We do not know if the risk of these side effects is increased 
by the use of dilanubicel.  
 
Graft-versus-host-disease (GVHD). GVHD is a complication of transplant that can occur 
when another person’s immune cells (specifically their T cells) react against the cells in your 
body. This is a risk of any unrelated donor transplant, though studies have shown that it is 
lower in cord blood transplant than in transplant with other donor types. It is possible that the 
use of dilanubicel (which is not matched to your HLA type) may make this risk higher, though 
this has not happened in prior studies. We think that this is unlikely because T cells from the 
cord blood to be expanded are removed before we grow the cells in the lab, and no new T 
cells are made during the process.  
 
GVHD ranges from a mild skin disorder to severe involvement of the skin and/or liver, and/or 
gut.  It may be fatal in some patients. You will be monitored closely for this complication and 
given specific treatment to prevent and treat it. There are 2 forms of GVHD: acute (generally 
occurs early in the transplant process) and chronic (generally occurs later in the transplant 
course and is longer lasting).  
 
Acute GVHD may produce skin rashes, liver disease, diarrhea, and an increased risk of 
infection. All of these can range in severity from mild to fatal. To confirm the diagnosis of acute 
GVHD, you may be asked to have a skin biopsy (taking a piece of tissue to make the 
diagnosis of GVHD) and possibly a liver or gut biopsy. The treatment of acute GVHD may 
require you to take high doses of steroids and other drugs such as anti-thymocyte globulin 
(ATG). 
 
Chronic GVHD may produce skin rashes, hair loss, thickened skin, dry eyes, dry mouth, liver 
disease, diarrhea and an increased risk of infection. Chronic GVHD may be mild and respond 


Protocol RG1004070 Consent Form A 
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to drugs that suppress the immune system, or it could be very severe. It may also last for 
several years, requiring continued use of multiple immunosuppressive drugs. 
 
Damage to the vital organs in your body. This could result in malfunction of any organ in 
your body such as heart, lungs, liver, gut, kidneys and bladder, brain etc. The lungs and the 
liver are the most vulnerable. Some patients will experience severe lung problems due to 
infections and/or due to a reaction of the lungs to the chemotherapy and/or radiation. Some 
patients can suffer sinusoidal obstruction syndrome of the liver (SOS) due to the 
chemotherapy and/or radiation. Patients who have SOS become jaundiced (yellowish skin), 
have liver function abnormalities, abdominal swelling, and abdominal pain. Although many 
patients recover completely, these complications may result in organ failure and permanent 
damage or even death. 
 
Other complications. There may be additional side effects or complications not 
previously described in the consent form, which could be mild, moderate, or severe, or 
could even result in death.  
 
Serious infections.  Full and complete recovery of your immune system  
may take many months following the initial recovery of your white cell count. During this time, 
there is an increased risk of viral, fungal or bacterial infections. You will be prescribed certain 
drugs to reduce the chance of those infections, but these drugs are not always effective. If you 
have one of those infections you may have to stay in the hospital longer or be re-hospitalized 
after transplant. Infections can be fatal.   
 
Recurrence of disease.  Your disease may recur even if the transplant is initially successful.   
Risks of Cord Blood as a Donor Source 
The following problems may occur as a result of the use of umbilical cord blood as a donor 
source.  We do not know if the risk of these side effects is increased by the use of dilanubicel.  
 
Slow bone marrow recovery (delayed engraftment).  Blood counts, including red blood 
cells, white blood cells, and platelets, may be very slow to recover after cord blood transplant.  
Until the new cord blood stem cells begin to grow, you are at risk of developing infections or 
bleeding.  Infections can be treated with antibiotics but sometimes can be very serious.  
Bleeding can be corrected, at least in part, by transfusions, but could also be life threatening.  
However, there are risks associated with the transfusion of red blood cells and platelets.  
These risks include serious allergic reactions and infections, including hepatitis, 
cytomegalovirus (CMV), and human immunodeficiency virus (HIV).  All blood products will be 
screened for these infections in order to reduce risk. 
 
Graft Failure.  The cord blood stem cells may fail to “take” or engraft.  This is a risk with any 
type of donor, but is more common with cord blood. Past experience suggests that this occurs 
in about 10-20% of cord blood transplant patients overall. The risk of graft failure may be 
higher in this study with the use of a single cord blood unit. There is a chance that if you have 
graft failure your blood counts may not recover and you could die from this problem. Should 
the graft fail, you may be able to receive a second transplant with stem cells from another 
donor, including additional cord blood donors.  
 
Cytomegalovirus Reactivation. We have learned that patients who have been exposed to a 
virus called cytomegalovirus (“CMV”) before their cord blood transplant are at high risk of 
reactivating this virus after the transplant. CMV is a very common virus, similar to the 


Protocol RG1004070 Consent Form A 
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chickenpox virus, that about 50 to 80% of people have been exposed to at some time in their 
life. In healthy people, the virus remains inactive and does not cause any harm. However, it 
often becomes reactivated in people with a weakened immune system, and it can cause 
serious disease in the lungs, digestive tract and other organs. Because cord blood transplant 
patients are at higher risk for reactivation of CMV, you will be monitored very closely with a 
special blood test that can detect very early reactivation of CMV. If positive, you will be given 
appropriate treatments to control the virus. This treatment can last for a long period of time in 
some patients. 
 
Genetic Disease Transmission.  It is very rare, but genetic diseases (such as thalassemia, 
sickle cell anemia or Gaucher’s disease) may be passed to you through the transplanted cord 
blood stem cells or dilanubicel.  Each cord blood unit can only be tested for a few of the many 
possible genetic diseases.  We will do our best to obtain screening results from the cord blood 
banks for diseases like thalassemia and sickle cell anemia, but they may not always be 
available. The family of each cord blood donor has been asked about the development of 
medical problems or known genetic diseases within the family to further reduce the possibility 
of passage of a disease to you from the cord blood cells. 
 
Incorrect Labeling of the Cord Blood Unit.  Though rare, it is possible that incorrect labeling 
of a cord blood unit could occur.  Confirmation of identity will occur on every unit either by the 
cord blood bank providing the cord blood unit or by our institution. Should the labeling be 
incorrect, the transplant will be delayed until another source of stem cells is located.   
 
Toxicities with Cord Blood Infusion – The unmanipulated cord blood cells can cause 
immediate toxicities, including allergic reactions, when the cells are infused. Immediate 
toxicities can happen either during or within the first 24 hours following either the infusion of 
the expanded and unmanipulated cord blood cells. In addition, the unexpanded cord blood 
cells are stored in a solution containing dimethyl sulfoxide (DMSO) to protect the cells during 
freezing, and are thawed in a solution containing dextran. DMSO and dextran can cause the 
following side effects, including allergic reactions, when the cells are infused.  
 
Likely  
(Over 10% of patients) 
Rare (Less than 1%) 
Unusual taste in the mouth 
Unpleasant odor from the lungs (and breath) for a
few days after getting the stem cells  
Itching 
Hives 
Rash 
Shortness of breath 
Low blood oxygen 
Wheezing, chest tightness 
Drop in blood pressure 
Fever 
Chills 
Sweating 
Nausea, vomiting 
Headache 
Stiff muscles 
Kidney failure  
Changes in heart rate rhythm or function 
 
If immediate toxicities occur, the infusion of either of the cord blood stem cells will be 
stopped and side effects will be closely monitored. Infusion of the cells may be restarted at 
a slower rate when all side effects have gone away.  


Protocol RG1004070 Consent Form A 
Page 13 of 21  
Risks of dilanubicel 
 
Dilanubicel is an investigational therapy and not all risks are known. By being in this research 
study, you may be at greater risk than you would otherwise be.  
 
Side effects may be mild or very serious. Your health care team may give you medicines to 
help lessen side effects. In some cases, side effects can last a long time or never go away. 
You should talk to your doctor about any side effects that you have while you are in this study.  
 
Dilanubicel Infusion Reactions: Immediate infusion reactions are possible, and they may 
occur either during the dilanubicel infusion or within the first 24 hours following the dilanubicel 
infusion. These possible reactions could include: 
• 
Fever  
• 
Chills 
• 
Fatigue 
• 
Difficulty Breathing (Dyspnea) 
• 
Rapid Breathing (Tachypnea)  
• 
Chest Tightness 
• 
Muscle Pain (Myalgia)  
• 
Low Blood Pressure (Hypotension) 
• 
Increased Heart Rate (Tachycardia) 
• 
Low Oxygen in Your Blood (Hypoxemia) 
• 
Reddening of the skin (Erythema) 
• 
Hives (Urticaria) 
Dilanubicel is frozen and stored in a solution containing dimethyl sulfoxide (DMSO) to protect 
the cells during freezing. DMSO can cause an allergic reaction and signs of an allergic 
reaction might include some of these above noted symptoms. You will be given medications 
(diphenhydramine and acetaminophen) to reduce the likelihood of an allergic reaction. 
Some patients have experienced fever for unknown reason, which occurred more frequently in 
the first 1-3 days after infusion of dilanubicel. Although these fevers increased with higher 
dilanubicel doses, it is unknown why this happened and if it is related to dilanubicel, other 
treatment, or other reasons. 
Some patients have experienced symptoms that resemble a severe infection or inflammatory 
syndrome occurring days to weeks after dilanubicel infusion. It is not yet known whether these 
symptoms are from an infection, due to the dilanubicel infusion or some other cause. 
Alloimmunization: Alloimmunization is a condition in which your body makes antibodies 
(proteins) in response to proteins on the surface of infused cells that are not your own. In 
general, people don’t have these antibodies unless they have had blood transfusions or were 
previously pregnant. Because dilanubicel is a cell therapy you could develop these antibodies. 
If you develop alloimmunization this could limit your ability to receive cells from certain donors 
if you need another bone marrow transplant. 
Immediate Rejection of dilanubicel: Because dilanubicel is not matched to you or your cord 
blood donor, it is possible that there could be immediate immune-mediated rejection of 
dilanubicel. The cord blood stem cells may fail to “take” or engraft.  As stated before, the risk 
of graft failure may be higher in this study with the use of a single cord blood unit. There is a 
chance that if you have graft failure your blood counts may not recover, which could be fatal. 


Protocol RG1004070 Consent Form A 
Page 14 of 21  
Should the graft fail, you may be able to receive a second transplant with stem cells from 
another donor, including additional cord blood donors. 
Transmissible Spongiform Encephalopathy: This product may carry a risk of transmitting 
diseases, such as Creutzfeldt-Jakob disease (CJD). 
Incidental Findings: It is possible that the study procedures could find a possible medical 
problem that is unrelated to this study and that was previously not known to you. If the 
research procedures uncover findings that may be important for you to know about, such as 
the possibility of a previously not known medical condition, you will be told by a member of the 
study staff. Or, you may allow the release and communication of the findings to your primary 
physician. These findings may require more testing or treatment. The cost of any additional 
tests or related treatment will be your responsibility.  
Reproductive Risks  
 
Chemotherapy and radiation treatments may make you sterile (unable to have children). The 
effects of dilanubicel on pregnancy, an unborn baby, or a nursing child are not known. Also, 
the drugs in this study may affect a baby, before or after the baby is born. 
For women who can become pregnant:  
 
- You should not become pregnant while you are in this study. 
- You should not nurse a baby while you are in this study. 
 
For women and men: 
- If you are having sex that could lead to pregnancy, you should use birth control while 
receiving study treatment and for at least 90 days after transplant and dilanubicel infusion. 
- Check with the study doctor about birth control methods and how long to use them. Some 
common methods might not be appropriate while you are in this study. 
What are the benefits? 
 
We do not know if this study would help you.  
Patients who get treatment in this study may get better, but their condition could stay the  
same or even get worse. We hope the information from this study will help other people 
with HIV and leukemia and lymphoma in the future. 
You have other choices besides this study. 
You do not have to join this study. You are free to say yes or no. Your regular medical care 
will not change.  If you do not join this study, you have other choices for treatment.  
Please talk to your doctor about your choices, which include: 
• 
You may be eligible for a single unit or double unit cord blood transplant without the 
use of dilanubicel; 
• 
Ongoing conventional chemotherapy may also be considered as an alternative to 
transplant in treatment of your cancer; 
• 
No further treatment; and 
• 
Comfort care.   


Protocol RG1004070 Consent Form A 
Page 15 of 21  
Protecting Privacy as an Individual and the Confidentiality of Personal 
Information  
If you join this study, some people or organizations might need to look at your medical records 
and research records for quality assurance or data analysis. They include: 
• 
Researchers involved with this study; 
• 
Fred Hutchinson Cancer Center (Fred Hutch), and University of Washington (UW); 
• 
US National Institutes of Health, National Cancer Institute, Office for Human 
Research Protections, Food and Drug Administration, and other agencies as 
required; 
• 
Center for International Blood and Marrow Transplant Research (CIBMTR); 
• 
Cord Blood Bank (that provided the unmanipulated unit or units for your transplant); 
• 
Institutional Review Boards (IRB), including the Fred Hutchinson Cancer Center 
IRB. An IRB is a group that reviews the study to protect your rights as a research 
participant. 
• 
Deverra Therapeutics and their agents. Deverra is a company that is collaborating 
with Fred Hutch on this study. 
We will do our best to keep personal information confidential. But we cannot guarantee total 
confidentiality. Personal information may be given out if required by law.  For example, 
workplace safety rules may require health workers to contact you about lab tests. Or a court 
may order study information to be disclosed. Such cases are rare. 
We will not use personal information in any reports about this study, such as journal articles or 
presentations at scientific meetings. 
 
If you join this study, information about your participation would be made part of your permanent 
medical record. This information would include a copy of this consent form. If an insurance 
company or employer or anyone else were authorized to see your medical record, they would see 
a copy of this consent form.  
This research is covered by a Certificate of Confidentiality from the U.S. government. This 
Certificate helps protect the confidentiality of information about people who join this study. If 
you join the study, the Certificate means that generally we would not have to give out 
identifying information about you even if we were asked to by a court of law. We would use 
the Certificate to resist any demands for identifying information.  
We could not use the Certificate to withhold research information if you give written consent to 
give it to an insurer, employer, or other person.   
This protection has some limits. We would voluntarily provide the information:  
• 
To a member of the federal government who needs it in order to audit or evaluate 
the research.  
• 
To the funding agency and groups involved in the research, if they need the 
information to make sure the research is being done correctly.  
• 
To the federal Food and Drug Administration (FDA), if required by the FDA.  
• 
To someone who is accused of a crime, if he or she believes that our research 
records could be used for defense.  
• 
To authorities, if we learn of child abuse, elder abuse, or if participants might harm 
themselves or others.  


Protocol RG1004070 Consent Form A 
Page 16 of 21  
How is my genetic information protected? 
 
A federal law called the Genetic Information Nondiscrimination Act (GINA) helps protect 
genetic information about people who join research studies.  
 
GINA restricts access to genetic information so that it cannot be used for health insurance 
coverage decisions. GINA prevents health insurance companies or group health plans 
from:  
 
• Asking for genetic information obtained in research studies, or 
• Using genetic information when making decisions regarding your eligibility or 
premiums  
GINA does not help or protect against genetic discrimination by companies that sell life, 
disability or long-term care insurance.  
Would we pay you if you join this study? 
There is no payment for being in this study.  
Would you have extra costs if you join this study?  
If you join this study, you would have some extra costs. Your insurance company might pay 
these costs, but some insurance policies do not cover these costs. We could help find out 
whether your insurance company would cover these costs. 
The extra costs are: 
• 
Cost of tests that are given more often than usual. 
• 
Paying the people who give dilanubicel, and the cost of the equipment they use. 
• 
Cost of standard doctor visits and lab tests. 
• 
Cost of any other medical care needed because of this study. 
If you join this study, you or your insurance company would have to pay for the costs of 
standard treatment in this study. 
You would not be billed for: 
• 
The cost of the dilanubicel 
• 
The cost of the research tests that are not part of your clinical care and tests to 
study how your immune system is recovering. 
If dilanubicel is approved as a treatment while this study is still going on, you or your 
insurance company might have to pay for dilanubicel in order to complete this study. 
 
What if you get sick or hurt after you join this study? 
 
For a life-threatening problem, call 911 right away or seek help immediately.  Contact your 
study doctor when the medical emergency is over or as soon as you can.    


Protocol RG1004070 Consent Form A 
Page 17 of 21  
 
For all other medical problems or illness related to this research, immediately contact Dr. 
Filippo Milano.  They will treat you or refer you for treatment.  You or your health insurance will 
have to pay for the treatment. There are no funds to pay you for a research-related injury, 
added medical costs, loss of a job, or other costs to you or your family.  State or national law 
may give you rights to seek payment for some of these expenses.  You do not waive any right 
to seek payment by signing this consent form. 
 
    You or your insurer will be billed for treatment of problems or complications that result from 
your condition or from standard clinical care. 
    You would not lose any legal right to seek payment for treatment if you sign this form. 
What will my information and blood and tissue samples be used for? 
Your information and blood and tissue samples will be used for the purposes of this study. 
Your blood and tissue samples might help researchers develop new products. This research 
could be done by for-profit companies. There is no plan to share with you any revenue 
generated from products developed using your blood and tissue samples. 
During this study, if the researchers learn new information that may be important to your 
general health or to your disease or condition, they will share that information with you.  
In addition, be aware that by agreeing to participate in this study, your information or tissue 
samples could be used for future research studies or sent to other investigators for future 
research studies without additional consent from you. These future research studies will be 
reviewed by an oversight group known as an institutional review board if required by law. The 
information that identifies you will first be removed from your information or tissue samples. If 
you do not want your information or tissue samples to be used for future research studies 
without your consent, you should not participate in this study. 
Your tissue contains DNA. DNA makes up the genes that serve as the "instruction book" for 
the cells in our bodies. By studying genes, researchers can learn more about diseases such 
as cancer. There are many different types of genetic tests. The testing on your tissue samples 
might include genetic testing called whole genome sequencing. Whole genome sequencing 
looks at all the known genes in your cells. This type of testing can provide useful information 
to researchers. It can also present risks if the test results became known to others, for 
example you could have problems with family members or insurance companies. There is 
also a risk that these test results could be combined with other genetic information to identify 
you. 
We invite you to donate left over tissue samples for research. 
After we do tests on tissue in this study, some tissue may be left over. We invite you to donate 
this leftover tissue for this research which may include genetic research. 
If you join this study, you would not have to donate tissue for this research. You would be free 
to say “yes” or “no.” Regular medical care would not change if you say “no.”  


Protocol RG1004070 Consent Form A 
Page 18 of 21  
If you donate tissue, it would be stored in a secure location. If we want to use your tissue for 
other research or share it with other scientists for research, an ethics review committee (IRB) 
would review the request. The IRB would decide if we need to ask you for permission to do 
the research.  
Your donated tissue would be used only for this research. This research could be done by for-
profit companies. Researchers would not report their results to you or your doctors. The 
research results would not be included in medical records. The results would not affect your 
medical care.  
Research with tissue might help develop new products. If these products make money, there 
is no plan to share the money with the participants who donate the tissue.  
If you donate tissue for research, you could withdraw the donation at any time by calling Dr. 
Filippo Milano at (206) 667-5925. You would have no penalty for withdrawing the donation, 
and regular medical care would not change. We could not return donated tissue, but we might 
be able to destroy the donated tissue. We could not destroy tissue if it is stored or shared 
without any label saying who donated it. In this case, it could still be used for research.   
Future genetic research 
Several genetic databases are available to help researchers understand different diseases. 
These databases contain DNA code and medical information from participants who have 
various diseases.  
As part of this study, we would like to release DNA code and information about your medical 
condition into a genetic database in order to help future research. The genetic database would 
not contain names, addresses, or other information that could be used to identify you.  
The DNA code in a genetic database cannot be used by itself to identify any specific person. 
A researcher who already has DNA code about you could use information from a genetic 
database to learn more about you. Once we release information to a genetic database, we no 
longer have any control over the use of this information.  
Patient Responsibilities 
If you join this research study, you will have the following responsibilities:  
• 
Go to all scheduled visits.  
• 
Tell your study doctor before taking any new medications.  
• 
Follow the study staff’s directions about the study.  
• 
Tell the study doctor about any illnesses or injuries.  
• 
Tell the study doctor about any side effects or problems that occur during the study.  
• 
Tell the study doctor if you plan to have any surgery or any other medical treatment 
or procedure.  
 
During the study, you will not be allowed to take certain medications. This means some 
prescription medications. It also means certain over-the-counter supplements and herbal 
medications. The study staff will let you know which medications you cannot take during the 
study.  


Protocol RG1004070 Consent Form A 
Page 19 of 21  
Your rights 
• 
You do not have to join this study. You are free to say “yes” or “no”.  
• 
If you get sick or hurt in this study, you do not lose any of your legal rights to seek 
payment by signing this form 
• 
During the study, we might learn new information that you need to know. For 
example, some information may affect your health or well-being. Other information 
might make you change your mind about being in this study. If we learn these kinds 
of information, we would tell you. 
• 
If you join this study, you would not have to stay in it. You could stop at any time 
(even before you start). Your regular medical care would not change. You would 
have no penalty for stopping, but it would be better not to join the study if you think 
that you would change your mind later.   
• 
If you decide to drop out, we would want you to tell the study doctor. The doctor 
could tell you about the effects of stopping dilanubicel and/or study treatments 
described beneath the section titled Conditioning (Pre-transplant Chemotherapy 
and Radiation). You and the doctor could talk about the follow-up care and testing 
that would help the most.  
• 
Before you leave the study, the doctor might ask you to sign a separate consent 
form to continue in the follow-up part of the study.  
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site at 
any time.  
For more information 
If you have questions or concerns about this study, you could talk to your doctor anytime. 
Other people you could talk to are listed below. 
 
If you 
have questions about: 
Call: 
This study (including 
complaints and requests for 
information) 
206-667-5925 (Dr. Filippo Milano) 
 
If you get sick or hurt in this 
study 
206-667-5925 (Dr. Filippo Milano) 
Your rights as a research 
participant 
206-667-5900 or email irodirector@fredhutch.org 
(Director of Institutional Review Office, Fred 
Hutchinson Cancer Center) 
Your bills and health 
insurance coverage 
206-606-1113  
Emergency number (24 hours): (206) 598-8902 


Protocol RG1004070 Consent Form A 
Page 20 of 21  
Read the following question and think about your choice. When you decide on the question, 
please circle YES or NO. 
Is it OK if we send your genetic information to one or more databases for future 
research? (circle one) 
YES  
NO  
 
Do you agree to donate your leftover samples (either fluid or tissue samples) for 
research? (circle one) 
YES  
NO  
 
 
Signatures 
Please sign below if you:  
• 
have read this form (or had it read to you); 
• 
had the opportunity to ask any questions you have; 
• 
had the opportunity to discuss the research with the person obtaining consent; and  
• 
agree to participate in this study. 
 
Participant (age 14+): 
 
 
 
 
 
Printed Name 
 
Signature 
 
Date 
 
 
Parent or legal guardian: 
 
 
 
 
 
Printed Name 
 
Signature 
 
Date 
Legally Authorized Representative: Please sign below if you:  
• 
have read this form (or had it read to you); 
• 
had the opportunity to ask questions;  
• 
had the opportunity to discuss the research with the person obtaining consent; and  
• 
agree to consent on behalf of the participant for him or her to participate in this 
study.  
 
Legally authorized representative: 
 
 
 
 
 
Printed Name 
 
Signature 
 
Date 
 
Relation to the participant 
 


Protocol RG1004070 Consent Form A 
Page 21 of 21  
If you served as an interpreter or witness during the consent process, sign below to indicate 
you attest to the accuracy of the presentation to the participant and the apparent 
understanding of the research by the participant. 
 
Witness or Interpreter: 
 
 
 
 
 
Printed Name 
 
Signature 
 
Date 
Researcher’s statement 
I have discussed the research study, including procedures and risks, with the person 
signing above. A copy of the signed consent form will be given to the participant. 
 
Person obtaining consent signature: 
 
 
 
 
 
Printed Name 
 
Signature 
 
Date 
 
 
Protocol RG1004070 
Current version date: September 2, 2022 
Previous version date: May 25, 2021 
Copies to Study Participant, Medical Records, Research File