Clinical trial: NCT01768845
Section: Confidentiality
Subsections: Confidentiality|Persons/Organizations Receiving The Information:|The Information Is Being Disclosed For The Following **Reasons:**

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 federal regulatory authorities (including the FDA if applicable) or the West Virginia University Institutional Review Board without your additional consent.  
In addition, there are certain instances where the researcher is legally required to give information to the appropriate authorities. These would include mandatory reporting of infectious diseases, mandatory reporting of information about behavior that is imminently dangerous to you or to others, such as suicide, child abuse, etc.  
In any publications that result from this research, neither your name nor any information from which you might be identified will be published without your consent.  
Chestnut Ridge Research Building 886 Chestnut Ridge Road PO Box 6845 Morgantown, WV 26506-6845 Page | 10 Phone: 304-293-7073 Fax: 304-293-3098 http://oric.research.wvu.edu Subject's Initials_________________
Date_________________  
(With HIPAA
Version: 04OCT2017 You can decide to sign or not to sign this authorization section. However, if you choose not to  
  
sign this authorization, you will not be able to take part in the research study. Whatever choice you make about this research study, it will not have an effect on your access to medical care.  
Since you are receiving HPC from an unrelated cord blood, information about your disease, treatment, complication and progress after transplant will be released to the NMDP/CIBMTR (transplant data registries). You will sign a separate consent form for this.  
Persons/Organizations providing the **information:** West Virginia University Hospitals, applicable health information from your referring physicians, hospitals and yourself (patient).

- 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 and other people and groups that look into your health information as part of this study in agreement with the study protocol.  
- The United States Department of Health and Human Services (which includes the National Institutes of Health, Food and Drug Administration (FDA)) and other groups that have the right to use the information as required by law.  
- The members and staff of WVU 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.  
The following information will be used: Information from your existing medical records and new information about you that is created or collected during the study such as: history and physicals, clinic visit notes, nursing and staff notes, laboratory results, pathology results, x-rays, EKG results, demographic data, pulmonary tests, imaging scans and study forms.

- Publication of study results (without identifying you) - Review of your data for quality assurance purposes
- 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
Clinical trial: NCT01768845
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Risks And Discomforts|Additional Risks Related To Supportive Care Procedures:

Treatments often have side effects. The treatments used in this protocol may cause all, some, or none of the side effects listed. In addition, there is always the risk of very uncommon or previously unknown side effects occurring.

Transfusion of Blood Products - The therapy used for the treatment of your disease will cause your blood counts to be decreased. It is likely that you will require the transfusion of blood products until your blood counts return to a safe level. There are risks associated with receiving blood products. These include the risk of transfusion reaction (itching, hives, rash, chills, fever, shortness of breath, the destruction of red blood cells and blood in your urine), and exposure to infectious diseases such as hepatitis (liver infection) and Human Immunodeficiency Virus (HIV), the virus that causes AIDS.  
Infusion of Umbilical HPC - Risks associated with the infusion of your donor's umbilical cord stem cells are the same as those associated with the transfusion of blood products.  
Preservatives may have been added to help store the stem cells, additional risks may occur from the preservative used. These risks include nausea, vomiting, reddening of your skin
(flushing) shortness of breath, hives low blood pressure and a peculiar body odor somewhat similar to garlic.  
Central Venous Catheter Placement - May result in bleeding, infection or pain at the site of entry or under the skin. There is also a small risk of collapsing the lung, requiring placement of a tube to re-expand the lung. You will be asked to sign a separate consent for this procedure.  
Prevention and Treatment of Infections - The drugs typically used to prevent and treat viral, fungal and bacterial infections found in transplant patients may cause rash, itching, fever, chills, shortness of breath, difficulty breathing, swelling, decreased kidney function, increases in the blood tests that measure your liver function, nausea, vomiting, diarrhea, loss of appetite, a decrease in your blood counts, abdominal discomfort and, peripheral neuropathy (disturbances in the function of the brain or spinal cord that may affect the nerves and muscles of the body). Cancer chemotherapy drugs and TBI will make most people **sterile (incapable of having**
children). The long-term effects on reproductive cells (sperm or ova) in the human body are unknown. Chemotherapy may cause lasting effects on the reproductive potential of both men and women. You understand that you should discuss options to store your reproductive cells with your physician before receiving this treatment.  
This treatment may involve risks to the unborn child. If you are pregnant or breast-feeding, you will not be permitted to receive treatment. If you are a woman who may become pregnant, you will not be allowed to undergo treatment until you have had a pregnancy test and the test indicates that you are not pregnant. If you are pregnant, alternative treatment will be discussed. You must use a medically approved method of birth control while receiving this therapy.  
Alternatives You do not have to participate in this study. Alternatives that could be considered in your case include:
Phone: 304-293-7073 Fax: 304-293-3098 http://oric.research.wvu.edu Chestnut Ridge Research Building 886 Chestnut Ridge Road PO Box 6845 Morgantown, WV 26506-6845 Page | 9  
(With HIPAA
Version: 04OCT2017
- 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 the symptoms associated with cancer (such as pain, fatigue, appetite problems). It does not treat the cancer directly, but tries to improve the way that you feel and keep you active.
Clinical trial: NCT01768845
Section: Procedures
Subsections: Description Of Procedures|Conditioning **Regimen:**|High Intensity (Myeloablative) Conditioning Regimen:|Reduced Intensity Conditioning Regimen:

Before your treatment begins you will have a detailed medical history taken and undergo a physical examination including blood tests and tests of your heart and lungs to determine if it is safe for you to undergo umbilical cord Hematopoietic Progenitor Cell (HPC)
transplantation. You will also have tests to evaluate your disease. You will have about 6 - 8 teaspoons of blood drawn. This amount is equal to about 1/10th of the amount taken if you were to donate a unit of blood. If your tests show that it is safe for you to undergo a HPC transplant then the following events will take place during the course of your treatment.  
You will be hospitalized for approximately 4-6 weeks or longer if necessary. You will need to remain in the 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 supervision for at least one year following your transplant. Before your 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. The source of your HPC will be from an unrelated donor's umbilical cord, collected at the time of their birth.  
Your treatment will begin 6 days before you are scheduled to receive the donor's cord stem cells with the start of a conditioning regimen.

The conditioning regimen is a combination of chemotherapy and/or radiation given to patients before their donor cells are infused. This treatment allows donor cells to engraft (take hold) and Chestnut Ridge Research Building 886 Chestnut Ridge Road PO Box 6845 Morgantown, WV 26506-6845 Subject's Initials_________________
Phone: 304-293-7073 Fax: 304-293-3098 http://oric.research.wvu.edu Page | 2  
(With HIPAA
Version: 04OCT2017 start growing in your bone marrow. This treatment also helps to kill cancer cells that might not  
  
be detected.  
Different chemotherapy drugs and/or radiation can be used as part of the conditioning regimen and the combination of drugs and radiation and the dose used can have different strengths that can be called treatment "intensity".  
High intensity treatments are known as myeloablative regimens. These treatments destroy cancer cells because they use very high amounts of chemotherapy or radiation. These high intensity treatments often times have more side effects during and after transplant.  
Lower or "reduced" intensity treatment before transplant can have fewer serious problems from the chemotherapy or radiation. The killing of cancer cells may be lower but studies have shown that immune cells given in the transplant can help destroy any remaining cancer cells. Reduced intensity regimens are often used for people that may not be able to tolerate high dose chemotherapy or radiation due to their age or other medical problems and has shown to be effective in certain types of disease.  
Your physician will decide which conditioning regimen (high intensity or reduced intensity) is best for you. It will be based on several factors such as your age, your medical condition at the time of transplant and your disease. You will receive one of these two conditioning regimens:

Fludarabine -Days 1,2,3 and 4 by intravenous (IV) infusion Busulfan - Days 1,2,3 and 4 by IV infusion Total Body Irradiation-on Day 6 you will receive one treatment Anti-thymocyte Globulin (ATG)-Optional - on Days 3, 4 and 5 you may receive this drug as an IV
infusion. This is optional and your physician will decide if this is best for you. Cord Blood Transplant - On Day 7 you will receive your donor cord blood stem cells by IV
infusion.  
Subject's Initials_________________
Phone: 304-293-7073 Fax: 304-293-3098 http://oric.research.wvu.edu Chestnut Ridge Research Building 886 Chestnut Ridge Road PO Box 6845 Morgantown, WV 26506-6845 Page | 3  
(With HIPAA
Version: 04OCT2017

Fludarabine -Days 1,2, 3, 4 and 5 by intravenous (IV) infusion Cyclophosphamide - Day 1 by IV infusion Total Body Irradiation - on Day 6 you will receive one treatment Anti-thymocyte Globulin (ATG)- Optional - on Days 3,4,5 you may receive this drug as an IV
infusion. This is optional and your physician will decide if this is best for you. Cord Blood Transplant –On Day 7 you will receive your donor cord blood stem cells by IV
infusion.  
In order to get a high enough stem cell dose for your transplant, you most likely receive cells from two different cord bloods. This is based on factors such as size of the stem cell dose of the cord bloods that best match you and on your size (height/weight).  
It should take approximately 2-4 weeks following treatment for your donor's cells to engraft
(take hold) and begin to make adequate white blood cells. It may take longer than this for your platelet count to normalize without platelet transfusions. During this time, you will be monitored with blood tests to check your blood counts and the levels of other chemicals and drugs in your body and to detect infection. You will have approximately 3 teaspoons of blood drawn daily as standard care.  
Follow up procedures/testing and supportive care after you receive your donor cord blood stem cells are standard of care for stem cell transplant patients You will receive supportive care with platelet and red blood cell transfusions, and anti-microbial
(medicines to protect you against microorganisms such as bacteria, fungus and viruses). You may also receive immune globulins (proteins that help protect the body from infection). In a continued attempt to prevent graft-versus-host disease, you will be placed on medications to suppress your immune response. These medications will be continued for six to twelve months. You will need to continue taking these medicines at home after you are discharged from the hospital. You will be discharged from the hospital following your transplant when your blood counts recover, and you are able to eat and drink adequately and are having no fevers. When you are discharged from the hospital, it is important for you to understand that you will need to have a caregiver to stay with you at all times until your transplant physician tells you that it is safe for you to stay alone.  
Chestnut Ridge Research Building 886 Chestnut Ridge Road PO Box 6845 Morgantown, WV 26506-6845 Phone: 304-293-7073 Fax: 304-293-3098 http://oric.research.wvu.edu Subject's Initials_________________
Page | 4 Date_________________  
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Version: 04OCT2017  
  
Around day 30 after your transplant, your physician will do a blood test to see if your donor's hematopoietic progenitor cells (HPC) have engrafted (taken hold) adequately. The amount of blood required for this blood test is approximately 3 teaspoons. Additional testing after your transplant, such as additional blood testing, x-rays, CAT and PET scans, and pulmonary testing may be performed as your medical condition requires and your physician will determine the appropriate testing that is necessary. During the course of your treatment appropriate medical care will be available and referrals to specialized physicians will be made if needed.  
At the time you are well enough to return home, you will be followed as your condition requires by your local physician for lab and physical exams. You will be required to return to Cancer Center for follow-up by your transplant doctor. The frequency of the visits will be determined by your doctor and will be based on your medical condition. You will need to return on or around Day 180 (6 months) post stem cell transplant for the final required treatment visit for this study. After Day 180, you will be followed and monitored per the standard WVUH
BMT operating procedures.
Clinical trial: NCT01768845
Section: Purpose of Research
Subsections: Purpose Of The Study

You have been asked to participate in this study because you have a hematologic malignancy (a disease of your bone marrow or lymph nodes) that is not curable with standard therapy. Your disease may be treated with chemotherapy, radiation and hematopoietic progenitor cell (HPC -
the primitive cells in the blood and bone marrow that can restore the bone marrow) transplant.  
Page | 1 Subject's Initials_________________  
(With HIPAA
Version: 04OCT2017 You unfortunately do not have a matched adult donor to use as your HPC cell source or your  
  
disease has progressed and time does not allow a long search for a matched adult donor. However, you do have a matched umbilical cord blood HPC source available. Currently umbilical cord HPC transplants are not standard of care in the adult patient. This is currently being studied as a curative option in patients with a life threatening hematologic disease with no standard HPC donor source.  
The purpose of this study is to assess the engraftment rate, safety, disease progression, survival and incidence of complications (infections, Graft versus Host Disease) when using cord blood as a source of HPC in an adult/older adolescent. Approximately 40 patients are expected to participate in this study at West Virginia University Hospital.
Clinical trial: NCT01768845
Section: Voluntary Participation
Subsections: This Authorization Will Not Expire Unless You Cancel It. Voluntary Participation

Participation in this study is voluntary. You are free to withdraw your consent to participate in this study and such refusal to participate will not affect your future care. Withdrawal of consent after chemotherapy/TBI but before your HPC transplant, may result in your death. In the event that new information becomes available that may affect your willingness to continue, this information will be given to you so that you may make an informed decision about your participation. You have been given the opportunity to ask questions about the research, and you have received answers concerning areas I did not understand.
Clinical trial: NCT01768845
Section: Withdrawal from Study
Subsections: You May Cancel This Authorization At Any Time By Writing To The Principal Investigator:

Michael Craig, MD
Mary Babb Randolph Cancer Center - 1 Medical Center Drive Page | 11 Phone: 304-293-7073 Fax: 304-293-3098 http://oric.research.wvu.edu Chestnut Ridge Research Building 886 Chestnut Ridge Road PO Box 6845 Morgantown, WV 26506-6845 Subject's Initials_________________
Date_________________  
(With HIPAA
Version: 04OCT2017 Morgantown, WV 26506-8110 Phone 304-598-4520  
 If you cancel this authorization, any information that was collected already for this study cannot be withdrawn. Once information is disclosed, according to this authorization the recipient may redisclose it and then the information may no longer be protected by federal privacy regulations.  
You have a right to see and make copies of your medical records. You will not be able to see or copy your records related to the study until all work related to the study is completed. At that time you may ask to see the study doctor´s files related to your participation in the study and have the study doctor correct any information about you that is wrong.