Clinical trial: NCT01597778
Section: Alternatives
Subsections: Other Treatments Or Drugs|7. Alternative Treatments

Some drugs react with each other. It is important to tell the study doctor or staff about any other drugs or treatments you are taking. This includes over-the-counter drugs, vitamins and herbal treatments. It is also important that you tell the study staff about changes to any of your drugs during the study. For more information about risks and side effects, ask your study doctor.

Participation in this study is optional. If you choose not to take part, you may still receive an allogeneic transplant to treat your disease. The treatment and evaluations you would receive could be very similar to what would receive if you join this study. Your study doctor will talk with you about your options. If you decide not to participate in this study, your medical care will not be affected in any way. Your other choices may include:
Treatment with other drugs, radiation, or a combination of drugs and radiation without a transplant  
An allogeneic blood or marrow transplant that is not part of the study, or another type of transplant Participation in another clinical trial, if available (check with your doctor)
No treatment for your blood cancer at this time Comfort care
Every treatment option has benefits and risks. Talk with your doctor about your treatment choices before you decide if you will take part in this study.
Clinical trial: NCT01597778
Section: Confidentiality
Subsections: 10. Privacy, Confidentiality And Use Of Information|B. Individual Health Information To Be Used Or Disclosed:|B. Individual Health Information To Be Used Or Disclosed:|Health Information:|Health Information:|D. Parties Who May Receive Or Use My Individual Health Information:|D. Parties Who May Receive Or Use My Individual Health Information:|G. Potential For Re-Disclosure:|G. Potential For Re-Disclosure:|7. Privacy, Confidentiality And Use Of Information|B. Individual Health Information To Be Used Or Disclosed:|B. Individual Health Information To Be Used Or Disclosed:|Health Information:|Health Information:|D. Parties Who May Receive Or Use My Individual Health Information:|D. Parties Who May Receive Or Use My Individual Health Information:|G. Potential For Re-Disclosure:|G. Potential For Re-Disclosure:

Your confidentiality is one of our main concerns. We will do our best to make sure that the personal information in your medical record is kept private. However, we cannot guarantee total privacy. All your medical and demographic (such as race and ethnicity, gender and household income) information will be kept private and confidential. *(Name of Transplant Center)* and the organizations listed below will not disclose your participation by any means of communication to any person or organization, except by your written request, or permission, or unless required by federal, state or local laws, or regulatory agencies. Individuals authorized by the organizations below will have access to your research and medical information. They may use this information for inspections or audits to study the outcomes of your treatment. In agreeing to participate, you consent to such inspections and to the copying of parts of your records, if required by these organizations. We may give out your personal information if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. Information about your transplant from your original medical records may be seen or sent to national and international transplant registries, including:
/Institution/
The National Institutes of Health (NIH)
The National Heart, Lung, and Blood Institute (NHLBI)
The National Cancer Institute (NCI) Office of Human Research Protection
(OHRP)
The Food and Drug Administration (FDA) Institutional Review Boards (IRBs)
responsible for this study Data and Safety Monitoring Board
(DSMB), not part of /Institution/
Blood and Marrow Transplant Clinical Trials Network (BMT CTN), including the Center for International Blood and Marrow Transplant Research (CIBMTR), the National Marrow Donor Program (NMDP) and the EMMES Corporation who are coordinating the studies of the BMT CTN

My individual health information that may be used or disclosed to do this research includes:
Demographic information (for example:
date of birth, sex, weight).  
Medical history (for example: diagnosis, complications with prior treatment).  
Findings from physical exams.  
Laboratory test results obtained at the time of work up and after transplant (for example: blood tests, biopsy results).  
C. Parties Who May Disclose My Individual

My individual health information that may be used or disclosed to do this research includes:
Demographic information (for example:
date of birth, sex, weight).  
Medical history (for example: diagnosis, complications with prior treatment).  
Findings from physical exams.  
Laboratory test results obtained at the time of work up and after transplant (for example: blood tests, biopsy results).  
C. **Parties Who May Disclose My Individual**

The researcher and the researcher's staff may collect my individual health information from: [*List hospitals, clinics or providers from* which health care information can be requested].

The researcher and the researcher's staff may collect my individual health information from: [List hospitals, clinics or providers from which health care information can be requested].

The individual health information disclosed by parties listed in item c and information disclosed by me during the course of the research may be received and used by the following parties: Principal Investigator and the researcher's staff Study Sponsors National Heart, Lung, and Blood Institute
(NHLBI) and the National Cancer Institute (NCI), both of the National Institutes of Health (NIH),
Blood and Marrow Transplant Clinical Trials Network (BMT CTN), data and coordinating center U.S. government agencies that are responsible for overseeing research such as the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP)
U.S. government agencies that are responsible for overseeing public health concerns such as the Centers for Disease Control (CDC) and federal, state and local health departments.

The individual health information disclosed by parties listed in item c and information disclosed by me during the course of the research may be received and used by the following parties: Principal Investigator and the researcher's staff

My individual health information disclosed under this authorization may be subject to re-disclosure outside the research study and no longer protected. Examples include potential disclosures for law enforcement purposes, mandated reporting or abuse or neglect, judicial proceedings, health oversight activities and public health measures.

My individual health information disclosed under this authorization may be subject to re-disclosure outside the research study and no longer protected. Examples include potential disclosures for law enforcement purposes, mandated reporting or abuse or neglect, judicial proceedings, health oversight activities and public health measures.

Your confidentiality is one of our main concerns. We will do our best to make sure that the personal information in your medical record is kept private. However, we cannot guarantee total privacy. All your medical and demographic (such as race and ethnicity, gender and household income) information will be kept private and confidential. (Name of Transplant Center) and the organizations listed below will not disclose your participation by any means of communication to any person or organization, except by your written request, or permission, or unless required by federal, state or local laws, or regulatory agencies. Individuals authorized by the organizations below will have access to your research and medical information. They may use this information for inspections or audits to study the outcomes of your treatment. In agreeing to participate, you consent to such inspections and to the copying of parts of your records, if required by these organizations. We may give out your personal information if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. A description of this clinical trial will be available on *http://www.ClinicalTrials.gov*,
as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. For questions about access to your medical records, please contact /name/ at /number/.

My individual health information that may be used or disclosed to do this research includes:
Demographic information (for example:
date of birth, sex, weight).  
Medical history (for example: diagnosis, complications with prior treatment).  
Findings from physical exams.  
Laboratory test results obtained at the time of work up and after transplant (for example: blood tests, biopsy results).  
C. Parties Who May Disclose My Individual

My individual health information that may be used or disclosed to do this research includes:
Demographic information (for example:
date of birth, sex, weight).  
Medical history (for example: diagnosis, complications with prior treatment).  
Findings from physical exams.  
Laboratory test results obtained at the time of work up and after transplant (for example: blood tests, biopsy results).  
C. **Parties Who May Disclose My Individual**

The researcher and the researcher's staff may collect my individual health information from: [*List hospitals, clinics or providers from* which health care information can be requested].

The researcher and the researcher's staff may collect my individual health information from: [List hospitals, clinics or providers from which health care information can be requested].

The individual health information disclosed by parties listed in item c and information disclosed by me during the course of the research may be received and used by the following parties: Principal Investigator and the researcher's staff Study Sponsors National Heart, Lung, and Blood Institute
(NHLBI) and the National Cancer Institute (NCI), both of the National Institutes of Health (NIH),
Blood and Marrow Transplant Clinical Trials Network (BMT CTN), data and coordinating center U.S. government agencies that are responsible for overseeing research such as the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP)
U.S. government agencies that are responsible for overseeing public health concerns such as the Centers for Disease Control (CDC) and federal, state and local health departments.

The individual health information disclosed by parties listed in item c and information disclosed by me during the course of the research may be received and used by the following parties: Principal Investigator and the researcher's staff

My individual health information disclosed under this authorization may be subject to re-disclosure outside the research study and no longer protected. Examples include potential disclosures for law enforcement purposes, mandated reporting or abuse or neglect, judicial proceedings, health oversight activities and public health measures.

My individual health information disclosed under this authorization may be subject to re-disclosure outside the research study and no longer protected. Examples include potential disclosures for law enforcement purposes, mandated reporting or abuse or neglect, judicial proceedings, health oversight activities and public health measures.
Clinical trial: NCT01597778
Section: Participant's Rights
Subsections: 16. Contact Someone About Your Rights|E. Right To Refuse To Sign This Authorization:|E. Right To Refuse To Sign This Authorization:|F. Right To Revoke:|F. Right To Revoke:|H. Genetic Information Nondiscrimination Act (Gina)|H. Genetic Information Nondiscrimination Act (Gina)|12. Contact Someone About Your Rights|E. Right To Refuse To Sign This Authorization:|E. Right To Refuse To Sign This Authorization:|F. Right To Revoke:|F. Right To Revoke:|H. Genetic Information Nondiscrimination Act (Gina)|H. Genetic Information Nondiscrimination Act (Gina)|F. What If I Have Questions?

If you wish to speak to someone not directly involved in the study, or if you have any complaints about the project, or any questions about your rights as a research participant, then you may contact: [Insert appropriate contact details]
The ethical aspects of this research study have been reviewed and approved by [name of IRB]. For questions about your rights while taking part in this study, call the __________[name of center] Institutional Review Board (a group of people who review the research to protect your rights) at __________________ (telephone number).

I do not have to sign this Authorization. If I decide not to sign the Authorization, I will not be allowed to participate in this study or receive any treatment related to research that is provided through the study. My decision not to sign this authorization will not affect any other treatment, payment, or enrollment in health plans or eligibility for benefits.

I do not have to sign this Authorization. If I decide not to sign the Authorization, I will not be allowed to participate in this study or receive any treatment related to research that is provided through the study. My decision not to sign this authorization will not affect any other treatment, payment, or enrollment in health plans or eligibility for benefits.

I can change my mind and withdraw this authorization at any time by sending a written notice to the Principal Investigator to inform the researcher of my decision. If I withdraw this authorization, the researcher may only use and disclose the protected health information already collected for this research study. No further health information about me will be collected by or disclosed to the researcher for this study.

I can change my mind and withdraw this authorization at any time by sending a written notice to the Principal Investigator to inform the researcher of my decision. If I withdraw this authorization, the researcher may only use and disclose the protected health information already collected for this research study. No further health information about me will be collected by or disclosed to the researcher for this study.

A new federal law (2009), called the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and employers of 15 or more persons to discriminate against you based on your genetic information. Health insurance companies and group health plans may not request your genetic information that we get from this research. This means that they must not use your genetic information when making decisions regarding insurability. Be aware that this new federal law will not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.

A new federal law (2009), called the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and employers of 15 or more persons to discriminate against you based on your genetic information. Health insurance companies and group health plans may not request your genetic information that we get from this research. This means that they must not use your genetic information when making decisions regarding insurability. Be aware that this new federal law will not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. I. **This authorization does not have an**
expiration date.  
TITLE: Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow for Patients with Hematologic Malignancies

If you wish to speak to someone not directly involved in the study, if you have any complaints about the project, or would like more information about your rights as a research participant, you may contact: [Insert appropriate contact details].  
The ethical aspects of this research study have been reviewed and approved by [name of IRB]. For more information about your rights about providing blood and marrow samples for future research, call the __________[name of center] Institutional Review Board (a group of people who review the research to protect your rights) at __________________ (telephone number).  
Health Insurance Portability and Accountability Act (HIPAA)2 Authorization to use and disclose research purpose

I do not have to sign this Authorization. If I decide not to sign the Authorization, I will not be allowed to participate in this study or receive any treatment related to research that is provided through the study. My decision not to sign this authorization will not affect any other treatment, payment, or enrollment in health plans or eligibility for benefits.

I do not have to sign this Authorization. If I decide not to sign the Authorization, I will not be allowed to participate in this study or receive any treatment related to research that is provided through the study. My decision not to sign this authorization will not affect any other treatment, payment, or enrollment in health plans or eligibility for benefits.

I can change my mind and withdraw this authorization at any time by sending a written notice to the Principal Investigator to inform the researcher of my decision. If I withdraw this authorization, the researcher may only use and disclose the protected health information already collected for this research study. No further health information about me will be collected by or disclosed to the researcher for this study.

I can change my mind and withdraw this authorization at any time by sending a written notice to the Principal Investigator to inform the researcher of my decision. If I withdraw this authorization, the researcher may only use and disclose the protected health information already collected for this research study. No further health information about me will be collected by or disclosed to the researcher for this study.

A new federal law (2009), called the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and employers of 15 or more persons to discriminate against you based on your genetic information. Health insurance companies and group health plans may not request your genetic information that we get from this research. This means that they must not use your genetic information when making decisions regarding insurability. Be aware that this new federal law will not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.

A new federal law (2009), called the Genetic Information Nondiscrimination Act (GINA) generally makes it illegal for health insurance companies, group health plans, and employers of 15 or more persons to discriminate against you based on your genetic information. Health insurance companies and group health plans may not request your genetic information that we get from this research. This means that they must not use your genetic information when making decisions regarding insurability. Be aware that this new federal law will not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance. I. **This authorization does not have an**
expiration date.  
TITLE: Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow for Patients with Hematologic Malignancies

You can ask any questions that you have about giving an extra blood sample. If you forget to ask a question and think of it later, you can call [*insert office number*].
Clinical trial: NCT01597778
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: And Discomforts).|6. Risks And Discomforts|Table 1 - Risks And Side Effects|Risks And Toxicities Related To Transplant|Reproductive Risks|Unforeseen Risks|12. Physical Injury As A Result Of Participation|5. Risks And Discomforts|9. Physical Injury As A Result Of Participation|D. Will It Hurt?

If needed, you will receive blood transfusions to maintain normal blood cell levels and antibiotics to treat or prevent infection. You may also receive extra nutrients and pain drugs during or after your transplant. They will be given to you through your catheter.

You will have side effects while on the study. Side effects can range from mild to very serious. The risks and discomforts in participating in this study will be similar to what you may have with blood or marrow cell transplant if you do not participate in this trial. Other complications from transplants, such as graft-versus-host disease (GVHD) and infections happen equally in patients who have either type of regimen.  
Your health care team will give you medicines to help lower side effects such as feeling sick to your stomach (nausea). In some cases, side effects can be long lasting or may never go away. Risks Related to Medications or Total Body Irradiation Used in Conditioning Regimens All chemotherapy and radiation treatments used as conditioning regimens in this study are commonly used in allogeneic hematopoietic cell transplantation.

| What it means: This type of side effect is expected to occur in more than   |                                                                                                                                                                                                                                                                                                                       |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Likely                                                                      | 20% of patients. This means that 21 or more patients out of 100 might get  this side effect. What it means: This type of side effect is expected to occur in 20% of                                                                                                                                                   |
| Less Likely                                                                 | patients or fewer. This means that 20 patients or fewer out of 100 might get  this side effect. What it means: This type of side effect does not occur very often - in fewer  than 2% of patients - but is serious when it occurs. This means that 1 or 2  patients (or fewer) out of 100 might get this side effect. |
| Rare, but  Serious                                                          |                                                                                                                                                                                                                                                                                                                       |

The following problems may occur as a result of cord blood or marrow transplant. These risks may occur whether a transplant was done as part of the study or not: 1. Slow recovery of blood counts. The red blood cells, white blood cells, and platelets can be slow to recover after blood or marrow transplant. Until your blood counts recover, you will need blood and platelet transfusions, and will be at risk for bleeding and infections. To speed the recovery of the white cells as much as possible you will receive Filgrastim. 2. Graft failure. The cord blood or bone marrow stem cells (the "graft") may fail to grow inside your body. Past experience suggests that there can be up to a 10-15% chance of graft failure. If graft failure occurs, this may result in low blood counts for a long period of time. If your counts do not recover, you may need to receive a second transplant. Graft failure can be fatal.  
3. Graft-Versus-Host Disease (GVHD).  
GVHD results from the bone marrow or cord blood cells in the graft recognizing your body as foreign and attacking it. In most cases, GVHD can be successfully treated. Sometimes GVHD is severe or difficult to treat and may lead to death. You will be watched closely for this complication and given drugs to prevent and/or treat it.  
Acute GVHD may produce skin rash, nausea, vomiting, diarrhea, abdominal pain, abnormalities of liver function, and an increased risk of infection. Chronic GVHD may produce skin rashes, hair loss, thickened dry skin, dry eyes, dry mouth, liver disease, weight loss, diarrhea, and an increased risk of infection. To confirm the diagnosis of acute or chronic GVHD, you may be asked to have a biopsy (a small sample of your tissue to look at under the microscope) of your skin, gut, or, rarely, your liver. 4. Other complications. Other complications may include: a. **Damage to the vital organs in your body.**
The transplant could cause problems in any body organ such as the heart, lungs, liver, gut, kidneys and bladder, or brain. The kidneys and the liver are most likely to be damaged. Some patients will experience serious lung problems from infections or the chemotherapy and radiation.  
b. **Serious infections.** Full and complete recovery of your immune system may take many months. During this time, there is an increased risk of infections. You will be prescribed certain drugs to reduce the chance of those infections. However, these treatments do not always work. If you have an infection, you may have to stay in the hospital longer or be re-hospitalized after transplant. Although most infections can be successfully treated, some infections may result in death.  
c. Relapse of disease or a new blood cancer. Your leukemia or lymphoma may come back even if the transplant is initially successful. In rare cases, a new blood cancer may develop from the donor cells. Cyclophosphamide can cause damage to blood cells, which may result in a blood cancer such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The blood cancer usually develops 2-10 years after treatment, or 6 years on average. The risk of developing a new blood cancer after allogeneic blood or marrow transplant is probably less than 2%. However, if you receive bone marrow, your donor's marrow is exposed to the chemotherapy drug, cyclophosphamide, after the transplant. There is a risk that a blood cancer may develop in your donor's blood cells. This risk is unknown, but it may be as high as 5%. If cancer develops in your donor's blood cells, you may require additional treatment with chemotherapy or another blood or marrow transplant.  
d. **Risk to the unborn.** The treatments in this study have not been proven to be safe at any stage of pregnancy. Therefore, if you are pregnant or nursing, you are not eligible for this study. Women who can become pregnant must refrain from all acts of vaginal sex (abstinence) or use two forms of effective birth control while receiving chemotherapy, TBI, and drugs to prevent GVHD. Effective birth control is defined as the following:  
1. Consistent use of birth control pills 2. Injectable birth control methods
(Depo-Provera, Norplant)
3. Tubal sterilization or male partner who has undergone a vasectomy 4. Placement of an IUD (intrauterine device)
5. Use of a diaphragm with contraceptive jelly and/or condoms with contraceptive foam every time you have sex.

The drugs used in this research study may damage your reproductive organs, affect your ability to have children or possibly cause birth defects if you take them while you are pregnant. It is important that a woman is not pregnant or breast-feeding and does not become pregnant during the course of the study. If you are a woman and can become pregnant, you will need to take a pregnancy test before you start the study. You should discuss ways to prevent pregnancy while you are in the study. Women who have gone through puberty may find that their menstrual cycle becomes irregular or stops permanently. This does not mean that you cannot become pregnant. You must still use two effective methods of birth control or abstinence during your transplant and continue until you are finished with your GVHD prevention treatment. If you are a man, your body may not be able to produce sperm (become sterile). You should talk with your doctor about banking your sperm before having a transplant. Please check with your doctor to understand more about these risks.

New risks might appear at any time during the study. These risks might be different from what is listed in this Consent Form. We will promptly tell you about new information that may affect your decision to take part in the study. We may learn new things about reduced-intensity transplants that might make you want to stop being in the study. We will let you know if this happens and you can decide if you want to continue in the study.

It is important to tell your study doctor, __________________ *[investigator's* name(s)] or study staff if you feel that you have been injured from taking part in this study. You can tell the doctor in person or call him/her at __________________ [telephone number]. You will get all available medical treatment if you are injured from taking part in this study. You and/or your health plan will be charged for this treatment. The study will not pay for medical treatment. In case you are injured in this study, you do not lose any of your legal rights to receive payment by signing this Consent Form.

There are no major risks to having your blood drawn. It can be uncomfortable to have your blood taken and it can sometimes leave a bruise. In rare cases, you might faint. Only trained people will take your blood. There is not a major risk to give extra research samples of bone marrow when the samples are collected at the same time you donate bone marrow. Information about the bone marrow donation process for this study can be found in a separate consent form. Your transplant doctor or study coordinator will give you a copy of the donation consent form. The donation consent form has more information about the steps to donate, and the risks and side effects of the donation process. Only trained people will collect your bone marrow.

It is important that you tell your doctor, __________________ [investigator's name(s)] or study staff if you feel that you have been injured because you provided blood and marrow samples for future research. You can tell the doctor in person or call him/her at __________________ [telephone number]. You will get all available medical treatment if you are injured as a result providing blood and marrow samples for future research. You, or your health plan, or your family member's health plan will be charged for this treatment. The study will not pay for medical treatment. In case of injury resulting from this study, you do not lose any of your legal rights to seek payment by signing this Consent Form.

When you have your blood taken with a needle, it may feel like a pinch. It will hurt for a minute and sometimes the place where the needle went might be red and sore. You might get a little bruise from the needle but it goes away in a few days.
Clinical trial: NCT01597778
Section: Procedures
Subsections: 4. Study Treatments And Tests|C. What Will Happen To Me?

If you agree to give blood and marrow samples (marrow from donors age 18 and older only), here is what will happen:
a.) We will collect 1 extra blood sample at the same time you have routine blood tests done. The amount of blood collected from you is about 4 tablespoons (50 mL). If you weigh less than 50 kg, the amount of blood collected will be based on your weight (1 mL per kg).  
b.) If you are age 18 or older, we will also collect up to 1 tablespoon (10 mL) of bone marrow when you donate for your family member. 3-5 mL will be saved for future research.  
c.) The blood and marrow samples will be sent to the BMT CTN Repository for processing and storage. A repository is a place that protects, stores, and sends out samples for approved studies. All samples will be given a unique bar code that cannot be linked to you by researchers testing your samples.  
d.) Samples stored in the Repository will be used mainly by clinicians and researchers in the BMT CTN network. In the future, the unused research samples and clinical data will be made available outside of this network.  
e.) Researchers can apply to study the samples stored in the Repository. The BMT CTN Steering Committee and/or the BMT CTN Executive Committee must approve each request before they will share samples or information with researchers. This is to make sure that the investigators who request the samples are qualified, and that the research is of high quality.  
f.) DNA from your stored samples might be used in genome-wide association (GWA) studies for a future project either done or supported by the NIH. Genome-wide association studies are a way for scientists to find genes that have a role in human disease or treatment. Each study can look at hundreds of thousands of genetic changes at the same time. If your coded samples are used in such a study, the researcher is required to add your test results and sample information to a shared, public research database. This public database is called the NIH Genotype and Phenotype Database and it is managed by the National Center for Biotechnology Information (NCBI). The NCBI will never have any information that would identify you, or link you to your information or research samples.

If you say it is OK for us to collect an extra blood sample for research, we will ask you for:
An extra blood sample. We would collect the extra sample at the same time as you have other blood tests done.  
We will watch you carefully for side effects, fevers, infections or other problems.
Clinical trial: NCT01597778
Section: Purpose of Research
Subsections: 3. Study Purpose|A. Purpose:|A. Purpose:|2. Study Purpose|A. Purpose:|A. Purpose:|A. Why Am I Here?|B. Why Are You Collecting An Extra Sample Of Blood?

We are inviting you to take part in this study because you have a cancer of the blood or lymph glands and a stem cell transplant is a treatment option. Tissue typing shows that you do not have a completely matched donor available in your family. You also do not have a matched donor outside of your family who can donate when you need them to. However, you do have two other donor choices available for a transplant: (1) partially matched units of unrelated cord blood, and (2) a family donor who is a partial match. We are doing this research to learn more about reduced-intensity transplants that use a mismatched donor. We will use either cord blood from an unrelated donor or bone marrow from a family member, and then compare the transplant results. These results will help us understand if one kind of mismatched donor is better or if there is no difference at all.

As a research participant, I authorize the Principal Investigators and the researcher's staff to use and disclose my individual health information for the purpose of conducting the research study: A Multi-Center, Phase III, Randomized Trial of Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow for Patients with Hematologic Malignancies

As a research participant, I authorize the Principal Investigators and the researcher's staff to use and disclose my individual health information for the purpose of conducting the research study: A Multi-Center, Phase III, Randomized Trial of Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow for Patients with Hematologic Malignancies

We are collecting extra blood and marrow samples for future research because we want to learn more about reduced-intensity transplants that use a mismatched donor.  
Samples may also be used in the future by researchers with the BMT CTN and other organizations

As a research participant, I authorize the Principal Investigators and the researcher's staff to use and disclose my individual health information for the purpose of conducting the research study: A Multi-Center, Phase III, Randomized Trial of Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow for Patients with Hematologic Malignancies

As a research participant, I authorize the Principal Investigators and the researcher's staff to use and disclose my individual health information for the purpose of conducting the research study: A Multi-Center, Phase III, Randomized Trial of Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow for Patients with Hematologic Malignancies

Your bone marrow is a match for a person in your family who needs a transplant. Your bone marrow grows inside your bones. It helps your body make blood and keeps you healthy. A transplant will collect some of your marrow and give it to a person who needs it to make new, healthy cells. Your body will make more marrow afterwards. If you give us your permission, we would like to have an extra sample of your blood. We would collect the extra sample at the same time you have other blood tests done. We want to save the samples and use them for research in the future.

Research with blood samples will help us learn more about transplant and other diseases. We will keep all of the extra samples private and store them in a place called a Repository. Your name will not be on the samples. Doctors and other researchers can ask to use the samples in the Repository as a part of their research.
Clinical trial: NCT01597778
Section: Voluntary Participation
Subsections: Informed Consent To Participate In Research|18. Blood Samples For Research (Optional)|Statement Of Consent For Cost Effectiveness Research|Statement Of Consent For Research Samples|Donor Informed Consent To Participate In Research|Complete Appropriate Item Below, A Or B A. Adult Donor'S Consent|B. Parent'S Permission For Minor Donor|Pediatric Assent To Provide Extra Samples For Research|G. Do I Have To Be In This Study?

A Multi-Center, Phase III, Randomized Trial of Reduced Intensity(RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow for Patients with Hematologic Malignancies  
| Your Name:                                                                                                                                                                                                                             | ________________________________                                                                                                                                                                                                                   |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Study Title:                                                                                                                                                                                                                           | A Multi-Center, Phase III, Randomized Trial of Reduced Intensity(RIC)  Conditioning and Transplantation of Double Unrelated Umbilical Cord  Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow for  Patients with Hematologic Malignancies |
| Protocol:                                                                                                                                                                                                                              | BMT CTN #1101                                                                                                                                                                                                                                      |
| Co-Investigator:                                                                                                                                                                                                                       | Ephraim Fuchs, M.D. Johns Hopkins University 488 Bunting-Blaustein Cancer Research Building, 1650 Orleans Street Baltimore, MD 21231 Phone: 410- 955-8143 Email: fuchsep@jhmi.edu                                                                  |
| Co-Investigator:                                                                                                                                                                                                                       | Paul O'Donnell, M.D., Ph.D. Massachusetts General Hospital Cancer Center, 55 Fruit St. Boston, MA  02141Phone: 508-693-7430 Email: pvodonnell@mgh.harvard.edu                                                                                      |
| Co-Investigator:                                                                                                                                                                                                                       | Claudio Brunstein, M.D. University of Minnesota Medical Center 420 Delaware Street SE, MMC 286, Minneapolis, MN 55455 Phone: 612-624-5620 Email: bruns072@umn.edu                                                                                  |
| Transplant Center Investigator:                                                                                                                                                                                                        | ________________________                                                                                                                                                                                                                           |
| (Insert contact information for PI at your site) Sponsor: The National Institutes of Health (NIH) is sponsoring this study by  providing financial support through the Blood and Marrow Transplant  Clinical Trials Network (BMT CTN). |                                                                                                                                                                                                                                                    |

This section of the informed consent form is about future research studies that will use blood samples from people who are taking part in the main study. You may choose to give blood samples for these future research studies if you want to. You can still be a part of the main study even if you say 'no' to give blood samples for future research studies.  
There are no major risks associated with drawing blood. Having your blood drawn can be uncomfortable and can sometimes cause a bruise. In rare cases, a blood draw can cause fainting. Only trained people will draw your blood.  
If you agree to provide blood samples, here is what will happen:
a.) We will collect five extra blood samples at the same time you have routine blood tests done. The amount of blood collected from you is about 4 tablespoons (50mL) each time. If you weigh less than 50 kg, the amount of blood collected will be based on your weight (1 mL per kg).  
b.) We will collect samples at five different dates in the study: Prior to transplant, Day 28, Day 56, Day 180, and Day 365.  
c.) The blood samples will be sent to the BMT CTN Repository for processing and storage. A repository is a place that protects, stores and sends out samples for approved research studies. All research samples will be given a bar code that cannot be linked to your name or other identifying information by future researchers testing your samples.  
d.) Samples stored in the Repository will be used mainly by clinicians and researchers in the BMT CTN network. In the future, the unused research samples and clinical information will be made available outside of this network.  
e.) Researchers can apply to study the materials stored in the Repository. The BMT CTN Steering Committee and/or the BMT CTN Executive Committee must approve each request before they will share samples or information with researchers. This is to make sure that the investigators requesting the samples are qualified, and that the research is of high quality.  
f.) DNA from your stored blood samples might be used in genome-wide association (GWA) studies for a future project either done or supported by the National Institutes of Health (NIH). Genome-wide association studies are a way for scientists to find genes that have a role in human disease or treatment. Each study can look at hundreds of thousands of genetic changes at the same time If your coded samples are used in such a study, the researcher is required to add your test results and sample information into a shared, public research database. This public database is called the NIH Genotype and Phenotype Database and it is managed by the National Center for Biotechnology Information (NCBI). The NCBI will never have any information that would identify you, or link you to your information or research samples.  
Some general things you should know about letting us store your blood samples for research are:
We will only store samples from people who give us permission.  
Research is meant to gain knowledge that my help people in the future. You will not get any direct benefit from taking part. Additionally, you or your doctor will not be given results and they will not be added to your medical record.  
A possible risk is the loss of confidentiality about your medical information. We will use safety measures with both your samples and clinical information to make sure that your personal information will be kept private. The chance that this information will be given to someone else is extremely small.  
Your blood will be used only for research and will not be sold. The research done with your blood may help to develop new products in the future. You will not get paid for any samples or for any products that may be developed from current or future research.  
You can change your mind at any time about allowing us to use your samples and health information for research. We ask that you contact [Principal Investigator] in writing and let him/her know you do not want us to use your research samples or health information for research. His/her mailing address is on the first page of this form. However, samples and information that have already been shared with other researchers cannot be taken back or destroyed.  
Health Insurance Portability and Accountability Act 1 (HIPAA1)
Authorization to use and disclose research purpose

The purpose of the cost effectiveness research, the procedures involved, and the risks and benefits have been explained to me. I have asked all the questions I have at this time and I have been told whom to contact if I have more questions. I have been told that I will be given a signed copy of this consent form to keep. I understand that I do not have to participate in the cost effectiveness research. If I decide to not participate, it will not affect my medical care in any way.  
I agree to be part of the cost-effectiveness research.  
I do not agree to be part of the cost-effectiveness research.
Signature Date

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

A Multi-Center, Phase III, Randomized Trial of Reduced Intensity (RIC) Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLAHaploidentical Related Bone Marrow for Patients with Hematologic Malignancies  
Your name:_________________________________________________  
| Study Title:                                     | Reduced Intensity (RIC) Conditioning and Transplantation of Double  Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical  Related Bone Marrow for Patients with Hematologic Malignancies   |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Protocol:                                        | BMT CTN #1101                                                                                                                                                                                         |
| Co-Investigator:                                 | Ephraim Fuchs, M.D. Johns Hopkins University 488 Bunting-Blaustein Cancer Research Building, 1650 Orleans Street Baltimore, MD 21231 Phone: 410- 955-8143 Email: fuchsep@jhmi.edu                     |
| Co-Investigator:                                 | Paul O'Donnell, M.D., Ph.D. Massachusetts General Hospital Cancer Center55 Fruit St, Boston, MA  012141Phone: 508-274-7430Email: pvodonnell@mgh.harvard.edu                                           |
| Co-Investigator:                                 | Claudio Brunstein, M.D. University of Minnesota Medical Center 420 Delaware Street SE, MMC 286, Minneapolis, MN 55455 Phone: 612-624-5620 Email: bruns072@umn.edu                                     |
| Transplant Center Investigator:                  | ________________________                                                                                                                                                                              |
| (Insert contact information for PI at your site) |                                                                                                                                                                                                       |  
Sponsor: The National Institutes of Health (NIH) is sponsoring this study by providing financial support through the Blood and Marrow Transplant Clinical Trials Network (BMT CTN).

I have read the explanation about this study and have been given the opportunity to discuss it and to ask questions. I hereby consent to give blood and marrow samples for this study.

| ____________________________________ Signature of Adult Donor & Date Signed THIS CONSENT DOCUMENT HAS BEEN  APPROVED FOR USE FROM _________  THROUGH __________.   |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
I have read the explanation about this study and have been given the opportunity to discuss it and to ask questions. I hereby give permission for my child to give a blood sample for this study.  
_____________________________________ Signature of Investigator & Date Signed  
______________________________________ Signature of Witness & Date Signed  
| ______________________________________ Signature of Parent(s)/Guardian & Date  Signed If other than parent, specify relationship:  ___________________________________   |
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Study Title: A Multi-Center, Phase III, Randomized Trial of Reduced Intensity(RIC)
Conditioning and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow for Patients with Hematologic Malignancies Protocol: **BMT CTN 1101**

If you do not want to give an extra blood sample, you need to tell us and your parent or guardian. Your doctor will not be angry or upset if you do not want to join. You can still give bone marrow to the person in your family who needs it. They will still get the exact same care. You can say yes now and change your mind at any time. Please talk this over with your parents before you decide if you want to give an extra blood sample for research. We will also ask your parents to give their permission for you to give an extra sample for research.  
Writing your name on this page means that you agree to give an extra blood sample and know what will happen to you. If you change your mind, all you have to do is tell the person in charge. You and your parent or guardian will get a copy of this form after you sign it.  
| Signature of Child      | Date   |
|-------------------------|--------|
| Signature of Researcher | Date   |
Clinical trial: NCT01597778
Section: Withdrawal from Study
Subsections: 4. Right To Ask Questions And/Or Withdraw|11. Ending Your Participation|3. Right To Ask Questions And/Or Withdraw|8. Ending Your Participation

You have the right to ask questions about the study at any time. If you have questions about the study or you want to leave the study, please contact: [insert contact info for site PI] Being in this study is voluntary. You can choose not to be in this study or leave this study at any time. If you choose not to take part or leave this study, it will not affect your regular medical care in any way. Your study doctor and study staff will be available to answer any questions that you may have about taking part in or leaving this study.

The study doctor or the study sponsor may stop the study at any time, and we may ask you to leave the study. If we ask you to leave the study, the reasons will be discussed with you. Possible reasons to end your participation in this study include:
You do not meet the study requirements.  
You need a medical treatment not allowed in this study.  
The study doctor decides that it would be harmful to you to stay in the study.  
You are having serious side effects.  
You become pregnant.  
You cannot keep appointments or take study drugs as directed.  
The study is stopped for any reason.  
You could have serious health risks if you stop treatment during the conditioning process before you receive your transplant. If you stop taking the immune suppressing drugs (see Section 6: Risks and Discomforts) too soon after transplant, your body could reject the donor stem cells or you could develop serious complications and possibly die. We ask that you talk with the research doctor and your regular doctor before you leave the study. Your doctors will tell you how to stop safely and talk with you about other treatment choices.  
If you decide to leave this study after the start of treatment, or your doctor asks you to leave the study for medical reasons, you will need to come back to the doctor's office for tests for your safety. Even if you leave the study, the information collected from your participation will be included in the study results, unless you specifically ask that it not be included.

You have the right to ask questions about the study at any time. If you have questions about your rights as a participant or you want to leave the study, please contact:

The study doctor or the study sponsor may stop the study at any time, and we may ask you to leave the study. We may ask you to leave the study if you do not follow directions or if you suffer from side effects of the blood draw or the marrow collection. The study sponsor may decide to end the study at any time. If we ask you to leave the study, the reasons will be discussed with you.  
Possible reasons to end your participation in this study include:
You do not meet the study requirements.  
You become unable to donate bone marrow to your family member.  
The study is stopped for any reason.