Clinical trial: NCT03904134
Section: Alternatives
Subsections: 7. **Alternative Treatments**

It is your choice to join this study. If you choose not to join, you may still receive a transplant to treat your disease. Your study doctor will talk with you about your options. If you decide not to join this study, your medical care will not be affected in any way.
Clinical trial: NCT03904134
Section: Confidentiality
Subsections: 10. **Privacy, Confidentiality And Use Of Information**|B. Individual **Health Information To Be Used Or Disclosed**:|G. Potential **For Re-Disclosure:**

Your privacy is very important to us. The study doctors will do everything they can to protect it. The study doctors have a privacy permit to help protect your records if there is a court case. However, some of your medical information may be given out if required by law. If this should happen, the study doctors will do their best to make sure that any information that goes to others will not identify you. All your medical and demographic information (such as race and ethnicity, gender and household income) will be kept private and confidential. *(Name of Transplant Center)* and the organizations listed below will not share that you are in the study in any way, except with your written permission, or unless required by law.  
Individuals authorized by the organizations below will be able to see 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 agree to such inspections and to the copying of parts of your records, if required by these organizations. 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 confidential (private). However, we cannot promise total privacy. We may have to 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:

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 Health Information**:
The researcher and the researcher's staff may collect my individual health information from:

My individual health information disclosed under this authorization may be subject to redisclosure outside the research study as required by law and would no longer be protected.  
Examples include potential disclosures for law enforcement purposes, mandated reporting or abuse or neglect, judicial proceedings, health oversight activities and public health measures. H. This consent form does not have an expiration date.  
TITLE: Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation
Clinical trial: NCT03904134
Section: Participant's Rights
Subsections: 4. **Right To Ask Questions And/Or Leave The Study**|[Insert Contact Information For Site Pi]. 16. **Contact Someone About Your Rights**|E. **Right To Refuse To Sign This Authorization:**|F. **Right To Revoke**:

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:

If you wish to talk 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, you may contact:

I do not have to sign this consent form. If I decide not to sign the consent form, 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 consent form will not affect any other treatment, payment, or enrollment in health plans or eligibility for benefits.

I can change my mind and withdraw my consent at any time by sending a written notice to the Principal Investigator to inform the researcher of my decision. If I withdraw my consent, 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.
Clinical trial: NCT03904134
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 6. **Risks And Discomforts**|Unforeseen Risks:|12. **Physical Injury As A Result Of Participation**|Risks To Participating **In Qol Substudy:**|Risks To Participating In Blood Sample Substudy:

The risks and side effects of transplant are the same if you join this study or if you don't join this study since you and your doctors will decide the type of conditioning regimen and GVHD prophylaxis you will receive. What is different is if you participate in this study, the protocol will help guide your doctors in choosing a donor for you, based on the likelihood that a matched unrelated donor can be found. It is possible that even though we think it should be easy to find a matched unrelated donor for you, this turns out not to be true and your transplant is delayed while your doctors search for a matched unrelated donor. It is also possible that we think it will be very difficult and take a long time to find a matched unrelated donor for you but it turns out that a matched unrelated donor does exist. In either of these cases, you may not do as well if your doctors follow the donor search algorithm. However, your doctors may choose to ignore our recommendation about whether to search for a matched unrelated donor if they think a different plan is better for you.

New risks might appear at any time during the study. We may learn new things 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 stay in the study. Your doctor will explain any risks of transplant to you. You will receive more information about the transplant process, including the risks and benefits. Your doctor will ask you to sign a separate consent form for the transplant itself.

Participation in this study and use of the donor search algorithm is unlikely to cause any direct physical injury. We think that guiding centers to use your likelihood of finding a matched unrelated donor to quickly identify a donor so you can get to transplant will be helpful because we believe that the success of transplant is the same no matter which donor is used, but we do not know if this will be true. Whenever you participate in a study, it is important to tell your study doctor *[investigator's* name(s)] or study staff if you feel that you have been hurt or injured from taking part in this study. You can tell the doctor in person or call *[telephone number]*.  
You will get all available medical treatment if you are injured from being in this study. You and/or your health plan will be charged for the donor search and your transplant care. The study will not pay for this treatment.

There are few risks from taking the quality of life surveys. Some of the questions or topics may make you feel uncomfortable or emotional. Talk to your doctor about your feelings. There is a small risk that a person who shouldn't be able to see your survey could find out which answers are yours. Your transplant center and the CIBMTR will do everything possible to stop this from happening. The survey isn't meant to find depression or other emotional health issues. We won't look at your information for signs or symptoms of distress. If you have any concerns about your feelings, thoughts, or emotional health during this study, tell your doctor right away. Your doctor will talk to you about your options.  
Payment and costs: You will not get paid for participating in the QOL Substudy. You will not be charged for taking part in this study.  
Right to ask questions and/or withdraw: You do not have to be part of the QOL Substudy.  
Your participation is voluntary. If you decide not to be part of the QOL Substudy, it will not affect your regular medical care or services. You can quit the QOL Substudy at any time. If you want to stop participating in the QOL Substudy (withdraw), let your study doctor know in writing. If you withdraw from the QOL Substudy, you can choose whether we can still use your quality of life information or not.

There is a small risk of an infection or fainting from the blood draw. If your blood samples are collected from your arm (instead of your central line), you may bleed a little bit and/or develop a small bruise. Infection from blood draws is rare, but may happen. If you are uncomfortable at the sight of blood, you may feel light-headed or faint. The greatest risk to you is the release of information from your health records. We will do our best to make sure that your personal information will be kept private. The chance that this information will be given to someone else is very small. The results of this study will be published, but your personal information (for examples, name and address) will remain confidential (private). BMT CTN may also use the information from this study for future medical research.  
Right to ask questions and/or withdraw: You do not have to be part of the Blood Sample Substudy. Your participation is voluntary. If you decide not to be part of the Blood Sample Substudy, it will not affect your regular medical care or services. You can quit the Blood Sample Substudy at any time. If you want to stop participating in the Blood Sample Substudy (withdraw), let your study doctor know in writing. If you withdraw from the Blood Sample Substudy, your blood samples will be discarded.
Clinical trial: NCT03904134
Section: Procedures
Subsections: 5. **Study Treatments And Tests** Study Participation|If You Agree To Complete Optional Quality Of Life Surveys, Here Is What Will Happen:|If You Agree To Provide Optional Blood Samples, Here Is What Will Happen:

If you join the study, we'll check your health before, during, and for at least **2 years** after your transplant. We will ask you to sign this consent form and give you a copy of the signed form to keep. If you join this study and you don't have a matched sibling donor, your doctor will check if you have another good donor. Your donor could be another family member or an unrelated person.

After you join the study, we will ask you questions about your health and how you're feeling. These questions can be answered either via an online survey or a paper survey mailed or given to you. The CIBMTR will collect the survey data, and will reach out to you if surveys are not completed to ensure you got the online link or paper survey and answer any questions you have. We will ask you to complete surveys:
One month or less before transplant 1 year (12 months) after transplant 2 years (24 months) after transplant, and 5 years (60 months) after transplant.  
Each survey will take 15-30 minutes to complete. The survey will ask about your physical, emotional, and social well-being including:
How well you can do your everyday activities If you have pain and how much pain affects daily life Fatigue (feeling tired) and how well you are sleeping How much you worry or feel nervous or have symptoms of depression How much you are able to participate in social roles and social activities How much you are bothered by specific symptoms to parts of your body Demographics, such as your race and ethnicity, level of education, work status, income, current state and ZIP code where you live, and health insurance coverage.  
This information will be used for research purposes. You can skip any questions you want. You can also stop the survey at any time. If you want to stop participating (withdraw) in the optional QOL Substudy, let your study doctor know in writing. If you withdraw, you can choose whether we can still use your information or not. If your phone number or email address changes, it's important that you let us know your new number so we can reach you. You can call:

- We'll take the blood samples from your catheter or by a vein in your arm. We'll collect this sample when you have your checkup before your transplant and up to 6 times during the first 2 years after your transplant.  
- We will collect 30mL (about 6 teaspoons) if you are an adult. Children would have less blood drawn based on their weight.  
- The 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. Each research sample will be coded with a unique code. The codes themselves do not contain information that could identify you, however, a link to this code does exist. The link is stored at the Data and Coordinating Center for the Blood and Marrow Transplant Clinical Trials Network (BMT CTN DCC). The staff at the Repository where your sample is being stored does not have a link to this code. Your research samples will continue to be stored at the BMT CTN Repository until they are used up for approved research.  
- Samples stored in the Repository will be used mainly by doctors and researchers in the BMT CTN network. In the future, the unused blood samples and health information will be made available outside of this network. Researchers can apply to study the health information and samples 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.  
- Your samples will be used only for research and will not be sold. The research done with your samples 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.
Clinical trial: NCT03904134
Section: Purpose of Research
Subsections: 3. **Study Purpose**|A. **Purpose:**

The main goal of this study is to see if there is a difference in how people do if they are very likely or very unlikely to find an HLA-matched unrelated donor. We also want to see:
- Barriers patients and their doctors face when trying to get a transplant - How many of the patients in this study get a transplant - How well patients do after having a transplant depending on the type of donor they use We will also ask about your overall health, and how well you can do your everyday activities (quality of life), if you:
- Have AML or ALL in first remission (no signs of the disease)
OR
- Have early stage MDS  
AND
- Receive transplant from a matched unrelated donor or half-matched family member - Have specific types of **conditioning regimen and graft-versus-host disease (GVHD)**
prophylaxis.
We'll ask about 33% of patients (those with AML, ALL and MDS as mentioned above) (1 out of 3), to let us contact them in 1, 2 and 5 years to see how well they're doing (**see Section 17: QOL**
Substudy). If we receive additional money to support the study, we will collect additional blood for research. The amount of blood collected will be 30mL (about 6 teaspoons) if you are an adult. Children would have less blood drawn based on their weight. Answering these surveys and giving blood for research is optional. This means you can still be part of the main study (looking at how you do based on your chance of finding an HLA-matched unrelated donor) if you say 'no' to this Substudy.

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: Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation (CTRL-ALT-D)
Clinical trial: NCT03904134
Section: Voluntary Participation
Subsections: Informed Consent Informed Consent To Participate In Research|Statement Of Consents For Qol And Blood Samples Substudies **(Optional)**

Clinical Transplant-Related Long-term Outcomes of  
  
Alternative Donor Allogeneic Transplantation  
| Your Name:                      | ________________________________                                                                                                                                             |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Study Title:                    | Clinical Transplant-Related Long-term Outcomes of Alternative Donor  Allogeneic Transplantation                                                                              |
| Protocol:                       | BMT CTN #1702                                                                                                                                                                |
| Co-Investigator:                | Stefan Ciurea, MD                                                                                                                                                            |
|                                 | University of Texas, MD Anderson Cancer Center                                                                                                                               |
|                                 | 1515 Holcombe Boulevard  Unit 423  Houston, TX 77030  Phone: (713) 745-0146                                                                                                  |
| Co-Investigator:                | Stephanie Lee, MD, MPH                                                                                                                                                       |
|                                 | Fred Hutchinson Cancer Research Center 1100 Fairview Ave N  D5-290  Seattle, WA 98109-4433  Phone: (206) 667-6190                                                            |
| 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). |

The purpose of the QOL Substudy and the Blood Sample Substudy, the procedures involved
(quality of life surveys and blood samples), 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 either substudy. If I decide to not participate, it will not affect my medical care in any way. For those without **a diagnosis of AML or ALL in first remission or early stage MDS:**
N/A - I do not have a diagnosis of AML or ALL in first remission or early stage MDS and therefore will not participate in either substudy.  
For those with **a diagnosis of AML or ALL in first remission or early stage MDS:**
Quality of Life Surveys I agree to take part in quality of life surveys. I do not agree to take part in quality of life surveys.
Clinical trial: NCT03904134
Section: Withdrawal from Study
Subsections: 11. **Ending Your Participation**

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, we will tell you why. Possible reasons your participation in this study could end include:
You do not meet the study requirements.  
You need a medical treatment not allowed in this study.  
The study doctor decides it would be harmful to you to stay in the study.  
The study is stopped for any reason.
If you leave the study, any information already collected from you will be included in the results, unless you ask that it not be included.