Clinical trial: NCT03959241
Section: Alternatives
Subsections: Other Treatments Or Medications|7. Alternative To Participation

Some medicines react with each other, so it is important that you tell the study doctor or staff about any other drugs, treatments, or medicines you are taking. This includes non-prescription or over-the-counter medicines, vitamins and herbal treatments.  
It is also important that you tell the study staff about any changes to these medicines while you're in 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 a 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.  
- A 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: NCT03959241
Section: Confidentiality
Subsections: 10. Privacy, Confidentiality, And Use Of Information

Your privacy is very important to us. The study doctors will make every effort to protect it. This study has a "Certificate of Confidentiality," which means 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 out to others will not identify you. Representatives from government agencies, including the U.S. Food and Drug Administration ("FDA"), institutional review boards, the Sponsors and/or the Sponsors' authorized representatives may need access to your original medical records and study records to check information collected for the study. By signing this Consent Form, you authorize this access. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. Your study number (code) is not related to your name, social security number, or medical record number at [insert facility name]. Coded study information may also be used for unexpected medical projects and research in the future. These projects could be related to **your disease or similar diseases, and development of the study drug.** At all times the projects will follow the law. You will not be able to access your personal health information related to this study until the study is done. This helps to maintain the scientific integrity of the study. After the study is complete, you can ask your study doctor for your health information. By signing this Consent Form, you agree to ask for your health information only after the study is done. Information about your transplant from your original medical records may be seen or sent to:  
- Data and Coordinating Center of the Blood and Marrow Transplant Clinical Trials Network
(BMT CTN DCC), including the Center for International Blood and Marrow Transplant Research (CIBMTR), the National Marrow Donor Program (NMDP)/Be The Match registry and The Emmes Corporation, who are coordinating the studies of the BMT CTN
- The Food and Drug Administration (FDA) and National Institutes of Health (NIH), which includes the National Heart, Lung and Blood Institute (NHLBI) and the National Cancer Institute (NCI)
- Office of Human Research Protection (OHRP) - Data and Safety Monitoring Board (DSMB), not part of [Institution]
- Institutional Review Boards (IRBs) responsible for this study Data about your clinical situation, including follow-up after 1 year, may be obtained by the BMT CTN from the CIBMTR. The CIBMTR collects information on all U.S. transplants. We won't identify you by name in any publications or reports that come from these organizations or agencies.
Clinical trial: NCT03959241
Section: Duration of Study Involvement
Subsections: Study Participation

If you decide to join the study, your participation will last for 1 **year** after your transplant for the main study. The Mi-Immune study will collect research samples from you at 2 years after your transplant. We will ask you to sign this Consent Form and you will get a copy of the signed form to keep. Most of the tests and procedures used for this study are the same as those normally used for transplant patients. However, there will be some extra tests if you join the study: 1) Questions about your health and how well you can do your normal everyday activities
(Patient Reported Outcomes (PRO) surveys). The CIBMTR Survey Research Group will contact you by email, phone or mail to collect PRO surveys online or on paper. Your transplant center will provide your name and contact information to the CIBMTR Survey Research Group when you enroll in the study, so that they may administer the survey to you. You will take the surveys before your conditioning regimen and on Days 98, 180, 365 after your transplant.  
2) Mi-Immune biological samples: blood, urine and stool samples
Clinical trial: NCT03959241
Section: Participant's Rights
Subsections: E. Right To Refuse To Sign This Authorization|F. Right To Revoke|G. Potential For Re-Disclosure

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.

My individual health information disclosed under this authorization may be subject to redisclosure 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. H. This authorization does not have an expiration date. TITLE: BMT CTN 1703: A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Hematopoietic Cell Peripheral Blood Stem Cell Transplantation COMPANION STUDY: BMT CTN 1801: Microbiome and Immune Reconstitution in Cellular Therapies and Hematopoietic Stem Cell Transplantation (Mi-Immune)  
  
- I have read and understood this Consent Form. The nature and purpose of the research study has been explained to me.  
- I have had the chance to ask questions and understand the answers I have been given. I
understand that I may ask questions at any time during the study.  
- I freely agree to be a participant in the study. - I understand that I may not directly benefit from taking part in the study. - I understand that, while information gained during the study may be published, I will not be identified, and my personal results will stay confidential.  
- I have had the chance to discuss my participation in this research study with a family member or friend.  
- I understand that I can leave this study at any time, and doing so will not affect my current care or prevent me from receiving future treatment.  
- I understand that I will be given a copy of this signed Consent Form.  
- I understand that I will be participating in the Companion Study - Mi-Immune and that I
will have blood, stool and urine samples collected.  
| Participant Name   | Date   |
|--------------------|--------|
| Signature          | Date   |  
I certify that I have provided a verbal explanation of the details of the research study, including the procedures and risks. I believe the participant has understood the information provided.  
| Name of Person Obtaining Consent      | Date   |      |
|---------------------------------------|--------|------|
|                                       |        |      |
| Signature of Person Obtaining Consent |        | Date |
Clinical trial: NCT03959241
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 6. Risks And Discomforts|Risks Of Medicines|Risks And Toxicities Related To Transplant|Reproductive Risks|- If You'Re Female:|- If You'Re Male:|Unforeseen Risks|12. Physical Injury As A Result Of Participation|Risks Related To Research Samples|Risks:

You will have side effects while on the study. Side effects can range from mild to lifethreatening. The risks and discomforts from this study are similar to what you would have even if you do not join this study. If you do, the effect on you might be better, worse or about the same. Your health care team may give you medicines to help lessen side effects such as feeling sick to your stomach (nausea). In some cases, side effects can be long lasting or may never go away.

All of the immune suppressive and conditioning regimen drugs listed below are commonly used in blood stem cell transplant. The tables below describe all conditioning regimens that are allowed to be used in this study. The regimen you will receive depends on your doctor's choice.  
| Table 2: Conditioning Regimens                                                                                              |                                               |                                              |                         |
|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|----------------------------------------------|-------------------------|
| Reduced Intensity Conditioning                                                                                              | Nonmyeloablative Conditioning                 |                                              |                         |
| Fludarabine/Busulfan (Flu/Bu)                                                                                               | Fludarabine/Cyclophosphamide (Flu/Cy)         |                                              |                         |
| - Fludarabine (120-180 mg/m2 )                                                                                              | -                                             | Fludarabine (90-120 mg/m2 )                  |                         |
| - Busulfan (less than or equal to 8  mg/kg PO or 6.4 mg/kg IV)                                                              | -                                             | Cyclophosphamide (120 mg/kg or 2250  mg/m2 ) |                         |
| Fludarabine/Melphalan ( Flu/Mel)                                                                                            | Fludarabine /Total Body Irradiation (Flu/TBI) |                                              |                         |
| -                                                                                                                           | Fludarabine (120-180 mg/m2 )                  | -                                            | Fludarabine (90 mg/m2 ) |
| -                                                                                                                           | Melphalan (less than or equal to 150  mg/m2 ) | -                                            | TBI (200 cGy)           |
| Fludarabine/ Cyclophosphamide/TBI  (Flu/Cy/TBI) - Fludarabine (150 mg/m2 ) - TBI (200 cGy) - Cyclophosphamide (29-50 mg/kg) |                                               |                                              |                         |  
| Table 3: Risks and Side Effects  Likely This side effect is expected to happen in more than 20% of patients. This  means that 21 or more patients out of 100 might get this side effect. Less Likely This side effect is expected to happen in 20% of patients or fewer. This  means that 20 patients or fewer out of 100 might get this side effect. This side effect does not happen often - in fewer than 3% of patients - but  is serious when it happens. This means that 0, 1, 2 or 3 patients out of 100  might get this side effect. Rare, but  Serious   |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
| Methotrexate Likely (May happen in more than 20%  of patients)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Rare, but Serious                                                                                   |              |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------|
| (May happen in 3% or  fewer patients)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                                                                                                     |              |
| -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Increased risk of  sunburn or rash                                                                  |              |
| -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Nausea, vomiting, loss  of appetite                                                                 |              |
| -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Sores in mouth which  may cause difficulty  swallowing                                              | Less Likely  |
| (May happen in 20% or fewer  patients, but more than 3%) - Anemia from low red  blood cell count which  may cause tiredness, or  may require transfusion - Blood clots which may  cause swelling, pain,  shortness of breath - Bruising, bleeding from  low platelet count - Diarrhea, sores in the  gastrointestinal tract - Fluid around the heart - Hair loss  - Hepatitis or liver  damage which may  cause yellowing of eyes  and skin, generalized  swelling - Infection, especially  when white blood cell  count is low - Kidney damage | -                                                                                                   | A new cancer |
| -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Internal bleeding  which may cause  belly pain, black  tarry stool, blood  in vomit                 |              |
| -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Scarring of the  lungs which may  cause shortness of  breath, confusion                             |              |
| -                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Severe skin rash  with blisters and  peeling which can  involve mouth  and other parts of  the body |              |  
| Mycophenolate Mofetil (MMF, Cellcept®) Likely (May happen in more than 20% of patients)                                                                                                                                                                                                                                                                   | Rare, but Serious                                                                                                               |              |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------|
| (May happen in 3% or fewer patients)                                                                                                                                                                                                                                                                                                                      |                                                                                                                                 |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Birth control may not  work as well                                                                                             |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Damage to unborn  baby if you become  pregnant while taking  this medicine                                                      |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Difficulty                                                                                                                      | breathing,   |
| cough                                                                                                                                                                                                                                                                                                                                                     |                                                                                                                                 |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Headache                                                                                                                        |              |
| -                                                                                                                                                                                                                                                                                                                                                         | High blood pressure                                                                                                             |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Low white blood cell  count with increased  risk of infection                                                                   |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Nausea, vomiting,  diarrhea, stomach pain                                                                                       |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Swelling of the hands,  feet, ankles, or legs                                                                                   |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Tremors                                                                                                                         | Less Likely  |
| (May happen in 20% or fewer patients, but more than 3%) - Anemia (low red blood  cell count) - Change in the levels of  salts in the blood - Decreased platelet  count, may cause blood  loss into stool or vomit,  increased bruising - Difficulty falling asleep  or staying asleep - Dizziness - Low blood pressure - Pain in joints or muscles - Rash | -                                                                                                                               | A new cancer |
| -                                                                                                                                                                                                                                                                                                                                                         | Change in vision                                                                                                                |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Encephalopathy or  brain dysfunction that  can lead to death                                                                    |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Excessive tiredness                                                                                                             |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Fast heartbeat                                                                                                                  |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Progressive  Multifocal  Leukoencephalopathy  - This is caused by a  virus that damages  the protective  covering in the brain. |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Severe difficulty  breathing                                                                                                    |              |
| -                                                                                                                                                                                                                                                                                                                                                         | Weakness                                                                                                                        |              |  
| Tacrolimus (FK506, Prograf®) Likely                                                                                                                                                   | Less Likely                                                                                                                    | Rare, but Serious                     |                                                                                                 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-------------------------------------------------------------------------------------------------|
| (May happen in more than 20% of  patients)                                                                                                                                            | (May happen in 20% or fewer  patients, but more than 3%)                                                                       | (May happen in 3%  or fewer patients) |                                                                                                 |
| -                                                                                                                                                                                     | Abnormal body movement,  including tremors                                                                                     |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Abnormal levels of sugar,  fat, or minerals (like sodium  or potassium) in your blood                                          |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Constipation, diarrhea,  nausea, vomiting, reflux,  lack of desire to eat                                                      |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Difficulty sleeping                                                                                                            |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Dizziness                                                                                                                      |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Feeling of "pins and  needles" in arms and legs                                                                                |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Headache                                                                                                                       |                                       |                                                                                                 |
| -                                                                                                                                                                                     | High blood pressure which  may cause dizziness, chest  pain                                                                    |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Itching, rash                                                                                                                  |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Kidney damage which may  cause swelling, may require  dialysis                                                                 |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Low red blood cell counts,  which may cause tiredness,  or may require blood  transfusions                                     |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Low platelet levels, which  may cause bruising,  bleeding                                                                      |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Low white blood cell  counts, which may lead to  infection                                                                     |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Liver damage                                                                                                                   |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Swelling of the body                                                                                                           | -                                     | A new cancer                                                                                    |
| -                                                                                                                                                                                     | A tear or a hole in your bowels which may cause  belly pain and may  require surgery                                           |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Allergic reaction which  may cause rash, low  blood pressure,  wheezing, shortness of  breath, swelling of the  face or throat |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Change in the heart  rhythm, abnormal  heartbeat, or heart stops  beating                                                      |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Damage to brain, which  may cause headache,  seizure, blindness                                                                |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Damage to lungs, which  may cause shortness of  breath, fluid around lungs                                                     |                                       |                                                                                                 |
| -                                                                                                                                                                                     | Heart attack or heart  failure which may cause  chest pain, swelling of  ankles, and tiredness                                 | -                                     | Damage to  small blood  vessels with  resulting small  blood clots and  possible organ  damage. |
| It is very important that you do not eat grapefruit or drink grapefruit juice while taking  Tacrolimus. Grapefruit has an ingredient called bergamottin, which can affect some of the |                                                                                                                                |                                       |                                                                                                 |  
It is very important that you do not eat grapefruit or drink grapefruit juice while taking Tacrolimus. Grapefruit has an ingredient called bergamottin, which can affect some of the treatment drugs used in this study. Common soft drinks that have bergamottin are *Fresca*, Squirt, Sundrop, and Sunny Delight.  
| Cyclophosphamide (Cytoxan®) Likely (May happen in more than 20% of patients)   | Less Likely                                                                                                 |    |                                                                                                                                 |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----|---------------------------------------------------------------------------------------------------------------------------------|
| (May happen in 20% or  fewer patients, but more than 3%)                       | Rare, but Serious                                                                                           |    |                                                                                                                                 |
| (May happen in 3% or  fewer patients)                                          |                                                                                                             |    |                                                                                                                                 |
| -                                                                              | Absence of menstrual  cycles which may decrease  the ability to have children                               |    |                                                                                                                                 |
| -                                                                              | Blood in urine                                                                                              |    |                                                                                                                                 |
| -                                                                              | Feeling tired                                                                                               |    |                                                                                                                                 |
| -                                                                              | Hair loss, skin changes,  rash, change in nails                                                             |    |                                                                                                                                 |
| -                                                                              | Infection, especially when  white blood cell count is  low                                                  |    |                                                                                                                                 |
| -                                                                              | Nausea, vomiting,  diarrhea, loss of appetite,  pain in belly                                               |    |                                                                                                                                 |
| -                                                                              | Sores in mouth                                                                                              | -  | Allergic reaction  which may cause  rash, low blood  pressure, wheezing,  shortness of breath,  swelling of the face  or throat |
| -                                                                              | Decrease in platelets  which may cause  bleeding                                                            |    |                                                                                                                                 |
| -                                                                              | Decrease in red  blood cells, which  may require blood transfusions                                         |    |                                                                                                                                 |
| -                                                                              | Loss or absence of  sperm which may  lead to an inability  to father children                               | -  | A new cancer                                                                                                                    |
| -                                                                              | Damage to the  heart or heart  failure which may  cause shortness of  breath, swelling,  cough or tiredness |    |                                                                                                                                 |
| -                                                                              | Scarring of the  lungs which may  cause shortness of  breath, fluid  arounds the lungs                      |    |                                                                                                                                 |
| -                                                                              | Swelling of the  brain which may  cause dizziness,  confusion                                               |    |                                                                                                                                 |  
| Busulfan                                   | Likely                                                                                  | Less Likely                                                                                                                                                                                                     | Rare, but Serious   |                                                                                                                                |
|--------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------|
| (May happen in more than  20% of patients) | (May happen in 3% or fewer  patients)                                                   |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Abnormal or fast  heartbeat                                                             |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Abnormal salt and/or  vitamin levels that  may require IV fluids                        |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Anemia (low red  blood cells) which  may require blood  transfusions                    |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Chills, fever                                                                           |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Constipation,  diarrhea, heartburn,  nausea, vomiting, loss  of appetite, stomach  pain |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Cough, stuffy nose                                                                      |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Damage to the liver or  kidneys                                                         |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Difficulty sleeping                                                                     |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Dizziness, headache                                                                     |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Feeling tired                                                                           | (May happen in 20% or fewer  patients, but more than 3%) - Blood in the urine - Coughing up blood - Damage to or scarring  of the lungs - Loss or absence of  sperm - Menopause - Seizure - Visual disturbances | -                   | Allergic reaction  which may cause rash,  low blood pressure,  wheezing, shortness  of breath, swelling of  the face or throat |
| -                                          | Fluid around the heart                                                                  |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Heart failure which  may cause shortness  of breath, swelling of  ankles, and tiredness |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Low blood pressure  which may cause  feeling faint                                      |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | High blood pressure                                                                     |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Infection, especially  when white blood cell  count is low                              |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Low platelet counts  which may cause  bruising or bleeding                              |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Pain                                                                                    |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Rash                                                                                    |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Sadness, worry                                                                          |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Sores in mouth which  may cause difficulty  swallowing                                  |                                                                                                                                                                                                                 |                     |                                                                                                                                |
| -                                          | Swelling of the body                                                                    |                                                                                                                                                                                                                 |                     |                                                                                                                                |  
| Fludarabine Likely                         | Less Likely                                                          | Rare, but Serious                                                                                                                                                                                                                                                                                                                                     |    |                |
|--------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|----------------|
| (May happen in more than  20% of patients) | (May happen in 3% or fewer  patients)                                |                                                                                                                                                                                                                                                                                                                                                       |    |                |
| -                                          | Anemia (low red  blood cells) which  may require blood  transfusions |                                                                                                                                                                                                                                                                                                                                                       |    |                |
| -                                          | Cough                                                                |                                                                                                                                                                                                                                                                                                                                                       |    |                |
| -                                          | Feeling tired or  irritable                                          |                                                                                                                                                                                                                                                                                                                                                       |    |                |
| -                                          | Infection, especially  when white blood cell  count is low           |                                                                                                                                                                                                                                                                                                                                                       |    |                |
| -                                          | Low platelet counts,  which may cause  bruising or bleeding          |                                                                                                                                                                                                                                                                                                                                                       |    |                |
| -                                          | Pain                                                                 | (May happen in 20% or fewer  patients, but more than 3%) - Chills - Confusion - Damage to brain,  lungs, or other organs.  This may cause  tiredness, changes in  thinking or shortness  of breath - Feeling of "pins and  needles" in arms and  legs - Nausea, vomiting,  loss of appetite  - Sores in mouth which  may cause difficulty  swallowing | -  | Blood in urine |
| -                                          | Changes in vision                                                    |                                                                                                                                                                                                                                                                                                                                                       |    |                |
| -                                          | Kidney damage which  may require dialysis                            |                                                                                                                                                                                                                                                                                                                                                       |    |                |
| -                                          | Liver damage                                                         |                                                                                                                                                                                                                                                                                                                                                       |    |                |
| -                                          | Seizures                                                             |                                                                                                                                                                                                                                                                                                                                                       |    |                |  
| Melphalan                                  | Likely                                                                                                                          | Less Likely                           | Rare, but Serious   |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------|
| (May happen in more than  20% of patients) | (May happen in 20% or fewer  patients, but more than 3%)                                                                        | (May happen in 3% or fewer  patients) |                     |
| -                                          | Inflammation of blood  vessels                                                                                                  |                                       |                     |
| -                                          | Kidney problems  which may require  dialysis                                                                                    |                                       |                     |
| -                                          | Liver problems which  may cause yellow eyes  or skin                                                                            |                                       |                     |
| -                                          | Low platelet counts,  which may cause  bruising or bleeding                                                                     |                                       |                     |
| -                                          | Scarring of the lungs  which may cause  shortness of breath                                                                     | -                                     | A new cancer        |
| -                                          | Allergic reaction  which may cause  rash, low blood  pressure, wheezing,  shortness of breath,  swelling of the face  or throat |                                       |                     |
| -                                          | Heart failure which  may cause shortness  of breath, swelling of  ankles, and tiredness                                         |                                       |                     |
| -                                          | Anemia                                                                                                                          | (low                                  | red                 |
| blood                                      | cells)                                                                                                                          | which                                 |                     |
| may                                        | require                                                                                                                         | blood                                 |                     |
| transfusions                               |                                                                                                                                 |                                       |                     |
| -                                          | Diarrhea                                                                                                                        |                                       |                     |
| -                                          | Feeling tired                                                                                                                   |                                       |                     |
| -                                          | Infection,                                                                                                                      | especially                            |                     |
| when white blood cell  count is low        |                                                                                                                                 |                                       |                     |
| -                                          | Nausea, vomiting                                                                                                                |                                       |                     |
| -                                          | Sores in mouth which  may cause difficulty  swallowing                                                                          |                                       |                     |
| -                                          | Swelling of the body                                                                                                            |                                       |                     |  
| Low Dose Total Body Irradiation (TBI) Likely Less Likely                                                                                                                                                                                                    | Rare, but Serious                                                                                                                                                                                                   |                                                                                                                                                                                                                               |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (May happen in more than  20% of patients)                                                                                                                                                                                                                  | (May happen in 3% or fewer  patients)                                                                                                                                                                               |                                                                                                                                                                                                                               |
| - Anemia (low red blood  cells) which may  require blood  transfusions - Infection, especially  when white blood cell  count is low - Low platelet counts,  which may cause  bruising or bleeding - Mouth sores - Nausea, vomiting,  stomach pain, diarrhea | (May happen in 20% or fewer  patients, but more than 3%) - Eye cloudiness - Hair loss - Inability to have  children - Painful swelling of the  salivary glands under  the ears for a few days - Redness of the skin | - A new cancer - Back pain - Difficulty swallowing - Hormone problems  (such as thyroid  disease or diabetes) - Kidney problems - Learning problems - Liver problems - Lung inflammation - Slow growth (for  example, height) |

Everyone who has a stem cell transplant faces these risks. These are serious, and in some cases can cause death. These risks are not specific to this study. 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. You may receive filgrastim, a medicine to help speed up the recovery of white blood cells. Graft failure: The stem cells from your donor (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. Graft failure may cause low blood counts for a long time. If your counts do not recover, you may need to receive a second transplant. Graft failure can be fatal. Graft-Versus-Host Disease (GVHD): GVHD happens when the donated cells see your body as foreign and attack it. GVHD can be treated, but treatment can take months to years. 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. 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, chemotherapy or 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 take medicines to lower your risk of 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%. 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 and could affect the health of infants exposed to them via mother's milk. Therefore, if you are pregnant or nursing, you are not eligible for this study. Women who can become pregnant must use effective birth control while receiving chemotherapy, TBI, and drugs to prevent GVHD, and for 1 year after transplant. Effective birth control is defined as the following:
1. Refraining from all acts of vaginal sex (abstinence)
2. Consistent use of birth control pills 3. Injectable birth control methods (Depo-Provera, Norplant) 4. Tubal sterilization or male partner who has undergone a vasectomy 5. Placement of an IUD (intrauterine device) 6. 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.  
It is important that both women who can become pregnant and their male partners **use**
birth control for 1 year after transplant **while on this study.**

If you 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 an effective method of birth control during your transplant and continue until you are finished with your GVHD prevention treatment. You may want to talk with your doctor about ova banking before having a transplant. Effective birth control is defined as the following:
1. Not have any vaginal sex (abstinence) 2. Consistently use birth control pills or patch 3. Use injectable birth control (for example, Depo-Provera or Norplant) 4. Have tubal sterilization (tied tubes) 5. Have placement of an IUD (intrauterine device) 6. Use of a diaphragm with contraceptive jelly and/or condoms with contraceptive foam every time you have vaginal sex.  
Tell your doctor right away if you become pregnant during the study. Your doctor will discuss the risks to your unborn child and options with you and will watch you closely if you become pregnant.

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. You must use one of the following birth control methods:
1. Not have any vaginal sex (abstinence) 2. Vasectomy or female partner who had a tubal ligation (tied tubes) 3. Use of condoms with contraceptive foam every time you have sex. Or your partner must use: 1. Consistently use birth control pills or patch 2. Use injectable birth control (for example, Depo-Provera or Norplant) 3. Have placement of an IUD (intrauterine device) 4. Use of a diaphragm with contraceptive jelly and/or condoms with contraceptive foam every time you have vaginal sex.  
Tell your doctor right away if your partner becomes pregnant during the study. Your doctor will discuss the risks to your unborn child and your options.

Other 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. There may be some unknown or unanticipated discomforts or risks associated with this treatment in addition to those specified above, but every precaution will be taken to assure your personal safety and to minimize discomforts.

It is important that you tell your doctor or study staff if you feel that you have been hurt or injured because of taking part in this study. You will get medical treatment if you are injured as a result of taking part in this study. You and/or your health plan will be charged for this treatment. The study sponsor 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 form.

The risk of injury is small. 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.  
There are no major risks to collecting your urine or stool samples. A possible risk is the loss of confidentiality about your medical information. We will use safety measures with both your samples and health information to make sure that your personal information will be kept private. It's very unlikely that your personal information will be given to someone else (see the Privacy, Confidentiality and Use of Information section below).  
III -  1703  
| Tests and  Samples   |                   |               |          |          |          |    |
|----------------------|-------------------|---------------|----------|----------|----------|----|
| during Study         | Pre-Infusion      |               |          |          |          |    |
| Before               | Day -1 or 0       |               |          |          |          |    |
| conditioning         | Weekly,  Day 7-77 | Day 84        | Day 98   | Day 180  |          |    |
| Blood samples        | X                 | X             | X        | X        | X        | X  |
| 39ML                 | 24ML              | 31ML OR 39ML  | 31ML     | 39ML     | 39ML     |    |
| (8 TSPS*)            | (5 TSPS)          | (6 OR 8 TSPS) | (6 TSPS) | (8 TSPS) | (8 TSPS) |    |
| 1                    |                   |               |          |          |          |    |
| Urine samples1       | X                 | 1 X           | 1 X      | 1 X      | 1 X      |    |
| 10-12ML              | 10-12ML           | 10-12ML       | 10-12ML  | 10-12ML  |          |    |
| (3 TSPS)             | (3 TSPS)          | (3 TSPS)      | (3 TSPS) | (3 TSPS) |          |    |
| Stool samples2       | X 2               | X 2           | X 2      | X 2      | X 2      |    |
| 10-12ML              | 10-12ML           | 10-12ML       | 10-12ML  | 10-12ML  |          |    |
| (3 TSPS)             | (3 TSPS)          | (3 TSPS)      | (3 TSPS) | (3 TSPS) |          |    |
| *TSPS = Teaspoons    |                   |               |          |          |          |    |  
| Day 270 X 31ML  (6 TSPS) 1 X 10-12ML  (3 TSPS) X 2 10-12ML  (3 TSPS)   |
|------------------------------------------------------------------------|  
| Day 365 X 39ML  (8 TSPS) 1 X 10-12ML  (3 TSPS) X 2 10-12ML  (3 TSPS)   |
|------------------------------------------------------------------------|  
| Day 730 X 39ML  (8 TSPS) 1 X 10-12ML  (3 TSPS) X 2 10-12ML  (3 TSPS)   |
|------------------------------------------------------------------------|

There is a small risk of an infection or fainting from the blood draw. 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.  
⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧ ⬧
Health Insurance Portability and Accountability Act 1 (HIPAA1) Authorization to use and
Clinical trial: NCT03959241
Section: Purpose of Research
Subsections: 3. Study Purpose|Disclose Individual Health Information For Research Purposes A. Purpose

We are inviting you to take part in this study because you have a cancer of the blood or lymph glands and a blood stem cell transplant is a treatment option. The purpose of this study is to compare 2 combinations of drugs to prevent GVHD. These combinations are listed below.  
| Group A (current standard of care)   | Group B (this is being used more often in stem  cell transplant)   |
|--------------------------------------|--------------------------------------------------------------------|
| Tacrolimus and methotrexate          | Tacrolimus, mycophenolate mofetil and  cyclophosphamide            |  
Doctors want to know which combination (A or B) is better, or if they give the same results. The study will help doctors decide which treatment is best at preventing GVHD for future transplant patients.

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 trial: NCT03959241
Section: Voluntary Participation
Subsections: Before You Begin The Study

First, you will need to have several tests or check-ups to see if you can be in the study. These exams, tests or procedures are part of regular cancer care. They may be done even if you do not join the study. These include:
- Medical history
- Physical examination, including height and weight
- Blood and urine tests
- Heart function tests, including EKG and ejection fraction
- Lung (pulmonary) function tests
- Tests to evaluate your cancer, including a bone marrow aspirate/biopsy if you have acute leukemia, chronic myeloid leukemia or myelodysplastic syndrome. This is where samples of your bone marrow are taken from your hip bone with a needle.  
- Imaging studies if you have lymphoma
- Chest X-ray or chest CT
- A pregnancy test if you are a woman able to have children. If you are pregnant, you will not be able to take part in this study.  
- Blood, urine, and stool samples for a Mi-Immune Study (see Section 18: Mi-Immune Study Research Samples)
Clinical trial: NCT03959241
Section: Withdrawal from Study
Subsections: 11. Ending Your Participation

Being in this study is voluntary. You can choose to not be in this study, or leave this study at any time. If you choose not to take part or leave this study, your regular medical care will not be affected in any way. Tell your doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop safely. The study doctor or the study sponsor may stop the study at any time. We may ask you to leave the study if you do not follow directions or if you suffer from side effects of the treatment. 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.  
Even if you leave the study, the information collected from your participation will be included in the study evaluation. If you don't want any of your information to be used or if you want to cancel this authorization, you must let your study doctor know.