A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 66 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will: * Receive the standard or new drug combination after transplant * Visit the doctor's office for check-ups and tests after transplant that are routine for most transplant patients * Take surveys about physical and emotional well-being * Give blood and stool samples."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares a new drug combination with a standard one to prevent graft-versus-host disease (GVHD), when donated cells attack the body. It is for adults with blood cancers getting blood stem cells from an unrelated donor who is only a partial tissue match. Researchers will also check how safe the drugs are.
The purpose of this clinical trial is to compare drug combinations to learn which drugs work best to prevent graft-versus-host-disease (GVHD) in people who have received a stem cell transplant. The source of stem cells is from someone who is not related and has a different blood cell type than the study participant. The researchers will compare the new drug combination to a standard drug combination. They will also learn about the safety of each drug combination. Participants will: * Receive the standard or new drug combination after transplant * Visit the doctor's office for check-ups and tests after transplant that are routine for most transplant patients * Take surveys about physical and emotional well-being * Give blood and stool samples.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 or older. For strong treatment before transplant, you must be under 66 if it uses chemotherapy, or under 61 if it uses whole-body radiation.
- Plan to receive an allowed treatment before transplant and blood stem cells from an unrelated donor age 16–35 who matches 4–7 of 8 tissue markers.
- For strong treatment: have acute leukemia in remission, meaning signs of cancer have decreased, or MDS, a bone marrow cancer. Blood and bone marrow tests must meet study limits.
- For lower-strength treatment: have an allowed leukemia, MDS, lymphoma, or certain other bone marrow cancers, including myelofibrosis, which causes marrow scarring. Cancer test results and response to chemotherapy must meet study rules.
- Have heart pumping strength of at least 45% for strong treatment, or 40% for lower-strength treatment. The lower-strength group must have no signs of heart failure.
- Meet kidney, lung, and liver health requirements.
- Meet the study's ability-to-do-daily-tasks score: at least 70 for strong treatment or 60 for lower-strength treatment. The strong-treatment group must also meet limits on other health problems.
- You or your legal representative must be able to give consent. Be willing and able to follow study procedures and attend follow-up visits.
Who can't join
- Have a suitable fully matched related or unrelated stem cell donor.
- Cannot or will not give consent, or cannot complete study visits and tests.
- Have had a transplant using another person's stem cells, or a transplant using your own cells within the past 3 months.
- Are pregnant or breastfeeding.
- Have an uncontrolled bacterial, viral, or fungal infection when treatment to prepare for transplant starts.
- Are also in another study testing ways to prevent GVHD.
- Receive treatment before transplant to lower antibodies that could attack the donor's cells.
- Have HIV with virus levels that stay detectable. Well-controlled HIV may be allowed if treatment and testing meet study rules.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria, MAC RECIPIENTS: 1. Age 18 to \< 66 years (chemotherapy-based conditioning) or \< 61 years (TBI-based conditioning) at the time of signing informed consent 2. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and institutional requirements 3. Stated willingness to comply with all study procedures and availability for the duration of the study 4. Planned MAC regimen (see Table 8 in Section 7.4 for allowed MAC regimens) 5. Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35 6. Product planned for infusion is MMUD T-cell replete PBSC as allograft 7. HCT-CI \< 5 (Appendix H - Hematopoietic Cell Transplant Comorbidity Index Scoring). The presence of prior malignancy will not be used to calculate HCT-CI for this trial, to allow for the inclusion of patients with secondary or therapy-related AML or MDS. 8. One of the following diagnoses: 1. AML, ALL, or other acute leukemia in first remission or beyond with ≤ 5% marrow blasts and no circulating blasts or evidence of extramedullary disease. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning. 2. Patients with MDS with no circulating blasts and with \< 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \< 5% vs 5-10% blasts in MDS). Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning. 9. Cardiac function: Left ventricular ejection fraction ≥ 45% based on most recent echocardiogram or multi-gated acquisition scan (MUGA) results 10. Estimated creatinine clearance ≥ 45mL/min calculated by equation 11. Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥ 50% and forced expiratory volume in first second (FEV1) predicted ≥ 50% based on most recent PFT results 12. Liver function acceptable per local institutional guidelines 13. KPS of ≥ 70% (Appendix I - Performance Status) Inclusion Criteria, RIC/NMA RECIPIENTS: 1. Age ≥ 18 years at the time of signing informed consent 2. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and local institutional requirements 3. Stated willingness to comply with all study procedures and availability for the duration of the study 4. Planned NMA/RIC regimen (see 5. Table 9 in Section 7.4 for allowed NMA/RIC regimens) 6. Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35 7. Product planned for infusion is MMUD T-cell replete PBSC allograft 8. One of the following diagnoses: 1. Patients with acute leukemia or chronic myeloid leukemia (CML) with no circulating blasts, no evidence of extramedullary disease, and with \< 5% blasts in the bone marrow. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning. 2. Patients with MDS with no circulating blasts and with \< 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \< 5% vs 5-10% blasts in MDS.) Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning. 3. Patients with chronic lymphocytic leukemia (CLL) or other leukemias (including prolymphocytic leukemia) with chemosensitive disease at time of transplantation. 4. Higher-risk chronic myelomonocytic leukemia (CMML) according to CMML-specific prognostic scoring system or high-risk MDS/myeloproliferative neoplasms (MPN) not otherwise specified are eligible, provided there is no evidence of high-grade bone marrow fibrosis or massive splenomegaly at the time of enrollment. 5. Patients with lymphoma with chemosensitive disease at the time of transplantation. 6. Patients with primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia, polycythemia vera or MDS with grade 4 fibrosis. 9. Cardiac function: Left ventricular ejection fraction ≥ 40% based on most recent echocardiogram or MUGA results with no clinical evidence of heart failure 10. Estimated creatinine clearance ≥ 45mL/min calculated by equation 11. Pulmonary function: DLCO corrected for hemoglobin ≥ 50% and FEV1 predicted ≥ 50% based on most recent PFT results 12. Liver function acceptable per local institutional guidelines 13. KPS of ≥ 60% (Appendix I - Performance Status) Exclusion Criteria: 1. Suitable HLA-matched related or 8/8 high-resolution matched unrelated donor available 2. Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing 3. Subjects with a prior allogeneic transplant 4. Subjects with an autologous transplant within the past 3 months 5. Subjects who are breastfeeding or pregnant 6. Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen 7. Concurrent enrollment on a GVHD prevention clinical trial 8. Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior to transplant 9. Patients who are HIV-positive with persistently positive viral load. HIV-infected patients on effective anti-retroviral therapy (ART) with undetectable viral load within 6 months are eligible for this trial. Patients with well-controlled HIV are eligible provided resistance panels are negative, the patient is compliant with ART, and their disease remains well controlled.
Study sites (13)
AL
- University of Alabama Birmingham · Birmingham, AL 35294More trials in Birmingham
CA
- City of Hope · Duarte, CA 91010More trials in Duarte
- Stanford · Palo Alto, CA 94304More trials in Palo Alto
FL
- University of Miami · Miami, FL 33136More trials in Miami
KS
- University of Kansas Medical Center · Westwood, KS 66205More trials in Westwood
MA
- Dana-Farber Cancer Institute · Boston, MA 02446More trials in Boston
MI
- Karmanos Cancer Institute · Detroit, MI 48201More trials in Detroit
NC
- University of North Carolina · Chapel Hill, NC 27514More trials in Chapel Hill
NY
- Memorial Sloan Kettering · New York, NY 10065More trials in New York
OR
- Oregon Health & Science University · Portland, OR 97239More trials in Portland
TX
- MD Anderson · Houston, TX 77030More trials in Houston
VA
- University of Virginia · Charlottesville, VA 22903More trials in Charlottesville
WA
- Fred Hutchinson Cancer Center · Seattle, WA 98109More trials in Seattle