A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disea… (NCT06859424) | Clinical Trial Compass
RecruitingPhase 2
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
United States358 participantsStarted 2025-07-25
Plain-language summary
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.
Who can participate
Age range
18 Years – 66 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18 to \< 66 years (chemotherapy-based conditioning) or \< 61 years (TBI-based conditioning) at the time of signing informed consent
. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and institutional requirements
. Stated willingness to comply with all study procedures and availability for the duration of the study
. Planned MAC regimen (see Table 8 in Section 7.4 for allowed MAC regimens)
. Available partially HLA-MMUD (4/8-7/8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35
. Product planned for infusion is MMUD T-cell replete PBSC as allograft
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. One of the following diagnoses:
Exclusion criteria
. Suitable HLA-matched related or 8/8 high-resolution matched unrelated donor available
. Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing
. Subjects with a prior allogeneic transplant
. Subjects with an autologous transplant within the past 3 months
. Subjects who are breastfeeding or pregnant
. Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen
. Concurrent enrollment on a GVHD prevention clinical trial
. Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior to transplant