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 range18 Years – 66 Years

SexALL

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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
✓. 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

What they're measuring

Graft-versus-host disease-free, relapse-free survival (GRFS)

Timeframe: 1 year post-HCT

Graft-versus-host disease-free, relapse-free survival (GRFS)

Timeframe: 1 year post-HCT

Trial details

NCT IDNCT06859424

SponsorCenter for International Blood and Marrow Transplant Research

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2028-06

Contact for this trial

Leigh Anne Blackmon, MSW

763-406-8087 accelerate@nmdp.org

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