Study of Abatacept Added to Tacrolimus and MMF to Prevent Graft Versus Host Disease After Double Umbilical Cord Blood Transplant in Adults with Blood Cancers

What this Trial Is About

This research aims to evaluate whether adding abatacept to the standard graft versus host disease GVHD prevention treatment of tacrolimus and mycophenolate mofetil MMF can reduce or prevent acute graft versus host disease aGVHD in people with blood cancers receiving double umbilical cord blood transplants dCBT. This condition often affects patients after transplant and is more common in those with mismatched donors, particularly among Black, Asian, and Hispanic populations. The study is a Phase 2 trial focused on safety and effectiveness of abatacept in this setting. Participants will receive a conditioning regimen before the transplant that includes cyclophosphamide, fludarabine, thiotepa, and total body irradiation. They will then undergo a double umbilical cord blood transplant. For GVHD prevention, they will receive tacrolimus and MMF starting five days before transplant, with tacrolimus continuing for at least 180 days and MMF for 30 days. Abatacept will be administered at a dose of 10 mgkg on days before and after transplant day -1, and days 5, 14, and 28. Throughout the study, participants will undergo exams, tests, and procedures as part of their usual cancer care and transplant monitoring. Researchers will evaluate the rate of severe aGVHD-free survival at 180 days post-treatment as the main outcome. Additional assessments include survival rates, relapse rates, chronic GVHD incidence up to three years, infection reactivations, blood cell engraftment times, donor cell persistence, and biomarker levels related to aGVHD. The total involvement includes transplant, treatment, and follow-up assessments for up to multiple years to monitor safety and effectiveness.

ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis