Phase 2 Study of Co-Transplanting an Unmodified Haplo-Identical Graft with Cord Blood for High-Risk Blood Cancers

What this Trial Is About

Researchers are studying a new transplant method for patients with certain blood cancers who do not have a matching donor. This study evaluates whether combining two types of donor cellshaplo-identical grafts and cord bloodcan improve survival without evidence of disease. This approach aims to increase donor availability, especially for Black, Asian, and Hispanic populations who have lower chances of finding matched donors. The study uses post-transplant cyclophosphamide to reduce complications after transplant. The treatment involves giving patients an unmodified haplo-identical graft first, followed by an infusion of cord blood after completing cyclophosphamide therapy. Cord blood and haplo-identical donors are carefully selected based on compatibility factors including cell counts and antibodies. The goal is to deliver enough donor cells to support recovery and reduce disease relapse. This is a Phase 2 study focusing on patients with high-risk acute myelogenous leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, or lymphoma. Participants will be closely monitored for at least six months after transplant to measure progression-free survival, which is the main outcome. Additional follow-up will continue for up to three years to assess survival, graft-versus-host disease, relapse rates, infections, and recovery of blood cells. Researchers will gather laboratory tests, clinical assessments, and detailed safety information to evaluate the treatments effects. The study aims to improve transplant options and outcomes for patients lacking matched donors.

Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood