HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib Following Fludarbine/Melphalan/Total Body Irradiation Conditioning Regimen

What this Trial Is About

Researchers are evaluating a new approach for patients with hematologic malignancies who require allogeneic stem cell transplantation but lack a suitable matched related or unrelated donor. The study focuses on using HLA-haploidentical peripheral blood stem cell transplantation combined with post-transplant cyclophosphamide and bortezomib. Bortezomib is being studied for its potential to prevent graft versus host disease (GVHD) and improve immune recovery after transplant. This is a Phase 2 interventional trial sponsored by Henry Ford Health System. Participants will receive a conditioning regimen of fludarabine, melphalan, and total body irradiation before undergoing the haploidentical stem cell transplant. The transplant uses peripheral blood stem cells from a related haploidentical donor matched at least 5 out of 10 alleles. Post-transplant, patients receive cyclophosphamide and bortezomib to help prevent GVHD and support immune function. The study does not include a placebo or control group and involves only one treatment arm. During the study, researchers will monitor the engraftment rate within 30 days after transplant as the primary outcome. Participants will undergo various health assessments including liver and kidney function tests, lung capacity measurements, and heart function evaluations prior to enrollment. Safety and transplant success will be closely tracked throughout the study period. The trial plans to enroll adults aged 18 to 65 years and will continue until January 2028.

HLA-Haploidentical Peripheral Blood Stem Cell Transplantation With Post-transplant Cyclophosphamide and Bortezomib