Phase III Trial of Early Donor Lymphocyte Infusion After Bone Marrow Transplant Using Cyclophosphamide for High-Risk Blood Cancers

What this Trial Is About

Researchers are investigating whether giving an infusion of donor lymphocytes early after allogeneic hematopoietic cell transplantation HCT can help reduce the risk of relapse in adults aged 18 to 65 with high-risk blood cancers such as leukemia, lymphoma, myelodysplastic syndrome, or multiple myeloma. This study is a phase III clinical trial focusing on determining the safest and most effective dose of donor lymphocyte infusion DLI after transplant using a specific chemotherapy regimen including post-transplant cyclophosphamide. Participants receive a myeloablative conditioning regimen with drugs like busulfan, fludarabine, cyclophosphamide, mycophenolate mofetil, and sirolimus before undergoing either HLA-matched-related or HLA-haploidentical bone marrow transplantation. Donor lymphocytes are infused at escalating doses on day 7 or 21 post-transplant to evaluate safety and tolerability, with two cohorts based on donor matching. Donors also provide blood, bone marrow, and stool samples for research. Participants undergo extensive screening including physical exams, blood and urine tests, spinal taps, eye and dental exams, heart and lung tests, imaging scans, and bone marrow biopsies. After transplant and DLI, recipients stay near the hospital for at least 100 days for monitoring and provide various biological samples. Follow-up visits continue for up to 5 years to assess outcomes such as graft-versus-host disease, relapse rates, survival, and engraftment. Donors have 2 to 3 visits for sample collection and evaluation.

Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies