Phase II Study of T Cell Receptor Alpha/Beta Depletion Peripheral Blood Stem Cell Transplantation for Children and Adults With Hematological Malignancies

What this Trial Is About

Researchers are evaluating a phase II, open-label study of T cell receptor alpha/beta depletion (TCR α/β TCD) peripheral blood stem cell transplantation for children and adults with blood cancers, including acute leukemias and myelodysplasia. This study focuses on the safety and feasibility of this investigational transplantation approach in patients up to 60 years old. Participants receive treatment based on the most medically appropriate regimen, with a preference for regimens including Fludarabine, Total Body Irradiation, Busulfan, Melphalan, Antithymocyte Globulin, and Cyclophosphamide. On Day 0, patients receive an infusion of alpha/beta T cell-depleted hematopoietic stem cells. Several conditioning regimens are used depending on patient characteristics, including specialized approaches for pediatric patients and those with juvenile myelomonocytic leukemia or infant leukemia. During the study, participants are monitored for outcomes such as graft-versus-host disease within 100 days, transplant engraftment by 42 days, graft failure by 100 days, and overall survival over 12 months. Safety and organ function are assessed, and patients receive medications including Rituximab and Levetiracetam to reduce risks. The trial is sponsored by the Masonic Cancer Center at the University of Minnesota and continues until November 2030.

MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies