Study of Automated CD34 Stem Cell Selection to Reduce Graft-versus-Host Disease in Patients Needing a Stem Cell Boost After Allogeneic Transplantation for Blood Cancers and Disorders

What this Trial Is About

This research investigates the use of a CD34 selected hematopoietic stem cell boost for patients who have experienced graft failure or delayed engraftment after an allogeneic hematopoietic stem cell transplant for neoplastic blood disorders. The study aims to reduce the risk of graft versus host disease GVHD by using a CD34 selected graft processed with the automated CliniMACS Prodigy, which is designed to streamline the procedure and reduce strain on the cell therapy lab. This method has been shown to be safe and effective in earlier studies and is being further evaluated in this phase 1 trial. Participants will receive an infusion of CD34 selected hematopoietic stem cells with or without a conditioning regimen based on the clinicians discretion. The conditioning may include fludarabine, total body irradiation, and cyclophosphamide depending on donor match and clinical factors. This treatment is intended for those with graft failure or low graft function, identified by reduced marrow cellularity, donor chimerism, or transfusion needs. The study follows patients for outcomes up to six years. During the study, participants will be closely monitored for severe acute and chronic GVHD, donor chimerism, and clinical improvement, along with secondary outcomes like non-relapse mortality, disease relapse, overall survival, and neutrophil counts. Data will be collected throughout the six-year follow-up to evaluate the safety and effectiveness of the CD34 selected stem cell infusion using the automated system. The study includes careful assessment of immune responses and transplant function over time.

UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy