CD45RA Depleted Peripheral Stem Cell Addback for Patients at Risk for Viral or Fungal Infections Post TCRαβ/CD19 Depleted Hematopoietic Stem Cell Transplant

What this Trial Is About

Researchers are studying a new approach to reduce complications after allogeneic hematopoietic stem cell transplant (HSCT) for patients with acute leukemias at high risk for relapse. The study focuses on lowering the risk of graft versus host disease (GVHD) and life-threatening infections, which are common problems when donor cells are not fully matched. The trial evaluates whether adding back donor CD45RA-depleted peripheral stem cells after TCRαβ/CD19 depleted HSCT can improve immune recovery and reduce infection risk. Participants will receive standard myeloablative conditioning regimens based on their disease type and clinical status, including total body irradiation (TBI) or busulfan-containing regimens. The donor peripheral stem cells are processed using the CliniMACS device to deplete TCRαβ+ T cells and CD45RA naive T cells. After the initial stem cell transplant, patients will be given a CD45RA-depleted infusion and receive a short course of GVHD prevention medication. This is a non-randomized, single-institution pilot trial. During the study, participants will be monitored for the incidence of acute GVHD up to 100 days after transplant. Researchers will assess immune recovery and infection risk as secondary considerations. Organ and infection status will be evaluated following standard bone marrow transplant procedures. The total study duration includes close follow-up after transplant to observe immune and clinical outcomes. Consent will be obtained from participants or their guardians as appropriate.

CD45RA Depleted Peripheral Stem Cell Addback for Viral or Fungal Infections Post TCRαβ/CD19 Depleted HSCT