Treatment Study Using CD45RA Depleted Stem Cell Addback to Reduce Viral and Fungal Infections After TCRCD19 Depleted Hematopoietic Stem Cell Transplant in Patients Under 25 with Acute Leukemia

What this Trial Is About

Researchers are studying patients with acute leukemias at high risk for relapse who undergo allogeneic hematopoietic stem cell transplant HSCT. The study evaluates a technique involving the addback of CD45RA depleted donor peripheral stem cells after TCRCD19 depleted HSCT. This approach aims to improve immune recovery and reduce the risk of viral and fungal infections while managing graft versus host disease GVHD. Participants receive standard myeloablative conditioning regimens based on their disease type and clinical status. Those with acute lymphoblastic leukemia or lymphoblastic lymphoma follow a total body irradiation TBI regimen including thiotepa and cyclophosphamide. Others may receive either the TBI regimen or a busulfan-containing regimen. After the transplant, patients receive an infusion of CD45RA depleted peripheral stem cells processed using the CliniMACS device, followed by a short course of GVHD prophylaxis. Throughout the study, participants are monitored for the development of acute GVHD up to 100 days after transplantation. Researchers also evaluate immune reconstitution and the incidence of infections. The study involves evaluations of organ and infection status according to bone marrow transplant procedures. The total age range for participants is under 25 years, and informed consent is required. The study is sponsored by the Childrens Hospital of Philadelphia and is ongoing until July 2028.

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