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

Recruiting now · Not applicable

Conditions studied: Acute Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphoblastic Leukemia, Mixed Lineage Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma, Juvenile Myelomonocytic Leukemia

In brief

The major morbidities of allogeneic hematopoietic stem cell transplant with non-human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life threatening infections. T depletion of the donor hematopoietic stem cell graft is effective in preventing GVHD, but immune reconstitution is slow, increasing the risk of infections. An addback of donor CD45RA (naive T cells) depleted cells may improve immune reconstitution and help decrease the risk of infections.

Key facts

Study ID

NCT03810196

Run by

Children's Hospital of Philadelphia

People needed

50

Starts

2019-03-01

Expected to finish

2028-07-01

Last updated by the study team

2026-07-08

Who can join

Age: any, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: Patients <25 years.
• First allogeneic HSCT only.
• Disease eligibility: Acute leukemias at high risk for relapse including positive minimal residual disease at end consolidation, high risk cytogenetics, or relapse. Hematologic malignancies including: acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, mixed lineage or bi-phenotypic leukemia, lymphoblastic or Burkitts, juvenile myelomonocytic leukemia
• Evaluation of organ and infectious status as per our Bone Marrow Transplant standard operating procedure (BMT SOP).
• Signed consent by parent/guardian or able to give consent if >18 years.

You may not qualify if…

• Patients who do not meet institutional disease, organ or infectious criteria
• No suitable donor available for mobilized peripheral stem cells
• Patients with genetic disorders including Fanconi anemia, Kostmann syndrome, dyskeratosis congenital or other DNA repair defects.
• Patients with Hodgkin lymphoma or non-Burkitts, non-lymphoblastic lymphoma
• Pregnant Participants
• Donor selection and eligibility
• Unrelated donor meets National Marrow Donor Program criteria for donation
• HLA testing/matching
• Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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