NCT03810196 · Children's Hospital of Philadelphia
CD45RA Depleted Peripheral Stem Cell Addback for Viral or Fungal Infections Post TCRαβ/CD19 Depleted HSCT
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
CliniMACS Cell Processing System for TCRαβ + T Cell and CD45RA Depleted Peripheral Stem Cell Addback
Peripheral stem cell (PSC) product will be processed using the CliniMACS device for TCRαβ and T cell depletion. Approximately 10% of the PSCs will undergo CD45RA depletion and cryopreservation. Patients will receive CD45RA depleted infusion after the TCRab PSCT.
Primary outcome measures
Incidence of acute graft vs. host disease (GVHD)
Time frame: Up to 100 days post-transplantation
Incidence of acute graft vs. host disease (GVHD) (reaction of donor immune cells against host tissues)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Philadelphia, Pennsylvania
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Frequently asked questions
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Will I receive a placebo instead of treatment?
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Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations