🔎 Trials Near Me

Home › Acute Myeloid Leukemia › NCT03810196

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

Recruiting

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

Who can join

Up to age 25 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Age: Patients \<25 years.
2. First allogeneic HSCT only.
3. 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
4. Evaluation of organ and infectious status as per our Bone Marrow Transplant standard operating procedure (BMT SOP).
5. Signed consent by parent/guardian or able to give consent if \>18 years.

Exclusion Criteria:

1. Patients who do not meet institutional disease, organ or infectious criteria
2. No suitable donor available for mobilized peripheral stem cells
3. Patients with genetic disorders including Fanconi anemia, Kostmann syndrome, dyskeratosis congenital or other DNA repair defects.
4. Patients with Hodgkin lymphoma or non-Burkitts, non-lymphoblastic lymphoma
5. Pregnant Participants

Donor selection and eligibility

1. Unrelated donor meets National Marrow Donor Program criteria for donation
2. HLA testing/matching
3. Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection

About the study

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.

What is being tested

Sponsor: Children's Hospital of Philadelphia · Participants: 50 · Started: Mar 1, 2019

Contact the study team

Official record on ClinicalTrials.gov — NCT03810196

Locations in the U.S.

PennsylvaniaChildren's Hospital of Philadelphia, Philadelphia

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.