Status:
RECRUITING
CD45RA Depleted Peripheral Stem Cell Addback for Viral or Fungal Infections Post TCRαβ/CD19 Depleted HSCT
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Acute Leukemia
Acute Myeloid Leukemia
Eligibility:
All Genders
Up to 25 years
Phase:
NA
Brief Summary
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 deple...
Detailed Description
The risk of severe graft versus host disease (GVHD) is increased with the use of unrelated and partially matched related donors. T cell depletion reduces the risk of severe GVHD, but immune reconstitu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03810196
Start Date
March 1 2019
End Date
June 1 2027
Last Update
March 5 2025
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104