Using CD45RA Depleted Stem Cells to Improve Immune Recovery After Transplant
CD45RA Depleted Peripheral Stem Cell Addback for Patients at Risk for Viral or Fungal Infections Post TCRαβ/CD19 Depleted Hematopoietic Stem Cell Transplant
This study is testing if using special stem cells can help patients with acute leukemia recover their immune system faster after a transplant and reduce the risk of complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | N/A to 25 Years |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT03810196 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of CD45RA depleted peripheral stem cells to enhance immune reconstitution in patients undergoing hematopoietic stem cell transplant (HSCT) for acute leukemias. The approach aims to reduce the risk of graft versus host disease (GVHD) while also addressing the slow recovery of the immune system, which increases susceptibility to infections. By adding back these specific donor cells after T cell depletion, the study seeks to improve patient outcomes and decrease infection rates. The trial is conducted at a single institution, focusing on a specific patient population with high-risk acute leukemias.
Who should consider this trial
Good fit: Ideal candidates are patients under 25 years old with high-risk acute leukemias who are undergoing their first allogeneic HSCT.
Not a fit: Patients with genetic disorders affecting DNA repair or those without a suitable donor for stem cells may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce infection rates and improve recovery for patients undergoing HSCT.
How similar studies have performed: While the approach of T cell depletion has been studied, the specific use of CD45RA depleted cells in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Timothy Olson, MD, PhD — Children's Hospital of Philadelphia
- Study coordinator: Megan Atkinson
- Email: cttsbmtintake@chop.edu
- Phone: 215-590-2820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.