Clinical trial Recruiting at 1 site Interventional Ages Any age to 25

Using CD45RA Depleted Stem Cells to Improve Immune Recovery After Transplant

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

Run by Children's Hospital of Philadelphia · NCT03810196 · Data updated 2026-11-12

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

Study typeInterventional
AgesAny age to 25 Years
SexAll
Enrollment50 (estimated)
SponsorChildren's Hospital of Philadelphia
Academic / other
Locations1 site (Philadelphia, Pennsylvania)
StatusRecruiting
StartedMarch 1, 2019
Main results expectedJuly 2027
Study endsJuly 2028
Registry record updatedJuly 8, 2026
Trial IDNCT03810196 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients under 25 years old with high-risk acute leukemias who are undergoing their first allogeneic HSCT.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.