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 type | Interventional |
|---|---|
| Ages | Any age to 25 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | March 1, 2019 |
| Main results expected | July 2027 |
| Study ends | July 2028 |
| Registry record updated | July 8, 2026 |
| Trial ID | NCT03810196 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
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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.
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Hematopoietic stem cell transplant for blood cancers
This study is testing two different ways of doing stem cell transplants for people with blood cancers to see which method works better and is safer.
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T cell receptor depletion for blood cancer treatment
This study is testing a new way to treat blood cancers by using a special treatment before a stem cell transplant to see if it helps both kids and adults do better after the procedure.
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Donor stem cell transplant with chemotherapy and radiation for blood cancers
This study is testing if a donor stem cell transplant combined with different doses of chemotherapy and radiation can help people with blood cancers recover better.
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Vitamin A and D supplementation for patients undergoing allogeneic hematopoietic transplantation
This study is testing if giving high doses of vitamins A and D before a stem cell transplant can help patients with certain blood cancers have fewer complications like infections and graft-versus-host disease.
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Comparing two conditioning regimens for haploidentical stem cell transplantation
This study is testing two different treatment plans for patients getting stem cell transplants from partially matched donors to see which one works better in preventing complications like graft failure and relapse.
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Depleting specific immune cells in stem cell transplants for blood cancers
This study is testing if removing certain immune cells during stem cell transplants can help children and young adults with blood cancers have better outcomes and fewer complications.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.