NCT03810196Recruiting
CD45RA Depleted Peripheral Stem Cell Addback for Viral or Fungal Infections Post TCRαβ/CD19 Depleted HSCT
CD45RA Depleted Peripheral Stem Cell Addback for Patients at Risk for Viral or Fungal Infections Post TCRαβ/CD19 Depleted Hematopoietic Stem Cell Transplant
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 16 Jan 2019
- Start date
- 1 Mar 2019
- Primary completion date
- Jul 2027
- Lead sponsor
- Children's Hospital of Philadelphia
- Diseases
- Acute lymphoblastic leukaemia, Myelodysplastic syndromes, Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT03810196
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Mar 2019 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients who do not meet institutional disease, organ or infectious criteria
- Patients with genetic disorders including Fanconi anemia, Kostmann syndrome, dyskeratosis congenital or other DNA repair defects.
Other
- No suitable donor available for mobilized peripheral stem cells
- 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
Who the study is looking for
- 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.
Age in the registry: - to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.