CD45RA Depleted T-cell Infusion for Prevention of Infections After TCRab/CD19-depleted Allo-HSCT
NCT02942173 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2023-03-16
Summary
The purpose of this prospective randomized study is to determine whether infusions of T-memory cells prevent infections in children with leukemia after allogeneic alpha, beta T-cell receptor (TcRab)/CD19-depleted hematopoietic stem cell transplantation (HSCT).
Conditions
- Leukemia
- Lymphoma
- Myelodysplastic Syndromes
- GvHD
- Opportunistic Infections
- Graft-versus-Host Disease
Interventions
- BIOLOGICAL
-
CD45RA-depleted peripheral blood mononuclear cells
Infusion of escalating doses of CD45RA-depleted donor-derived allogeneic peripheral blood mononuclear cells
Sponsors & Collaborators
-
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
lead OTHER
Principal Investigators
-
Michael Maschan, PhD · Fedaral Research Center for pediatric hematology, oncology and immunology
-
Larisa Shelikhova, PhD · Fedaral Research Center for pediatric hematology, oncology and immunology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2019-08-21
- Completion
- 2020-08-21
Countries
- Russia
Study Locations
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