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Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study Status, Oversight, Referencesv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2025 to Mar 21, 2025
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Children's Hospital of Philadelphia
131 trials monitored
See 11 trials at risk
Leukemia
2,948 trials monitored
See 180 trials at risk
Non-Hodgkin Lymphoma
2,013 trials monitored
See 115 trials at risk
Acute Myeloid Leukemia (AML)
1,269 trials monitored
See 74 trials at risk
and 2 more diseases
The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte depletion of alternative donor hematopoietic stem cell (HSC) grafts is effective in preventing GVHD, but immune reconstitution may be delayed, increasing the risk of infections. The central hypothesis of this study is that an addback of CD45RO memory T lymphocytes, derived from a fraction of the original donor peripheral stem cell product depleted of CD45RA naïve T lymphocytes, will accelerate immune reconstitution and help decrease the risk of infections in TCRab/CD19 depleted PSCT.
Trial Details
NCT Number NCT06839456
Lead Sponsor Children's Hospital of Philadelphia
Conditions
(from sponsor)		 Leukemia, High Risk Acute Lymphoblastic Leukemia, High Risk Acute Myeloid Leukemia, Relapse Leukemia, MDS (Myelodysplastic Syndrome), Relapsed Non-Hodgkin Lymphoma, Acquired Aplastic Anemia, Inherited BMF Syndrome +6 more
Related terms Anemia, Refractory, with Excess of Blasts, Bone Marrow Failure Disorders, Congenital Bone Marrow Failure Syndromes, Hemoglobinopathies, Immunologic Deficiency Syndromes, Leukemia, Lymphoma, Non-Hodgkin, Metabolism, Inborn Errors
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov