Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT
Recruiting
Phase 1
Phase 2
Interventional Study
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
Immunodeficiency
Primary Immune Regulatory Disorder
Hemoglobinopathies
Bone Marrow Failure
Inborn Errors of Metabolism
HLH
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Month – 25
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Children's Hospital of Philadelphia · Other
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About This Trial
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, …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Disease for which allogeneic HSCT may be curative.
2. Remission status of hematologic malignancies and additional disease-specific eligibility determinations will be according to standards of practice within the CHOP Cellular Immunotherapy and Transplant Program (CTTS).
3. Pa…
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