Actively Recruiting
Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT
Led by Children's Hospital of Philadelphia · Updated on 2026-04-15
100
Participants Needed
1
Research Sites
362 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Disease for which allogeneic HSCT may be curative.
- Remission status of hematologic malignancies and other disease-specific criteria follow standard practice.
- Patients must be 25 years old or younger.
- Organ and infection status must be evaluated as per transplant program procedures.
- Signed consent by parent/guardian or by patient if 18 years or older.
- Participants of childbearing potential must have a negative pregnancy test according to institutional procedures.
You will not qualify if you...
- Performance score less than 60.
- No suitable donor available for mobilized peripheral stem cells.
- Diagnosis of Hodgkin lymphoma or non-Burkitt, non-lymphoblastic lymphoma.
- Planned use of alemtuzumab during conditioning.
- Availability of a 10/10 HLA matched sibling donor.
- Failure to meet institutional disease, organ, or infection criteria.
- Donors not meeting specific matching and donation criteria as outlined.
- Donors unwilling to undergo stem cell mobilization or sign study consent.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
M
Megan Atkinson
CONTACT
L
Linda Zitkus, BSN,RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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