Actively Recruiting
Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults
Led by Alice Bertaina · Updated on 2025-05-29
204
Participants Needed
1
Research Sites
565 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the CliniMACS® TCRαβ-Biotin System and CliniMACS® CD19 is to improve the safety and efficacy of allogeneic HLA-partially matched related or unrelated donors HSCT when no matched donors are available, to treat malignant and nonmalignant disorders for which HSCT is the recommended best available therapy. Initially this device will be used in a single-center, open-label, single-arm, phase II clinical trial to evaluate the efficacy of haploidentical PBSC grafts depleted of TCRα/β+ and CD19+ cells using the CliniMACS® TCRαβ/CD19 System in children and adults with hematological and non-hematological malignancies.
CONDITIONS
Official Title
Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 1 month and less than 60 years
- Life expectancy greater than 10 weeks
- Eligible for allogeneic hematopoietic stem cell transplant per institutional guidelines
- Diagnosed with life-threatening malignant or non-malignant hematological disorders suitable for HSCT
- For malignant cases: high-risk acute lymphoblastic leukemia or acute myeloid leukemia in remission, childhood myelodysplastic syndrome, juvenile myelomonocytic leukemia, mixed-phenotype acute leukemia, non-Hodgkin lymphomas in remission, or other eligible hematologic malignancies
- For non-malignant cases: receiving first HSCT with mismatched donors or increased risk of graft rejection or graft-versus-host disease
- Minimum genotypic match of 5 out of 10 alleles required
- Donor and recipient must match at least one allele in HLA-A, HLA-B, HLA-C, HLA-DQB1, and HLA-DRB1
- Lansky or Karnofsky performance score greater than 50
- Ability to provide informed consent or have legal representative consent (parents/guardians for minors)
- Agreement to use effective birth control if of childbearing potential during transplant and immunosuppression
You will not qualify if you...
- Pregnant or breastfeeding females
- Prior allogeneic hematopoietic stem cell transplant
- Secondary or treatment-related myelodysplastic syndrome or acute myeloid leukemia
- Severe liver dysfunction (ALT/AST >10 times normal, bilirubin >3 times normal)
- Kidney dysfunction (serum creatinine >1.5 times normal or unmanageable dialysis)
- Severe cardiovascular disease (heart failure or ejection fraction <30%)
- Active infections including HIV
- Serious uncontrolled medical conditions
- Lack of informed consent
- Any severe concurrent illness posing increased risk as judged by the principal investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94306
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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