Actively Recruiting
Treatment of CD19 Chimeric Antigen Receptor T Cells for Pediatric Patients With CD19-positive B-cell Acute Lymphoblastic Leukemia Who Are Indicated for Hematopoietic Stem Cell Transplantation
Led by Seoul National University Hospital · Updated on 2024-02-08
50
Participants Needed
1
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 2 clinical trial targeting pediatric and adolescent patients diagnosed with CD19-positive B-ALL, considered very high-risk group. The study aims to administer CD19 CAR-T therapy as an alternative to hematopoietic stem cell transplantation in patients eligible for such transplantation. The trial includes patients aged 25 or younger.
CONDITIONS
Official Title
Treatment of CD19 Chimeric Antigen Receptor T Cells for Pediatric Patients With CD19-positive B-cell Acute Lymphoblastic Leukemia Who Are Indicated for Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Under 25 years old at the time of CD19 CAR-T administration
- Diagnosed with B-cell acute lymphoblastic leukemia confirmed by a physician
- CD19 expression on leukemia cells confirmed at initial diagnosis or relapse
- Achieved hematologic complete remission with less than 5% blasts in bone marrow after chemotherapy
- Eligible for hematopoietic stem cell transplantation based on at least one of these: Philadelphia chromosome-positive, hypodiploidy with fewer than 44 chromosomes, E2A-HLF gene fusion, minimal residual disease positive after consolidation and maintenance therapy, failure of first-line therapy, or investigator's judgment
You will not qualify if you...
- Previous hematopoietic stem cell transplantation
- Inability to obtain sufficient leukapheresis product for CD19 CAR-T production
- Known infection with human immunodeficiency virus (HIV)
- Uncontrolled active infections unless properly treated without progression
- Pregnant or breastfeeding women
- Clinically inappropriate for study participation based on investigator's judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Children's Hospital
Seoul, South Korea
Actively Recruiting
Research Team
H
Hyoung Jin Kang, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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