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

Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 25
Healthy Volunteers: f
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• Subject eligibility criteria include individuals who are under the age of 25 at the time of SNUH-CD19-CAR-T administration. Confirmation of B-cell acute lymphoblastic leukemia diagnosed at the initial assessment by a treating physician for the first diagnosis is required. Immunophenotypic analysis of CD19 expression on leukemia cells must be confirmed through immune profiling at the time of the initial diagnosis of B-cell acute lymphoblastic leukemia. In patients experiencing hematologic relapse of B-cell acute lymphoblastic leukemia, CD19 expression should also be confirmed at the time of relapse confirmation.

‣ Patients must achieve hematologic complete remission defined as less than 5% blasts in the bone marrow after the first-line or second-line chemotherapy (first salvage therapy). Eligible patients for hematopoietic stem cell transplantation, defined by indications for transplantation, include those meeting at least one of the following criteria:

⁃ Philadelphia chromosome-positive due to t(9;22)(q34;q11) translocation.

⁃ Hypodiploidy defined by fewer than 44 chromosomes.

⁃ E2A-HLF gene fusion due to t(17;19) translocation.

⁃ Detection of minimal residual disease (MRD) positive at 0.01% or higher by next-generation sequencing confirmed after consolidation therapy and maintenance therapy.

⁃ Failure of the first-line therapy.

⁃ Cases not meeting any of the above criteria but deemed eligible for hematopoietic stem cell transplantation based on the investigator's judgment.

Locations
Other Locations
Republic of Korea
Seoul National University Children's Hospital
RECRUITING
Seoul
Contact Information
Primary
Hyoung Jin Kang, Professor
kanghj@snu.ac.kr
02-2072-3452
Time Frame
Start Date: 2024-01-19
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 50
Sponsors
Leads: Seoul National University Hospital

This content was sourced from clinicaltrials.gov

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