Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol

CCCG-ALL2025 LR-B-ALL plan is designed based on the CCCG-ALL2020 plan. This is a clinical trial using 14 days of blinatumomab (Blina-14) as early intensification after induction therapy and 2nd Blina-14 in consolidation therapy in all newly diagnosed provisional low-risk (LR) pediatric acute lymphoblastic leukemia (ALL) patients, regardless of measurable residual diseases (MRD) status. We will compare the efficacy of chemotherapy combined with Blina-14, comparing to CAT+ intensification or historical regimens. Patients with early remission in depth will receive chemo-light late intensification and maintenance therapy afterwards. Early complete remission in depth and maintenance reduction will be determined by next-generation sequencing (Ig-NGS MRD).

NCT Number	NCT06882057
Lead Sponsor	Institute of Hematology & Blood Diseases Hospital, China
Conditions	Acute Lymphoblastic Leukemia ALL, Childhood Leukemia, Acute Lymphoblastic, B Cell Acute Lymphoblastic Leukemia (B-ALL)
Enrollment	3,000 participants
Start Date	2025-03-03
Primary Completion	2029-12-31 (estimated)
Study Completion	2033-06 (estimated)
Updated on ClinicalTrials.gov	2025-08-26