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Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol

Study acronym: CCCG-LR-B-ALL
StatusRecruiting
PhasePhase 2/3
Started2025-03-03
View on ClinicalTrials.gov ↗

Amendment history

2025-08-23
notable
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-03→confirmed 2025-03-03
Study sites26→27
2025-03-11
minor
Original filing
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).
Trial Details
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