At a glance
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Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed Low Risk Childhood B-cell Acute Lymphoblastic Leukemia
In Brief
A Phase 3 clinical trial evaluating Blinatumomab, Reinduction-2 omission, and 1 other intervention for Acute Lymphoblastic Leukemia ALL and 2 related conditions. Currently recruiting, targeting 3,000 participants across 27 sites in 2 countries.
Detailed Summary
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).
Study Details
Timeline
Interventions
All LR-B-ALL patients will be treated with 14 days of blinatumomab (Blina-14) as early intensification to replace CAT+ (historically given in LR-B-AL with MRD19\>0.1% in the 2020 protocol). Additionally, second 14 days of blinatumomab will be given after completion of HDMTX consolidation treatment.
Reinduction-2 will be omitted for patients with NGS-MRD46\<10\^-6 who have receive the two courses of Blina-14.
Patients with FCM-MRD19\<0.01% and IgH rearrangement NGS MRD 46\<10\^-6 will receive chemo-light maintenance-2 with 4 cyles of 8-week course of MTX + 6MP (totally 32 weeks).