Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed Intermediate/High Risk Childhood B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are studying children with intermediate- and high-risk B-cell childhood acute lymphoblastic leukemia (I/HR-B-ALL) to improve their event-free survival, overall survival, and quality of life. The study builds on previous research and trials to reduce adverse reactions and the need for transplantation. It aims to compare two different blinatumomab treatment schedules and evaluate a modified mini-hyperCVD plus venetoclax regimen for those who cannot receive blinatumomab, focusing on the rate of minimal residual disease negativity. Participants first undergo an induction remission phase with PVDL+CAT. Patients who can receive blinatumomab are randomly assigned to either a continuous 28-day blinatumomab plus three cycles of high-dose methotrexate (Group A) or two 14-day blinatumomab cycles alternating with three cycles of high-dose methotrexate (Group B) as consolidation therapy. Those not eligible for blinatumomab receive venetoclax plus mini-hyperCVD during induction, followed by CAT during early intensification. All patients then continue with six cycles of alternating venetoclax or daunorubicin-based therapy. Throughout the study, participants will have additional bone marrow punctures and intrathecal treatments to assess remission depth. Researchers will monitor outcomes such as event-free survival, cumulative relapse incidence, overall survival, and adverse effects for up to five years. The study also includes new evaluation methods like IgH rearrangement next-generation sequencing for minimal residual disease and pharmacotyping. The trial is expected to last about six and a half years after the last patient is enrolled.

Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol