Study of Blinatumomab and Venetoclax Treatments for Children With Intermediate and High-Risk B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

This research aims to improve event-free survival, overall survival, and quality of life for children diagnosed with intermediate- and high-risk B-cell childhood acute lymphoblastic leukemia IHR-B-ALL. The study builds upon prior multicenter studies and current clinical trials to explore the effectiveness of two blinatumomab treatment schedules and a modified mini-hyperCVD plus venetoclax regimen for patients unable to receive blinatumomab. Participants will be assigned to one of three groups Group A receives continuous 28 days of blinatumomab followed by three cycles of high-dose methotrexate HDMTX Group B receives two 14-day cycles of blinatumomab alternating with three cycles of HDMTX and a non-randomized group receives venetoclax plus mini-hyperCVD as induction, followed by CAT as early intensification. All patients continue treatment with six cycles of alternating venetoclax or daunorubicin-based therapy. Throughout the study, participants undergo multiple bone marrow punctures and intrathecal treatments to assess remission depth, including IgH rearrangement NGS MRD evaluations. Researchers will monitor event-free survival, overall survival, relapse incidence, and adverse effects over several years. The study duration is approximately six and a half years from the last patient randomized, with follow-up lasting up to five years per participant.

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