A Phase 3 Multicenter Trial for Pediatric Philadelphia Chromosome-positive B-Acute Lymphoblastic Leukemia 2025 Project

What this Trial Is About

Researchers are evaluating a "chemotherapy-light" treatment approach for newly diagnosed pediatric and adolescent patients with Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL). This trial studies the use of the third-generation tyrosine kinase inhibitor (TKI) olverembatinib combined with the bi-specific T cell engager blinatumomab and the BCL-2 inhibitor venetoclax. The study aims to assess the effectiveness and safety of this modified treatment compared to prior standard protocols. The treatment plan includes olverembatinib used throughout the regimen, combined with vincristine and prednisone during the first two weeks, followed by blinatumomab for 28 days as induction therapy to improve response and reduce toxicity. Consolidation involves two cycles of high-dose methotrexate with blinatumomab and four doses of triple intrathecal therapy. The dosage of cytarabine is lowered in the second consolidation phase to reduce toxicity. Maintenance therapy adds dexamethasone and vincristine with alternating cycles of venetoclax or daunorubicin over five cycles. Cyclophosphamide and asparaginase are omitted to lessen side effects. Participants will undergo assessments including cerebrospinal fluid and blood tests to monitor olverembatinib levels and bone marrow evaluations with next-generation sequencing to track minimal residual disease. The primary outcome is measurable residual disease at day 48 after induction. Secondary outcomes include early disease response, event-free survival, overall survival, and relapse rates over several years. The study involves long-term follow-up for up to seven years to evaluate treatment outcomes and safety.

Newly-diagnosed Pediatric Ph-positive B-ALL Protocol