ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL

This open-label, non-randomized, phase II exploratory study aims to evaluate the efficacy and safety of combining pathway-specific tyrosine kinase inhibitors with chemotherapy and venetoclax in patients with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL). Patients are stratified by genetic alteration: those with ABL class fusions (ABL1, ABL2, PDGFRA, PDGFRB) receive olverembatinib, while those with JAK pathway alterations (CRLF2 rearrangement, JAK mutation/fusion, EPOR fusion, SH2B3 deletion, IL7R mutation) receive Gecacitinib. Both groups undergo sequential induction, consolidation, intensification, and maintenance therapy as per protocol. The primary endpoint is the rate of flow cytometry minimal residual disease (MRD)-negative complete remission (CR MRD-) at 3 months after induction therapy. Secondary endpoints include overall complete remission rate, NGS MRD-negative CR rate at 3 months, overall survival (OS), disease-free survival (DFS), relapse-free survival (RFS), cumulative incidence of relapse, and 60-day mortality.

NCT Number	NCT07454226
Lead Sponsor	Institute of Hematology & Blood Diseases Hospital, China
Conditions	Ph-Like, Acute Lymphoblastic Leukemia
Enrollment	92 participants
Start Date	2026-05-30
Primary Completion	2028-03-01 (estimated)
Study Completion	2030-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-13