Phase 2 Study of Olverembatinib, Blinatumomab, and Chidamide for Adults Newly Diagnosed with Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating a combination treatment for adults newly diagnosed with Philadelphia Chromosome-positive acute lymphoblastic leukemia PhALL. This phase 2, single-arm, open-label study explores the safety and effectiveness of combining a third-generation tyrosine kinase inhibitor Olverembatinib, a CD3CD19 bispecific T-cell engager Blinatumomab, and a histone deacetylase inhibitor Chidamide, known as the ABC regimen. The study aims to improve early and deep complete molecular remission rates and overall outcomes for this leukemia subtype, especially in patients with high-risk genetic markers like IKZF1 deletions. Participants will receive treatment in phases over several years. Initially, after pretreatment with glucocorticoid, they undergo one year of induction and consolidation therapy with Olverembatinib, Blinatumomab, and Chidamide following a specific schedule of doses and cycles. This is followed by three years of maintenance therapy using Olverembatinib and Chidamide. After treatment, participants enter a five-year follow-up phase to monitor long-term effects and disease status. Throughout the study, participants will be closely monitored for complete molecular remission at three months and other outcomes such as overall survival, event-free survival, and adverse events over up to five years. Specific genetic subgroups like IKZF1del and IKZF1plus will be assessed for treatment response. Regular clinical evaluations, laboratory tests, and safety assessments are part of the study to track participants health and treatment adherence during this multi-year trial.

A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL