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

ABC study is a phase 2, single-arm, open-label study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in patients with newly diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ALL). This study combined third generation TKI (Olverembatinib), histone deacetylase inhibitors (Chidamide) and CD3/CD19 bispecific T-cell engager (Blinatumomab) as first line regimen (ABC regimen) for Ph+ ALL. Investigatorsaim to explore the efficacy and safety of ABC regimen. The primary endpoint is the complete molecular remission （CMR） at 3 months, secondary endpoints are overall survival (OS), event-free survival (EFS), adverse event (AE), IKZF1del, IKZF1plus, IKZF1lpus/CD20 subgroup EFS/OS.

NCT Number	NCT06220487
Lead Sponsor	Nanfang Hospital, Southern Medical University
Conditions	Acute Lymphoblastic Leukemia, Philadelphia Chromosome, Philadelphia-Positive ALL, Adult ALL, IKZF1 Gene Mutation
Enrollment	67 participants
Start Date	2024-02-01
Primary Completion	2025-12-31 (estimated)
Study Completion	2028-01-01 (estimated)
Updated on ClinicalTrials.gov	2024-01-24