A 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
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.
• Signed written informed consent;
• Newly diagnosed adult B-precursor Ph+ ALL;
• Age greater or equal to 18 years;
• ECOG Performance Status 0-1;
• Ineligible for allo-HSCT.
• Renal and hepatic function as defined below:
• AST (GOT), ALT (GPT), and AP \<2 x upper limit of normal (ULN). Creatinine clearance equal or greater than 50 mL/min.
• Pancreatic function as defined below:
• Serum amylase less or equal to 1.5 x ULN Serum lipase less or equal to1.5 x ULN
• Normal cardiac function;
• Negative HIV test, negative HBV DNA and HCV RNA;
⁃ Negative pregnancy test in women of childbearing potential.