OncoMatch/Clinical Trials/NCT06220487
A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL
Is NCT06220487 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Prednisone, Olverembatinib, Blinatumomab, Chidamide for acute lymphoblastic leukemia.
Treatment: Prednisone, Olverembatinib, Blinatumomab, Chidamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: ABL1 fusion
Required: BCR fusion
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
Cannot have received: car-t cell therapy
Lab requirements
Kidney function
Creatinine clearance equal or greater than 50 mL/min
Liver function
AST (GOT), ALT (GPT), and AP <2 x upper limit of normal (ULN)
Cardiac function
Normal cardiac function; LVEF <45% as determined by MUGA scan or echocardiogram; Complete left bundle branch block; Use of a cardiac pacemaker; ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads; Congenital long QT syndrome; History of or presence of significant ventricular or atrial arrhythmia; Clinically significant resting bradycardia (<50 beats per minute); QTc >450 msec on screening ECG (using the QTcF formula); Right bundle branch block plus left anterior hemiblock, bifascicular block; Myocardial infarction within 3 months prior to starting olverembatinib; Angina pectoris.
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; cardiac exclusion criteria as listed.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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