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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06220487 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ABL1?
Yes, ABL1 fusion is a required biomarker for enrollment.
Does this trial require BCR?
Yes, BCR fusion is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify