Actively Recruiting
A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL
Led by Nanfang Hospital, Southern Medical University · Updated on 2024-01-24
67
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Newly diagnosed adult B-precursor Philadelphia Chromosome-positive acute lymphoblastic leukemia
- Age 18 years or older
- ECOG Performance Status of 0 or 1
- Not eligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Liver enzymes AST, ALT, and alkaline phosphatase less than 2 times the upper limit of normal
- Creatinine clearance of 50 mL/min or higher
- Serum amylase and lipase less than or equal to 1.5 times the upper limit of normal
- Normal heart function
- Negative tests for HIV, hepatitis B virus DNA, and hepatitis C virus RNA
- Negative pregnancy test for women who can become pregnant
You will not qualify if you...
- Previous treatment with systemic chemotherapy or CAR-T therapy for acute lymphoblastic leukemia
- Impaired cardiac function, including left ventricular ejection fraction below 45%, complete left bundle branch block, use of a pacemaker, significant arrhythmias, clinically significant bradycardia, prolonged QTc interval, or recent myocardial infarction
- Gastrointestinal diseases or conditions that affect absorption of study drugs
- History or current autoimmune disease
- History or current central nervous system pathology or presence of central nervous system leukemia
- History of other cancers
- Active infections
- Nursing women or women of childbearing potential not using effective contraception, or men not agreeing to use effective contraception during the study and for at least three months after
- Any other condition deemed unsuitable for the study by the principal investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dept of Hematology, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
Research Team
H
Hongsheng Zhou, M.D; Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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