Status:
RECRUITING
A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Acute Lymphoblastic Leukemia
Philadelphia Chromosome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 lympho...
Detailed Description
Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) is now a relatively favorable-risk leukemia with the development of potent BCR::ABL1 tyrosine kinase inhibitors (TKIs). Achieveme...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- History of receiving systemic chemotherapy or CAR-T therapy for ALL.
- Impaired cardiac function, including any one of the following:
- .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.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of olverembatinib or chidamide (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). .History of or current autoimmune disease. .History of or current relevant CNS pathology. .Presence of CNS leukemia. .History of or current autoimmune disease. .History of other malignancies. .Presence active infection.
- Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.
- Not eigiable for this study, decided by PI
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT06220487
Start Date
February 1 2024
End Date
January 1 2028
Last Update
January 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dept of Hematology, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515