SYMPATICO
Phase 3 Study of Ibrutinib in Combination with Venetoclax in Subjects with Mantle Cell Lymphoma
Professor Chan Cheah
Pharmacyclics LLC
III
Mantle Cell Lymphoma
This trial is open for recruitment to patients with Mantle Cell Lymphoma who have not received treatment. It looks at combining two tablets called ibrutinib and venetoclax which act together to block important proteins inside lymphoma cells, causing them to die. Patients will take a fixed dose of ibrutinib daily by mouth. Venetoclax will be started at a low dose and will increase weekly until the target dose is reached. Both drugs will be taken continuously unless the side effects are unacceptable or they no longer work.
Inclusion Criteria:
- ≥65 years of age, or <65 years of age with a TP53 mutation
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-2
- Adequate hematologic, hepatic, and renal function
- Pathologically confirmed treatment-naïve MCL
- At least 1 measurable site of disease
Exclusion Criteria:
- Blastoid variant of MCL
- History or current evidence of CNS lymphoma
- Concurrent enrollment in another therapeutic investigational study or prior therapy including ibrutinib or other BTK inhibitors
- Prior treatment with venetoclax or other BCL2 inhibitors
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- History of HIV or active HCV or HBV
- Currently active, clinically significant cardiovascular disease; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
PCYC-1143-CA
NCT03112174