The purpose of this study is to determine if giving an experimental drug called venetoclax in combination with lenalidomide and rituximab is safe and effective for treating people with Mantle Cell Lymphoma (MCL).
Age ≥18 years
Diagnosis of mantle cell lymphoma (MCL) established by histologic assessment
Laboratory, radiographic, physical exam findings and/or symptoms attributable to MCL
ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death) less or equal to 2
Prior treatment for MCL with chemotherapy
Pregnant or breastfeeding women
Grade 2 or higher peripheral neuropathy
Known history of CNS (Central Nervous System) or leptomeningeal by MCL prior to study enrollment
Single group
Venetoclax
DrugPO days 8 - 28 cycles during cycle 1 only. Starting with ramp-up dose as follows (50 mg x 7 days then 100mg x 7 days then 200 mg x 7 days then 400 mg for remainder of therapy). Will be given days 1-28 at a dose of 400 mg cycle 2-12.
Lenalidomide
Drug10 mg day 1-7 of and 15 mg day 8-14 cycle #1. 20 mg PO day day 15-21 of cycle #1 and days 1-21 cycles 2-12.
Rituximab
Drug375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12
Maximum Tolerated Dose (MTD) of the combination of lenalidomide, venetoclax and rituximab
The proportion of patients with a Complete Response (CR)
Response will be assessed by the IRC (Immune-related Response Criteria) and the investigator on the basis of physical examinations and PET and CT scans using the Lugano 2014 criteria, taking into account results of bone marrow examinations for patients with bone marrow involvement at screening
The proportion of patients that respond to treatment
The proportion of patients who achieve either partial or complete response by PET, CT and marrow. Response will be assessed by the IRC and the investigator on the basis of physical examinations and PET and CT scans using the Lugano 2014 criteria, taking into account results of bone marrow examinations for patients with bone marrow involvement at screening
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