Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

Inclusion Criteria:

• 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: anattempt to quantify cancer patients' general well-being and activities of dailylife. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death) less orequal to 2

• All study participants must be registered into the mandatory Revlimid REMS® program,and be willing and able to comply with the requirements of the REMS® program

• Females of reproductive potential must adhere to the scheduled pregnancy testing asrequired in the Revlimid REMS® program.

• Men and Women of childbearing potential on appropriate contraception

• Adequate organ function

• Ability to understand and the willingness to sign a written informed consent.

• Ability to swallow oral capsules/tablets

Exclusion Criteria:

• 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 tostudy enrollment

• Significant cardiovascular disease

• Any condition that might significantly impair drug absorption as determined by theinvestigator

• Uncontrolled active systemic fungal, bacterial, viral, or other infection, orintravenous anti-infective treatment within 2 weeks before first dose of study drug

• History of stroke or intracranial hemorrhage within 6 months of 1st dose of studydrug

• Concurrent participation in another clinical trial

• Subject has received a moderate or strong CYP3A inhibitor or inducer within 1 weekprior to treatment initiation.

• Psychiatric illness or social situations that would limit compliance with studyrequirements

• Subject has known positivity to HIV

• Active infection with Hepatitis B or C virus as determined by a detectable viralload on PCR.

• Prior malignancy except for adequately treated basal cell or squamous cell skincancer, in situ cervical cancer, or any other cancer from which the subject has beendisease free for ≥ 2 years or which will not limit survival to< 2 years.