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

Prior treatment

• Prior treatment for MCL with chemotherapy
• Known history of CNS (Central Nervous System) or leptomeningeal by MCL prior to study enrollment
• Uncontrolled active systemic fungal, bacterial, viral, or other infection, or intravenous anti-infective treatment within 2 weeks before first dose of study drug
• Concurrent participation in another clinical trial
• Subject has received a moderate or strong CYP3A inhibitor or inducer within 1 week prior to treatment initiation.

Other illness

• Significant cardiovascular disease
• Any condition that might significantly impair drug absorption as determined by the investigator
• History of stroke or intracranial hemorrhage within 6 months of 1st dose of study drug
• Psychiatric illness or social situations that would limit compliance with study requirements
• Subject has known positivity to HIV
• Active infection with Hepatitis B or C virus as determined by a detectable viral load on PCR.

Age

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

Other

• Pregnant or breastfeeding women
• Grade 2 or higher peripheral neuropathy

• 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
• 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 as required 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