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: 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/tables

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 to study
enrollment

- Significant cardiovascular disease

- Any condition that might significantly impair drug absorption as determined by the
investigator

- Uncontrolled active systemic fungal, bacterial, viral, or other infection, or
intravenous 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 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.

- 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.

- 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.