Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (SYMPATICO)

Inclusion Criteria:

- Pathologically confirmed MCL (in tumor tissue), with documentation of either
overexpression of cyclin D1 in association with other relevant markers (eg, CD19,
CD20, PAX5, CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in
situ hybridization (FISH), or polymerase chain reaction (PCR)

- At least 1 measurable site of disease on cross-sectional imaging (CT/PET)

- At least 1, but no more than 5, prior treatment regimens for MCL

- Failure to achieve at least partial response (PR) with, or documented disease
progression after, the most recent treatment regimen

- Subjects must have adequate fresh or paraffin embedded tissue

Exclusion Criteria:

- History or current evidence of central nervous system lymphoma

- Concurrent enrollment in another therapeutic investigational study or prior therapy
with ibrutinib or other BTK inhibitors

- Prior treatment with venetoclax or other BCL2 inhibitors