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This clinical trial is open to women and men age 18 and older with previously treated mantle cell lymphoma (MCL). Mantle Cell Lymphoma (MCL) is a distinct B-cell lymphoma that represents 5-10% of all non-Hodgkin lymphomas (NHL), often follows an aggressive clinical course, and is considered incurable with standard chemoimmunotherapy.
While there are several therapeutic options available for MCL patients at relapse, none of them have long-lasting response durations. Also, the ability to improve outcomes with effective therapies while minimizing and managing toxicities can be difficult. The pre-clinical rationale, in addition to the early results of the phase 1 combination trial, suggest that this combination will provide a greater depth and duration of response than that seen with single agent ibrutinib therapy.
The primary objective of this study is to evaluate the efficacy of palbociclib in combination with ibrutinib in terms of progression-free survival (PFS) to therapy in patients with previously treated mantle cell lymphoma.
Brief study summary: