Phase II International Study of Pirtobrutinib Plus Rituximab for Adults with Indolent Mantle Cell Lymphoma

What this Trial Is About

Researchers are investigating a combination therapy using pirtobrutinib and rituximab for adults newly diagnosed with indolent forms of Mantle Cell Lymphoma MCL, a type of blood cancer. This international, open-label phase II trial aims to evaluate the activity and safety of this treatment. The study uses a two-stage design to assess the complete remission rate after six cycles of treatment, focusing on improving responses and reducing treatment toxicity compared to current therapies. Participants will receive the combination therapy starting at day 1 of the first cycle and continue for at least 24 cycles, each lasting 28 days. Rituximab treatment will conclude after 23 cycles, while pirtobrutinib continuation depends on minimal residual disease status and specific genetic markers. The study also includes detailed biological analyses to better understand the treatments effects on this lymphoma subtype. Throughout the study, participants will undergo regular assessments including blood tests, disease evaluations, and quality of life surveys at multiple time points up to 48 months. Researchers will monitor treatment safety, response rates, and molecular disease markers to measure effectiveness and tolerability. This comprehensive follow-up aims to capture long-term outcomes and support development of improved first-line therapies for indolent MCL.

Clinical Trial to Evaluate the Efficacy and Safety of Pirtobrutinib With Rituximab in Patients With Mantle Cell Lymphoma