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

This is a multicenter, international, open-label, single-arm phase II clinical trial designed to evaluate the activity and safety of a combination therapy with pirtobrutinib and rituximab (P-R) in treatment-naïve adult patients diagnosed with indolent clinical forms of Mantle Cell Lymphoma (MCL). The study applies a Simon's two-stage design, with an interim analysis after the first 16 patients to determine continuation based on complete remission rate (CRR) after 6 cycles.

NCT Number	NCT07285590
Lead Sponsor	Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea Collaborators: Evidenze CRO, Eli Lilly and Company
Conditions	Mantle Cell Lymphoma (MCL)
Enrollment	50 participants
Start Date	2025-09-30
Primary Completion	2032-12 (estimated)
Study Completion	2032-12 (estimated)
Updated on ClinicalTrials.gov	2025-12-16