Spots Global Cancer Trial Database for Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

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Trial Identification

Brief Title: Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Official Title: Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Study ID: NCT06263491

Conditions

Mantle Cell Lymphoma

Interventions

Rituximab

Pirtobrutinib

Study Description

Brief Summary: To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL.

Detailed Description: Primary Objectives * To determine the efficacy measured by ORR (CR + PR) at the end of cycle 3 of combination of PR (Pirtobrutinib plus rituximab) in MCL patients with low and intermediate risk. * To determine the safety profile of Pirtobrutinib with rituximab combination in MCL participants with low and intermediate risk. Secondary Objectives * To evaluate the CR, best overall response (OR: CR + PR), progression-free and overall survival from PR combination in MCL. * To assess MRD negative CR rates