NCT06263491

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	Given by PO
DRUG	Pirtobrutinib	Given by PO

Timeline

• Start date: 2024-05-29
• Primary completion: 2026-11-01
• Completion: 2027-03-01
• First posted: 2024-02-16
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study