NCT06522386

GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objectives: To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.

Detailed description

Secondary Objectives: * To evaluate the objective response rate to PRV combination therapy in patients with previously untreated MCL. * To evaluate the duration of response in patients with an objective response to PRV combination therapy. * To evaluate the progression-free survival and overall survival in patients treated with PRV combination therapy. * To evaluate the safety profile of PRV combination therapy in patients with previously untreated MCL.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Pirtobrutinib	Given by mouth
DRUG	Rituximab	Given by vein (IV)
DRUG	Venetoclax	Given by mouth

Timeline

• Start date: 2025-01-30
• Primary completion: 2027-02-28
• Completion: 2029-02-28
• First posted: 2024-07-26
• Last updated: 2026-04-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study