RecruitingPhase 2NCT06522386

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

40 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (called GATE1) is testing a three-drug combination — pirtobrutinib, rituximab, and venetoclax — as a first-line treatment for mantle cell lymphoma, a type of blood cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with mantle cell lymphoma (confirmed by biopsy with specific genetic markers) - Your cancer cells test positive for CD20 - You have never received treatment for mantle cell lymphoma (except a short course of steroids for urgent symptom relief) - You have symptoms or signs that mean treatment is needed (e.g., B symptoms, enlarging lymph nodes, low blood counts) - You are in reasonably good health (ECOG 0–2) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have central nervous system involvement by lymphoma - You have already received systemic therapy for mantle cell lymphoma - Your blood counts or organ function do not meet the required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPirtobrutinib

Given by mouth

DRUGRituximab

Given by vein (IV)

DRUGVenetoclax

Given by mouth


Locations(2)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06522386


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