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BTK Inhibitor

Pirtobrutinib, Rituximab and Venetoclax combination for Mantle Cell Lymphoma

Phase 2
Waitlist Available
Led By Michael Wang, MD, MS
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Age ≥ 18 years old.
2. Confirmed pathology diagnosis of MCL with t(11;14)(q13;q32) translocation and/or cyclin D1 overexpression (e.g., positive immunohistochemistry staining).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

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.

Who is the study for?
This trial is for patients with previously untreated Mantle Cell Lymphoma (MCL). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.
What is being tested?
The GATE1 trial is testing a combination of three drugs: Pirtobrutinib, Rituximab, and Venetoclax in people with MCL. The main goal is to see how many patients achieve complete disappearance of cancer signs after this treatment regimen during the initial therapy phase.
What are the potential side effects?
While specific side effects are not listed here, common ones for these drugs include low blood cell counts leading to increased infection risk, bleeding problems, fatigue, digestive issues such as nausea or constipation, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pirtobrutinib, Rituximab and Venetoclax combinationExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirtobrutinib
2020
Completed Phase 1
~240
Venetoclax
2019
Completed Phase 3
~1990
Rituximab
1999
Completed Phase 4
~2200

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,030 Previous Clinical Trials
1,797,207 Total Patients Enrolled
Michael Wang, MD, MSPrincipal InvestigatorM.D. Anderson Cancer Center
~27 spots leftby Feb 2027
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