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BTK Inhibitor

PRV Combination Therapy 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
Age ≥ 18 years old
Confirmed pathology diagnosis of MCL with t(11;14)(q13;q32) translocation and/or cyclin D1 overexpression
Must not have
Active or recent infections
Uncontrolled cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to determine the percentage of patients with untreated Mantle Cell Lymphoma who achieve a complete response after receiving a combination therapy called PRV.

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
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I am 18 years old or older.
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My cancer is confirmed as MCL with specific genetic features.
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My cancer cells test positive for CD20.
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I have not had any treatment or radiotherapy for my MCL.
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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any current or recent infections.
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My heart condition is not under control.
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My mantle cell lymphoma has spread to my brain or spinal cord.
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I have a condition that prevents my body from absorbing nutrients properly.
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I need oxygen therapy for my lung condition.
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I have an active inflammatory bowel disease.
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I have another cancer that is not in remission.
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I have a bleeding disorder or am currently experiencing active bleeding.
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I have had a stroke before.
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I have not had major surgery in the last 28 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Venetoclax
2019
Completed Phase 3
~2200
Pirtobrutinib
2020
Completed Phase 1
~240
Rituximab
1999
Completed Phase 4
~2990

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,063 Previous Clinical Trials
1,800,741 Total Patients Enrolled
Michael Wang, MD, MSPrincipal InvestigatorM.D. Anderson Cancer Center
~27 spots leftby Feb 2027
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