GATE1: Study on Pirtobrutinib, Rituximab, and Venetoclax for Untreated Mantle Cell Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06522386

Provider View

This clinical trial is testing a new combination of drugs—Pirtobrutinib, Rituximab, and Venetoclax—to see if they can help patients with untreated Mantle Cell Lymphoma (MCL) achieve a complete response, meaning no signs of cancer after treatment.

Patient Parameters

Program Overview

The main goal of this study is to find out how many patients with untreated Mantle Cell Lymphoma (MCL) can achieve a complete response, meaning their cancer is no longer detectable, after receiving a combination of Pirtobrutinib, Rituximab, and Venetoclax. This combination is given during the initial phase of treatment.

Description

The study also aims to:

  • Determine how well patients respond to the combination of Pirtobrutinib, Rituximab, and Venetoclax.
  • Measure how long the response lasts in patients who respond to the treatment.
  • Evaluate how long patients live without the cancer getting worse and their overall survival.
  • Assess the safety of the combination treatment in patients with untreated MCL.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of Mantle Cell Lymphoma (MCL) with specific genetic markers.
  • MCL cells must be CD20 positive.
  • No previous treatment for MCL, except for a short course of corticosteroids for acute symptoms.
  • Have symptoms or conditions that require treatment, such as B symptoms or enlarged lymph nodes.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Have measurable disease, such as a lymph node larger than 1.5 cm or specific blood and bone marrow involvement.
  • Meet specific lab test criteria, including adequate blood cell counts and organ function.
  • Have a heart function of at least 50% as measured by an ECHO or MUGA scan.
  • Be able to understand and sign an informed consent form.
  • Agree to provide blood, bone marrow, and tissue samples for research.
  • Be willing to return for follow-up visits.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
  • Men must agree not to donate sperm during and after the study.

Exclusion Criteria

  • Cancer has spread to the central nervous system.
  • Pregnant or breastfeeding, or planning to become pregnant or breastfeed during or shortly after the study.
  • Have conditions that prevent taking medication by mouth.
  • Use of certain medications that interact with the study drugs.
  • Have serious health conditions that could interfere with the study.
  • Have a history of bleeding disorders or active bleeding.
  • Have active or recent infections, including COVID-19, HIV, or hepatitis.
  • Have uncontrolled heart disease or recent heart problems.
  • Have a prolonged QT interval on an ECG.
  • Have had a stroke in the past 6 months.
  • Have lung disease requiring oxygen.
  • Have active inflammatory bowel disease.
  • Have psychiatric or social issues that could affect study participation.
  • Have had major surgery or a live vaccine recently.
  • Have another active cancer that is not in remission or requires treatment.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77030HoustonTexas

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