Phase II Study of Pirtobrutinib and Venetoclax for Patients with Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05529069

Provider View

This clinical trial is testing whether a combination of two drugs, pirtobrutinib and venetoclax, can help control mantle cell lymphoma (MCL) that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to find out if the combination of pirtobrutinib (also known as LOXO-305) and venetoclax is effective and safe for patients with mantle cell lymphoma (MCL) that has either come back after treatment or has not responded to previous therapies. Researchers will also look at how long patients live without the disease getting worse and overall survival rates.

Description

The main goal of this study is to see how well the combination of pirtobrutinib and venetoclax works in treating patients with relapsed or refractory mantle cell lymphoma (MCL). Researchers will also assess the safety of this treatment. Additionally, the study will explore other aspects of the treatment through various analyses.

Participants in this study will receive the combination of pirtobrutinib and venetoclax and will be monitored for their response to the treatment and any side effects. The study will also evaluate how long patients live without the disease progressing and their overall survival.

The study includes exploratory research to better understand the treatment's effects and to analyze data using advanced methods.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of mantle cell lymphoma (MCL) through a tissue biopsy.
  • Able to take oral medications.
  • MCL that has returned or not responded to previous treatments, including those who have had certain other therapies.
  • Willing to provide informed consent and comply with study requirements.
  • Aged 18 years or older.
  • At least one measurable site of disease, such as a lymph node or other area.
  • Good overall health with an ECOG performance status of 2 or less.
  • No active cancer other than certain skin cancers or other cancers in remission.
  • Adequate blood and organ function as determined by specific tests.
  • Women must not be pregnant and must use effective birth control during and after the study.
  • Men must use effective birth control if their partner is of childbearing potential.
  • Must have completed certain washout periods for previous treatments before starting the study.

Exclusion Criteria

  • Known involvement of the central nervous system (CNS) by lymphoma.
  • History of bleeding disorders or recent stroke.
  • Recent vaccination with a live vaccine.
  • Allergies to study drugs or their components.
  • Major bleeding or heart rhythm issues with previous treatments.
  • Pregnant or breastfeeding women.
  • Uncontrolled HIV, hepatitis B, or hepatitis C infections.
  • Other significant uncontrolled medical conditions.
  • Recent major surgery or other cancer treatments.
  • Uncontrolled autoimmune conditions or infections.
  • Recent stem cell transplant or CAR-T therapy.
  • Use of certain medications that affect the study drugs.
  • Consumption of grapefruit, Seville oranges, or star fruit.

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