Study on Pirtobrutinib and Venetoclax for Treating Waldenström Macroglobulinemia

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05734495

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment combining two drugs, pirtobrutinib and venetoclax, for patients with Waldenström Macroglobulinemia (WM) who have already received other treatments.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if a combination of two drugs, pirtobrutinib and venetoclax, can be a safe and effective treatment for people with Waldenström Macroglobulinemia (WM), a type of blood cancer. Pirtobrutinib works by blocking a protein that helps cancer cells grow, while venetoclax targets another protein that helps these cells survive. Although these drugs are approved for other uses, they are not yet approved for WM or in combination. Participants will undergo various procedures, including blood tests and scans, and will receive the treatment for up to two years, with follow-up for up to four years. The study aims to enroll about 42 participants and is supported by Eli Lilly, which provides the drug pirtobrutinib and funding.

Description

This study is a Phase II trial, meaning it focuses on assessing the safety and effectiveness of the drug combination in patients with symptomatic Waldenström Macroglobulinemia (WM) who have been treated before. Pirtobrutinib and venetoclax are being tested together to see if they can help control the disease. Participants will be screened to ensure they meet the study criteria, and those eligible will receive the treatment for up to two years. The study includes regular visits for treatment, blood tests, scans, and bone marrow tests. Participants will be monitored for up to four years or until they start a new therapy. The study is open-label, meaning both the researchers and participants know which treatment is being given. The trial is supported by Eli Lilly, which provides the study drug and funding.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of Waldenström Macroglobulinemia, including a specific genetic type (MYD88 Wild-Type).
  • Must have received at least one previous treatment for WM.
  • Can have used a BTK inhibitor or venetoclax before, as long as the disease did not progress while on venetoclax.
  • Must have symptoms that require treatment, such as fever, night sweats, fatigue, weight loss, or low blood counts.
  • Must be 18 years or older.
  • Must have measurable disease, indicated by certain blood test levels.
  • Must be in good general health, with a performance status score of 2 or less.
  • Women of childbearing potential must agree to use two forms of birth control or abstain from sex during the study and for six months after.
  • Men must agree to use a condom during sex with women of childbearing potential during the study and for six months after.
  • Must have normal organ and bone marrow function, as shown by specific blood test results.
  • Can have other cancers if they do not interfere with the study treatment.
  • Must be able to attend study visits and follow the study requirements.
  • Must understand and agree to sign a consent form.

Exclusion Criteria

  • Cannot have used non-covalent BTK inhibitors before.
  • Cannot have had major bleeding or severe heart rhythm issues with previous BTK inhibitor treatment.
  • Cannot be taking other experimental drugs.
  • Cannot be pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study or within six months after.
  • Cannot have known central nervous system lymphoma.
  • Cannot have active HIV or cytomegalovirus infections.
  • Cannot have active hepatitis B or C infections.
  • Cannot be taking warfarin or certain other medications that affect drug metabolism.
  • Cannot be on systemic immunosuppressive therapy, except for low-dose steroids.
  • Cannot have received live vaccines within four weeks of starting the study.
  • Cannot have uncontrolled infections or other significant health issues.
  • Cannot have had major surgery within four weeks of starting the study.
  • Cannot have conditions that affect drug absorption.
  • Cannot have a history of alcohol or drug abuse.
  • Cannot have difficulty swallowing pills or complying with study requirements.
  • Cannot have uncontrolled autoimmune blood disorders.
  • Cannot have significant heart disease or abnormal heart rhythms.
  • Cannot have other serious health conditions that could affect the study.
  • Cannot have allergies to the study drugs.

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