Study on Adding Venetoclax to Treatment for First-Line Chronic Lymphocytic Leukemia to Achieve Long-Lasting Remissions

Sponsor: Genentech, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06524375

Provider View

This clinical trial is testing whether adding the drug venetoclax to the current treatment for first-line chronic lymphocytic leukemia (CLL) can help achieve deep and long-lasting remissions, allowing patients to take breaks from treatment.

Patient Parameters

Program Overview

The goal of this study is to find out if adding venetoclax to the treatment plan for patients with first-line chronic lymphocytic leukemia (CLL) can lead to deep and lasting remissions. This means that the disease becomes undetectable in the blood, allowing patients to have periods without treatment. The study is called BRAVE, which stands for Btki Responders to Achieve deep remission (or off-treatment periods) with VEnetoclax.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with chronic lymphocytic leukemia (CLL) and currently on a stable dose of a covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) like ibrutinib, acalabrutinib, or zanubrutinib for at least 6 months as first-line treatment.
  • Showing at least a partial response to the current treatment based on specific medical criteria.
  • Have a performance status score of 2 or less, indicating the ability to carry out daily activities with some limitations.
  • Have adequate kidney and liver function as determined by medical tests.

Exclusion Criteria

  • Have previously received B-cell lymphoma (Bcl-2) inhibitor therapy.
  • Have disease that is not improving or is stable on the current cBTKi treatment.
  • Have CLL that has transformed into a more aggressive form of cancer, such as non-Hodgkin lymphoma or pro-lymphocytic leukemia.
  • Have a history of heart muscle disease (cardiomyopathy).
  • Have an allergy to venetoclax or any of its ingredients.
  • Have significant heart disease.
  • Have active bleeding issues or a history of bleeding disorders.
  • Are pregnant or breastfeeding.
  • Have uncontrolled autoimmune conditions affecting red blood cells or platelets.

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