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

Sponsor: Genentech, Inc.

Sponsor score: 40

ClinicalTrials ID:NCT06524375

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.

Locations

FACILITYZIPCITYSTATE
Highlands Oncology Group72762SpringdaleArkansas
Rocky Mountain Cancer Centers (Aurora) - USOR80012-5405AuroraColorado
University Cancer & Blood Center, LLC30607AthensGeorgia
Fort Wayne Medical Oncology and Hematology, Inc46804Fort WayneIndiana
Mission Blood and Cancer - MercyOne Cancer Center50314-3030Des MoinesIowa
American Oncology Partners of Maryland, PA20817-1915BethesdaMaryland
Dana Farber Cancer Inst.02115BostonMassachusetts
Nebraska Cancer Specialists St Francis - Grand Island68803Grand IslandNebraska
Nebraska Cancer Specialists68130-2042OmahaNebraska
Astera Cancer Care East Brunswick08816-4096East BrunswickNew Jersey

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.