A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-treatment Period.

Last updated: May 2, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Chronic Lymphocytic Leukemia

Lymphoproliferative Disorders

Lymphocytic Leukemia, Chronic

Treatment

cBTKi Monotherapy

Venetoclax

Clinical Study ID

NCT06524375
ML45219
  • Ages > 18
  • All Genders

Study Summary

The main purpose of the study is to evaluate if adding venetoclax to participants receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable measurable residual disease [uMRD < or 10^-4 in peripheral blood (PB)] by end of combination treatment (EOCT) to allow off-treatment period.

The acronym BRAVE stands for Btki Responders to Achieve deep remission (or off-treatment periods) with VEnetoclax.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosed with CLL and currently receiving a stable dose of cBTKi (i.e., ibrutinib,acalabrutinib, or zanubrutinib) for at least 6 months for 1L treatment with aresponse of at least a PR per iwCLL criteria

  2. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (</=) 2

  3. Adequate renal and liver function

Exclusion

Exclusion Criteria:

  1. Prior B-cell lymphoma (Bcl-2) inhibitor therapy

  2. Anti-cluster of differentiation 20 (CD20) therapy within the month prior toscreening

  3. Progressive or stable disease on cBTKi

  4. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter'stransformation or pro-lymphocytic leukemia)

  5. History of cardiomyopathy

  6. Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose)

  7. Clinically significant cardiovascular disease

  8. Active bleeding or history of bleeding diathesis

  9. Pregnant women and nursing mothers

  10. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: cBTKi Monotherapy
Phase: 2
Study Start date:
August 09, 2024
Estimated Completion Date:
February 08, 2028

Connect with a study center

  • Highlands Oncology Group

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Highlands Oncology Group

    Springdale, Arkansas 72762
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers (Aurora) - USOR

    Aurora, Colorado 80012-5405
    United States

    Active - Recruiting

  • University Cancer & Blood Center, LLC

    Athens, Georgia 30607
    United States

    Active - Recruiting

  • University Cancer and Blood Center, LLC

    Athens, Georgia 30607
    United States

    Active - Recruiting

  • Fort Wayne Medical Oncology and Hematology, Inc

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

  • Mission Blood and Cancer - MercyOne Cancer Center

    Des Moines, Iowa 50314-3030
    United States

    Active - Recruiting

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland 20817-1915
    United States

    Active - Recruiting

  • American Oncology Partners of Maryland, Pa

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Dana Farber Cancer Inst.

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute - Hematologic Oncology Treatment Center

    Boston, Massachusetts 02215-5418
    United States

    Active - Recruiting

  • Nebraska Cancer Specialists St Francis - Grand Island

    Grand Island, Nebraska 68803
    United States

    Active - Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska 68130-2042
    United States

    Active - Recruiting

  • Astera Cancer Care East Brunswick

    East Brunswick, New Jersey 08816-4096
    United States

    Active - Recruiting

  • San Juan Oncology Associates, PC

    Farmington, New Mexico 87401
    United States

    Active - Recruiting

  • Oncology Hematology Care Inc - Cincinnati - USOR

    Cincinnati, Ohio 45236-2725
    United States

    Active - Recruiting

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Asante Rogue Regional Medical Center

    Medford, Oregon 97504-8332
    United States

    Active - Recruiting

  • Oncology Associates of Oregon, P.C.

    Springfield, Oregon 97477
    United States

    Active - Recruiting

  • Tennessee Oncology, PLLC

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • Tennessee Oncology, PLLC - Chattanooga

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • Tennessee Oncology - Midtown

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Nebraska Cancer Specialists

    Fort Worth, Texas 76177
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Texas Oncology- Northeast Texas

    Tyler, Texas 75702
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.