Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

Status: closed to accrual

The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)

Inclusion Criteria

Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
Measurable disease by Computer Tomography/Magnetic Resonance Imaging
Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin < 3.0 x ULN
Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute

Exclusion Criteria

Previous systemic treatment for CLL
Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
Known central nervous system involvement
History of confirmed progressive multifocal leukoencephalopathy (PML)
Uncontrolled hypertension Note: Other protocol defined criteria may apply

Additional locations may be listed on ClinicalTrials.gov for NCT06073821.

State:

United States

California

Los Angeles

UCLA / Jonsson Comprehensive Cancer Center

Status: Active

Contact: Efrata Negatu

Phone: 310-633-8400

Email: ENegatu@mednet.ucla.edu

District of Columbia

Washington

MedStar Georgetown University Hospital

Status: Active

Name Not Available

Kansas

Kansas City

University of Kansas Cancer Center

Status: Active

Name Not Available

North Carolina

Durham

Duke University Medical Center

Status: Active

Name Not Available

Utah

Salt Lake City

Huntsman Cancer Institute/University of Utah

Status: Active

Name Not Available

Chronic lymphocytic leukemia is a type of blood cancer that affects people around the

world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have

symptoms like night sweats, weight loss and fever. They have shorter life expectancy

compared to healthy people. There is an urgent need for new treatment to prolong life and

control disease-related symptoms.

In this study, participants with CLL without prior treatment will receive either

venetoclax plus obinutuzumab combination treatment that is considered a standard first

line treatment or receive sonrotoclax plus zanubrutinib. It is hypothesized that

sonrotoclax plus zanubrutinib may be better than venetoclax plus obinutuzumab in treating

CLL.

The main purpose of this study is to compare the duration the participants live without

the CLL getting worse between participants who received sonrotoclax plus zanubrutinib

versus venetoclax plus obinutuzumab. Approximately 652 participants will be included in

this study around the world. Participants will have equal chance to be allocated to

receive either of the treatment combinations.

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Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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