Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

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)

Official Title

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Details

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 participant 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 venetoclax plus obinutuzumab versus sonrotoclax plus zanubrutinib. Approximately 640 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.

Keywords

CLL, Chronic Lymphocytic Leukemia, Leukemia, Lymphoid Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Venetoclax, Obinutuzumab, Zanubrutinib, Sonrotoclax, Sonrotoclax Plus Zanubrutinib, Venetoclax Plus Obinutuzumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA Department of Medicine Hematologyoncology accepting new patients
    Los Angeles California 90095 United States
  • Valkyrie Clinical Trials accepting new patients
    Los Angeles California 90067 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BeiGene
ID
NCT06073821
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 640 study participants
Last Updated