Chronic Lymphocytic Leukemia Clinical Trial
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
Summary
The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with leukemia-cll/" >chronic lymphocytic leukemia (CLL)
Full Description
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.
Eligibility Criteria
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
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There are 39 Locations for this study
Anchorage Alaska, 99508, United States
Los Angeles California, 90067, United States
Orange California, 92868, United States
Fort Wayne Indiana, 46804, United States
Des Moines Iowa, 50309, United States
Louisville Kentucky, 40207, United States
Billings Montana, 59102, United States
Westbury New York, 11590, United States
Kingwood Texas, 77339, United States
Seattle Washington, 98109, United States
St Leonards New South Wales, 2065, Australia
Westmead New South Wales, 2145, Australia
Benowa Queensland, 4217, Australia
Birtinya Queensland, 4575, Australia
Brisbane Queensland, 4102, Australia
Clayton Victoria, 3168, Australia
Fitzroy Victoria, 3065, Australia
Heidelberg Victoria, 3084, Australia
Malvern Victoria, 3144, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3004, Australia
Murdoch Western Australia, 6150, Australia
Nedlands Western Australia, 6009, Australia
Greenfiled Park Quebec, J4V 2, Canada
Sherbrooke Quebec, J1H 5, Canada
Quebec , G1J 1, Canada
Busan Busan Gwang'yeogsi, 49241, Korea, Republic of
Seongnamsi Gyeonggido, 13620, Korea, Republic of
Hwasungun Jeonranamdo, 58128, Korea, Republic of
Seoul Seoul Teugbyeolsi, 03080, Korea, Republic of
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Seoul Seoul Teugbyeolsi, 05505, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06591, Korea, Republic of
Auckland , 1023, New Zealand
Christchurch , 8011, New Zealand
Takapuna , 0622, New Zealand
Tauranga , 3112, New Zealand
Wellington , 6021, New Zealand
San Juan , 00917, Puerto Rico
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