Chronic Lymphocytic Leukemia Clinical Trial
A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
Summary
To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated leukemia-cll/" >CLL/SLL, as measured by progression free survival.
Full Description
This is a global phase 3, open label, randomized study of zanubrutinib versus bendamustine plus rituximab (B+R) in participants with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), including participants without del(17p) [Cohort 1] and participants with del(17p) [Cohort 2 and Cohort 3]. Participants in Cohort 1 are randomized 1:1 to zanubrutinib (Arm A) or bendamustine plus rituximab (Arm B). Randomization will be stratified by age, Binet stage, immunoglobulin variable region heavy chain (IGHV) mutational status, and geographic region. Participants in Cohort 2 will receive treatment with zanubrutinib. Participants in Cohort 3 will receive treatment with zanubrutinib and venetoclax.
Eligibility Criteria
Key Inclusion Criteria:
Unsuitable for chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR)
Confirmed diagnosis of CD20-positive CLL or SLL, requiring treatment
Measurable disease by imaging
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Life expectancy ≥ 6 months
Adequate bone marrow function
Adequate renal and hepatic function
Key Exclusion Criteria:
Previous systemic treatment for CLL/SLL
Requires ongoing need for corticosteroid treatment
Known prolymphocytic leukemia or history of or suspected Richter's transformation.
Clinically significant cardiovascular disease
Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix of breast, or localized Gleason score 6 prostate cancer
History of severe bleeding disorder
History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug
Severe or debilitating pulmonary disease
Inability to swallow capsules or disease affecting gastrointestinal function
Active infection requiring systemic treatment
Known central nervous system involvement by leukemia or lymphoma
Underlying medical condition that will render the administration of study drug hazardous or obscure interpretation of toxicity or AEs
Known infection with human immunodeficiency virus (HIV) or active hepatitis B or C infection
Major surgery ≤ 4 weeks prior to start of study treatment
Pregnant or nursing females
Vaccination with live vaccine within 35 days prior to the first dose of study drug.
Ongoing alcohol or drug addiction
Known hypersensitivity to zanubrutinib, bendamustine, rituximab, or venetoclax (as applicable) or any other ingredients of the study drugs
Requires ongoing treatment with strong cytochrome P450 (CYP3A) inhibitor or inducer
Concurrent participation in another therapeutic clinical study
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 24 Locations for this study
Washington District of Columbia, 20007, United States
Atlanta Georgia, 30322, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60208, United States
Mount Sterling Kentucky, 40353, United States
Boston Massachusetts, 02215, United States
Kansas City Missouri, 64132, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89014, United States
Florham Park New Jersey, 07932, United States
New York New York, 10029, United States
New York New York, 10032, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Durham North Carolina, 27705, United States
Portland Oregon, 97239, United States
Watertown South Dakota, 57201, United States
Nashville Tennessee, 37203, United States
Lubbock Texas, 79410, United States
Tyler Texas, 75702, United States
Charlottesville Virginia, 22908, United States
Seattle Washington, 98108, United States
Seattle Washington, 98109, United States
Concord New South Wales, 2139, Australia
Tweed Heads New South Wales, , Australia
Waratah New South Wales, , Australia
Westmead New South Wales, , Australia
Auchenflower Queensland, , Australia
Herston Queensland, , Australia
Woolloongabba Queensland, , Australia
Adelaide South Australia, , Australia
Woodville South South Australia, , Australia
Hobart Tasmania, , Australia
Bentleigh East Victoria, , Australia
Box Hill Victoria, , Australia
East Melbourne Victoria, , Australia
Fitzroy Victoria, , Australia
Frankston Victoria, , Australia
Perth Western Australia, , Australia
South Brisbane , , Australia
Innsbruck , , Austria
Linz , , Austria
Linz , , Austria
Salzburg , , Austria
Wels , , Austria
Wilrijk Antwerpen, , Belgium
Yvoir Namur, , Belgium
Arlon , , Belgium
Brussels , , Belgium
Gent , , Belgium
Liège , , Belgium
Ottignies , , Belgium
Brno , , Czechia
Hradec Králové , , Czechia
Olomouc , , Czechia
Ostrava-Poruba , , Czechia
Praha , , Czechia
Poitiers Cedex Poitou-charentes, , France
Argenteuil , , France
Bordeaux , , France
Caen , , France
La Roche sur Yon , , France
Le Mans , , France
Limoges , , France
Lyon , , France
Marseille , , France
Nantes , , France
Paris , , France
Pessac , , France
Pierre-Bénite , , France
Reims , , France
Rennes , , France
Rouen , , France
Tours , , France
Vandoeuvre-lès-Nancy , , France
Brescia , , Italy
Brescia , , Italy
Brescia , , Italy
Genova , , Italy
Meldola , , Italy
Milano , , Italy
Milano , , Italy
Milano , , Italy
Modena , , Italy
Ravenna , , Italy
Roma , , Italy
Roma , , Italy
San Giovanni Rotondo , , Italy
Terni , , Italy
Torino , , Italy
North Shore Auckland, , New Zealand
Grafton Aukland, , New Zealand
Palmerston North Manawatu-wanganui, , New Zealand
Christchurch , , New Zealand
Tauranga , , New Zealand
Legnica Dolnoslaskie, , Poland
Brzozów , , Poland
Chorzów , , Poland
Gdańsk , , Poland
Gdynia , , Poland
Gliwice , , Poland
Kraków , , Poland
Lublin , , Poland
Łódź , , Poland
Ekaterinburg , , Russian Federation
Kaluga , , Russian Federation
Kazan , , Russian Federation
Kemerovo , , Russian Federation
Moscow , , Russian Federation
Moscow , , Russian Federation
Nizhny Novgorod , , Russian Federation
Penza , , Russian Federation
Perm , , Russian Federation
Ryazan , , Russian Federation
Saint Petersburg , , Russian Federation
Sochi , , Russian Federation
Tula , , Russian Federation
Volgograd , , Russian Federation
Yekaterinburg , , Russian Federation
Badalona Barcelona, , Spain
Sabadell Barcelona, , Spain
Barcelona , , Spain
Barcelona , , Spain
Barcelona , , Spain
Madrid , , Spain
Madrid , , Spain
Madrid , , Spain
Madrid , , Spain
Majadahonda , , Spain
Pamplona , , Spain
Valencia , , Spain
Zaragoza , , Spain
Lund Skane, , Sweden
Borås Vastra Gotaland, , Sweden
Göteborg Vastra Gotaland, , Sweden
Lulea , , Sweden
Orebro , , Sweden
Stockholm , , Sweden
Uppsala , , Sweden
Hualien City , , Taiwan
New Taipei City , , Taiwan
Tainan City , , Taiwan
Taipei , , Taiwan
Birmingham England, , United Kingdom
Cambridge England, , United Kingdom
Canterbury England, , United Kingdom
London England, , United Kingdom
Maidstone England, , United Kingdom
Manchester England, , United Kingdom
Bournemouth , , United Kingdom
Leeds , , United Kingdom
London , , United Kingdom
London , , United Kingdom
Norwich , , United Kingdom
Nottingham , , United Kingdom
Plymouth , , United Kingdom
Southampton , , United Kingdom
Sunderland , , United Kingdom
Sutton , , United Kingdom
Wolverhampton , , United Kingdom
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