Chronic Lymphocytic Leukemia Clinical Trial
A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia
Summary
This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory leukemia-cll/" >chronic lymphocytic leukemia or small lymphocytic lymphoma.
Full Description
This is a global, Phase 3, randomized study of zanubrutinib versus ibrutinib in approximately 600 participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
The primary efficacy endpoint is overall response rate determined by investigator assessment. Participants will be randomized in a 1:1 manner to either zanubrutinib or ibrutinib. Treatment with zanubrutinib and ibrutinib will be open label.
Eligibility Criteria
Key Inclusion Criteria
Confirmed diagnosis of CLL or SLL that meets the 2008 IWCLL criteria
CLL/SLL requiring treatment per 2008 IWCLL criteria
Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
Measurable disease by CT/magnetic resonance imaging (MRI)
ECOG performance status of 0, 1, or 2
Life expectancy ≥ 6 months
Adequate bone marrow function
Adequate renal and hepatic function
Key Exclusion Criteria
Known prolymphocytic leukemia or history of, or currently 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 or breast
History of severe bleeding disorder or history of spontaneous bleeding requiring blood transfusion or other medical intervention
History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
Severe or debilitating pulmonary disease
Active fungal, bacterial, and/or viral infection requiring systemic therapy
Known central nervous system involvement by leukemia or lymphoma
Known infection with HIV or active viral hepatitis B or C infection
Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
Major surgery within 4 weeks of the first dose of study drug
Prior treatment with a BTK inhibitor
Toxicity from prior anticancer therapy that has not recovered to ≤ Grade 1
Pregnant or lactating women
Vaccination with a live vaccine within 35 days prior to the first dose of study drug
Hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug
Concurrent participation in another therapeutic clinical trial
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 78 Locations for this study
Little Rock Arkansas, 72205, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Aurora Colorado, 80012, United States
Fort Myers Florida, 33909, United States
Saint Petersburg Florida, 33705, United States
Augusta Georgia, 30912, United States
Niles Illinois, 60714, United States
Louisville Kentucky, 40202, United States
Boston Massachusetts, 02215, United States
Hattiesburg Mississippi, 39401, United States
Bolivar Missouri, 65613, United States
Kansas City Missouri, 66211, United States
Omaha Nebraska, 68198, United States
Las Vegas Nevada, 89169, United States
Brick New Jersey, 08724, United States
Florham Park New Jersey, 07932, United States
Morristown New Jersey, 07960, United States
Lake Success New York, 11042, United States
New York New York, 10032, United States
Durham North Carolina, 27705, United States
Greenville North Carolina, 27834, United States
Columbus Ohio, 43210, United States
Eugene Oregon, 97401, United States
Portland Oregon, 97239, United States
Greenville South Carolina, 29601, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37211, United States
Austin Texas, 78705, United States
Dallas Texas, 75230, United States
Dallas Texas, 75231, United States
Dallas Texas, 75246, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Lubbock Texas, 79410, United States
San Antonio Texas, 78240, United States
Tyler Texas, 75702, United States
Roanoke Virginia, 24014, United States
Seattle Washington, 98108, United States
Seattle Washington, 98109, United States
Spokane Washington, 99208, United States
Newcastle New South Wales, , Australia
Woolloongabba Queensland, , Australia
Box Hill Victora, , Australia
Fitzroy Victoria, , Australia
Perth Western Australia, 6000, Australia
Clayton , , Australia
Frankston , 3199, Australia
Kurralta Park , 5037, Australia
Milton , 4066, Australia
Wodonga , , Australia
Brussel Brussels, 1090, Belgium
Yvoir Namur, , Belgium
Wilrijk , , Belgium
Hefei Anhui, 23000, China
Beijing Beijing, 10019, China
Beijing Beijing, 10073, China
Fuzhou Fujian, 35000, China
Quanzhou Fujian, 36200, China
Guangzhou Guangdong, , China
Guanzhou Guangdong, 51051, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43002, China
Nanjing Jiangsu, 21002, China
Xuzhou Jiangsu, 22100, China
Nanchang Jiangxi, , China
Changchun Jilin, 13002, China
Shenyang Liaoning, 11002, China
Shanghai Shanghai, 20009, China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, 30002, China
Hangzhou Zhejiang, 31000, China
Wenzhou Zhejiang, 32500, China
Beijing , 10005, China
Shanghai , 20003, China
Tianjin , 30006, China
Brno Jihomoravský Kraj, , Czechia
Hradec Králové , , Czechia
Olomouc , , Czechia
Ostrava , , Czechia
Cesson-Sévigné , , France
La Roche-sur-Yon , , France
Le Mans , , France
Pierre Benite , 69495, France
Poitiers , , France
Tours , , France
Bielefeld Nordrhein-Westfalen, 33604, Germany
Hamm Nordrhein-Westfalen, 59063, Germany
Köln Nordrhein-Westfalen, 50937, Germany
Münster Nordrhein-Westfalen, 48149, Germany
Dresden , 1127, Germany
Roma Lazio, , Italy
Milan Milano, , Italy
Milano , , Italy
Torino , 10126, Italy
Dordrecht Zuid-Holland, , Netherlands
Apeldoorn , , Netherlands
Groningen , , Netherlands
Takapuna Auckland, , New Zealand
Christchurch South Island, , New Zealand
Auckland , , New Zealand
Hamilton , , New Zealand
Newtown , 6021, New Zealand
Tauranga , 3143, New Zealand
Legnica Dolnoslaskie, , Poland
Brzozów JPodkarpackie, , Poland
Łódź Lódzkie, , Poland
Chorzów Slaskie, , Poland
Białystok , , Poland
Gdańsk , , Poland
Gdańsk , , Poland
Kraków , , Poland
Skorzewo , , Poland
Oviedo Asturias, , Spain
Santander Cantabria, , Spain
Pamplona Navarra, , Spain
Barcelona , , Spain
Barcelona , , Spain
Barcelona , , Spain
Barcelona , , Spain
Barcelona , , Spain
Girona , , Spain
Madrid , , Spain
Madrid , , Spain
Majadahonda , , Spain
Toledo , , Spain
Lund Skane, , Sweden
Borås , 50182, Sweden
Lulea , , Sweden
Stockholm , 17176, Sweden
Tekirdağ , , Turkey
Aberdeen Aberdeen City, , United Kingdom
Norwich Norfolk, , United Kingdom
Sunderland Northumberland, , United Kingdom
Sunderland Northumberland, , United Kingdom
Oxford Oxfordshire, , United Kingdom
Birmingham , , United Kingdom
Canterbury , CT1 3, United Kingdom
Leeds , , United Kingdom
London , , United Kingdom
London , , United Kingdom
Manchester , , United Kingdom
Nottingham , , United Kingdom
Plymouth , , United Kingdom
Southampton , , United Kingdom
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