Non Hodgkin Lymphoma Clinical Trial
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
Summary
The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.
Eligibility Criteria
Key Inclusion Criteria:
Histologically confirmed diagnosis of B-cell follicular lymphoma
≥2 prior systemic treatments for follicular lymphoma.
Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy.
Disease progression after completion of most recent therapy or refractory disease.
Presence of measurable disease.
Availability of archival tissue confirming diagnosis.
Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
Adequate renal and hepatic function.
Key Exclusion Criteria:
Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
Known central nervous system involvement by leukemia or lymphoma.
Evidence of transformation from follicular lymphoma to other aggressive histology.
Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment
Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix of breast, or localized Gleason score 6 prostate cancer.
Clinically significant cardiovascular disease.
Major surgery ≤ 4 weeks prior to start of study treatment.
Active fungal, bacterial or viral infection requiring systemic treatment.
History of severe bleeding disorder.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 13 Locations for this study
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Maywood Illinois, 60153, United States
Las Vegas Nevada, 89014, United States
Florham Park New Jersey, 07932, United States
Durham North Carolina, 27710, United States
Concord New South Wales, , Australia
Darlinghurst New South Wales, , Australia
Waratah New South Wales, , Australia
Westmead New South Wales, , Australia
Auchenflower Queensland, , Australia
South Brisbane Queensland, , Australia
Adelaide South Australia, , Australia
Clayton Victoria, , Australia
Fitzroy Victoria, , Australia
Frankston Victoria, , Australia
Perth Western Australia, , Australia
Garran , , Australia
Gomel , , Belarus
Minsk , , Belarus
Minsk , , Belarus
Vitebsk , , Belarus
Sofia Sofiya-grad, , Bulgaria
Sofia Sofiya, , Bulgaria
Pleven , , Bulgaria
Sofia , , Bulgaria
Ottawa Ontario, , Canada
Montréal Quebec, , Canada
Beijing Beijing, 10003, China
Guangzhou Guangzhou, 51051, China
Wuhan Hubei, , China
Nanjing Jiangsu, , China
Shanghai Shanghai, , China
Chengdu Sichuan, 61004, China
Tianjin Tianjin, , China
Hangzhou Zhejiang, , China
Beijing , , China
Beijing , , China
Chongqing , , China
Guangzhou , , China
Heilongjiang , , China
Henan , , China
Zhejiang , , China
Brno Jihormoravsky KRAJ, , Czechia
Praha 2 Praha, , Czechia
Hradec Králové 5 Vychodocesky KRAJ, , Czechia
Bordeaux Cedex Aquitaine, , France
Pessac Cedex Aquitaine, , France
Rouen Cedex 1 Haute-normandie, , France
Paris Ile-de-france, , France
Essey-lès-Nancy Limousin, Lorraine, , France
Vandœuvre-lès-Nancy Limousin, Lorraine, , France
Dunkerque Nord-pas-de-calais, , France
Amiens Cedex 1 Picardie, , France
Poitiers Cedex Poitou-charentes, , France
Marseille Cedex 05 Provence Alpes COTE D'azur, , France
Lyon Rhone-alpes, , France
Stuttgart Baden-wuerttemberg, , Germany
Ulm Baden-wuerttemberg, , Germany
Augsburg Bayern, , Germany
Busto Arsizio Varese, , Italy
Bari , , Italy
Bologna , , Italy
Milano , , Italy
Milano , , Italy
Ravenna , , Italy
Varese , , Italy
Daegu Chungcheongnam-do, , Korea, Republic of
Goyang-si Gyeonggi-do, , Korea, Republic of
Incheon Gyeonggi-do, , Korea, Republic of
Seongnam-si Gyeonggi-do, , Korea, Republic of
Busan Gyeongsangbuk-do, , Korea, Republic of
Hwasun Jeollanam-do, , Korea, Republic of
Daegu , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Seoul , , Korea, Republic of
Otahuhu Auckland, , New Zealand
Auckland , , New Zealand
Christchurch , , New Zealand
Legnica Dolnoslaskie, , Poland
Łódź Lodzkie, , Poland
Lublin Lubelskie, , Poland
Kraków Malopolskie, , Poland
Opole Opolskie, , Poland
Gdańsk Pomorskie, , Poland
Gliwice Slaskie, , Poland
Kemerovo , , Russian Federation
Moscow , 11547, Russian Federation
Nizhny Novgorod , , Russian Federation
Rostov , 34402, Russian Federation
Saint Petersburg , , Russian Federation
Sochi , , Russian Federation
Tula , , Russian Federation
Volgograd , 40013, Russian Federation
Yekaterinburg , , Russian Federation
L'Hospitalet De Llobregat Barcelona, , Spain
Majadahonda Madrid, , Spain
Pozuelo de Alarcón Madrid, , Spain
Cadiz , , Spain
Madrid , , Spain
Madrid , , Spain
Madrid , , Spain
Salamanca , , Spain
Zaragoza , , Spain
Tainan Tainan CITY, , Taiwan
Changhua , , Taiwan
Kaohsiung , , Taiwan
New Taipei City , , Taiwan
Taipei , , Taiwan
Taipei , , Taiwan
Bournemouth England, , United Kingdom
London England, , United Kingdom
London England, , United Kingdom
Leeds , , United Kingdom
Norwich , , United Kingdom
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