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.

View Eligibility Criteria

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
Clinically significant cardiovascular disease.
Major surgery or significant injury ≤ 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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

217

Study ID:

NCT03332017

Recruitment Status:

Active, not recruiting

Sponsor:

BeiGene

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There are 13 Locations for this study

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Emory University
Atlanta Georgia, 30322, United States
Northwestern University
Chicago Illinois, 60611, United States
University of Illinois Hospital & Health Sciences System
Chicago Illinois, 60612, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Comprehensive Cancer Centers
Las Vegas Nevada, 89014, United States
Summit Medical Group, PA
Florham Park New Jersey, 07932, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Concord Repatriation General Hospital
Concord New South Wales, , Australia
Saint Vincent's Hospital Sydney
Darlinghurst New South Wales, , Australia
Calvary Mater Newcastle Hospital
Waratah New South Wales, , Australia
Westmead Hospital
Westmead New South Wales, , Australia
Icon Cancer Care - Wesley
Auchenflower Queensland, , Australia
Icon Cancer Care South Brisbane
South Brisbane Queensland, , Australia
Royal Adelaide Hospital
Adelaide South Australia, , Australia
Monash Health
Clayton Victoria, , Australia
Saint Vincent's Hospital Melbourne
Fitzroy Victoria, , Australia
Peninsula Private Hospital
Frankston Victoria, , Australia
Royal Perth Hospital
Perth Western Australia, , Australia
The Canberra Hospital
Garran , , Australia
Gomel Regional Clinical Oncology Dispensary
Gomel , , Belarus
Minsk City Clinical Oncological Dispensary
Minsk , , Belarus
N.N. Alexandrov National Cancer Centre of Belarus
Minsk , , Belarus
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk , , Belarus
University Multiprofile Hospital for Active Treatment Alexandrovska
Sofia Sofiya-grad, , Bulgaria
University Multiprofile Hospital for Active Treatment Saint Ivan Rilski
Sofia Sofiya, , Bulgaria
University Multiprofile Hospital for Active Treatment
Pleven , , Bulgaria
Acibadem City Clinic MHAT Tokuda
Sofia , , Bulgaria
The Ottawa Hospital
Ottawa Ontario, , Canada
Jewish General Hospital
Montréal Quebec, , Canada
Peking University People Hospital
Beijing Beijing, 10003, China
Nanfang Hospital,Southern Medical University
Guangzhou Guangzhou, 51051, China
Tongji Hospital of Tongji Medical College Huazhong University of Science Technology
Wuhan Hubei, , China
Jiangsu Province Hospital
Nanjing Jiangsu, , China
Fudan University Shanghai Cancer Center
Shanghai Shanghai, , China
West China Hospital ,Sichuan University
Chengdu Sichuan, 61004, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin Tianjin, , China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou Zhejiang, , China
Beijing Cancer Hospital
Beijing , , China
Peking University Third Hospital
Beijing , , China
Second Affiliated Hospital of Army Medical University, PLA (Xinqiao Hospital)
Chongqing , , China
Guangdong General Hospital
Guangzhou , , China
Harbin Medical University Cancer Hospital
Heilongjiang , , China
Henan Cancer Hospital
Henan , , China
Zhejiang Cancer Hospital
Zhejiang , , China
Fakultní Nemocnice Brno
Brno Jihormoravsky KRAJ, , Czechia
Všeobecná Fakultní Nemocnice v Praze
Praha 2 Praha, , Czechia
Fakultni Nemocnice Hradec Králové
Hradec Králové 5 Vychodocesky KRAJ, , Czechia
Centre de Lutte Contre le Cancer - Institut Bergonie
Bordeaux Cedex Aquitaine, , France
Hôpital Haut-Lévêque
Pessac Cedex Aquitaine, , France
Centre Henri-Becquerel
Rouen Cedex 1 Haute-normandie, , France
Hopital Necker - Enfants Malades
Paris Ile-de-france, , France
Clinic Louis Pasteur
Essey-lès-Nancy Limousin, Lorraine, , France
Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy Limousin, Lorraine, , France
Centre Hospitalier de Dunkerque
Dunkerque Nord-pas-de-calais, , France
Centre Hospitalier Universitaire d'Amiens - Hopital Sud
Amiens Cedex 1 Picardie, , France
Centre Hospitalier Universitaire de Poitier- Hopital de la Miletrie - Hopital Jean Bernard
Poitiers Cedex Poitou-charentes, , France
Hôpital de la Conception
Marseille Cedex 05 Provence Alpes COTE D'azur, , France
Centre Hospitalier Lyon Sud
Lyon Rhone-alpes, , France
Robert-Bosch-Krankenhaus
Stuttgart Baden-wuerttemberg, , Germany
Universitätsklinikum Ulm
Ulm Baden-wuerttemberg, , Germany
Klinikum Augsburg
Augsburg Bayern, , Germany
Ospedale di Busto Arsizio
Busto Arsizio Varese, , Italy
Policlinico di Bari
Bari , , Italy
Policlinico Sant'Orsola Malpighi
Bologna , , Italy
Istituto Europeo di Oncologia
Milano , , Italy
Ospedale San Raffaele
Milano , , Italy
Azienda Unita Sanitaria Locale di Ravenna Ospedale Santa Maria delle Croci
Ravenna , , Italy
IRCCS Ospedale di Circolo e Fondazione Macchi
Varese , , Italy
Kyungpook National University Hospital
Daegu Chungcheongnam-do, , Korea, Republic of
National Cancer Center
Goyang-si Gyeonggi-do, , Korea, Republic of
Gachon University Gil Medical Center
Incheon Gyeonggi-do, , Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si Gyeonggi-do, , Korea, Republic of
Inje University Busan Paik Hospital
Busan Gyeongsangbuk-do, , Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun Jeollanam-do, , Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu , , Korea, Republic of
Korea University Anam Hospital
Seoul , , Korea, Republic of
Samsung Medical Center
Seoul , , Korea, Republic of
Seoul National University Hospital
Seoul , , Korea, Republic of
Seoul Saint Mary's Hospital
Seoul , , Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , , Korea, Republic of
Soon Chun Hyang University Hospital Seoul
Seoul , , Korea, Republic of
Middlemore Hospital
Otahuhu Auckland, , New Zealand
Auckland City Hospital
Auckland , , New Zealand
Canterbury Health Labs
Christchurch , , New Zealand
Wojewódzki Szpital Specjalistyczny w Legnicy
Legnica Dolnoslaskie, , Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Łódź Lodzkie, , Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin Lubelskie, , Poland
Pratia MCM Kraków
Kraków Malopolskie, , Poland
Szpital Wojewódzki w Opolu
Opole Opolskie, , Poland
Uniwersyteckie Centrum Kliniczne
Gdańsk Pomorskie, , Poland
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie - Oddział w Gliwicach
Gliwice Slaskie, , Poland
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev
Kemerovo , , Russian Federation
N. N. Blokhin Russian Cancer Research Center
Moscow , 11547, Russian Federation
Nizhniy Novgorod Regional Clinical Hospital N.A.
Nizhny Novgorod , , Russian Federation
Rostov State Medical University
Rostov , 34402, Russian Federation
FGU Russian Scientific Research Institute of Hematology and Transfusiology
Saint Petersburg , , Russian Federation
State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region
Sochi , , Russian Federation
Tula Area Clinical Hospital
Tula , , Russian Federation
State Budgetary Healthcare Institution. Volgograd
Volgograd , 40013, Russian Federation
Central City Hospital # 7
Yekaterinburg , , Russian Federation
Institut Català d'Oncologia de l'Hospitalet de Llobregat
L'Hospitalet De Llobregat Barcelona, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda Madrid, , Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón Madrid, , Spain
Hospital Universitario Puerta del Mar
Cadiz , , Spain
Hospital Universitario 12 de Octubre
Madrid , , Spain
Hospital Universitario Ramón Y Cajal
Madrid , , Spain
MD Anderson Cancer Center
Madrid , , Spain
Hospital Universitario de Salamanca
Salamanca , , Spain
Hospital de Día Quirónsalud Zaragoza
Zaragoza , , Spain
National Cheng Kung University Hospital
Tainan Tainan CITY, , Taiwan
Changhua Christian Hospital
Changhua , , Taiwan
Kaohsiung Medical University Hospital
Kaohsiung , , Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City , , Taiwan
E-DA Hospital
Taipei , , Taiwan
National Taiwan University Hospital
Taipei , , Taiwan
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth England, , United Kingdom
Barts Health NHS Trust
London England, , United Kingdom
Sarah Cannon Research Institute London
London England, , United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds , , United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

217

Study ID:

NCT03332017

Recruitment Status:

Active, not recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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