A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
- Conditions
- Relapsed/Refractory Follicular Non-Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT03332017
- Lead Sponsor
- BeiGene
- Brief Summary
he purpose of the study is to evaluate the efficacy, safety, and tolerability BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 217
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Obinutuzumab Obinutuzumab Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days Zanubrutinib + Obinutuzumab Zanubrutinib Zanubrutinib 160 mg twice a day orally with or without food; Obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days Zanubrutinib + Obinutuzumab Obinutuzumab Zanubrutinib 160 mg twice a day orally with or without food; Obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days
- Primary Outcome Measures
Name Time Method Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment Through primary analysis data cut-off date of 08OCT2021 (up to approximately 3 years and 11 months) ORR is defined as the percentage of participants who achieve either complete response (CR) or partial response (PR) as best overall response, as assessed by the IRC using Lugano Classification for Non-Hodgkin Lymphoma
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Up to approximately 7 years Overall Survival (OS) Up to approximately 7 years Overall Response Rate (ORR) as Assessed by the Investigator Up to approximately 7 years Complete Response Rate Up to approximately 7 years Complete Metabolic Response Rate Up to approximately 7 years Progression Free Survival (PFS) Up to approximately 7 years Time to Response (TTR) Up to approximately 7 years Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) Up to approximately 7 years Safety and Tolerability
Apparent Clearance (CL/F) of Zanubrutinib Day 1 Cycle 1 and Day 2 Cycle 2: Predose Health-Related Quality of Life (HRQOL) as Assessed by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Up to approximately 7 years Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D Version (EQ-5D-5L) Up to approximately 7 years Area Under the Curve From 0 to 12 Hours Post Dose (AUC0-12) Day 1 Cycle 1 and Day 2 Cycle 2: Pre-dose
Trial Locations
- Locations (89)
University Multiprofile Hospital For Active Treatment Dr Georgi Stranski
🇧🇬Pleven, Bulgaria
Acibadem City Clinic Mhat Tokuda Ead
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital For Active Treatment Saint Ivan Rilski
🇧🇬Sofia, Bulgaria
University Multiprofile Hospital For Active Treatment Alexandrovska
🇧🇬Sofia, Bulgaria
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
🇵🇱Lodz, Poland
Centrum Onkologii Ziemi Lubelskiej
🇵🇱Lublin, Poland
Szpital Wojewodzki W Opolu
🇵🇱Opole, Poland
Vitebsk Regional Clinical Oncology Dispensary
🇧🇾Vitebsk, Belarus
Emory University Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
University of Illinois At Chicago
🇺🇸Chicago, Illinois, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Duke University
🇺🇸Durham, North Carolina, United States
Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Saint Vincents Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Icon Cancer Centre Wesley
🇦🇺Auchenflower, Queensland, Australia
Icon Cancer Foundation
🇦🇺South Brisbane, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
St Vincents Hospital Melbourne
🇦🇺Fitzroy, Victoria, Australia
Peninsula Private Hospital
🇦🇺Frankston, Victoria, Australia
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Minsk City Clinical Oncological Dispensary
🇧🇾Minsk, Belarus
Nn Alexandrov National Cancer Centre of Belarus
🇧🇾Minsk, Belarus
Peking University Peoples Hospital
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Guangdong Provincial Peoples Hospital
🇨🇳Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and 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, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Fakultni Nemocnice Brno
🇨🇿Brno, Czechia
Fakultni Nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Slezska Nemocnice V Opave
🇨🇿Opava, Czechia
Vseobecna Fakultni Nemocnice V Praze
🇨🇿Praha, Czechia
Centre Hospitalier Universitaire Damiens Hopital Sud
🇫🇷Amiens Cedex, France
Centre de Lutte Contre Le Cancer Institut Bergonie
🇫🇷Bordeaux, France
Centre Hospitalier de Dunkerque
🇫🇷Dunkerque, France
Clinique Louis Pasteur
🇫🇷Esseylesnancy, France
Necker University Hospital
🇫🇷Paris, France
Chu Bordeaux Hopital Haut Leveque
🇫🇷Pessac, France
Chu Hopital Lyon Sud
🇫🇷PierreBenite, France
Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard
🇫🇷Poitiers, France
Centre Henri Becquerel
🇫🇷Rouen Cedex, France
Klinikum Augsburg, Ii Medizinische Klinik
🇩🇪Augsburg, Germany
Azienda Ospedaliera Policlinico Di Bari
🇮🇹Bari, Italy
Policlinico Sorsola Malpighi, Aou Di Bologna
🇮🇹Bologna, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
Istituto Europeo Di Oncologia
🇮🇹Milano, Italy
Azienda Ospedaliero Universitaria Di Parma
🇮🇹Parma, Italy
Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia
🇮🇹Ravenna, Italy
Ospedale Di Circolo E Fondazione Macchi
🇮🇹Varese, Italy
Kyungpook National University Hospital
🇰🇷Daegu, Daegu Gwang'yeogsi, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnamsi, Gyeonggi-do, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
The Catholic University of Korea, Seoul St Marys Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Auckland City Hospital
🇳🇿Auckland, New Zealand
Aotearoa Clinical Trials
🇳🇿Auckland, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Malopolskie Centrum Medyczne Sc
🇵🇱Krakow, Poland
State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region
🇷🇺Sochi, Krasnodarskiy Kray, Russian Federation
N N Blokhin Russian Cancer Research Center Konstantin Laktionov
🇷🇺Moscow, Moskva, Russian Federation
Central City Hospital
🇷🇺Yekaterinburg, Sverdlovskaya Oblast', Russian Federation
Tula Area Clinical Hospital
🇷🇺Tula, Tul'skaya Oblast', Russian Federation
Institut Catala Doncologia
🇪🇸Barcelona, Spain
Hospital Universitario Puerta Del Mar
🇪🇸Cadiz, Spain
Md Anderson Cancer Center Madrid Spain
🇪🇸Madrid, Spain
Hospital Universitario Ramon Y Cajal
🇪🇸Madrid, Spain
Hospital Universitario de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo de Alarcon, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taipei Medical University Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital West Campus
🇨🇳Taipei, Taiwan
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
🇬🇧Bournemouth, United Kingdom
The Leeds Teaching Hospitals Nhs Trust
🇬🇧Leeds, United Kingdom
Barts Health Nhs Trust
🇬🇧London, United Kingdom
Norfolk and Norwich University Hospitals Nhs Foundation Trust
🇬🇧Norwich, United Kingdom