A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
NCT ID: NCT03332017
Last Updated: 2025-01-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
217 participants
INTERVENTIONAL
2017-11-14
2024-12-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Obinutuzumab
Intravenous administration
Zanubrutinib + 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
Zanubrutinib
Oral administration as a capsule
Obinutuzumab
Intravenous administration
Interventions
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Zanubrutinib
Oral administration as a capsule
Obinutuzumab
Intravenous administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ≥2 prior systemic treatments for follicular lymphoma.
3. Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy.
4. Disease progression after completion of most recent therapy or refractory disease.
5. Presence of measurable disease.
6. Availability of archival tissue confirming diagnosis.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
8. Adequate renal and hepatic function.
Exclusion Criteria
2. Known central nervous system involvement by leukemia or lymphoma.
3. Evidence of transformation from follicular lymphoma to other aggressive histology.
4. Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment
5. 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.
6. Clinically significant cardiovascular disease.
7. Major surgery ≤ 4 weeks prior to start of study treatment.
8. Active fungal, bacterial or viral infection requiring systemic treatment.
9. History of severe bleeding disorder.
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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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
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, , Belarus
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 Municipality, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 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 Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Fakultni Nemocnice Brno
Brno, , Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, , Czechia
Slezska Nemocnice V Opave
Opava, , Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, , Czechia
Centre Hospitalier Universitaire Damiens Hopital Sud
Amiens, , France
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, , France
Centre Hospitalier de Dunkerque
Dunkirk, , 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, , 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
Milan, , Italy
Istituto Europeo Di Oncologia
Milan, , 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
Auckland City Hospital
Auckland, , New Zealand
Aotearoa Clinical Trials
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Malopolskie Centrum Medyczne Sc
Krakow, , Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, , Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin, , Poland
Szpital Wojewodzki W Opolu
Opole, , Poland
State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region
Sochi, Krasnodarskiy Kray, Russia
N N Blokhin Russian Cancer Research Center Konstantin Laktionov
Moscow, Moscow, Russia
Central City Hospital
Yekaterinburg, Sverdlovsk Oblast, Russia
Tula Area Clinical Hospital
Tula, Tula Oblast, Russia
Kyungpook National University Hospital
Daegu, Daegu Gwang'yeogsi, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
Seoul, Seoul Teugbyeolsi, South Korea
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 Alarcón, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, , Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , 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
Countries
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References
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Trotman J, Folwer N, Auer R, Flowers C, Reed W, Stern JC, Huang J, Zinzani PL. Phase 2 Obinutuzumab Zanubrutinib (BGB-3111) in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL). American Society of Clinical Oncology, 2018.
Fowler N, Trotman J, Auer R, Flowers C, Reed W, Marimpietri C, Huang J, Zinzani PL.Randomized phase 2 zanubrutinib (BGB-3111) + obinutuzumab (obi) vs obi monotherapy in patients (pts) with relapsed/refractory follicular lymphoma (R/R FL). American Society of Clinical Oncology. 2019
Fowler NH, Trotman J, Auer R, Flowers CR, Reed WF, Ivanova E, Huang J, Zinzani PL.Randomized Phase 2 Zanubrutinib (BGB-3111) + Obinutuzumab vs Obinutuzumab Monotherapy in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL). American Society of Hematology. 2019
Trotman J, Zinzani PL, Song Y, Delarue R, Kim P, Ivanova E, Korde R, Mayer J, De Oliveira AC, Assouline SE, Flowers CR, Barnes G. Patient-reported outcomes in patients with relapsed or refractory follicular lymphoma treated with zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy: results from the ROSEWOOD trial. Curr Med Res Opin. 2024 Nov;40(11):1863-1871. doi: 10.1080/03007995.2024.2409837. Epub 2024 Oct 14.
Zinzani PL, Mayer J, Flowers CR, Bijou F, De Oliveira AC, Song Y, Zhang Q, Merli M, Bouabdallah K, Ganly P, Zhang H, Johnson R, Martin Garcia-Sancho A, Provencio Pulla M, Trneny M, Yuen S, Tilly H, Kingsley E, Tumyan G, Assouline SE, Auer R, Ivanova E, Kim P, Huang S, Delarue R, Trotman J. ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma. J Clin Oncol. 2023 Nov 20;41(33):5107-5117. doi: 10.1200/JCO.23.00775. Epub 2023 Jul 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-001552-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTR20220712
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-3111-212
Identifier Type: -
Identifier Source: org_study_id
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