A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
ROSEWOOD
An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma
4 other identifiers
interventional
217
17 countries
88
Brief Summary
This clinical study examined the safety and efficacy of the combination of zanubrutinib and obinutuzumab versus obinutuzumab alone in adults with follicular lymphoma whose disease returned after or did not respond to prior therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2017
Longer than P75 for phase_2
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedStudy Start
First participant enrolled
November 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 8, 2021
CompletedResults Posted
Study results publicly available
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2024
CompletedFebruary 18, 2026
January 1, 2026
3.9 years
October 31, 2017
April 3, 2024
January 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR) by Independent Central Review (ICR) Assessment
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma.
From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
Secondary Outcomes (14)
Overall Response Rate (ORR) as Assessed by the Investigator
From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
Duration of Response (DOR) as Determined by Investigator Assessment
From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
DOR as Determined by ICR
From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
Progression-free Survival (PFS)
From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
Overall Survival (OS)
From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
- +9 more secondary outcomes
Study Arms (2)
Obinutuzumab
EXPERIMENTALParticipants received 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 for an additional 24 months or until disease progression. Each treatment cycle was 28 days. Participants who experienced progressive disease or did not respond to therapy within 12 months may have received crossover treatment with zanubrutinib + obinutuzumab at the investigator's discretion.
Zanubrutinib + Obinutuzumab
EXPERIMENTALParticipants received zanubrutinib 160 mg twice a day orally with or without food and 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 for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
Interventions
Oral administration as a capsule
Intravenous administration
Eligibility Criteria
You may qualify if:
- Participants had a histologically confirmed diagnosis of B-cell follicular lymphoma.
- Participants had received two or more prior systemic treatments for follicular lymphoma.
- Participants had previously received both an anti-cluster of differentiation 20 (anti-CD20) antibody and an appropriate alkylator-based combination therapy.
- Participants had disease that had progressed after completion of the most recent therapy or was considered refractory to treatment.
- Participants had measurable disease present.
- Archival tissue confirming the diagnosis was available.
- Participants had an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Participants had adequate renal and hepatic function.
You may not qualify if:
- Participants had prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
- Participants had known central nervous system involvement by leukemia or lymphoma.
- Participants had evidence of transformation from follicular lymphoma to another aggressive histologic subtype.
- Participants had undergone an allogeneic hematopoietic stem cell transplantation within 12 months of enrollment.
- Participants had a prior malignancy within the past 2 years, except for those who had curatively treated basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized prostate cancer with a Gleason score of 6.
- Participants had clinically significant cardiovascular disease.
- Participants had undergone major surgery within 4 weeks prior to the start of study treatment.
- Participants had an active fungal, bacterial, or viral infection requiring systemic treatment.
- Participants had a history of severe bleeding disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeiGenelead
Study Sites (88)
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322-1013, United States
University of Illinois At Chicago
Chicago, Illinois, 60612-4795, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169-3321, United States
Duke University
Durham, North Carolina, 27710, United States
Canberra Hospital
Garran, Australian Capital Territory, ACT 2605, Australia
Concord Repatriation General Hospital
Concord, New South Wales, NSW 2139, Australia
Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, NSW 2010, Australia
Calvary Mater Newcastle
Waratah, New South Wales, NSW 2298, Australia
Westmead Hospital
Westmead, New South Wales, NSW 2145, Australia
Icon Cancer Centre Wesley
Auchenflower, Queensland, QLD 4066, Australia
Icon Cancer Foundation
South Brisbane, Queensland, QLD 4101, Australia
Royal Adelaide Hospital
Adelaide, South Australia, SA 5000, Australia
Monash Health
Clayton, Victoria, VIC 3168, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, VIC 3065, Australia
Peninsula Private Hospital
Frankston, Victoria, VIC 3199, Australia
Royal Perth Hospital
Perth, Western Australia, WA 6000, Australia
Minsk City Clinical Oncological Dispensary
Minsk, 220013, Belarus
Nn Alexandrov National Cancer Centre of Belarus
Minsk, 223040, Belarus
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, 210603, Belarus
University Multiprofile Hospital For Active Treatment Dr Georgi Stranski
Pleven, 5803, Bulgaria
Acibadem City Clinic Mhat Tokuda Ead
Sofia, 1407, Bulgaria
University Multiprofile Hospital For Active Treatment Saint Ivan Rilski
Sofia, 1407, Bulgaria
University Multiprofile Hospital For Active Treatment Alexandrovska
Sofia, 1431, Bulgaria
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Jewish General Hospital
Montreal, Quebec, QC H3t 1E2, Canada
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510080, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Fakultni Nemocnice Brno
Brno, 625 00, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 03, Czechia
Slezska Nemocnice V Opave
Opava, 746 01, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, 10000, Czechia
Centre Hospitalier Universitaire Damiens Hopital Sud
Amiens, 80054, France
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33000, France
Centre Hospitalier de Dunkerque
Dunkirk, 59240, France
Clinique Louis Pasteur
Esseylesnancy, 54270, France
Necker University Hospital
Paris, 75015, France
Chu Bordeaux Hopital Haut Leveque
Pessac, 33600, France
Chu Hopital Lyon Sud
PierreBenite, 69495, France
Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard
Poitiers, 86000, France
Centre Henri Becquerel
Rouen, 76038, France
Universitatsklinikum Augsburg
Augsburg, 86156, Germany
Azienda Ospedaliera Policlinico Di Bari
Bari, 70124, Italy
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Istituto Europeo Di Oncologia
Milan, 20141, Italy
Azienda Ospedaliero Universitaria Di Parma
Parma, 43126, Italy
Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia
Ravenna, 48121, Italy
Ospedale Di Circolo E Fondazione Macchi
Varese, 21100, Italy
Auckland City Hospital
Auckland, 1023, New Zealand
Aotearoa Clinical Trials
Auckland, 2025, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Pratia McM Krakow
Krakow, 30-727, Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, 93-513, Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin, 20-090, Poland
Szpital Wojewodzki W Opolu
Opole, 45-372, Poland
State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region
Sochi, Krasnodarskiy Kray, 354000, Russia
N N Blokhin Russian Cancer Research Center Konstantin Laktionov
Moscow, Moscow, 115478, Russia
Central City Hospital
Yekaterinburg, Sverdlovsk Oblast, 620137, Russia
Kyungpook National University Hospital
Junggu, Daegu Gwang'yeogsi, 41944, South Korea
Seoul National University Bundang Hospital
BundangGu SeongnamSi, Gyeonggi-do, 13620, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591, South Korea
Institut Catala Doncologia
Barcelona, 08908, Spain
Hospital Universitario Puerta Del Mar
Cadiz, 11009, Spain
Md Anderson Cancer Center Madrid Spain
Madrid, 28033, Spain
Hospital Universitario de Octubre
Madrid, 28041, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28048, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
National Cheng Kung University Hospital
North Dist, 704, Taiwan
Taipei Medical University Shuang Ho Hospital
Zhonghe Dist, 235041, Taiwan
National Taiwan University Hospital West Campus
Zhongzheng Dist, 10048, Taiwan
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth, BH7 7DW, United Kingdom
The Leeds Teaching Hospitals Nhs Trust
Leeds, LS9 7TF, United Kingdom
Barts Health Nhs Trust
London, EC1A 7BE, United Kingdom
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Norwich, NR4 7UY, United Kingdom
Related Publications (11)
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.
BACKGROUNDFowler 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
BACKGROUNDFowler 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
BACKGROUNDTrotman J, Zinzani PL, Song Y, et al. Health-Related Quality of Life (HRQoL) in Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL) Treated With Zanubrutinib + Obinutuzumab Versus Obinutuzumab Monotherapy: The ROSEWOOD Trial. Poster presented at: 65th ASH Annual Meeting and Exposition; December, 2023; San Diego, CA. https://doi.org/10.1182/blood-2023-181195
BACKGROUNDJudith Trotman, Pier Luigi Zinzani, Krimo Bouabdallah, Shanmei Liao, Adam Greenbaum, Laura Dima, Laurent Dumartin; Comparative Efficacy of Zanubrutinib Plus Obinutuzumab Versus Last Prior Treatment in Relapsed/Refractory Follicular Lymphoma: Growth Modulation Index Analysis from ROSEWOOD Study. Blood 2024; 144 (Supplement 1): 3029. doi: https://doi.org/10.1182/blood-2024-198500
RESULTZinzani 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.
PMID: 37506346RESULTZinzani PL, Mayer J, Trotman J, et al. Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma: Updated Analysis of the ROSEWOOD Study. Oral presentation at: 17th International Conference on Malignant Lymphoma; June, 2023; Lugano, Switzerland. https://doi.org/10.1002/hon.3163_81
RESULTTrotman J, Zinzani PL Mayer J, et al. Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma: Updated Analysis of the ROSEWOOD Study. Poster presented at: European Hematology Association; June, 2023; Frankfurt, Germany.
RESULTFlowers CR, Zinzani PL, Mayer J, et al. Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab in Patients With Relapsed or Refractory Follicular Lymphoma: Updated Analysis of the ROSEWOOD Study. Poster presented at: 2023 ASCO Annual Meeting; June, 2023; Chicago, IL. https://doi.org/10.1200/JCO.2023.41.16_suppl.7545
RESULTGaballa S, Xue M, Swami S, et al. Cost-effectiveness of Zanubrutinib + Obinutuzumab for Treatment of Relapsed or Refractory Follicular Lymphoma in the United States. Poster presented at: International Society for Pharmacoeconomics and Outcomes Research Europe 2024; November, 2024; Barcelona, Spain. https://www.ispor.org/heor-resources/presentations-database/presentation/intl2024-3896/136274 http://reg2022.csco.org.cn/24?lang=en
RESULTTrotman 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.
PMID: 39376156DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- BeiGene
Study Officials
- STUDY DIRECTOR
Study Director
BeiGene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2017
First Posted
November 6, 2017
Study Start
November 14, 2017
Primary Completion
October 8, 2021
Study Completion
December 27, 2024
Last Updated
February 18, 2026
Results First Posted
April 30, 2024
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.