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Relapsed/Refractory Follicular Non-Hodgkin LymphomaPhase 2ROSEWOODNCT03332017

A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma

A Phase 2 study testing Zanubrutinib and Obinutuzumab in people with Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, run by BeiGene at 88 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zanubrutinib and Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
217 participants
Where
88 sitesin 17 countries
Study dates
14 Nov 2017to 27 Dec 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.
  • Note: Other protocol-defined inclusion and exclusion criteria may have applied.

Trial locations and contacts

88 sites in 17 countries.

88 sites in 17 countries

Australia12 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, SA 5000

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, QLD 4066

  • Monash Health

    Clayton, Victoria, VIC 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, NSW 2139

  • Saint Vincents Hospital Sydney

    Darlinghurst, New South Wales, NSW 2010

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, VIC 3065

  • Peninsula Private Hospital

    Frankston, Victoria, VIC 3199

  • Canberra Hospital

    Garran, Australian Capital Territory, ACT 2605

  • Royal Perth Hospital

    Perth, Western Australia, WA 6000

  • Icon Cancer Foundation

    South Brisbane, Queensland, QLD 4101

  • Calvary Mater Newcastle

    Waratah, New South Wales, NSW 2298

  • Westmead Hospital

    Westmead, New South Wales, NSW 2145

Other trials in Australia

China12 sites

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

France9 sites

  • Centre Hospitalier Universitaire Damiens Hopital Sud

    Amiens, 80054

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33000

  • Centre Hospitalier de Dunkerque

    Dunkirk, 59240

  • Clinique Louis Pasteur

    Esseylesnancy, 54270

  • Necker University Hospital

    Paris, 75015

  • Chu Bordeaux Hopital Haut Leveque

    Pessac, 33600

  • Chu Hopital Lyon Sud

    PierreBenite, 69495

  • Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard

    Poitiers, 86000

  • Centre Henri Becquerel

    Rouen, 76038

Other trials in France

Spain8 sites

  • Institut Catala Doncologia

    Barcelona, 08908

  • Hospital Universitario Puerta Del Mar

    Cadiz, 11009

  • Md Anderson Cancer Center Madrid Spain

    Madrid, 28033

  • Hospital Universitario de Octubre

    Madrid, 28041

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28048

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223

  • Hospital Universitario de Salamanca

    Salamanca, 37007

Other trials in Spain

Italy7 sites

  • Azienda Ospedaliera Policlinico Di Bari

    Bari, 70124

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138

  • Ospedale San Raffaele

    Milan, 20132

  • Istituto Europeo Di Oncologia

    Milan, 20141

  • Azienda Ospedaliero Universitaria Di Parma

    Parma, 43126

  • Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia

    Ravenna, 48121

  • Ospedale Di Circolo E Fondazione Macchi

    Varese, 21100

Other trials in Italy

United States4 sites

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322-1013

  • University of Illinois At Chicago

    Chicago, Illinois, 60612-4795

  • Duke University

    Durham, North Carolina, 27710

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169-3321

Other trials in United States

Bulgaria4 sites

  • University Multiprofile Hospital For Active Treatment Dr Georgi Stranski

    Pleven, 5803

  • Acibadem City Clinic Mhat Tokuda Ead

    Sofia, 1407

  • University Multiprofile Hospital For Active Treatment Saint Ivan Rilski

    Sofia, 1407

  • University Multiprofile Hospital For Active Treatment Alexandrovska

    Sofia, 1431

Other trials in Bulgaria

Czechia4 sites

  • Fakultni Nemocnice Brno

    Brno, 625 00

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 03

  • Slezska Nemocnice V Opave

    Opava, 746 01

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 10000

Other trials in Czechia

Poland4 sites

  • Pratia McM Krakow

    Krakow, 30-727

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-513

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, 20-090

  • Szpital Wojewodzki W Opolu

    Opole, 45-372

Other trials in Poland

South Korea4 sites

  • Seoul National University Bundang Hospital

    BundangGu SeongnamSi, Gyeonggi-do, 13620

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

  • Kyungpook National University Hospital

    Junggu, Daegu Gwang'yeogsi, 41944

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi, 06591

Other trials in South Korea

Taiwan4 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807

  • National Cheng Kung University Hospital

    North Dist, 704

  • Taipei Medical University Shuang Ho Hospital

    Zhonghe Dist, 235041

  • National Taiwan University Hospital West Campus

    Zhongzheng Dist, 10048

Other trials in Taiwan

United Kingdom4 sites

  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

    Bournemouth, BH7 7DW

  • The Leeds Teaching Hospitals Nhs Trust

    Leeds, LS9 7TF

  • Barts Health Nhs Trust

    London, EC1A 7BE

  • Norfolk and Norwich University Hospitals Nhs Foundation Trust

    Norwich, NR4 7UY

Other trials in United Kingdom

Belarus3 sites

  • Minsk City Clinical Oncological Dispensary

    Minsk, 220013

  • Nn Alexandrov National Cancer Centre of Belarus

    Minsk, 223040

  • Vitebsk Regional Clinical Oncology Dispensary

    Vitebsk, 210603

Other trials in Belarus

New Zealand3 sites

  • Auckland City Hospital

    Auckland, 1023

  • Aotearoa Clinical Trials

    Auckland, 2025

  • Christchurch Hospital

    Christchurch, 8011

Other trials in New Zealand

Russia3 sites

  • N N Blokhin Russian Cancer Research Center Konstantin Laktionov

    Moscow, Moscow, 115478

  • State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region

    Sochi, Krasnodarskiy Kray, 354000

  • Central City Hospital

    Yekaterinburg, Sverdlovsk Oblast, 620137

Other trials in Russia

Canada2 sites

  • Jewish General Hospital

    Montreal, Quebec, QC H3t 1E2

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Germany1 site

  • Universitatsklinikum Augsburg

    Augsburg, 86156

Other trials in Germany

About this study

Official title: An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma

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.

Read the detailed description

This study randomly assigned participants in a 2:1 ratio to receive either zanubrutinib plus obinutuzumab or obinutuzumab alone. The assignment considered how many prior treatments participants had received, whether their cancer had stopped responding to rituximab, and whether they were enrolled in Mainland China or other regions. Each treatment cycle lasted 28 days, with zanubrutinib taken by mouth twice daily and obinutuzumab given intravenously on a set schedule, followed by optional maintenance for up to 24 months. Participants who had obinutuzumab alone could have switched to the combination treatment if their disease worsened or did not respond after 12 months, if confirmed by an independent review.

Being tested
Zanubrutinib, Obinutuzumab
Keywords
Relapsed/Refractory Follicular non-Hodgkin Lymphoma
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZanubrutinibDrug

    Also called BGB-3111, Brukinsa

    Oral administration as a capsule

  • ObinutuzumabDrug

    Also called Gazyva

    Intravenous administration

Study groups in NCT03332017
Study groupRoleWhat they receive
ObinutuzumabExperimentalParticipants 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.
Receives: Drug: Obinutuzumab
Zanubrutinib + ObinutuzumabExperimentalParticipants 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.
Receives: Drug: Zanubrutinib; Drug: Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Overall Response Rate (ORR) as Assessed by the Investigator

    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.

    Measured: 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.

  2. Duration of Response (DOR) as Determined by Investigator Assessment

    DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method.

    Measured: 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.

  3. DOR as Determined by ICR

    DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method.

    Measured: 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.

  4. Progression-free Survival (PFS)

    PFS was defined as the time from randomization to the date of first documented disease progression or death from any cause, whichever occurred first, as determined by the ICR or investigator assessment. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the PFS calculation. Median PFS was estimated using the Kaplan-Meier method.

    Measured: 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.

  5. Overall Survival (OS)

    OS was defined as the time from randomization to the date of death from any cause. Median OS was estimated using the Kaplan-Meier method.

    Measured: 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.

  6. Complete Response Rate

    CRR was defined as the percentage of participants who achieved a complete response or complete metabolic response as their best overall response, as determined by ICR and investigator assessment. Responses were assessed from randomization until the data cutoff date, the start of a new anticancer therapy, or the crossover date for participants in the monotherapy arm who switched to combination therapy.

    Measured: 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.

  7. Time to Response (TTR)

    TRR was defined as the time from randomization to the first date that response criteria (CR or PR) were met, as determined by ICR and investigator assessment. Only participants who achieved an overall response were included in the analysis. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the TRR calculation.

    Measured: 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.

  8. Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, Role Functioning, and Symptom Scores

    The EORTC QLQ-C30 includes 30 questions covering 5 functional scales (physical, role, emotional, cognitive, social), 1 global health scale, 3 symptom scales (fatigue, nausea/vomiting, pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Participants report their health over the past week. Most items use a 4-point scale (1 = Not at all to 4 = Very much), while 2 global QOL items use a 7-point scale (1 = Very poor to 7 = Excellent). Raw scores are linearly transformed to a 0-100 scale; higher GHS and functional scores and lower symptom scores indicate better quality of life.

    Measured: Baseline, Week 12, and Week 24

  9. Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)

    The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.

    Measured: Baseline, Week 12, and Week 24

  10. Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is linked to the study drug.

    Measured: From first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.

  11. Area Under the Curve (AUCss) of Zanubrutinib at Steady State

    Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model.

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.

  12. Zanubrutinib Plasma Concentrations

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.

  13. Minimum Observed Concentration (Cmin) of Zanubrutinib at Steady State

    Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model.

    Measured: Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.

  14. Maximum Observed Concentration (Cmax) of Zanubrutinib at Steady State

    Measured: Cycle 1 Day 1 (2 hours postdose) and Cycle 2 Day 1 (predose and 2 hours postdose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start14 Nov 2017
  3. Primary completion8 Oct 2021
  4. Study completion27 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03332017
Sponsor's protocol ID
BGB-3111-212
Other IDs
2017-001552-54, CTR20220712, 2023-509975-17-00, 2023, 2017
Acronym
ROSEWOOD
Status last verified
Jan 2026
First submitted
31 Oct 2017
Last updated
18 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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, 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

  • Judith 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

  • 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.

    PubMed 37506346

  • Zinzani 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

  • Trotman 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.

  • Flowers 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

  • Gaballa 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

  • 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.

    PubMed 39376156

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zanubrutinib and Obinutuzumab in people with Relapsed/Refractory Follicular Non-Hodgkin Lymphoma, run by BeiGene at 88 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in Australia, China, France, Spain, Italy and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) by Independent Central Review (ICR) Assessment (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03332017, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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