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

January 30, 2026 updated by: BeiGene

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, ACT 2605
        • Canberra Hospital
    • New South Wales
      • Concord, New South Wales, Australia, NSW 2139
        • Concord Repatriation General Hospital
      • Darlinghurst, New South Wales, Australia, NSW 2010
        • Saint Vincents Hospital Sydney
      • Waratah, New South Wales, Australia, NSW 2298
        • Calvary Mater Newcastle
      • Westmead, New South Wales, Australia, NSW 2145
        • Westmead Hospital
    • Queensland
      • Auchenflower, Queensland, Australia, QLD 4066
        • Icon Cancer Centre Wesley
      • South Brisbane, Queensland, Australia, QLD 4101
        • Icon Cancer Foundation
    • South Australia
      • Adelaide, South Australia, Australia, SA 5000
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia, VIC 3168
        • Monash Health
      • Fitzroy, Victoria, Australia, VIC 3065
        • St Vincents Hospital Melbourne
      • Frankston, Victoria, Australia, VIC 3199
        • Peninsula Private Hospital
    • Western Australia
      • Perth, Western Australia, Australia, WA 6000
        • Royal Perth Hospital
  • Belarus
      • Minsk, Belarus, 220013
        • Minsk city Clinical Oncological Dispensary
      • Minsk, Belarus, 223040
        • NN Alexandrov National Cancer Centre of Belarus
      • Vitebsk, Belarus, 210603
        • Vitebsk Regional Clinical Oncology Dispensary
  • Bulgaria
      • Pleven, Bulgaria, 5803
        • University Multiprofile Hospital For Active Treatment Dr Georgi Stranski
      • Sofia, Bulgaria, 1431
        • University Multiprofile Hospital for Active Treatment Alexandrovska
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Mhat Tokuda Ead
      • Sofia, Bulgaria, 1407
        • University Multiprofile Hospital For Active Treatment Saint Ivan Rilski
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital
    • Quebec
      • Montreal, Quebec, Canada, QC H3t 1E2
        • Jewish General Hospital
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer hospital
      • Beijing, Beijing Municipality, China, 100000
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, China, 100044
        • Peking University Peoples Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial Peoples Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Henan cancer hospital
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Fudan University Shanghai Cancer Center
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni nemocnice Brno
      • Hradec Králové, Czechia, 500 03
        • Fakultni nemocnice Hradec Kralove
      • Opava, Czechia, 746 01
        • Slezska nemocnice v Opave
      • Prague, Czechia, 10000
        • Vseobecna Fakultni Nemocnice V Praze
  • France
      • Amiens, France, 80054
        • Centre Hospitalier Universitaire Damiens Hopital Sud
      • Bordeaux, France, 33000
        • Centre de Lutte Contre Le Cancer Institut Bergonie
      • Dunkirk, France, 59240
        • Centre Hospitalier de Dunkerque
      • Esseylesnancy, France, 54270
        • Clinique Louis Pasteur
      • Paris, France, 75015
        • Necker University Hospital
      • Pessac, France, 33600
        • CHU Bordeaux Hôpital Haut Lévèque
      • PierreBenite, France, 69495
        • Chu Hopital Lyon Sud
      • Poitiers, France, 86000
        • Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard
      • Rouen, France, 76038
        • Centre Henri Becquerel
  • Germany
      • Augsburg, Germany, 86156
        • Universitätsklinikum Augsburg
  • Italy
      • Bari, Italy, 70124
        • Azienda Ospedaliera Policlinico Di Bari
      • Bologna, Italy, 40138
        • Policlinico Sorsola Malpighi, Aou Di Bologna
      • Milan, Italy, 20132
        • Ospedale San Raffaele
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia
      • Parma, Italy, 43126
        • Azienda Ospedaliero Universitaria di Parma
      • Ravenna, Italy, 48121
        • Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia
      • Varese, Italy, 21100
        • Ospedale di Circolo e Fondazione Macchi
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Auckland, New Zealand, 2025
        • Aotearoa Clinical Trials
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
  • Poland
      • Krakow, Poland, 30-727
        • Pratia MCM Krakow
      • Lodz, Poland, 93-513
        • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi Lubelskiej
      • Opole, Poland, 45-372
        • Szpital Wojewodzki w Opolu
  • Russia
    • Krasnodarskiy Kray
      • Sochi, Krasnodarskiy Kray, Russia, 354000
        • State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region
    • Moscow
      • Moscow, Moscow, Russia, 115478
        • N N Blokhin Russian Cancer Research Center Konstantin Laktionov
    • Sverdlovsk Oblast
      • Yekaterinburg, Sverdlovsk Oblast, Russia, 620137
        • Central City Hospital
  • South Korea
    • Daegu Gwang'yeogsi
      • Junggu, Daegu Gwang'yeogsi, South Korea, 41944
        • Kyungpook National University Hospital
    • Gyeonggi-do
      • BundangGu SeongnamSi, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
    • Seoul Teugbyeolsi
      • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center
      • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St Marys Hospital
  • Spain
      • Barcelona, Spain, 08908
        • Institut Catala Doncologia
      • Cadiz, Spain, 11009
        • Hospital Universitario Puerta del Mar
      • Madrid, Spain, 28041
        • Hospital Universitario de Octubre
      • Madrid, Spain, 28033
        • Md Anderson Cancer Center Madrid Spain
      • Madrid, Spain, 28048
        • Hospital Universitario Ramon y Cajal
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Pozuelo de Alarcón, Spain, 28223
        • Hospital Universitario Quironsalud Madrid
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • North Dist, Taiwan, 704
        • National Cheng Kung University Hospital
      • Zhonghe Dist, Taiwan, 235041
        • Taipei Medical University Shuang Ho Hospital
      • Zhongzheng Dist, Taiwan, 10048
        • National Taiwan University Hospital West Campus
  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
      • Leeds, United Kingdom, LS9 7TF
        • The Leeds Teaching Hospitals Nhs Trust
      • London, United Kingdom, EC1A 7BE
        • Barts Health NHS Trust
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Emory University Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60612-4795
        • University of Illinois at Chicago
    • Nevada
      • Las Vegas, Nevada, United States, 89169-3321
        • Comprehensive Cancer Centers of Nevada
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Note: Other protocol-defined inclusion and exclusion criteria may have applied.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Obinutuzumab

Participants 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.
Drug: Obinutuzumab
Intravenous administration
Other Names:
  • Gazyva
Experimental: Zanubrutinib + Obinutuzumab
Participants 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.
Drug: Obinutuzumab
Intravenous administration
Other Names:
  • Gazyva
Drug: Zanubrutinib
Oral administration as a capsule
Other Names:
  • Brukinsa
  • BGB-3111

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) as Assessed by the Investigator
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.
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.
Duration of Response (DOR) as Determined by Investigator 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.
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.
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
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.
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.
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)
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.
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.
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)
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.
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.
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.
Complete Response Rate
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.
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.
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.
Time to Response (TTR)
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.
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.
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.
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
Time Frame: Baseline, Week 12, and Week 24
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.
Baseline, Week 12, and Week 24
Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)
Time Frame: Baseline, Week 12, and Week 24
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.
Baseline, Week 12, and Week 24
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: 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.
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.
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.
Area Under the Curve (AUCss) of Zanubrutinib at Steady State
Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.
Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model.
Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.
Zanubrutinib Plasma Concentrations
Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.
Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.
Minimum Observed Concentration (Cmin) of Zanubrutinib at Steady State
Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.
Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model.
Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.
Maximum Observed Concentration (Cmax) of Zanubrutinib at Steady State
Time Frame: Cycle 1 Day 1 (2 hours postdose) and Cycle 2 Day 1 (predose and 2 hours postdose)
Cycle 1 Day 1 (2 hours postdose) and Cycle 2 Day 1 (predose and 2 hours postdose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeiGene

Investigators

  • Study Director: Study Director, BeiGene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2017

Primary Completion (Actual)

October 8, 2021

Study Completion (Actual)

December 27, 2024

Study Registration Dates

First Submitted

October 31, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-3111-212
  • 2017-001552-54 (EudraCT Number)
  • CTR20220712 (Other Identifier: ChinaDrugTrials)
  • 2023-509975-17-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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