NCT03332017CompletedPhase 2
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 217 (actual)
- First submitted
- 31 Oct 2017
- Start date
- 14 Nov 2017
- Primary completion date
- 8 Oct 2021
- Lead sponsor
- BeiGene
- Diseases
- Follicular lymphoma
- NCT number
- NCT03332017
- EU CT number
- 2023-509975-17-00
- EudraCT number
- 2017-001552-54
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 217
- From 14 Nov 2017 to the primary completion date, 8 Oct 2021
- 79 sites in 17 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants had prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
- Participants had undergone an allogeneic hematopoietic stem cell transplantation within 12 months of enrollment.
- Participants had undergone major surgery within 4 weeks prior to the start of study treatment.
Other illness
- 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 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.
Other
- Participants had known central nervous system involvement by leukemia or lymphoma.
- Participants had evidence of transformation from follicular lymphoma to another aggressive histologic subtype.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (79)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| ICON Cancer Centre Wesley Coordinator of this site? Confirm its status | Auchenflower | Australia | Unknown status |
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Concord Repatriation General Hospital Coordinator of this site? Confirm its status | Concord | Australia | Unknown status |
| Saint Vincents Hospital Sydney Coordinator of this site? Confirm its status | Darlinghurst | Australia | Unknown status |
| St Vincents Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Peninsula Private Hospital Coordinator of this site? Confirm its status | Frankston | Australia | Unknown status |
| Canberra Hospital Coordinator of this site? Confirm its status | Garran | Australia | Unknown status |
| Royal Perth Hospital Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Icon Cancer Foundation Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Calvary Mater Newcastle Coordinator of this site? Confirm its status | Waratah | Australia | Unknown status |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski Coordinator of this site? Confirm its status | Pleven | Bulgaria | Unknown status |
| University Multiprofile Hospital For Active Treatment Saint Ivan Rilski Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| University Multiprofile Hospital for Active Treatment Alexandrovska Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Acibadem City Clinic Mhat Tokuda Ead Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Minsk city Clinical Oncological Dispensary Coordinator of this site? Confirm its status | Minsk | Belarus | Unknown status |
| Nn Alexandrov National Cancer Centre of Belarus Coordinator of this site? Confirm its status | Minsk | Belarus | Unknown status |
| Vitebsk Regional Clinical Oncology Dispensary Coordinator of this site? Confirm its status | Vitebsk | Belarus | Unknown status |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Peoples Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Guangdong Provincial Peoples Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Completed |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Completed |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Universitätsklinikum Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Unknown status |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Completed |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Completed |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Completed |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| L’Hopital Alexandra Lepeve Coordinator of this site? Confirm its status | Dunkirk Cedex 1 | France | Completed |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Completed |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Completed |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Completed |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Completed |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen Cedex | France | Completed |
| The Royal Bournemouth and Christchurch Hospitals Nhs Foundation Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Unknown status |
| The Leeds Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Norfolk and Norwich University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
| University Hospital Consorziale Policlinico Coordinator of this site? Confirm its status | Bari | Italy | Completed |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| European Institute Of Oncology S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Unità Sanitaria Locale della Romagna Coordinator of this site? Confirm its status | Ravenna | Italy | Completed |
| Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi Coordinator of this site? Confirm its status | Varese | Italy | Completed |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | BundangGu SeongnamSi | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | GangnamGu | South Korea | Unknown status |
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Junggu | South Korea | Unknown status |
| The Catholic University of Korea, Seoul St Marys Hospital Coordinator of this site? Confirm its status | SeochoGu | South Korea | Unknown status |
| Aotearoa Clinical Trials Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Christchurch Hospital Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Completed |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Coordinator of this site? Confirm its status | Lublin | Poland | Completed |
| N N Blokhin Russian Cancer Research Center Konstantin Laktionov Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region Coordinator of this site? Confirm its status | Sochi | Russia | Unknown status |
| Central City Hospital Coordinator of this site? Confirm its status | Yekaterinburg | Russia | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | North Dist. | Taiwan | Unknown status |
| Taipei Medical University Shuang Ho Hospital Coordinator of this site? Confirm its status | Zhonghe Dist | Taiwan | Unknown status |
| National Taiwan University Hospital West Campus Coordinator of this site? Confirm its status | Zhongzheng Dist | Taiwan | Unknown status |
| Emory University/Winship Cancer Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Comprehensive Cancer Centers of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.