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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
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

Full criteria on ClinicalTrials.gov

Sites (79)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
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AdelaideAustraliaUnknown status
ICON Cancer Centre Wesley
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AuchenflowerAustraliaUnknown status
Monash Health
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ClaytonAustraliaUnknown status
Concord Repatriation General Hospital
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ConcordAustraliaUnknown status
Saint Vincents Hospital Sydney
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DarlinghurstAustraliaUnknown status
St Vincents Hospital Melbourne
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FitzroyAustraliaUnknown status
Peninsula Private Hospital
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FrankstonAustraliaUnknown status
Canberra Hospital
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GarranAustraliaUnknown status
Royal Perth Hospital
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PerthAustraliaUnknown status
Icon Cancer Foundation
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South BrisbaneAustraliaUnknown status
Calvary Mater Newcastle
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WaratahAustraliaUnknown status
Westmead Hospital
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WestmeadAustraliaUnknown status
University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski
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PlevenBulgariaUnknown status
University Multiprofile Hospital For Active Treatment Saint Ivan Rilski
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SofiaBulgariaUnknown status
University Multiprofile Hospital for Active Treatment Alexandrovska
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SofiaBulgariaUnknown status
Acibadem City Clinic Mhat Tokuda Ead
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SofiaBulgariaUnknown status
Minsk city Clinical Oncological Dispensary
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MinskBelarusUnknown status
Nn Alexandrov National Cancer Centre of Belarus
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MinskBelarusUnknown status
Vitebsk Regional Clinical Oncology Dispensary
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VitebskBelarusUnknown status
Jewish General Hospital
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MontrealCanadaUnknown status
The Ottawa Hospital
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OttawaCanadaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Peking University Peoples Hospital
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BeijingChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Guangdong Provincial Peoples Hospital
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GuangzhouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Jiangsu Province Hospital
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NanjingChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaUnknown status
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaCompleted
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaCompleted
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaCompleted
Universitätsklinikum Augsburg
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AugsburgGermanyUnknown status
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Hospital Universitario De Salamanca
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SalamancaSpainCompleted
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceCompleted
Institut Bergonie
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BordeauxFranceCompleted
L’Hopital Alexandra Lepeve
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Dunkirk Cedex 1FranceCompleted
Hopital Necker Enfants Malades
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ParisFranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceCompleted
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceCompleted
Centre Henri Becquerel
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Rouen CedexFranceCompleted
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
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BournemouthUnited KingdomUnknown status
The Leeds Teaching Hospitals NHS Trust
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LeedsUnited KingdomUnknown status
Barts Health NHS Trust
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LondonUnited KingdomUnknown status
Norfolk and Norwich University Hospitals NHS Foundation Trust
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NorwichUnited KingdomUnknown status
University Hospital Consorziale Policlinico
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BariItalyCompleted
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyCompleted
European Institute Of Oncology S.r.l.
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MilanItalyCompleted
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyCompleted
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
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VareseItalyCompleted
Seoul National University Bundang Hospital
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BundangGu SeongnamSiSouth KoreaUnknown status
Samsung Medical Center
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GangnamGuSouth KoreaUnknown status
Kyungpook National University Hospital
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JungguSouth KoreaUnknown status
The Catholic University of Korea, Seoul St Marys Hospital
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SeochoGuSouth KoreaUnknown status
Aotearoa Clinical Trials
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AucklandNew ZealandUnknown status
Auckland City Hospital
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AucklandNew ZealandUnknown status
Christchurch Hospital
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ChristchurchNew ZealandUnknown status
Pratia S.A.
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CracowPolandCompleted
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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LublinPolandCompleted
N N Blokhin Russian Cancer Research Center Konstantin Laktionov
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MoscowRussiaUnknown status
State Healthcare Institution Oncologic Dispensary No Health Department of Krasnodar Region
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SochiRussiaUnknown status
Central City Hospital
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YekaterinburgRussiaUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
National Cheng Kung University Hospital
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North Dist.TaiwanUnknown status
Taipei Medical University Shuang Ho Hospital
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Zhonghe DistTaiwanUnknown status
National Taiwan University Hospital West Campus
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Zhongzheng DistTaiwanUnknown status
Emory University/Winship Cancer Institute
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AtlantaUnited StatesUnknown status
University of Illinois at Chicago
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ChicagoUnited StatesUnknown status
Duke University
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DurhamUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada
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Las VegasUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.