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New drug combo shows promise for Tough-to-Treat lymphoma

NCT ID NCT03332017

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding zanubrutinib to obinutuzumab works better than obinutuzumab alone for adults with follicular lymphoma that returned or didn't respond to prior treatments. About 217 people took part. The main goal was to see how many patients had their tumors shrink or disappear.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

217 people

The number who actually took part.

Started

Nov 2017

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Acibadem City Clinic Mhat Tokuda Ead

    Sofia, 1407, Bulgaria

  • Aotearoa Clinical Trials

    Auckland, 2025, New Zealand

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Azienda Ospedaliera Policlinico Di Bari

    Bari, 70124, Italy

  • Azienda Ospedaliero Universitaria Di Parma

    Parma, 43126, Italy

  • Barts Health Nhs Trust

    London, EC1A 7BE, United Kingdom

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Calvary Mater Newcastle

    Waratah, New South Wales, NSW 2298, Australia

  • Canberra Hospital

    Garran, Australian Capital Territory, ACT 2605, Australia

  • Central City Hospital

    Yekaterinburg, Sverdlovsk Oblast, 620137, Russia

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Hospitalier Universitaire Damiens Hopital Sud

    Amiens, 80054, France

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

    Poitiers, 86000, France

  • Centre Hospitalier de Dunkerque

    Dunkirk, 59240, France

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33000, France

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, 20-090, Poland

  • Christchurch Hospital

    Christchurch, 8011, New Zealand

  • Chu Bordeaux Hopital Haut Leveque

    Pessac, 33600, France

  • Chu Hopital Lyon Sud

    PierreBenite, 69495, France

  • Clinique Louis Pasteur

    Esseylesnancy, 54270, France

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169-3321, United States

  • Concord Repatriation General Hospital

    Concord, New South Wales, NSW 2139, Australia

  • Duke University

    Durham, North Carolina, 27710, United States

  • Emory University Winship Cancer Institute

    Atlanta, Georgia, 30322-1013, United States

  • Fakultni Nemocnice Brno

    Brno, 625 00, Czechia

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 03, Czechia

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000, 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

  • Hospital Universitario Puerta Del Mar

    Cadiz, 11009, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222, Spain

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28048, Spain

  • Hospital Universitario de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • Icon Cancer Centre Wesley

    Auchenflower, Queensland, QLD 4066, Australia

  • Icon Cancer Foundation

    South Brisbane, Queensland, QLD 4101, Australia

  • Institut Catala Doncologia

    Barcelona, 08908, Spain

  • Istituto Europeo Di Oncologia

    Milan, 20141, Italy

  • Jewish General Hospital

    Montreal, Quebec, QC H3t 1E2, Canada

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Kyungpook National University Hospital

    Junggu, Daegu Gwang'yeogsi, 41944, South Korea

  • Md Anderson Cancer Center Madrid Spain

    Madrid, 28033, Spain

  • Minsk City Clinical Oncological Dispensary

    Minsk, 220013, Belarus

  • Monash Health

    Clayton, Victoria, VIC 3168, Australia

  • N N Blokhin Russian Cancer Research Center Konstantin Laktionov

    Moscow, Moscow, 115478, Russia

  • National Cheng Kung University Hospital

    North Dist, 704, Taiwan

  • National Taiwan University Hospital West Campus

    Zhongzheng Dist, 10048, Taiwan

  • Necker University Hospital

    Paris, 75015, France

  • Nn Alexandrov National Cancer Centre of Belarus

    Minsk, 223040, Belarus

  • Norfolk and Norwich University Hospitals Nhs Foundation Trust

    Norwich, NR4 7UY, United Kingdom

  • Ospedale Di Circolo E Fondazione Macchi

    Varese, 21100, Italy

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000, China

  • Peninsula Private Hospital

    Frankston, Victoria, VIC 3199, Australia

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138, Italy

  • Pratia McM Krakow

    Krakow, 30-727, Poland

  • Royal Adelaide Hospital

    Adelaide, South Australia, SA 5000, Australia

  • Royal Perth Hospital

    Perth, Western Australia, WA 6000, Australia

  • Saint Vincents Hospital Sydney

    Darlinghurst, New South Wales, NSW 2010, Australia

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Bundang Hospital

    BundangGu SeongnamSi, Gyeonggi-do, 13620, South Korea

  • Slezska Nemocnice V Opave

    Opava, 746 01, Czechia

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, VIC 3065, Australia

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

    Sochi, Krasnodarskiy Kray, 354000, Russia

  • Szpital Wojewodzki W Opolu

    Opole, 45-372, Poland

  • Taipei Medical University Shuang Ho Hospital

    Zhonghe Dist, 235041, Taiwan

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi, 06591, South Korea

  • The Leeds Teaching Hospitals Nhs Trust

    Leeds, LS9 7TF, United Kingdom

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6, Canada

  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

    Bournemouth, BH7 7DW, United Kingdom

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

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

    Wuhan, Hubei, 430030, China

  • Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia

    Ravenna, 48121, Italy

  • Universitatsklinikum Augsburg

    Augsburg, 86156, Germany

  • University Multiprofile Hospital For Active Treatment Alexandrovska

    Sofia, 1431, Bulgaria

  • University Multiprofile Hospital For Active Treatment Dr Georgi Stranski

    Pleven, 5803, Bulgaria

  • University Multiprofile Hospital For Active Treatment Saint Ivan Rilski

    Sofia, 1407, Bulgaria

  • University of Illinois At Chicago

    Chicago, Illinois, 60612-4795, United States

  • Vitebsk Regional Clinical Oncology Dispensary

    Vitebsk, 210603, Belarus

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 10000, Czechia

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Westmead Hospital

    Westmead, New South Wales, NSW 2145, Australia

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-513, Poland

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China