Clinical trial No longer in our active list Phase 3 Interventional Ages 18 and up

Comparing two treatment combinations for relapsed lymphoma

Official title: A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

Run by BeOne Medicines · NCT05100862 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing whether a new combination of two drugs can help people with relapsed follicular or marginal zone lymphoma live longer without their cancer getting worse compared to another drug combination.

More Marginal Zone Lymphoma trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment780 (estimated)
SponsorBeOne Medicines
Industry-sponsored
Drugs / interventionsobinutuzumab, rituximab, zanubrutinib
Locations277 sites (Fresno, California and 276 other locations)
Trial IDNCT05100862 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals with histologically confirmed grade 1-3a follicular lymphoma or marginal zone lymphoma who have previously undergone systemic therapy.

Probably not a fit

Patients with transformed aggressive lymphoma or those requiring ongoing corticosteroid treatment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of zanubrutinib combined with obinutuzumab against lenalidomide combined with rituximab in patients with relapsed or refractory follicular lymphoma and marginal zone lymphoma. The primary measure of success will be progression-free survival, assessed by an independent review committee using advanced imaging techniques. Participants must have previously received systemic therapy and show a need for further treatment. The study aims to provide insights into which treatment combination offers better outcomes for these specific lymphoma types.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatment options for patients with relapsed or refractory lymphoma.

How similar studies have gone: Other studies have shown promising results with similar treatment combinations, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Key Inclusion Criteria:

* Histologically confirmed grade 1-3a FL or MZL
* Previously treated with ≥ 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy
* Need for systemic therapy for FL or MZL
* Measurable disease by computed tomography or magnetic resonance imaging
* Adequate bone marrow, liver and renal function

Key Exclusion Criteria:

* Transformation to aggressive lymphoma
* Requiring ongoing need for corticosteroid treatment
* Clinically significant cardiovascular disease
* Prior malignancy within the past 2 years
* Active fungal, bacterial, and/or viral infection that requires systemic therapy
* Prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (\< 24 months)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it's running

  • Aichi Cancer Center Hospital Clinical Oncology
    Nagoya, Aichi-ken, Japan
    Recruiting
  • Chiba Cancer Center
    Chiba, Chiba, Japan
    Recruiting
  • Matsuyama Red Cross Hospital
    Matsuyama, Ehime, Japan
    Recruiting
  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
    Hiroshima, Hiroshima, Japan
    Recruiting
  • National Hospital Organization Hokkaido Cancer Center
    Sapporo, Hokkaido, Japan
    Recruiting
  • Aiiku Hospital
    Sapporo, Hokkaido, Japan
    Recruiting
Show 44 more locations
  • Kagoshima University Hospital
    Kagoshima, Kagoshima-ken, Japan
    Recruiting
  • Kanagawa Cancer Center
    Yokohama, Kanagawa, Japan
    Recruiting
  • University Hospital, Kyoto Prefectural Univ of Medicine
    KyotoShi, Kyoto, Japan
    Recruiting
  • Tohoku University Hospital
    Sendai, Miyagi, Japan
    Recruiting
  • Kurashiki Central Hospital
    Kurashikishi, Okayama-ken, Japan
    Recruiting
  • Kansai Medical University Hospital
    Hirakata, Osaka, Japan
    Recruiting
  • Kindai University Hospital
    Sakai, Osaka, Japan
    Recruiting
  • Tokyo Metropolitan Komagome Hospital
    Bunkyoku, Tokyo, Japan
    Recruiting
  • National Cancer Center Hospital
    ChuoKu, Tokyo, Japan
    Recruiting
  • Cancer Institute Hospital of Jfcr
    Kotoku, Tokyo, Japan
    Recruiting
  • Yamagata University Hospital
    Yamagata, Yamagata, Japan
    Recruiting
  • Kumamoto University Hospital
    Kumamoto, Japan
    Recruiting
  • National Hospital Organization Okayama Medical Center
    Okayama, Japan
    Recruiting
  • Yokohama Municipal Citizens Hospital
    Yokohama, Japan
    Recruiting
  • Ucsf Fresno University of California San Francisco Fresno
    Fresno, California, United States
    Active not recruiting
  • Kaiser Permanente Southern California
    Irvine, California, United States
    Completed
  • Cancer and Blood Specialty Clinic
    Los Alamitos, California, United States
    Active not recruiting
  • Los Angeles Cancer Network
    Los Angeles, California, United States
    Active not recruiting
  • Valkyrie Clinical Trials
    Los Angeles, California, United States
    Active not recruiting
  • UCLA Hematologyoncology
    Los Angeles, California, United States
    Completed
  • Scripps Health
    San Diego, California, United States
    Completed
  • Sharp Healthcare Sharp Memorial Hospital
    San Diego, California, United States
    Active not recruiting
  • Baptist Md Anderson Cancer Center
    Jacksonville, Florida, United States
    Completed
  • Ascension Sacred Heart
    Pensacola, Florida, United States
    Completed
  • Northwest Georgia Oncology Centers Marietta
    Marietta, Georgia, United States
    Active not recruiting
  • Cancer Care Specialists of Illinois
    Decatur, Illinois, United States
    Completed
  • Fort Wayne Medical Oncology and Hematology
    Fort Wayne, Indiana, United States
    Active not recruiting
  • Mission Cancer and Blood
    Waukee, Iowa, United States
    Active not recruiting
  • Cotton Oneil Cancer Center
    Topeka, Kansas, United States
    Completed
  • Cancer Center of Kansas
    Wichita, Kansas, United States
    Active not recruiting
  • Baptist Health Lexington
    Lexington, Kentucky, United States
    Active not recruiting
  • Christus Highland Cancer Treatment Center
    Shreveport, Louisiana, United States
    Active not recruiting
  • Luminis Health Anne Arundel Medical Center
    Annapolis, Maryland, United States
    Completed
  • University of Maryland Greenebaum Comprehensive Cancer Center
    Baltimore, Maryland, United States
    Active not recruiting
  • Ascension St Agnes Hospital
    Baltimore, Maryland, United States
    Completed
  • American Oncology Partners of Maryland Pa
    Bethesda, Maryland, United States
    Active not recruiting
  • Henry Ford Hospital
    Detroit, Michigan, United States
    Active not recruiting
  • Corewell Health the Michigan Cancer Consortium
    Grand Rapids, Michigan, United States
    Active not recruiting
  • Hattiesburg Hematology and Oncology Clinic
    Hattiesburg, Mississippi, United States
    Active not recruiting
  • University of Missouri Hospital, Ellis Fischel Cancer Center
    Columbia, Missouri, United States
    Active not recruiting
  • Oncology Hematology Associates
    Springfield, Missouri, United States
    Active not recruiting
  • St Vincent Frontier Cancer Center
    Billings, Montana, United States
    Completed
  • Nebraska Cancer Specialists
    Omaha, Nebraska, United States
    Active not recruiting
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada, United States
    Completed

+227 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.