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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 780 (estimated) |
| Sponsor | BeOne Medicines Industry-sponsored |
| Drugs / interventions | obinutuzumab, rituximab, zanubrutinib |
| Locations | 277 sites (Fresno, California and 276 other locations) |
| Trial ID | NCT05100862 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
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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
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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
- Principal investigator: Study Director — BeiGene
- Study coordinator: Study Director BeiGene
- Email: clinicaltrials@beigene.com
- Phone: 1-877-828-5568
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Zanubrutinib, rituximab, lenalidomide plus tislelizumab for relapsed/refractory follicular lymphoma
This trial tests whether adding the PD‑1 blocker tislelizumab to zanubrutinib, rituximab, and lenalidomide helps adults with relapsed or refractory follicular lymphoma who have had at least two prior therapies.
-
Zanubrutinib plus rituximab as first-line treatment for marginal zone lymphoma
This tests whether combining zanubrutinib and rituximab is effective and safe as first-line treatment for people with CD20-positive marginal zone lymphoma who have not received prior systemic therapy.
-
Combination treatment for relapsed or refractory follicular lymphoma
This study is testing a new combination of three medications to see if it can help people with relapsed or refractory follicular lymphoma feel better.
-
Combining rituximab and zanubrutinib for treating indolent B-cell lymphomas
This study is testing if combining two medications, rituximab and zanubrutinib, can help people with untreated indolent B-cell lymphomas feel better and improve their treatment outcomes.
-
Polatuzumab vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in untreated DLBCL (MCD/BN2/N1)
This study tests a targeted combination therapy to see if it can treat previously untreated DLBCL with specific molecular subtypes.
-
Nemtabrutinib plus rituximab for marginal zone lymphoma
This phase 2 trial tests whether combining nemtabrutinib with rituximab can help people with marginal zone lymphoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.