A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

NCT04002297 · tracked via the Priya Life Science China tracker

Sponsor

BeOne Medicines

Phase

Phase 3

Started

2019-08-20

Last updated

2026-05-18

Condition(s) studied

Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

zanubrutinibbendamustinerituximab

zanubrutinib: Administered as two 80 mg capsules by mouth twice a day

bendamustine: Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6

rituximab: Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6

Study summary

This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.

Eligibility

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

Key Inclusion Criteria: 1. ≥70 years of age at the time of informed consent, OR ≥60 and \<70 years of age with comorbidities precluding autologous stem cell transplantation 2. Histologically confirmed diagnosis of MCL 3. No prior systemic treatments for MCL 4. Measurable disease by CT/MRI 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 6. Adequate marrow and organ function Key Exclusion Criteria: 1. Known central nervous system involvement by lymphoma 2. Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant 3. Clinically significant cardiovascular disease 4. History of severe bleeding disorder 5. Unable to swallow capsules or disease significantly affecting gastrointestinal function 6. Active fungal, bacterial and/or viral infection requiring systemic therapy 7. Requires ongoing treatment with a strong CYP3A inhibitor or inducer NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Progression-free survival (PFS) determined by independent central review — Up to approximately 7 years
PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.

Trial sites (176)

Facility	City	Region
Chao Family Comprehensive Cancer Center	Orange	California
Rush University Medical Center	Chicago	Illinois
Beth Israel Deaconess Medical Center (Bidmc)	Boston	Massachusetts
University of Michigan Health System	Ann Arbor	Michigan
Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
Icahn School of Medicine At Mount Sinai	New York	New York
Clinical Research Alliance, Inc	Westbury	New York
Providence Portland Medical Center	Portland	Oregon
West Penn Hospital	Pittsburgh	Pennsylvania
The University of Texas Md Anderson Cancer Center	Houston	Texas
Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
Seattle Cancer Care Alliance	Seattle	Washington
Canberra Hospital	Garran	Australian Capital Territory
Concord Repatriation General Hospital	Concord	New South Wales
The Tweed Valley Hospital	Cudgen	New South Wales
Saint Vincents Hospital Sydney	Darlinghurst	New South Wales
Gosford Hospital	Gosford	New South Wales
Calvary Mater Newcastle	Waratah	New South Wales
Sunshine Coast Hospital and Health Service	Birtinya	Queensland
Icon Cancer Foundation	South Brisbane	Queensland
Flinders Medical Centre	Bedford PK	South Australia
Royal Hobart Hospital	Hobart	Tasmania
Monash Health	Clayton	Victoria
St Vincents Hospital Melbourne	Fitzroy	Victoria
Peninsula Private Hospital	Frankston	Victoria
Barwon Health the Geelong Hospital	Geelong	Victoria
Royal Perth Hospital	Perth	Western Australia
Ordensklinikum Linz Gmbh Elisabethinen	Linz	Austria
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg	Salzburg	Austria
Medical University Vienna Oncology	Vienna	Austria
Az Sint Jan Brugge	Bruges	Belgium
Universitair Ziekenhuis Brussel	Brussels	Belgium
Uz Antwerpen	Edegem	Belgium
Az Groeninge Campus Loofstraat	Kortrijk	Belgium
Centre Hospitalier Universitaire (Chu) de Liege Site Du Sart Tilman	Liège	Belgium
Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne	Yvoir	Belgium
The Ottawa Hospital	Ottawa	Ontario
Ciusss de Lestrie Chus	Sherbrooke	Quebec
Peking University Peoples Hospital	Beijing	Beijing Municipality
Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing Municipality

+ 136 more sites — see the full list on the official registry below.

On this site

📄 Brukinsa (zanubrutinib) drug profile → 📄 Rituxan (rituximab) drug profile →

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A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04002297 on ClinicalTrials.gov ↗ ← All trials in China