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Clinical Trials in the USA / NCT03336333
Active, not recruiting Phase 3

A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

NCT03336333 · tracked via the Priya Life Science USA tracker
Sponsor
BeiGene
Phase
Phase 3
Started
2017-10-31
Last updated
2026-03-09

Condition(s) studied

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Investigational drug(s) / intervention(s)

ZanubrutinibBendamustineRituximabVenetoclax

Zanubrutinib: Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)

Bendamustine: Administered intravenously (IV) at a dose of 90 mg/m\^2/day on the first 2 days of each cycle for 6 cycles.

Rituximab: Administered intravenously (IV) at a dose of 375 mg/m\^2 on day 0 of cycle 1, and at a dose of 500 mg/m\^2 on day 1 of cycles 2 to 6

Venetoclax: 400 mg tablets administered orally once daily.

Study summary

To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * Unsuitable for chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR) * Confirmed diagnosis of CD20-positive CLL or SLL, requiring treatment * Measurable disease by imaging * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * Life expectancy ≥ 6 months * Adequate bone marrow function * Adequate renal and hepatic function Key Exclusion Criteria: * Previous systemic treatment for CLL/SLL * Requires ongoing need for corticosteroid treatment * Known prolymphocytic leukemia or history of or suspected Richter's transformation. * Clinically significant cardiovascular disease * Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix of breast, or localized Gleason score 6 prostate cancer * History of severe bleeding disorder * History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug * Severe or debilitating pulmonary disease * Inability to swallow capsules or disease affecting gastrointestinal function * Active infection requiring systemic treatment * Known central nervous system involvement by leukemia or lymphoma * Underlying medical condition that will render the administration of study drug hazardous or obscure interpretation of toxicity or AEs * Known infection with human immunodeficiency virus (HIV) or active hepatitis B or C infection * Major surgery ≤ 4 weeks prior to start of study treatment * Pregnant or nursing females * Vaccination with live vaccine within 35 days prior to the first dose of study drug. * Ongoing alcohol or drug addiction * Known hypersensitivity to zanubrutinib, bendamustine, rituximab, or venetoclax (as applicable) or any other ingredients of the study drugs * Requires ongoing treatment with strong cytochrome P450 (CYP3A) inhibitor or inducer * Concurrent participation in another therapeutic clinical study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (158)

FacilityCityRegionStatus
Augusta University Augusta Georgia
Northwestern University Chicago Illinois
Dana Farber Cancer Institute Boston Massachusetts
Research Medical Center Kansas City Missouri
Washington University St Louis Missouri
Comprehensive Cancer Centers of Nevada Las Vegas Nevada
Summit Medical Group Florham Park New Jersey
Icahn School of Medicine At Mount Sinai New York New York
Columbia University Medical Center New York New York
University of Rochester Rochester New York
Duke University Durham North Carolina
Oregon Health and Science University Portland Oregon
Prairie Lakes Healthcare System Watertown South Dakota
Tennessee Oncology, Pllc Nashville Nashville Tennessee
Joe Arrington Cancer Research and Treatment Center Lubbock Texas
University of Virginia Charlottesville Virginia
Va Puget Sound Health Care System Seattle Washington
Fred Hutchinson Cancer Research Center Seattle Washington
Concord Repatriation General Hospital Concord New South Wales
The Tweed Valley Hospital Cudgen New South Wales
Calvary Mater Newcastle Waratah New South Wales
Westmead Hospital Westmead New South Wales
Icon Cancer Centre Wesley Auchenflower Queensland
Princess Alexandra Hospital Brisbane Queensland
Royal Brisbane and Womens Hospital Herston Queensland
Royal Adelaide Hospital Adelaide South Australia
The Queen Elizabeth Hospital Woodville South South Australia
Royal Hobart Hospital Hobart Tasmania
Box Hill Hospital Box Hill Victoria
Monash Health Clayton Victoria
St Vincents Hospital Melbourne Fitzroy Victoria
Peninsula Private Hospital Frankston Victoria
Peter Maccallum Cancer Centre Melbourne Victoria
Royal Perth Hospital Perth Western Australia
Medizinische Universitatsklinik Innsbruck Innsbruck Austria
Krankenhaus Der Barmherzigen Schwestern Linz Linz Austria
Allgemeines Krankenhaus Der Stadt Linz Linz Austria
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg Salzburg Austria
Klinikum Wels Grieskirchen Wels Austria
Universitair Ziekenhuis Brussel Brussels Belgium

+ 118 more sites — see the full list on the official registry below.

On this site

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

More BeiGene trials in the USA

Other trials for the same condition

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 NCT03336333 on ClinicalTrials.gov ↗ ← All trials in the USA