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)
Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR) — Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021) PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the ICR per 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with small lymphocytic lymphoma (SLL).
Trial sites (158)
Facility
City
Region
Status
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.
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.