A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
On this site
📄 Brukinsa (zanubrutinib) drug profile → 📄 Rituxan (rituximab) drug profile → 📄 Venclexta (venetoclax) drug profile →More BeiGene trials in Spain
Other trials for the same condition
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 Spain