At a glance
ClinicalIndex Comparison Record- ✓Unsuitable for chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR)
- ✓Confirmed diagnosis of CD20-positive CLL or SLL, requiring treatment
- ✓Measurable disease by imaging
- ✓ECOG performance status of 0, 1 or 2
- ✕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
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An International, Phase 3, Open-Label, Randomized Study of BGB-3111 Compared With Bendamustine Plus Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)
In Brief
A Phase 3 clinical trial evaluating Zanubrutinib, Bendamustine, and 2 other interventions for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma. Active but no longer recruiting, targeting 590 participants across 158 sites in 15 countries.
Detailed 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.
Study Details
Timeline
Interventions
Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)
Administered intravenously (IV) at a dose of 90 mg/m\^2/day on the first 2 days of each cycle for 6 cycles.
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
400 mg tablets administered orally once daily.