56
Participants
Start Date
December 27, 2017
Primary Completion Date
May 3, 2021
Study Completion Date
January 6, 2023
Induction Venetoclax
"1 cycle = 28 days.~* Cycle 1-6: Obinutuzumab IV. Cycle 1, Day 1 obinutuzumab 100 mg and Cycle 1, Day 2 obinutuzumab 900 mg for total dose of 1000 mg. On Cycle 1, Day 8 and Day 15 obinutuzumab 1000 mg. Starting with Cycle 2, obinutuzumab 1000 mg on Day 1 only of each cycle.~* Cycle 1-6: Bendamustine 90 mg/m² IV on Days 1 and 2 of each cycle over 15 minutes after obinutuzumab.~* Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10 administered before obinutuzumab and/or bendamustine."
Maintenance Venetoclax
Patients whose disease is the same or improved will receive venetoclax 800 mg by mouth daily for 24 cycles (1 cycle=1 month) and obinutuzumab 1000 mg IV every 2 months for 12 cycles. Patients with no evidence of disease will receive obinutuzumab 1000 mg IV every 2 months for 12 cycles.
Fox Chase, Philadelphia
Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore
University of Virginia, Charlottesville
Winship Cancer Institute of Emory University, Atlanta
Vanderbilt-Ingram Cancer Center, Nashville
University of Wisconsin, Madison
Gunderson Health System Cancer Center, La Crosse
Mayo Clinic, Rochester
Washington University School of Medicine, St Louis
Rutgers Cancer Institute of NJ, New Brunswick
Collaborators (1)
Genentech, Inc.
INDUSTRY
PrECOG, LLC.
OTHER