230
Participants
Start Date
February 22, 2019
Primary Completion Date
February 28, 2026
Study Completion Date
February 28, 2026
Zanubrutinib
zanubrutinib (160mg by mouth BID)
Obinutuzumab
"obinutuzumab (1000mg IVPB on Days 1\*, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 8) starting on Cycle 1 (28-day cycles). \* On Cycle 1, obinituzumab will be administered in split dose at 100mg IVPB on Day 1 and 900mg IVPB on Day 2 in patients at increased risk for IRR (ALC \>25,000 cells/ul or baseline lymph nodes \>5 cm diameter)."
Venetoclax
Venetoclax will be added to the regimen starting on Cycle 3, and will be incorporated into the regimen using the 5-week ramp-up schedule to mitigate the risk of tumor lysis syndrome (beginning at 20mg and gradually increasing to 400mg), and venetoclax will be administered a ta fixed dose level of 400mg by mouth daily of 28-day cycles thereafter.
RECRUITING
Memorial Sloan Kettering Cancer Center, New York
RECRUITING
Memorial Sloan Kettering Westchester, Harrison
RECRUITING
Memorial Sloan Kettering Nassau, Uniondale
RECRUITING
Memorial Sloan Kettering Commack, Commack
RECRUITING
Northwestern University, Evanston
RECRUITING
Massachusetts General Hospital (Data Collection and Specimen Analysis), Boston
RECRUITING
Memorial Sloan Kettering at Basking Ridge, Basking Ridge
RECRUITING
Memorial Sloan Kettering Monmouth, Middletown
BeiGene USA, Inc.
INDUSTRY
Roche-Genentech
INDUSTRY
Massachusetts General Hospital
OTHER
Memorial Sloan Kettering Cancer Center
OTHER