30
Participants
Start Date
September 30, 2011
Primary Completion Date
September 12, 2023
Study Completion Date
September 12, 2023
Ofatumumab (This arm is closed)
Ofatumumab Day 1 Week 1: 1000 mg, Day 2 week 1: 1000mg. Patients who exhibit a baseline leukocytosis ≥ 20,000 will receive 300 mg of ofatumumab on day 1, week 1. Thereafter, they can receive the 1000 mg dose Ofatumumab Day 1, Weeks 2-4: 1000 mg Will reassess 8-10 weeks after conclusion of treatment with CT CAP, and following this q 12 wks for 2 yrs, then q 6mo until POD or for a maximum of 5 years
Ofatumumab + Bendamustine
Ofatumumab day 1 + Bendamustine 90 mg/m2 days 1 \& 2 x 6 cycles q 28 days Cycle 1, day 1: Ofatumumab 1000 mg followed by Bendamustine 90 mg/m2. Patients who exhibit a leukocytosis ≥ 20,000 will receive 300 mg of ofatumumab on day 1, week 1. Thereafter, they can receive the 1000 mg dose. Cycle 1, day 2: Ofatumumab 1000mg followed by Bendamustine 90 mg/m2 Cycles 2-6: Ofatumumab 1000 mg day 1, Bendamustine 90 mg/m2 days 1 and 2 Will reassess 4-6 weeks after conclusion of treatment with CT CAP, and following this q 12 wks for 2 yrs, then q 6mo until POD or for a maximum of 5 years
Memorial Sloan Kettering Cancer Center, New York
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow
Memorial Sloan Kettering West Harrison, Harrison
Memorial Sloan Kettering Cancer Center at Mercy Medical Center, Rockville Centre
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack
Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge
Collaborators (1)
GlaxoSmithKline
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER