66
Participants
Start Date
January 16, 2015
Primary Completion Date
August 22, 2016
Study Completion Date
March 29, 2019
Bendamustine
"Debulking:~2 cycles of Bendamustine (70 mg/m² iv) will be administered before induction unless a contraindication is existing or it is not clinically indicated."
GA101
"Induction~GA101 iv infusion:~Cycle 1: Day 1 100 mg Day 1 (or 2) 900 mg Day 8 1000 mg Day 15 1000 mg Cycle 2-6: Day 1 1000 mg~Maintenance After the induction ibrutinib po 420 mg daily and GA101 iv 1000 mg every three months will be continued.~GA101: Cycle 1-8 Day 1 1000 mg"
Ibrutinib
"Ibrutinib will be administered as a daily oral dosage of 420 mg starting on cycle 2 day 1.~Cycle 2-6: Day 1 420 mg daily~Maintenance After the induction ibrutinib po 420 mg daily and GA101 iv 1000 mg every three months will be continued.~Ibrutinib: Cycle 1-8 420 mg daily"
German CLL Study Group, Cologne
Hoffmann-La Roche
INDUSTRY
Janssen-Cilag Ltd.
INDUSTRY
German CLL Study Group
OTHER