135
Participants
Start Date
October 31, 2015
Primary Completion Date
May 31, 2017
Study Completion Date
September 30, 2023
GA101
"Part 1 :6 cycles~Obinutuzumab/GA101:~First cycle:~D1: 100mg, D2: 900mg D8 and D15: 1000 mg i.v~Cycle 2 to 6 (every 28 days) :~D1 of every cycle: 1000 mg i.v PART 2 4 cycles~-patients have BM MRD \>10-4 or PR: Cycle 1 to 4 Obitinuzumab/GA101: 1000 mg i.v on day 1"
Ibrutinib
"Part 1 :6 cycles~Cycle 2 to 6 (every 28 days) :Ibrutinib:~D3 Month 1 to Day 30 Month 15: 420mg daily PO PART 2:4 cycles~* patients in CR with BM MRD \< 10-4 : Ibrutinib alone 420mg daily~* patients with BM MRD \>10-4 whatever responses or PR :Cycle 1 to 4 Ibrutinib 420mg daily with Cyclophosphamide and Fludarabine"
Cyclophosphamide
"PART 2 :~patients with BM MRD \>10-4 or PR (except PD and SD), receive : 4 cycles of FC+GA101 every 28 days Cyclophosphamide : 250 mg/m² per os, D2 to D4 in association with GA101, ibrutinib and fludarabine"
Fludarabine
"PART 2 :~patients with BM MRD \>10-4 or PR (except PD and SD), receive : 4 cycles of FC+GA101 every 28 days : Fludarabine : 40 mg/m² per os, D2 to D4 in association with GA101, ibrutinib and cyclophosphamide"
Sponsor FILO, Tours
Roche Pharma AG
INDUSTRY
Janssen-Cilag Ltd.
INDUSTRY
French Innovative Leukemia Organisation
OTHER