Overview

Phase II Trial GA101 Inbrutinib B CLL

Status:
Completed
Trial end date:
2018-03-01
Target enrollment:
Participant gender:
Summary
Phase II study testing chemo-free induction therapy with Ibrutinib + Obinutuzumab nine months / Study Part 1: All patients will receive 8 courses of GA101 + ibrutinib 420mg PO every 28 days Study Part 2: After evaluation at D1 of month 9: If patients are in CR with BM MRD < 10-4, they will continue ibrutinib alone at a dose of 420mg daily If patients have BM MRD >10-4 whatever IWCLL 2008 responses or PR they will receive four courses of GA101 + FC at 28-day intervals + Ibrutinib PO until final evaluation of M16
Phase:
Phase 2
Details
Lead Sponsor:
French Innovative Leukemia Organisation
Collaborators:
Janssen-Cilag Ltd.
Roche Pharma AG
Treatments:
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Obinutuzumab
Vidarabine