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- Title
Ibrutinib, Fludarabine, Cyclophosphamide, and Obinutuzumab (GA101) (iFCG) Treatment for First-Line Therapy of Patients with CLL with Mutated IGHV and Without Deletion 17p.
- Authors
Jain, Nitin; Thompson, Philip; Burger, Jan; Borthakur, Gautam; Bose, Prithviraj; Estrov, Zeev; Ferrajoli, Alessandra; Koichi Takahashi; Garg, Naveen; Wang, Xuemei; Gandhi, Varsha; Plunkett, William; Kanagal-Shamanna, Rashmi; Patel, Keyur; Lopez, Wanda; Kantarjian, Hagop; O'Brien, Susan; Keating, Michael; Wierda, William
- Abstract
Context: Chemotherapy has remained the standard treatment for young patients (pts) with CLL. The role of chemotherapy in the era of novel therapies is evolving. Objective: To determine CR rate with minimal rediual disease (MRD) negativity after 3 courses of iFCG regimen in pts with CLL with mutated IGHV, and without deletion 17p. Design: Investigatorinitiated phase II trial with ibrutinib, fludarabine, cyclophosphamide, and obinutuzumab (iFCG) for previously untreated pts with IGHV-M CLL (NCT02629809). Setting: Comprehensive Cancer Center Patients or Other Participants: Diagnosis of CLL/SLL requiring first-line treatment, age ≥18, IGHV-M, no del(17p) Interventions: Pts received 3 courses of iFCG. Pts meeting primary endpoint received ibrutinib with obinutuzumab (iG) for C4-6, then ibrutinib C7-12. Pts not achieving the primary endpoint received iG (C4-12). All pts with undetectable MRD at 1 yr stop all therapy, including ibrutinib. Responses per IWCLL 2008 criteria. Main Outcomes Measures: The primary endpoint is CR/CRi with undetectable BM MRD (4-color flow-cytometry, sensitivity 10-4) after 3 courses of iFCG. The historical rate of C3 undetectable BM MRD with FCR in IGHV-M pts was 26% (Strati, Blood 2014). Target undetectable BM MRD after iFCG x3 is 45%; sample size 45. Results: 32 pts initiated treatment. Median follow-up 10.9 months. Baseline characteristics are shown in Table 1. Twenty-eight pts have completed 3 courses of iFCG and had initial response assessment. All 28 pts achieved a response; 24/28 (86%) achieved MRD-negative remission in BM at 3 month (Table 2). Overall, 13/ 28 (46%) achieved CR/CRi with undetectable MRD at 3 months. Responses continue to improve over time (6 months: CR/CRi 74%,
- Publication
Clinical Lymphoma, Myeloma & Leukemia, 2017, Vol 17, pS13
- ISSN
2152-2650
- Publication type
Article
- DOI
10.1016/j.clml.2017.09.041