Journal article
TIDEL-Ii: First-line use of imatinib in CML with early switch to nilotinib for failure to achieve time-dependent molecular targets
DT Yeung, MP Osborn, DL White, S Branford, J Braley, A Herschtal, M Kornhauser, S Issa, DK Hiwase, M Hertzberg, AP Schwarer, R Filshie, CK Arthur, YL Kwan, J Trotman, CJ Forsyth, J Taper, DM Ross, J Beresford, C Tam Show all
Blood | Published : 2015
Abstract
The Therapeutic Intensification in De Novo Leukaemia (TIDEL)-II study enrolled 210 patients with chronic phase chronic myeloid leukemia (CML) in two equal, sequential cohorts. All started treatment with imatinib 600 mg/day. Imatinib plasma trough level was performed at day 22 and if 10% BCR-ABL1 at 3 months. Confirmed major molecular response was achieved in 64% at 12 months and 73% at 24 months. MR4.5 (BCR-ABL1 ≤0.0032%) at 24 months was 34%. Overall survival was 96% and transformation-free survival was 95% at 3 years. This trial supports the feasibility and efficacy of an imatinib-based approach with selective, early switching to nilotinib. This trial was registered atwww.anzctr.org.au as#..
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Awarded by National Cancer Institute
Funding Acknowledgements
This work was supported in part by grants from Novartis Pharmaceuticals Australia. This study was sponsored by the Australasian Leukaemia and Lymphoma Group. D.T.Y. is a PhD candidate at the University of Adelaide and this work is submitted in partial fulfillment of the requirement for the PhD. D.T.Y. receives PhD scholarship funding from the Leukaemia Foundation of Australia and the Royal Adelaide Hospital Research Foundation A. R. Clarkson Scholarship. D.T.Y. received a Clinical Research Training Institute training award from the American Society of Hematology. T.P.H. is a National Health and Medical Research Council Practitioner Fellow. Novartis has no role in gathering, analyzing, or interpreting the data.