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Blood, 9 April 2009, Vol. 113, No. 15, pp. 3428-3434. Prepublished online as a Blood First Edition Paper on February 11, 2009; DOI 10.1182/blood-2007-08-103499. This Article Full Text Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2007-08-103499v1 113/15/3428    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Castagnetti, F. Articles by Rosti, G. Search for Related Content PubMed PubMed Citation Articles by Castagnetti, F. Articles by Rosti, G. Related Collections Free Research Articles Myeloid Neoplasia Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Results of high-dose imatinib mesylate in intermediate Sokal risk chronic myeloid leukemia patients in early chronic phase: a phase 2 trial of the GIMEMA CML Working Party Fausto Castagnetti1, Francesca Palandri1, Marilina Amabile1, Nicoletta Testoni1, Simona Luatti1, Simona Soverini1, Ilaria Iacobucci1, Massimo Breccia2, Giovanna Rege Cambrin3, Fabio Stagno4, Giorgina Specchia5, Piero Galieni6, Franco Iuliano7, Fabrizio Pane8, Giuseppe Saglio3, Giuliana Alimena2, Giovanni Martinelli1, Michele Baccarani1, Gianantonio Rosti1, and for the GIMEMA CML Working Party 1 Institute of Hematology L. & A. Seràgnoli, University of Bologna, Bologna; 2 Department of Hematology, University La Sapienza Rome, Rome; 3 Department of Internal Medicine, S. Luigi Gonzaga Hospital Orbassano, Torino; 4 Department of Hematology, University of Catania, Catania; 5 Department of Hematology, University of Bari, Bari; 6 Division of Hematology, Mazzoni Hospital, Ascoli Piceno; 7 Hematology Unit, Giannettasio Hospital, Rossano Calabro; and 8 Centro Indagini Genetiche e Molecolari, Federico II University, Napoli, Italy Imatinib mesylate has become the treatment of choice for chronic myeloid leukemia (CML): the standard dose for chronic- phase (CP) CML is 400 mg daily. Response rates are different according to Sokal score, being significantly lower in intermediate and high Sokal risk patients. Phase 1 and 2 trials have shown a dose-response effect and high-dose imatinib trials in early CP CML showed better results compared with standard dose. Our study is the first prospective trial planned to evaluate the efficacy and tolerability of high-dose imatinib in previously untreated intermediate Sokal risk CML patients. Seventy-eight patients were treated with 400 mg imatinib twice daily: complete cytogenetic response (CCgR) rates at 12 and 24 months were 88% and 91%; moreover, at 12 and 24 months 56% and 73% of CCgR patients achieved a major molecular response. The incidence of adverse events was slightly higher than reported by the most important standard-dose trials. With a median follow-up of 24 months, 3 patients progressed to advanced phase. In intermediate Sokal risk newly diagnosed CML patients, high-dose imatinib induced rapid and high response rates, apparently faster than those documented in the International Randomized Study of IFN and Imatinib for the same risk category. These clinical trials are registered at www.clinicaltrials.gov as no. NCT00510926 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

	Copyright © 2009 by American Society of Hematology         Online ISSN: 1528-0020