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Clinical Trial
. 2009 Apr 9;113(15):3428-34.
doi: 10.1182/blood-2007-08-103499. Epub 2009 Feb 11.

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

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Clinical Trial

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 Castagnetti et al. Blood. .

Abstract

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.

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