This is a phase III multicenter, open-label study designed to investigate the efficacy (hematological response, cytogenetic response and molecular response) and feasibility (tolerance, compliance and safety) of the tyrosine kinase inhibitor imatinib mesylate (formerly STI 571, GLIVEC, Novartis Pharma) at conventional dose (400 mg/daily) if compared with high dose (800 mg/daily) (serial number protocol ICSG/CML/022) in patients with Ph+ chronic myeloid leukemia (CML) in chronic phase (CP) previously untreated, at high Sokal risk.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli"
Bologna, Italy
To determine the rate of complete cytogenetic response at 12 months in adult patients with previously untreated high Sokal risk CML treated with imatinib at 2 different dose levels of 400 and 800 mg/daily.
The rate of major cytogenetic response,the kinetic and duration of cytogenetic response, the time to accelerated and blast crisis and overall survival,safety and tolerability of the treatment.
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