A Phase III Study Comparing Imatinib Standard Dose (400 mg/Day) Versus Imatinib High Dose (800 mg/Day) in the Treatment of Newly Diagnosed High Risk Chronic Myeloid Leukemia in Chronic Phase
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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.
Michele Baccarani, MD
Istituto di Ematologia e Oncologia Medica "L. e A. Seràgnoli" Università degli Studi di Bologna
Italy: The Italian Medicines Agency