In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.
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Major Molecular Response Rate (MMR) at 12 Months Between All 3 Arms - With Imputation
Timeframe: Baseline, 12 months
Percentage of Participants With MMR at 12 Months Between All 3 Arms by Sokal Risk Group With Imputation
Timeframe: 12 months