A Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, will be 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 is included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive nilotinib therapy at a dose of 400 mg BID, using an abbreviated safety and efficacy assessment schedule. The extension protocol CAMN107A2303E1 (NCT00718263) was registered incorrectly as a separate study. But this study has now been suppressed.
18 Years and up
Accepting Healthy Volunteers?
- Chronic myelogenous leukemia in chronic phase patients within the first 6 months of diagnosis.
- Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome of (9:22) translocations
- Previously documented T315I mutation
- Treatment with a tyrosine kinase inhibitor prior to study entry is not allowed except for no more than 2 weeks in duration of imatinib
- Any medical treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
- Impaired cardiac function.
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
- Currently receiving treatment with any medications that have the potential to prolong the QT interval.
Other protocol-defined inclusion/exclusion criteria may apply