Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

• Status: Terminated
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Imatinib Mesylate

Criteria

Inclusion criteria:

Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase.

Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as:

• 6 to < 12 months of treatment and -have 36 - 95% Ph+ metaphases, or

• 12 to <18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics, no FISH [fluorescence in situ hybridization] analysis was allowed).

Exclusion criteria:

• Patient who have received more than 18 months of imatinib therapy

• Patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study.

• Prior treatment with greater than 400 mg/day imatinib.

• Uncontrolled or significant cardiovascular disease.

• Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).

• Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)

• Currently taking certain medications that could affect the rhythm of your heart.

Other protocol-defined inclusion/exclusion criteria may apply