A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

• Status: Completed
• Trial end date: 2019-08-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Imatinib Mesylate

Criteria

Key Inclusion criteria:

• 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

Key Exclusion criteria:

• 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.