NCT00760877

Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)

An Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients With Evidence of Persistent Leukemia by RQ-PCR.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib. The study also explored the impact and significance of the achieved CMR on patient outcomes (progression free survival (PFS), event free survival (EFS) and overall survival (OS), characterized the kinetics of CMR achieved in both treatment arms and after the cross-over.

Conditions

• CHRONIC MYELOGENOUS LEUKEMIA

Interventions

Type	Name	Description
DRUG	Nilotinib	Supplied in 200 mg capsules
DRUG	Imatinib	Supplied in 100 mg and 400 mg capsules

Timeline

• Start date: 2009-06-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2008-09-26
• Last updated: 2016-11-08
• Results posted: 2016-08-16

Locations

30 sites across 6 countries: Argentina, Australia, Brazil, Canada, France, Spain