NCT01043874

Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response

A Phase IV Study of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have Suboptimal Molecular Response on Imatinib

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.

Conditions

• Philadelphia Chromosome Positive
• Chronic Myelogenous Leukemia in Chronic Phase

Interventions

Type	Name	Description
DRUG	Nilotinib	400 mg BID

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2010-01-07
• Last updated: 2016-04-08
• Results posted: 2015-02-09

Locations

20 sites across 1 country: Japan