NCT01206088

Tasigna in Glivec-resistant or Intolerant Patients in CML

A Phase IV Study for Nilotinib in Patients With Imatinib-resistant or Intolerant Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate efficacy and safety of nilotinib in patients with Imatinib resistant or intolerant CML-CP or AC. Efficacy evaluation will be made by Complete cytogenetic response rate(CCyR) at 12 months after nilotinib administration.

Conditions

• CML
• Nilotinib
• Imatinib Resistant
• Imatinib Intolerant

Interventions

Type	Name	Description
DRUG	nilotinib	administration of nilotinib as 2nd line

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2010-09-21
• Last updated: 2017-02-28

Locations

1 site across 1 country: South Korea