NCT01254188

Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients

Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) Patients in Chronic Phase

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 421 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Nilotinib	This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2010-12-06
• Last updated: 2016-03-03
• Results posted: 2016-03-03

Locations

100 sites across 19 countries: Algeria, Argentina, Australia, Brazil, Canada, Egypt, India, Israel, Lebanon, Malaysia, Mexico, Oman, Russia, Saudi Arabia, South Africa, Taiwan, Thailand, Tunisia, United Arab Emirates