NCT00802841

Randomized Phase Lll Study of Imatinib Dose Optimization vs Nilotinib in CML Patients With Suboptimal Response to Imatinib

A Randomized Phase Lll Study of Imatinib Dose Optimization Compared With Nilotinib in Patients With Chronic Myelogenous Leukemia and Suboptimal Response to Standard-dose Imatinib

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

There is no available data on the clinical benefit of dose escalation for patients with suboptimal response to imatinib, and patients may still improve their response with continuation of therapy at the standard dose as shown in the IRIS trial after 5 years of follow-up. However, there is no data yet regarding the potential benefit of using nilotinib in the group of patients with suboptimal response. In this study, the efficacy of nilotinib 400mg BID will be compared to imatinib 600mg QD.

Detailed description

The comparative efficacy between imatinib dose escalation (600 mg QD) and nilotinib (400 mg BID), in terms of CCyR after 6 months, for patients with CML in chronic phase with suboptimal response to imatinib standard dose will be determined.

Conditions

• Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	nilotinib	Supplied as 200 mg tablets
DRUG	imatinib	Supplied as 100 mg and 400 mg tablets

Timeline

• Start date: 2009-05-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2008-12-05
• Last updated: 2015-11-16
• Results posted: 2015-11-16

Locations

56 sites across 12 countries: Argentina, Brazil, China, Colombia, Germany, Guatemala, India, Mexico, Panama, Poland, Russia, Venezuela