Overview

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

Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Imatinib Mesylate