drugset / Trial / NCT01400074

Efficacy of Nilotinib Versus Imatinib in Ph+ CML in Early CP Who Have a Suboptimal Molecular Response to Imatinib

NCT01400074

Phase 3 Unknown 100 enrolled Seoul St. Mary's Hospital Novartis · collab
RandomizedCrossoverOpen-labelTreatment

Summary

In this study, the efficacy of nilotinib at 400 mg BID will be compared with imatinib at 400 mg BID in suboptimal molecular response patients. To determine study eligibility, suboptimal molecular response will be defined as patients who have achieved a complete cytogenetic response (CCyR) but have not achieved a MMR, after at least 18 months of treatment on first line imatinib therapy at a minimum dose of 400mg daily (Baccarani 2006).

Timeline

Start
2009-01
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Imatinib Small molecule 400 mg
Comparator Nilotinib Small molecule 400 mg Oral