CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 191 enrolled
Drug / intervention
nilotinib +1 moredrug
Likely dose
nilotinib 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00802841
NCT00802841Phase 3Completed
CompareCT.gov

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

Novartis Pharmaceuticals·interventional·Posted Dec 5, 2008·Updated Nov 16, 2015

In Brief

A Phase 3 clinical trial evaluating nilotinib and imatinib for Chronic Myelogenous Leukemia. Completed, enrolled 191 participants across 56 sites in 12 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myelogenous Leukemia
CountriesArgentina, Brazil, China, Colombia, Germany, Guatemala, India, Mexico, Panama, Poland, Russia, Venezuela
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2008
Enrollment StartMay 1, 2009
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 17.6 years ago

Interventions

nilotinibdrug

Supplied as 200 mg tablets

imatinibdrug

Supplied as 100 mg and 400 mg tablets