CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 207 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/NCT00760877
NCT00760877Phase 3Completed
CompareCT.gov

An Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients With Evidence of Persistent Leukemia by RQ-PCR.

Novartis Pharmaceuticals·interventional·Posted Sep 26, 2008·Updated Nov 8, 2016

In Brief

A Phase 3 clinical trial evaluating Nilotinib and Imatinib for CHRONIC MYELOGENOUS LEUKEMIA. Completed, enrolled 207 participants across 30 sites in 6 countries.

Detailed Summary

The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib. The study also explored the impact and significance of the achieved CMR on patient outcomes (progression free survival (PFS), event free survival (EFS) and overall survival (OS), characterized the kinetics of CMR achieved in both treatment arms and after the cross-over.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCHRONIC MYELOGENOUS LEUKEMIA
CountriesArgentina, Australia, Brazil, Canada, France, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 26, 2008
Enrollment StartJun 1, 2009
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 17.8 years ago

Interventions

Nilotinibdrug

Supplied in 200 mg capsules

Imatinibdrug

Supplied in 100 mg and 400 mg capsules