At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 846 enrolled

Drug / intervention

nilotinib +1 moredrug

Likely dose

nilotinib 50 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/NCT00471497

NCT00471497Phase 3Completed

Compare CT.gov

A Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Novartis Pharmaceuticals·interventional·Posted May 10, 2007·Updated Nov 18, 2020

In Brief

A Phase 3 clinical trial evaluating nilotinib and imatinib for Myelogenous Leukemia, Chronic. Completed, enrolled 846 participants across 213 sites in 35 countries.

Detailed Summary

In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMyelogenous Leukemia, Chronic

CountriesArgentina, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Venezuela

Collaborators--

Timeline

Phase 3CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedMay 2007

Enrollment StartJul 2007

Primary CompletionSep 2009

Study CompletionAug 2019

TodayJul 2026

First PostedMay 10, 2007

Enrollment StartJul 31, 2007

Primary CompletionSep 2, 2009

Study CompletionAug 21, 2019

TodayJul 2, 2026

Enrollment to primary: 2.1 yearsPosted 19.1 years ago

Interventions

nilotinibdrug

Nilotinib was supplied as 50 mg, 150 mg and 200 mg hard gelatin capsules and administered orally at 300 mg BID (twice a day) or 400 mg BID (twice a day)depending on the randomized dose.

imatinibdrug

Imatinib was supplied as 100 mg and 400 mg tablets and administered orally at 400 mg QD (once a day).