CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 421 enrolled
Drug / intervention
Nilotinibdrug
Likely dose
Nilotinib 300 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/NCT01254188
NCT01254188Phase 3Completed
CompareCT.gov

Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) Patients in Chronic Phase

Novartis Pharmaceuticals·interventional·Posted Dec 6, 2010·Updated Mar 3, 2016

In Brief

A Phase 3 clinical trial evaluating Nilotinib for Chronic Myeloid Leukemia. Completed, enrolled 421 participants across 100 sites in 19 countries.

Detailed Summary

This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myeloid Leukemia
CountriesAlgeria, Argentina, Australia, Brazil, Canada, Egypt, India, Israel, Lebanon, Malaysia, Mexico, Oman, Russia, Saudi Arabia, South Africa, Taiwan, Thailand, Tunisia, United Arab Emirates
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2010
Enrollment StartApr 1, 2011
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.6 years ago

Interventions

Nilotinibdrug

This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.