CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 225 enrolled
Drug / intervention
Imatinib +1 moredrug
Likely dose
Imatinib 400mgfrom 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/NCT02272777
NCT02272777Phase 3Completed
CompareCT.gov

An Open-label Multi-center Study of Imatinib and Nilotinib in CAMN107ECN02 On-treatment Patients With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase After the End of CAMN107ECN02 Core Study

Novartis Pharmaceuticals·interventional·Posted Oct 23, 2014·Updated Aug 19, 2019

In Brief

A Phase 3 clinical trial evaluating Imatinib and Nilotinib for Leukemia. Completed, enrolled 225 participants across 12 sites.

Detailed Summary

The extension study followed the core study CAMN107ECN02 (NCT01275196). which is an open-label, two armed study. All patients enrolled in this extension study were able to benefit from the treatment given in CAMN107ECN02 per investigator's evaluation. Therefore, in this extension study patient continued treatment of the drug (imatinib or nilotinib) which they were taking at the end of CAMN107ECN02. Treatment arms in CAMN107ECN02 were retained. As long as EC approval and agreement from investigators were obtained, the selected sites for CAMN107ECN02 were applied in this extension study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 23, 2014
Enrollment StartJul 17, 2014
Primary CompletionJan 30, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 11.7 years ago

Interventions

Imatinibdrug

Imatinib 400mg QD，300mg QD or 600mg QD

Nilotinibdrug

Nilotinib 300mg BID or 400mg QD