At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 215 enrolled
Drug / intervention
Nilotinib followed by treatment-freedrug
Likely dose
Nilotinib followed by treatment-free 150 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.
A Single-arm, Multicenter, Nilotinib Treatment-free Remission Study in Patients With BCR-ABL1 Positive Chronic Myelogenous Leukemia in Chronic Phase Who Have Achieved Durable Minimal Residual Disease (MRD) Status on First Line Nilotinib Treatment.
In Brief
A Phase 2 clinical trial evaluating Nilotinib followed by treatment-free for Chronic Myelogenous Leukemia. Completed, enrolled 215 participants across 113 sites in 19 countries.
Detailed Summary
The main purpose of the study was to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myelogenous Leukemia
CountriesArgentina, Austria, Belgium, Bulgaria, Colombia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Netherlands, Poland, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 2013
Enrollment StartMar 2013
Primary CompletionMay 2016
Study CompletionJan 2025
TodayJul 2026
First PostedFeb 5, 2013
Enrollment StartMar 19, 2013
Primary CompletionMay 31, 2016
Study CompletionJan 23, 2025
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.4 years ago
Interventions
Nilotinib followed by treatment-freedrug
Nilotinib is being used as commercial available capsules (except in Japan where clinical supplies is used) of 150 mg and 200 mg strength. Treatment occurs during consolidation, continuation, prolonged continuation, re-initiation and re-initiation-2 phases of the study.