At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 59 enrolled
Drug / intervention
nilotinibdrug
Likely dose
nilotinib 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 Phase II Randomized, Multicenter Study of Treatment-free Remission in Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Patients Who Achieve and Sustain MR4.5 After Switching to Nilotinib
In Brief
A Phase 2 clinical trial evaluating nilotinib for CML. Completed, enrolled 59 participants across 54 sites.
Detailed Summary
To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCML
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 2012
Enrollment StartAug 2013
Primary CompletionSep 2018
Study CompletionSep 2018
TodayJul 2026
First PostedDec 7, 2012
Enrollment StartAug 12, 2013
Primary CompletionSep 28, 2018
Study CompletionSep 29, 2018
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 13.6 years ago
Interventions
nilotinibdrug
Nilotinib will be provided as 150 mg capsules. Patients will take nilotinib 300mg twice daily on study and dose modifications to 450mg once daily is permitted per protocol.