At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 45 enrolled
Drug / intervention
Nilotinibdrug
Likely dose
Nilotinib 400 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 IV Study of Nilotinib in Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have Suboptimal Molecular Response on Imatinib
In Brief
A Phase 4 clinical trial evaluating Nilotinib for Philadelphia Chromosome Positive and Chronic Myelogenous Leukemia in Chronic Phase. Completed, enrolled 45 participants across 20 sites.
Detailed Summary
To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal molecular response to imatinib at 18 months or later.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
First PostedJan 2010
Primary CompletionDec 2013
Study CompletionJan 2014
TodayJul 2026
First PostedJan 7, 2010
Enrollment StartDec 1, 2009
Primary CompletionDec 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.5 years ago
Interventions
Nilotinibdrug
400 mg BID