At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 59 enrolled
Drug / intervention
nilotinibdrug
Likely dose
nilotinib 50mgfrom 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 Multi-center, Open Label, Non-controlled Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Pediatric Patients With Newly Diagnosed Ph+ Chronic Myelogenous Leukemia (CML) in Chronic Phase (CP) or With Ph+ CML in CP or Accelerated Phase (AP) Resistant or Intolerant to Either Imatinib or Dasatinib
In Brief
A Phase 2 clinical trial evaluating nilotinib for Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia. Completed, enrolled 59 participants across 36 sites in 13 countries.
Detailed Summary
To evaluate the safety, efficacy and pharmacokinetics of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to \<18 years).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Hungary, Italy, Japan, Malaysia, Netherlands, Russia, South Korea, Spain, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartAug 2013
Primary CompletionJun 2016
Study CompletionAug 2020
TodayJul 2026
First PostedMay 1, 2013
Enrollment StartAug 20, 2013
Primary CompletionJun 1, 2016
Study CompletionAug 28, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.2 years ago
Interventions
nilotinibdrug
Nilotinib supplied in 50mg, 150mg, and 200mg capsules. It was administered orally at 230mg/m2, twice daily for up to 66 cycles (1 cycle = 28 days). Dose administration was rounded to the nearest 50mg dose (to a maximum dose of 400mg).