CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 148 enrolled
Drug / intervention
Nilotinibdrug
Likely dose
Nilotinib 400 mg orally twice dailyAI-extracted
Key inclusion· 5
  • ✓Ph-positive or Bcr-positive CML in early chronic phase (time from diagnosis ≤12 months)
  • ✓Minimal prior therapy: no prior TKI or <1 month interferon-alpha; hydroxyurea allowed
  • ✓Age ≥16 years (≥18 if enrolling in optional symptom assessment)
  • ✓ECOG performance status 0-2
Key exclusion· 7
  • ✕Significant cardiac disease: NYHA class 3-4, LVEF <45%, complete left bundle branch block, cardiac pacemaker, QTc >450 msec, ventricular/atrial tachyarrhythmias, clinically significant bradycardia (<50 bpm)
  • ✕Myocardial infarction within 12 months or unstable angina within 12 months
  • ✕Active uncontrolled psychiatric disorders (psychosis, major depression, bipolar disorder)
  • ✕Late chronic phase (>12 months from diagnosis) or blastic phase CML

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00129740
NCT00129740Phase 2Completed
CompareCT.gov

Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Oral Nilotinib

M.D. Anderson Cancer Center·interventional·Posted Aug 12, 2005·Updated Sep 24, 2019

In Brief

A Phase 2 clinical trial evaluating Nilotinib for Leukemia, Myelogenous, Chronic. Completed, enrolled 148 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if an experimental agent, AMN107 (nilotinib), can help to control CML in chronic phase. The safety of this experimental agent will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myelogenous, Chronic
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 12, 2005
Enrollment StartJun 27, 2005
Primary CompletionJul 11, 2018
TodayJul 2, 2026
Enrollment to primary: 13.0 yearsPosted 20.9 years ago

Interventions

Nilotinibdrug

400 mg orally twice daily