CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 620 enrolled
Drug / intervention
Nilotinibdrug
Likely dose
Nilotinib 300 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.

Search/NCT01743989
NCT01743989Phase 3Completed
CompareCT.gov

A Prospective, Randomized, Open Label, Two Arm Phase III Study to Evaluate Treatment Free Remission (TFR) Rate in Patients With Philadelphia-positive CML After Two Different Durations of Consolidation Treatment With Nilotinib 300mg BID.

Novartis Pharmaceuticals·interventional·Posted Dec 6, 2012·Updated Jul 15, 2021

In Brief

A Phase 3 clinical trial evaluating Nilotinib for Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP). Completed, enrolled 620 participants across 208 sites in 21 countries.

Detailed Summary

This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained in treatment-free remission (≥MR4.0) without molecular relapse 12 months after starting the Treatment-Free Remission (TFR) phase.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhiladelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
CountriesAustria, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2012
Enrollment StartApr 15, 2013
Primary CompletionJul 8, 2020
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 13.6 years ago

Interventions

Nilotinibdrug

Participants received a daily oral nilotinib dose of 300 mg BID, given as two 150 mg capsules BID.