CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 128 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.

Search/NCT01227577
NCT01227577Phase 4Completed
CompareCT.gov

A Single-arm, Open-label, Multi-center Study of Complete Molecular Response (CMR) in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Novartis Pharmaceuticals·interventional·Posted Oct 25, 2010·Updated Feb 8, 2016

In Brief

A Phase 4 clinical trial evaluating Nilotinib for Chronic Myelogenous Leukemia in Chronic Phase. Completed, enrolled 128 participants across 32 sites.

Detailed Summary

"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myelogenous Leukemia in Chronic Phase
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2010
Enrollment StartNov 1, 2010
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 15.7 years ago

Interventions

Nilotinibdrug

Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.