CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 171 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/NCT02546674
NCT02546674Phase 4Completed
CompareCT.gov

A Phase IV Single Arm, Multicenter, Open-label Study Assessing Deep Molecular Response in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive CML in Chronic Phase After Two Years of Treatment With Nilotinib 300mg BID

Novartis Pharmaceuticals·interventional·Posted Sep 11, 2015·Updated Jul 22, 2022

In Brief

A Phase 4 clinical trial evaluating Nilotinib for Chronic Myeloid Leukemia. Completed, enrolled 171 participants across 70 sites.

Detailed Summary

The main purpose of this study was to evaluate the rate of deep molecular response (MR4.5) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase chronic myeloid leukemia (CML) using EUTOS (European Treatment and Outcome Study for CML)-standardized laboratories. All participants received nilotinib 300 mg twice daily (BID).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myeloid Leukemia
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 11, 2015
Enrollment StartFeb 18, 2016
Primary CompletionFeb 23, 2021
Study CompletionMar 25, 2021
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 10.8 years ago

Interventions

Nilotinibdrug

A daily dose of 300 mg was given to all participants as two 150 mg capsules BID. The prescription of study drug was not study dependent and followed medical needs of the participant only. The study treatment was administered for 24 months.