drugset / Trial / NCT02546674

Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.

NCT02546674

Phase 4 Completed 171 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2016-02-18
Primary completion
2021-02-23
Completion
2021-03-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Nilotinib Small molecule 300 mg