drugset

drugset / Trial / NCT01254188

Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients

NCT01254188 ↗

Phase 3 Completed 421 enrolled Novartis Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase

Timeline

Start: 2011-04
Primary completion: 2014-11
Completion: 2014-11

Publications

Hughes TP, Munhoz E, Aurelio Salvino M, Ong TC, Elhaddad A, Shortt J, Quach H, Pavlovsky C, Louw VJ, Shih LY, Turkina AG, Meillon L, Jin Y, Acharya S, Dalal D, Lipton JH. Nilotinib dose-optimization in newly diagnosed chronic myeloid leukaemia in chronic phase: final results from ENESTxtnd. Br J Haematol. 2017 Oct;179(2):219-228. doi: 10.1111/bjh.14829. Epub 2017 Jul 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nilotinib	Small molecule	300 mg	—
Subject	Nilotinib	Small molecule	400 mg	—

Indications