Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib

Phase 2 Terminated 18 enrolled Novartis Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

This exploratory study will evaluate the change in molecular response in chronic myelogenous leukemia - chronic phase patients with a complete cytogenetic response and have a suboptimal molecular response to imatinib

Timeline

Start: 2008-10
Primary completion: 2012-03
Completion: 2012-03

Outcome

Outcome not reported

Stopped (Enrollment): “Slower than expected enrollment”

Publications

Ailawadhi S, Akard LP, Miller CB, Jillella A, DeAngelo DJ, Ericson SG, Lin F, Warsi G, Radich J. Exploratory study on the impact of switching to nilotinib in 18 patients with chronic myeloid leukemia in chronic phase with suboptimal response to imatinib. Ther Adv Hematol. 2017 Jan;8(1):3-12. doi: 10.1177/2040620716678118. Epub 2016 Nov 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nilotinib	Small molecule	300 mg	Oral