drugset / Trial / NCT02159040

Phase II Study to Evaluate Overall Response in Patients With Higher Risk Myelodysplastic Syndromes (MDS) Treated With Azacitidine With or Without Deferasirox.

NCT02159040

Phase 2 Terminated 1 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of the study is to compare the overall response rate (inclusive of complete response, partial response and hematologic improvement) per IWG 2006 criteria in patients with higher risk MDS treated with azacitidine with or without deferasirox achieved over the course of one year. Hematologic improvement must be maintained for at least 8 weeks.

Timeline

Start
2014-09-11
Primary completion
2015-06-26
Completion
2015-06-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Deferasirox Unknown 10 mg/kg
Background Azacitidine Other / unclassified 75 mg/m2 Subcutaneous