A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine Mepesuccinate) in the Treatment of Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation.
Phase of Trial: Phase II
Latest Information Update: 24 Aug 2016
At a glance
- Drugs Omacetaxine mepesuccinate (Primary)
- Indications Chronic myeloid leukaemia
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors ChemGenex Pharmaceuticals; Teva Branded Pharmaceutical Products R&D; Teva Pharmaceutical Industries
- 31 Aug 2018 Biomarkers information updated
- 02 Jun 2014 Duration of maintenance therapy changed from up to 2 years to 3 years.
- 13 Feb 2014 The US FDA has approved omacetaxine mepesuccinate for injection based on results from this and another pivotal phase II trial according to a Teva Pharmaceuticals Industries media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History