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.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Deferasirox | Unknown | 10 mg/kg | — |
| Background | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |