Conditions: High Risk MDS
Keywords: Int-2 MDS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 75mg/m2 7days/28 day cycle arm 2: azacitidine 75mg/m2 7 days/28 day cycle deferasirox 10 mg/kg/day

Interventions: intervention 1: Azacitidine intervention 2: Azacitidine plus Deferasirox
Intervention descriptions: intervention 1: SC or IV AZA at 75mg/m2 7 days/28 day cycle intervention 2: SC or IV AZA at 75mg/m2 7 days/28 day cycle DFX 10mg/kg/day

Protocol document: