Conditions: Myelodysplastic Syndromes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 151
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if azacitidine, combined with Best Supportive Care (BSC), is effective in treating myelodysplastic syndromes (MDS) when given according to a different doses and dosing schedules.

Detailed description:
Comparison/Control Interventions: The comparison is azacitidine at different doses and schedules.

Duration of Intervention: Treatment lasted for a maximum of 18 cycles, which is up to 24 months.

Arms:
arm 1: Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle. arm 2: Azacitidine administered subcutaneously at 75mg/m\^2 for 5days with 2 days off, then for an additional 2 days, on a 28 day cycle. arm 3: Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle. arm 4: Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 4 weeks. arm 5: Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 6 weeks.

Interventions: intervention 1: azacitidine
Intervention descriptions: intervention 1: Azacitidine is administered subcutaneously

Total of 18 cycles on treatment or early discontinuation.

Protocol document: