NCT00102687

Alternative Dosing Regimens of Subcutaneous Azacitidine for Myelodysplastic Syndromes

A Multicenter, Randomized, Open-Label Study Comparing Three Alternative Dosing Regimens of Subcutaneous Azacitidine Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	azacitidine	Azacitidine is administered subcutaneously Total of 18 cycles on treatment or early discontinuation.

Timeline

• Start date: 2005-01-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2005-02-01
• Last updated: 2019-11-22
• Results posted: 2010-05-28

Locations

31 sites across 1 country: United States