NCT00495547

SIMIDIS: Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome

A Multicenter, Non-Randomized, Open-Label Study to Evaluate Efficacy and Safety of Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome Red Cell Transfusion Dependent With Low or Intermediate -1 Risk.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the efficacy of the treatment in response rate terms. Otherwise this study wants to evaluate the safety of the treatment.

Detailed description

A total of up to 30 patients diagnosed of myelodysplastic syndrome red cell transfusion dependent with low or intermediate -1 risk will be included. The patients will be evaluated at scheduled visits in up to three study periods: Pre-treatment, Treatment and Follow up. The Pre-treatment includes Screening and baseline visits. After providing informed consent, patients will be evaluated for study eligibility. During Treatment Period patients will be evaluated once a month although biochemistry and haematology parameters will be evaluated every 2 weeks. If an erythroid response after 24 weeks is determined, a extension treatment will be carry out without disease progression.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Azacitidine	Azacitidine
DRUG	Beta Erythropoietin	Beta Erythropoietin

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2007-07-03
• Last updated: 2014-04-07

Locations

10 sites across 1 country: Spain