SIMIDIS: Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome
Drug: Beta Erythropoietin
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
- Evaluate the efficacy of the treatment in response rate terms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Evaluate the safety of the treatment [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495547
|Hospital Germans Trias i Pujol|
|Hospital Clínic Universitari|
|Hospital del Mar|
|Hospital Reina Sofía|
|Hospital Virgen Blanca|
|Hospital la Paz|
|Hospital Central de Asturias|
|Hospital Son Llatzer|
|Palma de mallorca, Spain|
|Hospital Clinico Universitario|
|Hospital La Fe de Valencia|
|Study Director:||Sanz Guillermo, Dr||Hospital La Fe|
|Study Director:||Del Cañizo Consuelo, DR||Hospital Clinico de Salamanca|