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