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|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (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.
|Contact: Sanz Guillermo, Dremail@example.com|
|Hospital Germans Trias i Pujol||Recruiting|
|Contact: Xicoy Blanca, Dr|
|Hospital del Mar||Not yet recruiting|
|Contact: De Pedro Carmen, Dr|
|Hospital Clínic Universitari||Recruiting|
|Contact: Nomdedeu Benet, Dr|
|Hospital Reina Sofía||Not yet recruiting|
|Contact: Torres Antonio, Dr|
|Hospital Virgen Blanca||Recruiting|
|Contact: Ramoas Fernando, Dr|
|Hospital la Paz||Recruiting|
|Contact: De Paz Raquel, Dr|
|Hospital Central de Asturias||Recruiting|
|Contact: Bernal Teresa, Dr|
|Hospital Son Llatzer||Recruiting|
|Palma de mallorca, Spain|
|Contact: bargay Joan, Dr|
|Hospital Clinico Universitario||Recruiting|
|Contact: Del Cañizo Consuelo, Dr|
|Hospital La Fe de Valencia||Recruiting|
|Contact: Sanz Guillermo, Dr|
|Study Director:||Sanz Guillermo, Dr||Hospital La Fe|
|Study Director:||Del Cañizo Consuelo, DR||Hospital Clinico de Salamanca|