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.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the efficacy of the treatment in response rate terms
Sanz Guillermo, Dr
Hospital La Fe
Spain: Ministry of Health