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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Azacitidine
Beta Erythropoietin
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Clínic Universitari
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Reina Sofía
Córdoba, Spain
Evaluate the efficacy of the treatment in response rate terms
Time frame: 6 months
Evaluate the safety of the treatment
Time frame: 2 months
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