Clinical Trial: Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) Without the 5q Deletion and Transfusion Dependent Anaemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional



Official Title: Multicentre, Open-label, Randomized Phase II Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 International Prognostic

Brief Summary:

Primary Outcome Measures:

• To evaluate the efficacy of treatment with Azacitidine in patients with transfusion-dependent, low risk International Prognostic Scoring System (IPSS) 0 int-1, Myelodysplastic Syndrome (MDS) without chromosome 5 (5q) deletion. The main objective will be based on the erythroid haematologic response according to International Working Group (IWG) 2006 criteria.

Secondary Outcome Measures:

  • Haematologic response, bases on the following parameters: platelets, and neutrophils according to International Working Group (IWG) Criteria.
  • Medullary and cytogenetic response according to International Working Group (IWG) 2006 criteria.
  • The effect of treatment response on quality of life, through the Functional Assessment of Cancer Therapy-Anemia (FACT-an) questionnaire.
  • Overall survival, Event-Free Survival and the Acute Leukaemia Transformation Rate.