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

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.

Timeline

Start

2010-11

Primary completion

2015-12

Completion

2015-12

Drugs

Indications