Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

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 Scoring System(IPSS )) Without the 5q Deletion and Transfusion Dependent Anaemia

Study ID: NCT01338337

Conditions

Myelodysplastic Syndrome (MDS)

Interventions

Azacitidine

Study Description

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.

Detailed Description: