Myelodysplastic Syndrome (MDS) Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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