Differentiation Therapy With Decitabine in Treating Patients With Myelodysplastic Syndrome

Arms (1)

1. type

   EXPERIMENTAL

   label

   Arm I: decitabine

   description

   INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts \< 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

   interventionNames

   1. Other: flow cytometry
   2. Other: DNA methylation analysis
   3. Other: cytogenetic analysis
   4. Drug: decitabine
   5. Genetic: microarray analysis
   6. Genetic: gene expression analysis
   7. Other: pharmacological study
   8. Genetic: polymorphism analysis

Primary outcomes (1)

1. measure

   Number of Patients With Response as Defined by IWG (International Working Group) Criteria for Myelodysplasia

   timeFrame

   Formal assessment at week 12 for study primary end-point (hematologic improvement).

   description

   Complete Response (CR) include less than 5% marrow blasts without evidence of dysplasia and normalization of peripheral blood counts, including a hemoglobin level of 110 g/L or more, a neutrophil count of 1.5 × 109/L or more, and a platelet count of 100 × 109/L or more. For PR, patients must demonstrate all CR criteria if abnormal before treatment except that marrow blasts should decrease by 50% or more compared with pretreatment levels, or patients may demonstrate a less-advanced MDS disease category than prior to treatment. Stable disease (SD) is defined by failure to achieve at least a partial response but no evidence of progression. Disease progression (DP) includes at least 50% decrease from maximum remission in granulocytes or platelets, reduction in hemoglobin by greater than or equal to 2g/dL, or transfusion dependence. Hematologic improvement (HI) includes hemoglobin increase by at least 1.5g/dL, reduction in transfusions, increase of platelets, increase of neutrophil count