Intravenous Low-Dose Decitabine Versus Supportive Care in Elderly Patients With Primary Myelodysplastic Syndrome (MDS) (>10% Blasts or High-Risk Cytogenetics), Secondary MDS or Chronic Myelomonocytic Leukemia (CMML) Who Are Not Eligible for Intensive Therapy: An EORTC-German MDS Study Group Randomized Phase III Study
- Compare the efficacy of low-dose decitabine vs standard supportive care, in terms of
overall survival, of elderly patients with myelodysplastic syndromes.
- Compare the response rate and progression-free survival of patients treated with these
- Determine the toxicity of decitabine in these patients.
- Assess the duration of hospitalization and number of blood transfusions in patients
treated with these regimens.
- Assess the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to cytogenetic risk factors (good vs poor vs intermediate vs unknown), disease
(primary myelodysplastic syndrome (MDS) vs secondary MDS), and participating center.
Patients with a successful cytogenetic exam are also stratified according to overall
International Prognostic Scoring System score (intermediate 1 vs intermediate 2 vs high
risk). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive decitabine IV over 4 hours every 8 hours for 3 days. Treatment
repeats every 6 weeks for 4-8 courses in the absence of disease progression or
- Arm II: Patients receive standard supportive care. Quality of life is assessed at
baseline, every 6 weeks during therapy, every 2 months for 1 year, and then every 3
Patients are followed every 2 months for 1 year and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this
study within 2 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Duration of overall survival
Pierre W. Wijermans, MD, PhD
HagaZiekenhuis - Locatie Leyenburg
United States: Federal Government