RATIONALE: Decitabine may help myelodysplasia cells develop into normal stem cells. It is not yet known if decitabine is more effective than standard supportive care in treating myelodysplastic syndrome. PURPOSE: Randomized phase III trial to compare the effectiveness of low-dose decitabine with that of standard supportive care in treating older patients who have myelodysplastic syndrome.
OBJECTIVES: * 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 regimens. * 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 unacceptable toxicity. * 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 months thereafter. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Innsbruck Universitaetsklinik
Innsbruck, Austria
St. Johanns-Spital
Salzburg, Austria
Institut Jules Bordet
Brussels, Belgium
U.Z. Gasthuisberg
Leuven, Belgium
H. Hartziekenhuis - Roeselaere.
Roeselare, Belgium
Centre Hospitalier Peltzer-La Tourelle
Duration of overall survival
Best response rate as measured by Cheson response criteria
Overall progression-free survival
Toxicity as assessed by CTC v2.0
Quality of life as assessed by EORTC QLQ30
Days in Hospital
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Verviers, Belgium
University Hospital Rebro
Zagreb, Croatia
First Medical Clinic of Charles University Hospital
Prague, Czechia
Institute of Hematology and Blood Transfusion
Prague, Czechia
Charite University Hospital - Campus Virchow Klinikum
Berlin, Germany
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