Low-Dose Decitabine Compared With Standard Supportive Care in Treating Older Patients With Myelodysplastic Syndrome
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.
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Duration of overall survival [ Designated as safety issue: No ]
- Best response rate as measured by Cheson response criteria [ Designated as safety issue: No ]
- Overall progression-free survival [ Designated as safety issue: No ]
- Toxicity as assessed by CTC v2.0 [ Designated as safety issue: Yes ]
- Quality of life as assessed by EORTC QLQ30 [ Designated as safety issue: No ]
- Days in Hospital [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Estimated Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043134
Show 46 Study Locations
|OverallOfficial:||Pierre W. Wijermans, MD, PhD||HagaZiekenhuis - Locatie Leyenburg|
|OverallOfficial:||Michael Luebbert, MD||University Hospital Freiburg|