NCT00043134Unknown3 期
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
European Organisation for Research and Treatment of Cancer - EORTC46 个研究点 分布在 10 个国家目标入组 220 人开始时间: 2002年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 220
- 试验地点
- 46
- 主要终点
- Duration of overall survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of primary or secondary myelodysplastic syndromes (MDS)
- •Any FAB or WHO criteria cellular type allowed
- •Bone marrow blast count on aspiration or biopsy of 1 of the following:
- •No more than 10% with poor cytogenetic risk factors (defined as any numerical or structural abnormality of chromosome 7 and/or complex abnormalities)
- •21-30% for patients with acute myeloid leukemia (AML) secondary to MDS (i.e., refractory anemia with excess blasts in transformation by FAB classification)
- •Patients who failed the cytogenetic exam are allowed provided bone marrow blasts are at least 5% and/or 2-3 cytopenias are present
- •No rapid progression towards full-blown AML
- •No blast crisis of chronic myeloid leukemia
- •No t(8;21) alone or in combination with other abnormalities
- •Ineligible for intensive chemotherapy (e.g., cytarabine or an anthracycline)
- •PATIENT CHARACTERISTICS:
- •60 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •See Disease Characteristics
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •Hepatitis B surface antigen negative
- •Creatinine less than 1.5 times ULN
- •Cardiovascular
- •No severe cardiovascular disease
- •No arrhythmias requiring chronic treatment
- •No congestive heart failure
- •No New York Heart Association class III or IV heart disease
- •No symptomatic ischemic heart disease
- •HIV negative
- •No active uncontrolled infection
- •No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix within the past 2 years
- •No prior or concurrent evidence of CNS or psychiatric disorders requiring hospitalization
- •No psychological, familial, sociological, or geographical condition that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 6 weeks since prior growth factors for primary MDS
- •No concurrent antiangiogenic drugs (e.g., thalidomide)
- •No concurrent interleukin, interferon, or anti-thymocyte globulin
- •Chemotherapy
- •See Disease Characteristics
- •More than 6 weeks since prior hydroxyurea for primary MDS
- •No other prior chemotherapy for MDS or AML
- •Prior chemotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed
- •Endocrine therapy
- •No concurrent steroids (except as inhalation therapy)
- •Radiotherapy
- •Prior radiotherapy for solid tumors or lymphoma (resulting in secondary MDS) allowed
- •Not specified
- •More than 6 weeks since prior immunosuppressive agents for primary MDS
- •No concurrent amifostine
- •No concurrent cyclosporine
- 另有 1 项未显示
排除标准
- 未提供
结局指标
主要结局
Duration of overall survival
次要结局
- 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
研究者
研究点 (46)
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