NCT01133886Unknown2 期
Use of Decitabine in Myelodysplastic Syndrome (MDS) Following Azacitidine (AZA) Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall response rate in the efficacy-evaluable (EE) population
研究概览
简要总结
The purpose of this study is to assess the response rate at 6 months in Myelodysplastic Syndrome (MDS) patients, Chronic Myelomonocytic Leukaemia (CMML-2) patients, and Acute Myeloid Leukaemia (AML) patients with up to 30% bone marrow blasts, treated with low-dose decitabine who have previously failed therapy with 5-azacitidine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written signed informed consent.
- •≥18 years of age.
- •Diagnosed MDS with 5% or more marrow blasts and IPSS risk intermediate 2 or high risk; or chronic myelomonocytic leukemia (CMML-2); or AML with 20-30% bone marrow blasts.
- •Patients who have failed therapy with azacitidine.
- •Performance status 0-2 (ECOG scale).
- •Adequate hepatic (bilirubin < 1.5 X ULN or AST< 2.5 X ULN) and renal functions (creatinine <1.5 X ULN).
排除标准
- •Nursing and pregnant females.
- •Females of childbearing potential and males not willing to practice an effective method of contraception whilst receiving decitabine and for 2 months after the last infusion.
- •Patients with previous malignancy or concurrent malignancy.
- •Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure and unstable angina pectoris.
- •Ongoing oral corticosteroids are not permitted. However, use of corticosteroids (topical and inhaled) is permitted and prophylactic steroids are allowed for transfusion reactions.
- •Patients who have received any investigational agent within the 30 days preceding the first dose of study drug.
- •Patients who have received prior intensive combination chemotherapy or high-dose cytarabine (>/= 1g/m*2 per dose). (Prior biologic therapies, targeted therapies and single agent chemotherapy are allowed).
- •Patients who have an active viral or bacterial infection. Note: No patient is allowed to enter the study unless infections have been fully treated and the patient has remained afebrile for 7 days without antibiotics.
- •Patients who have concurrent autoimmune hemolytic anemia or immune thrombocytopenia.
- •Patients who have previously been treated with decitabine.
- •Patients who have known positive serology for HIV.
- •Patients with a condition that may be unable to comply with the treatment and monitoring requirements of the study.
研究组 & 干预措施
Decitabine
Experimental
干预措施: Decitabine (Drug)
结局指标
主要结局
Overall response rate in the efficacy-evaluable (EE) population
时间窗: 6 months
次要结局
- Overall survival(18 months)
- Time to AML progression (for MDS and CMML-2 patients only) or death(18 months)
- Haematological improvement(18 months)
- Transfusion requirements(18 months)
- Cytogenetic response(18 months)
- Treatment related toxicity(Up until one month after last IMP dose)
研究者
研究点 (1)
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