NCT01251627已完成2 期
A Phase II Multicenter Open-label Study to Assess the Efficacy of Decitabine in the Treatment of Chronic Myelomonocytic Leukemia
Fondazione Italiana Sindromi Mielodisplastiche-ETS21 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 21
- 主要终点
- To assess the activity of decitabine in the treatment of CMML
研究概览
简要总结
The study aims to assess the activity of decitabine in the treatment of CMML.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 and older
- •CMML diagnosis according to WHO criteria
- •If WBC<=12000/mm3:IPSS High or INT-2
- •If WBC>12000/mm3: at least two of the following criteria:
- •Blast cells>5% in the bone marrow
- •Citogenetic abnormality other then t(5;12) (q33;p13)
- •Anemia (Hb<10g/dl)
- •Thrombocytopenia (Plt<100000/mm3)
- •Splenomegaly(>5cm below costal margin)
- •Extramedullary localization
- •Patients untretaed or previously treated with Hydroxyurea or Imatinib or Etoposide given orally or non intensive chemotherapy or intensive chemotherapy given more thann 3 months befor inclusion
- •Performance Status ECOG 0,1 or 2
- •Estimated life expectancy>=6 months
- •Adequate hepatic function:
- •Total bilirubin < 1.5 times upper limit of normal (except moderate unconjugate hyperbilirubinemia due to intra medullary hemolysis)
- •AST and ALT < 3 times limit of normal
- •Adequate renal function:
- •Serum creatinine < 1.5 times limit of normal
- •Creatinine clearance > 30ml/min
- •Informed consent
- •Negative pregnancy test or adequate contraception methods
排除标准
- •Myeloproliferative/myelodisplastic syndome othe than CMML
- •Acute blastic transformation of CMML with bone marrow blast cells>20%
- •Patients eligible for allogenic bone marrow transplantation with identified donor
- •CMML with t(5;12) o PDGFBR rearrangement
- •Intensive chemotherapy given less than 3 months before
- •Previous treatment with hypomethylating agent
- •Age< 18 years old
- •Pregnancy or breastfeeding
- •Performance Status ECOG>2
- •Estimate life expectancy<6 months
- •HIV infection
- •Chronic active hepatitis secondary to HCV or HBV (HBSAq positive)
- •Serious concomitantsystemic disorders, including active bacterial fungal or viral infection, that in the opinion of the investigator, would compromise the safety of the patient and/or his/her ability to complete the study
研究组 & 干预措施
Decitabine
Experimental
Eligible patients will recieve Dacogen 20mg/m2 in 1 hour iv infusion for 5 days every 28 days (1 cycle)plus Best Supportive Care.A total of 6 courses is planned.
干预措施: Decitabine (Drug)
结局指标
主要结局
To assess the activity of decitabine in the treatment of CMML
时间窗: 24 months
Activity will be evaluated as percentage of patients achieving complete or partial remission according to the International Working Group response criteria in myelodysplasia
次要结局
- to assess the activity of decitabine in the treatment of CMML in terms of overall survival, time to leukemic transormation, response duration in terms of time to relapse after CR, PR, time to disease progression, ecc(24 months)
研究者
研究点 (21)
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