NCT01098084已完成2 期
A Phase II Study of Decitabine in Patients With Chronic Myelomonocytic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 31
- 主要终点
- To determine response of patients with CMML to 6 courses of Decitabine according to IWG 2006 criteria, adapted for CMML with WBC>12000/mm3
研究概览
简要总结
The aim of this study is to determine the therapeutic efficacy of Decitabine in patients with chronic myelomonocytic leukemia (CMML) diagnosis according to WHO criteria either untreated or previously treated with Hydrea or Etoposide (given orally), non intensive chemotherapy or intensive chemotherapy given more than 3 months before inclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
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
- •Age 18 or older
- •CMML diagnosis according to WHO criteria
- •Stable excess in blood monocytes,>1x10G/l and >10% of WBC
- •Bone marrow blasts <20%
- •Dysplasia of at least one lineage or clonality marker or blood monocytosis during more than 3 months w/o other explanation
- •if WBC < or= 12 000/mm3: IPSS high or intermediate 2
- •if WBC > 12 000/mm3: at least two of the following criteria: blast cells > 5% in the bone marrow, clonal cytogenetic abnormality other than t(5;12)(q33;p13), anemia (Hb < 100 g/l), thrombocytopenia (platelet count < 100G/l), splenomegaly > 5 cm below costal margin, extramedullary localization
- •Either untreated or previously treated with
- •Hydrea or Etoposide given orally
- •non intensive chemotherapy
- •intensive chemotherapy given more than 3 months before inclusion
- •With performance status 0-2 on the ECOG scale
- •With estimated life expectancy of at least 12 weeks
- •With adequate organ function including the following:
- •Hepatic: total bilirubin < 1.5 times upper limit of normal (ULN), alanine transaminase (ALT) and aspartate transaminase (AST) < 3 times ULN
- •Renal: serum creatinine < 1.5 times ULN, creatinine clearance > 30 ml/min
- •With informed consent
- •Negative pregnancy and adequate contraception if relevant
排除标准
- •Myeloproliferative/myelodysplastic syndrome other than CMML
- •Acute blastic transformation of CMML with bone marrow blasts>20%
- •Patients eligible for allogenic bone marrow transplantation with identified donor
- •CMML with t(5;12) or PDGFbetaR rearrangement that could receive Imatinib
- •Previous treatment with a hypomethylating agent
- •Age < 18 years old
- •Pregnancy or breastfeeding
- •Performance status> 2 on the ECOG Scale
- •Estimated life expectancy < 12 weeks
- •Serious concomitant systemic disorder, 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
干预措施: Decitabine (Drug)
结局指标
主要结局
To determine response of patients with CMML to 6 courses of Decitabine according to IWG 2006 criteria, adapted for CMML with WBC>12000/mm3
次要结局
- Toxicity (hematological and non-hematological)
- Response duration
- Time to progression to AML
- Survival
研究者
研究点 (31)
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