EUCTR2008-000470-21-FR进行中（未招募）不适用
A Phase II study of Decitabine in patients with Chronic Myelomonocytic Leukemia - GFM-DEC-LMMC-2007-02
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients aged 18 and older
- •With CMML diagnosis according to WHO criteria
- •-Stable excess in blood monocytes, > 1 x 109/L and constituting > 10% WBC
- •- Lack of bcr-abl rearrangement (or Philadelphia chromosome)
- •- Bone marrow blast cells < 20%
- •-Dysplasia of at least one lineage or clonality marker or blood monocytosis during more than 3 months w/o other explanation.
- •If WBC <12 000/mm3 : IPSS high or intermediate 2
- •If WBC > or = 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 < 100 x 109/L)
- •-Splenomegaly > 5 cm below costal margin
- •-Extramedullary localization (documented cutaneous, pleural or pericardial effusion, etc…)
- •Either untreated or previously treated with
- •-Hydrea or Etoposide given orally
- •-Non intensive chemotherapy (e.g. low dose cytarabine)
- •-Intensive chemotherapy given more than 3 months before inclusion
- •With performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
- •With estimated life expectancy of at least 12 weeks (this is inherent to ECOG 0-2, and actually very hard to predict/verify, therefore we prefer to take this out)
- •With adequate organe function including the following
- •-Hepatic : total bilirubin < 1.5 times upper limit of normal (ULN) (except moderate unconjugated hyperbilirubinemia due to intra medullary hemolysis) , 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
- •With negative pregnancy and adequate contraception if relevant.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Myeloproliferative / myelodysplastic syndrome other than CMML
- •-Acute blastic transformation of CMML with bone marrow blast cells > 20%
- •-Patients eligible for allogeneic bone marrow transplantation with a identified donor
- •-CMML with t(5 ;12) or PDGF?R rearrangement that could receive imatinib
- •-Intensive chemotherapy given within 3 months
- •-Previous treatment with a hypomethylating agent
- •-Age < 18
- •-Pregnant or breastfeeding
- •-Performance status > 2 on the ECOG Scale.
- •-Estimated life expectancy lower than 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.
- •-Consent withdrawal
研究者
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