EUCTR2008-006349-23-GB进行中（未招募）1 期
CMML201: A phase 2 study of azacitidine in chronic myelomonocytic leukaemia (CMML) - CMML201
The Leeds Teaching Hospitals NHS Trust0 个研究点目标入组 30 人开始时间: 2009年4月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
入选标准
- •Patients with newly diagnosed or previously treated CMML-1 or CMML-2 according to WHO criteria (2008) with the following characteristics are eligibile for this study:
- •1. All CMML-2 patients are eligible.
- •2. For patients classified as CMML-1, the following must be present:
- •Symptomatic bone marrow failure / myeloproliferation defined as any of the following:
- •oRed cell transfusion dependence and pre-transfusion Hb <9.0
- •oSymptomatic anaemia (Hb <11.5g/dl)
- •oThrombocytopenia <50 x 109/l
- •oSymptomatic bleeding due to platelet functional defect or DIC/fibrinolysis
- •oWCC > 50 x 109/l
- •Düsseldorf Score intermediate or high (Appendix 4) for proliferative CMML-1 (i.e. WCC > 12 x 109/L)
- •IPSS Score of Int-2 or High Risk (Appendix 5) for non-proliferative CMML-1 (i.e. WCC <12 x 109/L)
- •Systemic symptoms including weight loss with no alternative explanation (10% of baseline weight within previous 6 months)
- •Symptomatic splenomegaly
- •Symptomatic extramedullary involvement e.g. skin infiltration, serous effusions
- •3. Subject is able and willing to sign the Informed Consent Form.
- •4. Age 18 years or over at the time of signing the informed consent form.
- •5. WHO performance status of 2 or less than 2 at study entry.
- •6. Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 days prior to start of study drug.
- •7. WCBP must agree to use at least 2 effective contraceptive methods throughout the study and for 3 months following the date of the last dose of study drug.
- •8. Men whose partner is a WCBP must use at least 2 effective contraceptive methods throughout the study and for 3 months following the date of the last dose of study drug.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. CMML with eosinophilia and 5q33 abnormality.
- •2. Previous chemotherapy for CMML except Hydroxycarbamide.
- •3. Creatinine concentration > 2 x the institutional upper limit of the normal range within 28 days of registration.
- •4. Pregnant or lactating females.
- •5. Use of any other experimental drug or therapy within 28 days of registration.
- •6. Known hypersensitivity to azacitidine.
- •7. Known hypersensitivity to mannitol.
- •8. Other active malignant disease (including basal or squamous cell carcinoma of the skin).
- •9. Known positive for HIV or infectious hepatitis, type B or C.
- •10. Active infection.
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