EUCTR2015-002281-23-GB进行中（未招募）1 期
A phase 2 study of the monocyte-targeted histone deacetylase inhibitor tefinostat (CHR-2845) in chronic myelomonocytic leukaemia (CMML) - Monocle
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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 with newly-diagnosed or previously-treated CMML meeting WHO criteria with the following characteristics will be eligible for the 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 one or more of: red cell transfusion dependence with pre-transfusion Hb <90g/l, symptomatic anaemia (Hb <115g/l), thrombocytopenia (platelets <50 x 109/l), mptomatic bleeding due to platelet function defect or DIC/fibrinolysis, hite blood cell count >50 x 109/l
- •CMML-specific Prognostic Score (CPSS) of intermediate-2 or high risk (16)
- •(details of derivation of CPSS score given below)
- •Systemic symptoms including weight loss with no alternative explanation (10% of baseline weight within previous 6 months)
- •Symptomatic splenomegaly
- •Symptomatic extrameduallary involvement, eg. skin infiltration, serous effusions
- •3. Subject is able and willing to sign the Informed Consent Form
- •4. Age greater than or equal to 18 years at the time of signing the Informed Consent Form
- •5. Willingness to undergo scheduled assessments as per the study protocol including bone marrow assessments
- •6. ECOG performance status of 0-2 at study entry
- •7. Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to starting study drug
- •8. Women of childbearing potential must use at least two effective contraceptive methods throughout the study and for three months following the date of the last dose of study drug
- •9. Men whose partner is a woman of childbearing potential must use at least two effective contraceptive methods
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. CMML with eosinophillia and 5q33 abnormality
- •2. Previous chemotherapy for CMML except Hydroxycarbamide and 5-azacitidine
- •3. Creatinine concentration > 2x the institutional upper limit of normal range
- •4. Liver transaminases (AST / ALT) > 3x the institutional upper limit of normal range or serum bilirubin > 4x the institutional upper limit of normal range
- •5. Pregnant or lactating females
- •6. Use of experimental drug or therapy within 28 days of registration
- •7. Other malignancy within the last 3 years other than curatively-treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ-confined or treated non-metastatic prostate cancer with negative prostate-specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional
- •cell bladder carcinoma
- •8. Known seropositivity for HIV infection or infectious hepatitis (type B or C)
- •9. Uncontrolled inter-current illness including, but not limited to, ongoing infection, psychiatric illness or social situation that the treating physician judges would limit compliance with study requirements
研究者
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