EUCTR2004-004527-35-IE进行中（未招募）1 期
A PHASE II TRIAL OF CLOFARABINE IN OLDER PATIENTS WITH ACUTE MYELOID LEUKAEMIA FOR WHOM INTENSIVE CHEMOTHERAPY IS NOT CONSIDERED SUITABLE
Bioenvision Limited0 个研究点目标入组 65 人开始时间: 2005年3月8日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 65
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
- •1.Patients must have untreated AML as defined by the WHO classification (Appendix I)
- •2.Patients must provide written informed consent.
- •3.Male or Post-Menopausal female patients = 65 years of age and unsuitable for intensive chemotherapy
- •4.Male patients who are fertile agree to use an effective barrier method of birth control (i.e., latex condom, diaphragm, cervical cap, etc) to avoid pregnancy.
- •5.Patients must be able to comply with study procedures and follow-up examinations.
- •6.Patients must have adequate organ function as indicated by the following laboratory values, obtained within 7 days prior to enrolment.
- •Inclusion Laboratory Values
- •ParameterRequired Value International Standard (IS units)
- •Serum Bilirubin< 1.5 x ULN
- •AST and ALT< 2 x ULN
- •Creatinine< 1.7g/dL
- •Prothrombin Time< 1.5 x control
- •ULN = Institutional Upper Limit of Normal.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •Patients who meet any of the following criteria will be excluded from study admission:
- •1.Patients who have an active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
- •2.Patients who have a psychiatric disorder(s) that would interfere with consent, study participation or follow-up.
- •3.Patients who are receiving other chemotherapy or corticosteroids (unless the latter is administered at a low dose for pre-medication purposes or for the treatment of chronic conditions – e.g., rheumatoid arthritis).
- •4.Patients who have received prior treatment for leukaemia. Patients who have received growth factor, cytokine support, leukopheresis or, hydroxyurea, will be allowed into the study but must discontinue treatment at least 24 hours prior to beginning treatment with clofarabine.
- •5.Patients who have any other severe concurrent disease (severe Coronary Artery Disease (CAD), significant neurological disorder, uncontrolled diabetes, etc), which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- •6.Patients who have symptomatic Central Nervous System (CNS) involvement.
- •7.Patients who have previously received clofarabine.
- •8.Patients who are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days.
- •9.Blast transformation of chronic myeloid leukaemia or acute promyelocytic leukaemia.
研究者
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