EUCTR2007-001194-29-DE进行中（未招募）不适用
An open-label, multi-center Phase I/II trial evaluating the safety and efficacy of azacitidine (Vidaza®) in patients with acute myeloid leukaemia not eligible for or resistant to chemotherapy - OSHO #075
niversität Leipzig0 个研究点开始时间: 2007年6月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1.20 patients with:
- •a)newly diagnosed de novo or secondary AMLs not eligible for induction chemotherapy
- •2.20 patients with
- •a)chemotherapy refractory AML (all age groups)
- •b)relapsed AML (all patients over the age of 60 years or those ineligible for chemotherapy)
- •These patients are entered if the meet the following inclusion criteria:
- •1.=18 years of age;
- •2.life expectancy =1 months;
- •3.Be capable of giving informed consent and have signed the informed consent form (ICF);
- •4.serum bilirubin levels =1.5 x the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis (as indicated by positive direct Coombs’ testing, decreased haptoglobin level, elevated indirect bilirubin and/or lactate dehydrogenase [LDH]), or ineffective erythropoiesis (as indicated by bone marrow findings);
- •5.serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels =2 x ULN;
- •6.serum creatinine levels =1.5 x ULN;
- •7.Women of childbearing potential may participate, providing they meet the following conditions:
- •-Must agree to use effective contraceptive methods throughout the study and for 3 months following the date of the last dose of study medication.
- •-Must have a negative serum pregnancy test obtained within 24 hours prior to Day 1.
- •8.Males with female partner of childbearing potential must agree to use effective contraceptive methods throughout the study and should avoid fathering a child for 3 months following the date of the last dose of study medication.
- •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
- •Patients meeting any of the following criteria will not be included in the study:
- •1.Any diagnosis of malignant disease within the previous 12 months (excluding basal cell carcinoma with no complications);
- •2.Any diagnosis of metastatic disease;
- •3.hepatic tumors;
- •4.Known or suspected hypersensitivity to azacitidine or mannitol;
- •5.Prior or active disease that, in the opinion of the Investigator, may interfere with the procedures or evaluations to be conducted in the study;
- •6.Serious medical illness likely to limit survival to =1 months after screening or likely to prevent granting of informed consent (e.g., history of severe congestive heart failure, clinically unstable cardiac disease, or pulmonary disease);
- •7.Psychiatric illness that would prevent granting of informed consent;
- •8.Active viral infection with known human immunodeficiency virus (HIV) or viral hepatitis type B or C;
- •9.Treatment with other investigational drugs, including thalidomide and arsenic trioxide, within the previous 30 days prior to Day 1, or ongoing adverse events from previous treatment with investigational drugs, regardless of the time period.
研究者
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