EUCTR2009-009938-33-IT进行中（未招募）不适用
Temozolomide in the chemo-immuno-therapy of refractory acute leukaemia of adult patients: The TRIAC protocol - TRIAC
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
- •Signed written informed consent.
- •Age ≥ 18 years
- •Histologically confirmed acute leukaemia
- •Diagnosis of acute refractory leukaemia or patient not eligible for first and second line standard chemotherapy
- •Levels of MGMT associated with leukaemic blasts (obtained from bone marrow or peripheral
- •blood): MGMT:beta-actin ratio (Western Blot analysis) not higher than 0.4 or MGMT activity (enzymatic determination) not exceeding 200 fM/mg protein
- •Effective contraception for both male and female patients if the risk of conception exists.
- •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
- •Presence of alteration of:
- •Liver: bilirubin > 3 times the upper limit of normal
- •Kidney: creatinine > 3 times the upper limit of normal
- •Cardiovascular system: Severe heart failure (class 3, 4 NYCG).
- •Pregnant or breast feeding women.
- •Drug habit or alcoholism.
研究者
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