EUCTR2013-003191-12-DE进行中（未招募）1 期
Randomized comparison between two dose levels of daunorubicin and between one versus two cycles of in-duction therapy for adult patients with acute myeloid leukemia =65 years - DAUNODOUBLE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 568
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
- •- Newly diagnosed AML other than acute promyelocytic leukemia (APL) according to WHO criteria, i.e. bone marrow aspirate or biopsy must contain =20% blasts of all nucleated cells or differential blood count must contain =20% blasts. In acute erythroid leukemia, =20% blasts in all non-erythroid bone marrow cells. In AML defined by cytogenetic aberrations, the rate of blasts may be <20%. Secondary AMLs are eligible for inclusion.
- •- Age 18-65 years
- •- ECOG performance status 0-2
- •- Adequate liver and renal function as assessed by the following laboratory requirements to be conducted within 10 days prior to Day 1/Baseline:
- •o Total bilirubin = 1.5 times the upper limit of normal
- •o ALT and AST = 2.5 times upper limit of normal
- •o Creatinine = 1.5 times upper limit of normal
- •- Adequate cardiac function, i.e. left ventricular ejection fraction (LVEF) of = 50% as assessed by transthoracal twodimensional echocardiography (M Mode”) or MUGA scan
- •- Signed Informed Consent
- •- Women must fulfill at least one of the following criteria in order to be eligible for trial inclusion:
- •o Post-menopausal (12 months of natural amenorrhoea or 6 months of amenorrhoea with Serum FSH > 40 U/ml)
- •o Postoperative (i.e. 6 weeks) after bilateral ovariectomy with or without hysterectomy
- •o Continuous and correct application of a contraception method with a Pearl Index of <1% (e.g. implants, depots, oral contraceptives, intrauterine device – IUD).
- •o Sexual abstinence
- •o Vasectomy of the sexual partner
- •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 568
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 568
排除标准
- •- Patients who are not eligible for standard chemotherapy as assessed by the treating physician
- •- Central nervous system manifestation of AML
- •- Cardiac disease: i.e. heart failure NYHA III or IV; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •- Patients undergoing renal dialysis
- •- Chronic pulmonary disease with clinical relevant hypoxia
- •- Known HIV or Hepatitis infection
- •- Uncontrolled active infection
- •- Medical conditions other than AML with an estimated life expectancy below 6 months
- •- Previous treatment of AML except hydroxyurea up to 5 days
- •- Relapsed or primary refractory AML
- •- Acute promyelocytic leukemia
- •- Previous anthracyclin-containing chemotherapy
- •- Treatment with any known non-marketed drug substance or experimental therapy within 4 weeks prior to enrollment
- •- Incapability of understanding purpose and possible consequences of the trial
- •- Pregnant or breastfeeding women
- •- Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)
研究者
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