EUCTR2008-004583-40-DE进行中（未招募）1 期
A randomized, multi-center phase II trial to assess the efficay of 5-azacytidine added to standard primery therapy in elderly patients with newly diagnosed AML. - AML-AZA
niversitaetsklinikum Muenster0 个研究点目标入组 234 人开始时间: 2009年1月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 234
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 AML (except APL) according to the FAB or WHO classification, including AML evolving from MDS or other hematological diseases and AML after previous cytotoxic therapy or radiation (secondary AML).
- •Bone marrow aspirate or biopsy must contain = 20% blasts of all nucleated cells or differential blood count must contain = 20% blasts. In AML FAB M6 = 30% of non-erythroid cells in the bone marrow must be leukemic blasts. In AML defined by cytogenetic aberrations the proportion of blasts may be < 20%.
- •Age = 61 years
- •Informed consent, personally signed and dated to participate in the study
- •Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the 5-azacytidine treatment and for at least 3 months after the last administration of 5-azacytidine.
- •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 who are not eligible for standard chemotherapy as described in chapter 5.2 and 5.3
- •Hyperleukocytosis (leukocytes > 20,000/µl) at study entry. These patients should be treated with hydroxyurea or receive leukocytapheresis treatment (leukocytes > 100 000/µl) according to routine practice and entered into the study when leukocyte counts of 20,000/µl and below are reached. This applies only for the controlled part of the study.
- •Patients with initial hyperleukocytosis above 20,000/µl can only be enrolled into the controlled part of the study, but not in the run-in dose finding part.
- •Known central nervous system manifestation of AML
- •Cardiac Disease: 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 (beta blockers or digoxin are permitted)
- •Chronically impaired renal function (creatinin clearance < 30 ml / min)
- •Inadequate liver function (ALT and AST = 2.5 x ULN) if not caused by leukemic infiltration
- •Total bilirubin = 1.5 x ULN if not caused by leukemic infiltration
- •Known HIV and/or hepatitis C infection
- •Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
- •Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders
- •Uncontrolled active infection
- •Concurrent malignancies other than AML with an estimated life expectancy less than three years
- •History of organ allograft
- •Hypersensitivity to cytarabine (not including drug fever or exanthema), daunorubicin, azacytidine or mannitol
- •Previous treatment of AML except hydoxyurea and up to 2 days =100 mg/m2/d cytarabine
- •Previous therapy with 5-azacytidine (i.e. for an antecedent myelodysplastic syndrome)
- •Patients with investigational drug therapy outside of this trial during or within 4 weeks of study entry should be discussed with the study office wether a study participation is possible
- •Any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
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