DRKS00000069已完成2 期
Phase II study of low-dose intravenous decitabine in patients aged > 60 years with acute myeloid leukemia who are not eligible for standard induction chemotherapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 235
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 60 Years 至 one（—）
- 性别
- All
入选标准
- •Patients older than 60 years with acute myeloid leukemia (> 30 % bone marrow blasts) not qualifying for, or not consenting to, standard induction chemotherapy or immediate allografting
- •- life expectancy > 3 months with successful treatment
- •- performance status ECOG 0, 1, 2
- •- age-adjusted normal cardiac, kidney, liver function (creatinine < 1.5 mg/dl unless leukemia-related, total bilirubin < 2.0 of upper normal limits)
- •- patients with >20 000 leukocytes/µl in whom HU cytoreduction according to the protocol is effective
- •- signed written informed consent
排除标准
- •- AML of FAB subtype M3
- •- previous induction-type chemotherapy for MDS or AML
- •- previous treatment with Decitabine, or 5-azacytidine or ATRA
- •- ´low-dose´ chemotherapy (e.g.hydroxyurea, cytosine arabinoside, melphalan.) within 8 weeks prior to Decitabine treatment, except for cytoreduction of leukocytosis > 20 000/µl according to protocol
- •- patients with > 20 000 leukocytes/µl in whom HU cytoreduction according to the protocol is ineffective
- •- treatment with cytokines within previous 4 weeks
- •- concomitant use of any other investigational drug
- •- other malignancy that is not in remission (previous chemotherapy for other
- •malignancies is not an exclusion criteria)
- •- cardiac insufficieny NYHA IV
- •- HIV infection
- •- other uncontrolled active infection
- •- psychiatric disorder that interferes with treatment
- •- known hypersensitivity to retinoids
- •- contact lenses
研究者
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