DRKS00000733已完成2 期
Prospective randomized multicenter phase II trial of low-dose decitabine (DAC) administered alone or in combination with the histone deacetylase inhibitor valproic acid (VPA) and all-trans retinoic acid (ATRA) in patients > 60 years with acute myeloid leukemia who are ineligible for induction chemotherapy - DECIDER Trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 204
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
- Randomized controlled 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
- •1.Written informed consent obtained according to international guidelines and local law;
- •2.Male or female patients aged > 60 years without upper age limit;
- •3.Patients with primary or secondary AML according to WHO (= 20% BM blasts) who are not expected to benefit from standard remission-induction chemotherapy;
- •4.Patients with < 30 000 leukocytes/µl;
- •5.Performance status ECOG 0, 1, 2;
- •6.Age-adjusted normal cardiac and kidney function (creatinine < 2.0 mg/dl unless leukemia-related);
- •7.Ability to understand the nature of the study and the study related procedures and to comply with them.
排除标准
- •1.AML of FAB subtype M3;
- •2.Previous remission-induction chemotherapy for MDS or AML, previous auto-/allografting;
- •3.Previous treatment with DAC, 5-azacytidine, VPA or another HDAC inhibitor, or ATRA;
- •4.Low-dose chemotherapy (e.g. hydroxyurea, cytosine arabinoside, melphalan, clofarabine etc.) within 8 weeks prior to DAC treatment, except for cytoreduction of leukocytosis = 30 000/µl with hydroxyurea, as proscribed by the study protocol (section 7.3 and 7.4);
- •5.Treatment with tyrosine kinase Inhibitors, immunomodulating agents (IMIDS) and other investigational AML treatments within previous 8 weeks;
- •6.Treatment with cytokines within previous 4 weeks;
- •7.Concomitant therapy which is considered relevant for the evaluation of efficacy or safety of the trial drug (i.e. other chemo- or immunotherapy);
- •8.Other malignancy requiring treatment (previous chemotherapy for other malignancies is not an exclusion criteria);
- •9.Cardiac insufficiency NYHA IV;
- •10.Insufficient hepatic function (bilirubin, AST or ALT > = 2.5 x Upper Limit of Normal (ULN));
- •11.Fatal hepatic function disorder during treatment with valproic acid in siblings;
- •12.Hepatic porphyria;
- •13.Manifest serious pancreatic function disorder;
- •14.Plasmatic coagulation disorder not related to AML;
- •15.Hepatitis B or C;
- •16.HIV infection;
- •17.Other uncontrolled active infections;
- •18.Known allergy against soy beans or peanuts;
- •19.Psychiatric disorder that interferes with treatment;
- •20.Patient without legal capacity who is unable to understand the nature, significance and consequences of the study;
- •21.Known hypersensitivity to, or intolerance of, one of the trial drugs, another retinoid or the excipients of the trial drugs;
- •22.Concomitant use of any other investigational drug or participation in a clinical trial within the last thirty days before the start of this study;
- •23.Female patients who are pregnant or breast feeding;
- •24.Fertile patients refusing to use safe contraceptive methods during the study (for details see clinical trial protocol section 5.3);
- •25.Known or persistent abuse of medication, drugs or alcohol.
研究者
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