NCT00199147Unknown4 期
Treatment of Elderly Patients (>60 Years) With Acute Myeloblastic Leukemia or Advanced MDS (RAEB-T): An Open Randomized Study to Test the Efficacy of G-CSF-Priming and a Feasibility Trial of Dose-Reduced Allogeneic Transplantation and of Autologous Stem Cell Transplantation
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2000年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- -Remission rate after induction therapy
研究概览
简要总结
Aim of the study is to compare the efficacy of intensive induction therapy with Cytarabine, Idarubicin and Etoposide (IdAV) given in parallel with (G-CSF priming) and followed by G-CSF versus the same IdAV chemotherapy only followed by G-CSF (without priming) in elderly patients with de novo AML, secondary AML and advanced MDS. Moreover, the ability to mobilize sufficient numbers of peripheral blood stem cells (PBSC) for autologous PBSC transplantation after consolidation therapy with dose-reduced FLAG-Ida chemotherapy followed by G-CSF will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of de-novo AML, FAB M0, 1, 2, 4-7 or
- •Diagnosis of secondary AML after previous chemotherapy and/or radiation therapy or after preceeding MDS or
- •Diagnosis of an advanced MDS, i.e. RAEB-t according to the FAB classification or
- •Extramedullary AML (chloroma, "granulocytic sarcoma")
- •Age greater than 60 years (not including 60 years)
- •ECOG performance status 0, 1, or 2
- •Written informed consent
排除标准
- •Patients with a t(15;17) translocation
- •Patients with severe cardiac disease (e.g. cardiac failure NYHA III/IV, myocardial infarction within the last 6 months; severe ventricular arrythmias (Lown III or IV)
- •Patients with severe complications of the leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock.
- •Severe pulmonary disease (diffusion capacity for CO2 of less than 50%)
- •Significant renal dysfunction (creatinine clearance < 60/min/min)
- •Bilirubin > 2mg% (>34.2 mmol/l)
- •Patients with a clinically active second malignancy
- •Patients with a psychiatric, addictive, or any disorder wich compromises ability to give truly informed consent for participating in this study
- •HIV positivity
- •Known refractoriness to platelet transfusion, inability to adequately substitute blood products
结局指标
主要结局
-Remission rate after induction therapy
-Remission duration
-Disease free survival
-Overall survival
次要结局
- -Toxicity according to WHO
- -Death in induction therapy
- -Feasibility to mobilize peripheral blood stem cells
- -Feasibility to perform autologous or allogeneic stem cell transplantation in elderly patients
研究者
研究点 (2)
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