NL-OMON38148已完成2 期
Clofarabine in combination with a standard remission induction regimen (AraC and idarubicin) in patients 18-60 years old with previously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasie (MDS): a phase I-II study of the EORTC-LG and GIMEMA (AML-14A trial) - Clofarabine in patients with untreated AML/MDS
European Organisation for Research in Treatment of Cancer (EORTC)0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age 20 * 60 years inclusive
- •WHO PS grade 0 * 2
- •previously untreated AML according to the new WHO criteria i.e. percentage bone marrow blasts > 20%
- •high risk MDS > 10% blast cells
- •All AML FAB subtypes except M3
- •All cytogenetic groups except those with the good risk features t(8;21), inv(16), and a WBC count at diagnosis of < 100 x 109/L
- •Written informed consent required
排除标准
- •Concomitant malignant disease
- •Central nervous system leukemia
- •Active uncontrolled infection
- •Inadequate renal function (creatinine > 2 mg/dl i.e. >= 2 x ULN) and liver function (bilirubin > 2 mg/dl, i.e. > 2 x ULN, ASAT/ALAT > 5 x ULN)
- •Concomitant severe uncontrolled cardiovascular disease i.e. symptomatic congestive heart failure or symptomatic ischemic heart disease
- •Any psychological, familial, sociological, and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Known HIV positivity
- •Pregnant (in case of doubt a pregnancy test is required) and breast feeding women
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