EUCTR2006-004912-28-BE进行中（未招募）1 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 myelodysplasia (MDS): a phase I-II study of the EORTC-LG and GIMEMA (AML-14A trial). - AML-14A
European Organisation for Research and Treatment on Cancer0 个研究点目标入组 60 人开始时间: 2012年1月3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
- 60
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
- •Age 18 – 60 years (including 60)
- •AML according to the new WHO criteria i.e. percentage bone marrow (BM) blasts = 20%, or MDS with = 10% blast cells in the BM
- •All AML FAB subtypes except M3
- •All cytogenetic groups except:
- •- those with t(15;17)
- •- those with t(8;21) or inv(16), and a WBC count at diagnosis of < 100 x109/l
- •Primary and secondary AML (including AML after MDS)
- •Previously untreated, except for = 14 days of hydroxyurea
- •WHO PS grade 0 – 2
- •Adequate renal and hepatic function tests as indicated by the following laboratory values:
- •- serum creatinine = 1.0 mg/dl(= 88.7micromol/L); if serum creatinine > 1.0 mg/dl (> 88.7micromol/L) then the glomerular filtration rate (GFR) must be > 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where the predicted GFR (ml/min/1.73 m2 ) = 186x(serum creatinine in mg/dl)-1.154 x (age in years)-0.203 x (0.742 if patient is female) x (1.212 if patient is black).
- •NOTE: if serum creatinine is measured in micromol/L recalculate it in mg/dl according to the equation: 1 mg/dl=88.7micromol/L and used above mentioned formula
- •- Aspartate Transaminase(AST)/Alanine transaminase(ALT) = 2.5 x ULN and alkaline phosphatase = 2.5 x ULN .
- •Potential fertile patients agree to use an effective barrier method of birth control during study treatment and for at least 3 months after end of study treatment.
- •Before patient registration/randomization, written informed consent must be given according to ICH/EU GCP, and national/local regulations
- •Patient can only be registered once in this Phase I/ Phase II trial
- •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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Blast crisis of chronic myeloid leukemia or AML supervening a myeloproliferative disorder
- •Central nervous system leukemia
- •Concomitant malignant disease
- •Active uncontrolled infection
- •Concomitant severe uncontrolled cardiovascular disease i.e. symptomatic congestive heart failure or symptomatic ischemic heart disease (NYHA grade III-IV).
- •Any psychological, familial, sociological, and geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •Known HIV positivity
- •Pregnancy (in case of doubt a pregnancy test is required) and breast feeding women
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