EUCTR2009-014455-68-BE进行中（未招募）不适用
A randomized phase II multicenter study with a safety run-in to assess the tolerability and efficacy of the addition of oral tosedostat to standard induction therapy in AML and RAEB = 66 years and very poor risk AML = 18 years.A study in the frame of the masterprotocol of parallel randomized phase II studies in elderly AML - HOVON 103 AML Tosedostat
HOVON Foundation0 个研究点目标入组 240 人开始时间: 2011年6月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- •Patients eligible for standard chemotherapy.
- •Patients 66 years and older
- •Patients with:
- •o a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML, or
- •o acute leukemia's of ambiguous lineage according to WHO 2008
- •o a diagnosis of refractory anemia with excess of blasts (MDS)
- •and IPSS-R > 4.5
- •Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:
- •o Serum creatinine =1.0 mg/dL (=88.7 µmol/L); if serum creatinine >1.0 mg/dL (>88.7 µmol/L), then the estimated 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) = 186 x (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 µmol/L, recalculate it in mg/dL according to the equation: 1 mg/dL = 88.7 µmol/L and use the above mentioned formula.
- •o Serum bilirubin = 2.5 x upper limit of normal (ULN)
- •o Aspartate transaminase (AST) = 2.5 x ULN
- •o Alanine transaminase (ALT) = 2.5 x ULN
- •o Alkaline phosphatase = 2.5 x ULN
- •WHO performance status 0, 1 or 2 (see Appendix F)
- •Written informed consent.
- •Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 230
排除标准
- •Acute promyelocytic leukemia
- •Patients previously treated for AML (any antileukemic therapy including investigational agents), a short treatment period (< 2 weeks)
- •with Hydroxyurea is allowed
- •Concurrent history of active malignancy in the two past years prior to diagnosis except for:
- •o Basal and squamous cell carcinoma of the skin o in situ carcinoma of the cervix
- •Blast crisis of chronic myeloid leukemia
- •Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etcetera)
- •Cardiac dysfunction as defined by:
- •o Myocardial infarction within the last 6 months of study entry,
- •o Reduced left ventricular function with an ejection fraction <
- •50% ad measured by MUG scan or echocardiogram or o Unstable angina or
- •o New York Heart Association (NYHA) grade II or greater congestive heart failure (see Appendix I) or
- •o Unstable cardiac arrthythmias
- •Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance
- •Patients with any serious concomitant medical condition which could, in the opinion of the investigator, compromise participation in the study.
- •Patients who have senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
- •Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
- •Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
研究者
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