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临床试验/EUCTR2014-001486-27-FR
EUCTR2014-001486-27-FR进行中（未招募）1 期

10-day decitabine versus conventional chemotherapy (3+7”) followed by allografting in AML patients = 60 years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study Group

European Orgainzation for the Research and Treatment of Cancer (EORTC)0 个研究点目标入组 600 人开始时间: 2015年1月6日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
600
研究概览入排标准研究者记录与标识符相似试验

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 = 60 years
  • •? WHO Performance status: = 2
  • •? Eligible for standard intensive chemotherapy
  • •?Patients of reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 3 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
  • •? Have newly diagnosed AML that is cytopathologically confirmed according to WHO classification (Patients can be diagnosed with AML two months prior to randomization)
  • •?De novo or secondary AML is allowed
  • •WBC is =30x109/L (measured within 72 hours prior to randomization)
  • •? The following laboratory assessments should be done within 7 days prior to randomization and should be within the following range:
  • •? SGOT (AST) and SGPT (ALT) < 2.5 x the upper limit of normal range (at the laboratory where the analyses were performed) unless considered AML-related
  • •? Total serum bilirubin level < 2.5 x the upper limit of normal range (at the laboratory where the analyses were performed) unless considered AML-related or due to Gilbert’s syndrome
  • •? Serum creatinine concentration < 2.5 x the upper limit of normal range (at the laboratory where the analyses were performed) unless considered AML-related
  • •? The following treatments for previous MDS or MPN are allowed as long as treatment has stopped one month before inclusion:
  • •-Growth factors, thrombomimetics, immunosuppression (cyclosporin A, steroids, Antithymocyte globulin etc.), chelation, interferons, anagrelide
  • •-Lenalidomide, low-dose chemotherapy (low-dose melphalan, hydroxyurea, low-dose cytarabine etc.), tyrosine-kinase inhibitors, histone deacetylase inhibitors (e.g. Valproic acid, panobinostat etc.), mTOR inhibitors, other experimental treatment that is not based on inhibition of DNA methyltransferase
  • •? Before patient registration/randomization, written informed consent must be given according to ICH/GCP and national/local regulations
  • •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 215
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 386

排除标准

  • •? Presence of acute promyelocytic leukaemia (APL, i.e. AML-M3 with t(15;17)(q22;q12); PML-RARA fusion gene and cytogenetic variants)
  • •? Presence of blast crisis of chronic myeloid leukaemia
  • •? Presence of active central nervous system (CNS) leukaemia
  • •? No prior treatment for AML (relapsed AML is not allowed), these are any antileukaemic therapy including investigational agents and hypomethylating agents (decitabine, 5-azacytidine). Exception: Treatment with Hydroxyurea (HU) is allowed to control the leukocytosis if given for a maximum of 5 days and is stopped at least two days prior to the start of any of the protocol regimens
  • •? No prior treatment for MDS or MPN with:
  • •-hypomethylating agents (decitabine, 5-azacytidine), OR
  • •-intensive chemotherapy or transplantation within the last three years
  • •? Presence of concomitant severe cardiovascular disease which would make intensive chemotherapy impossible, i.e. arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease, reduced left ventricular function assessed by MUGA scan or echocardiogram.
  • •? Presence of concomitant malignancy requiring chemotherapy or any malignancy (except basal and squamous cell carcinoma of the skin) for which the patient received chemotherapy within 6 months prior to randomization
  • •? Presence of active uncontrolled infection
  • •? Presence of any psychological, familial, sociological or geographical condition in the opinion of the investigator potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

研究者

发起方
European Orgainzation for the Research and Treatment of Cancer (EORTC)

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