跳至主要内容
临床试验/ISRCTN11036523
ISRCTN11036523已完成3 期

ational Cancer Research Institute acute myeloid leukaemia and high risk MDS trial 16. A trial for older patients with acute myeloid leukaemia and high risk myelodysplastic syndrome (MDS).

Cardiff University (UK)0 个研究点目标入组 2,247 人开始时间: 2005年10月11日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
2,247

研究概览

简要总结

2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23838349 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24062403 results

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. They have one of the forms of acute myeloid leukaemia, except acute promyelocytic leukaemia, as defined by the World Health Organisation (WHO) Classification - this can be any type of de novo or secondary AML - or high risk Myelodysplastic Syndrome, defined as greater than 10% marrow blasts (RAEB-2)
  • 2. They should normally be over the age of 60, but patients under this age are eligible if they are not considered fit for the MRC AML 15 trial
  • 3. They have given written informed consent

排除标准

  • 1. Patients have previously received cytotoxic chemotherapy for AML. (Hydroxyurea, or similar low-dose therapy, to control the white count prior to initiation of intensive therapy is not an exclusion.)
  • 2. They are in blast transformation of chronic myeloid leukaemia (CML)
  • 3. They have a concurrent active malignancy
  • 4. They are pregnant or lactating
  • 5. Patients with abnormal liver function tests exceeding twice the local upper limit of normal are not eligible for the Mylotarg randomisations
  • 6. Patients with Acute Promyelocytic Leukaemia

研究者

发起方
Cardiff University (UK)

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