ISRCTN62207270已完成4 期
A randomised trial for patients with acute myeloid leukaemia (AML) or high-risk myelodysplastic syndrome aged 60 or over
eukaemia Research Fund (UK)0 个研究点目标入组 217 人开始时间: 2001年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 217
研究概览
简要总结
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17315155
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patients are eligible for AML 14 if:
- •1. They have one of the forms of acute myeloid leukaemia (this can be any type of the de novo or secondary AML, except acute promyelocytic leukaemia) or myelodysplastic syndrome (refractory anemia with excess blasts [RAEB], refractory anemia with excess blasts in transformation [RAEB-t], chronic myelomonocytic leukemia [CMML]) with more than 10% myeloblasts in the bone marrow
- •2. They should normally be aged 60 or over, but patients under this age are eligible if the more intensive therapy employed in the current trial for younger patients with AML is not considered a suitable option
- •3. They have given informed consent
排除标准
- •Added as of 10/12/2009:
- •1. Previously received cytotoxic chemotherapy for leukaemia
- •2. Acute promyelocytic leukaemia
- •3. In blast transformation of chronic myeloid leukaemia
- •4. Concurrent active malignancy
- •5. Patients with liver function test elevation greater than twice normal cannot receive Gemtuzumab Ozogamicin (Mylotarg) and are therefore not eligible for the non-intensive randomisation
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