NL-OMON39855已完成3 期
A Randomized Phase III study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission. - HOVON 93 AML/HCT vs CT elderly AM
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age >= 60years and <= 75 years
- •- AML as defined by WHO
- •- Refractory anaemia with excess of blasts (RAEB)
- •- primary and secondary AML
- •- First complete remission following one or two cycles of induction chemotherapy, according to current participating cooperative group protocols
- •- Karnofsky score > 70%
- •- Written informed consent
排除标准
- •- AML FAB M3
- •- Organ dysfunction
- •* Patients with creatinine clearance < 50 ml/min
- •* Cardiac ejection fraction < 40%
- •* Severe defects in pulmonary function testing as defined by the pulmonary consultant, or receiving supplementary continuous oxygen
- •* Liver function tests: total bilirubin > 2x the upper limit of normal, SGOT and SGPT 4x the upper limit of normal
- •- Karnofsky score < 70%
- •- Patients with poorly controlled hypertension
- •- HIV positivity
研究者
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