NL-OMON39744招募中2 期
Sequential FLAMSA chemotherapy and T cell depleted reduced intensity conditioning allogeneic stem cell transplantation (TCD FLAMSA-RIC alloSCT) in elderly acute myeloid leukemia and high risk myelodysplasia patients - FLAMSA-RIC alloSCT
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 13
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
- •Patients with AML or high risk MDS
- •Not in remission after first intensive induction chemotherapy
- •60-75 years, inclusive
- •HLA-identical sibling or unrelated donor completely matched (10/10 for HLA A, B, C, DR, DQ)
- •WHO-performance status 0-2
- •Written informed consent
排除标准
- •Previous autologous or allogeneic SCT
- •Acute promyelocytic leukemia
- •Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix B);
- •Severe cardiac dysfunction (NYHA classification 3-4, see appendix C).
- •Significant hepatic dysfunction (serum bilirubin or transaminases >= 3 times upper limit of normal);
- •Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
- •Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.);
- •Severe neurological or psychiatric disease;
- •Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Patient known to be HIV-positive
研究者
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