EUCTR2005-002011-24-GB进行中（未招募）1 期
Dose-reduced versus standard conditioning followed by allogeneic stem cell transplantation in patients with MDS or sAML: A randomised phase III study (RICMAC) - RICMAC MDS/sAM
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
入选标准
- •Disease: Cytologically proven
- •primary or therapy-related myelodysplastic syndrome (MDS), either as
- •?refractory anaemia (RA) according FAB or RA with or without dysplasia according WHO,
- •?refractory anaemia with ringsideroblasts (RARS) according FAB or RARS with or without dysplasia according WHO,
- •?refractory anaemia with excess of blasts (RAEB) according FAB or RAEB I or RAEB II according WHO,
- •?refractory anaemia with excess of blast in transformation (RAEB T) according FAB,
- •?CMML (dysplastic type) according WHO,
- •or secondary acute myeloid leukaemia (sAML).
- •Blast count < 20 percent in bone marrow with or without chemotherapy at time of transplantation.
- •Patient eligible for standard and dose-reduced conditioning as per local guideline.
- •Patient age 18 – 60 years if donor is a HLA-matched unrelated donor (HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one mismatch allowed):
- •Patient age 18 – 65 years if donor is a HLA-matched related donor ((HLA-A, HLA-B, HLA-DRB1 and HLA-DQB1) (one antigen-mismatch allowed):
- •No major organ dysfunction.
- •Written informed consent of the patient.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Blasts > 20 % in bone marrow at time of transplantation
- •No written informed consent.
- •Central nervous involvement.
- •Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
- •Total bilirubin, SGPT or SGOT > 2 times upper the normal level.
- •Left ventricular ejection fraction < 30 %.
- •Creatinine clearance < 30 ml/min.
- •DLCO < 35 % and/or receiving supplementary continuous oxygen.
- •Positive serology for HIV.
- •Pregnant or lactating women.
- •Patients with a life-expectancy of less than six months because of another debilitating disease.
- •Serious psychiatric or psychological disorders.
- •Invasive fungal infection at time of registration.
研究者
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撤回
3 期
Dose-reduced versus standard conditioning followed by allogeneic stem cell Transplantation in patients with MDS or sAML: A randomised phase III studyMyelodysplastic Syndrome and secondairy Acute Myeloid Leukaemia10024324NL-OMON31335European Group for Blood and Marrow Transplantation (EBMT) tav Prof. Dr. T. de Witte10
终止
3 期
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