NCT01203228终止3 期
Dose-reduced Versus Standard Conditioning Followed by Allogeneic Stem Cell Transplantation in Patients With MDS or sAML: A Randomised Phase III Study (RICMAC)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 129
- 试验地点
- 14
- 主要终点
- non-relapse mortality
研究概览
简要总结
In this trial dose reduced conditioning is compared to standard conditioning followed by allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or secondary AML.
Conditioning is the very high dose chemotherapy treatment that is given in the days before the stem cell transplant.
The hypothesis is that a dose reduced conditioning will reduce the non-relapse mortality from 40% to 20% at one year after allogeneic stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 anti¬gen-mismatch allowed):
- •No major organ dysfunction.
- •Written informed consent of the patient.
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.
结局指标
主要结局
non-relapse mortality
时间窗: every 6 months for safety and in the final analysis at one year after allogeneic stem cell transplantation
次要结局
- organ related toxicity of conditioning(every 6 months for safety and in the final analysis at day +30 after allogeneic stem cell transplantation)
- Incidence of aGVHD(every 6 months for safety and in the final analysis at day +100 after allogeneic stem cell transplantation)
- incidence of cGVHD(every 6 months for safety and in the final analysis at one year after allogeneic stem cell transplantation)
- overall survival(every 6 months for safety and in the final analysis at 2 years after allogeneic stem cell transplantation)
- VOD(every 6 months for safety and in the final analysis at day +100 after allogeneic stem cell transplantation)
- event-free survival(every 6 months for safety and in the final analysis at 2 years after allogeneic stem cell transplantation)
- cumulative incidence of relapse(every 6 months for safety and in the final analysis at 2 years after allogeneic stem cell transplantation)
- infection incidence(every 6 months for safety and in the final analysis at day +100, 1 year and 2 years after allogeneic stem cell transplantation)
- Haematopoeitic recovery(every 6 months for safety and in the final analysis at day +30 after allogeneic stem cell transplantation)
研究者
研究点 (14)
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