NCT00599547已完成2 期
Allogeneic Stem Cell Transplantation After Dose-reduced Intensity Conditioning Regimen for Patients With Myelofibrosis With Myeloid Metaplasia (MMM): A Phase II-study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Transplant-related mortality by day +100 and by one year post-transplant, hematopoietic recovery by day +100 post-transplant, myeloid and T-cell chimerism by day +100 posttransplant, toxicity of the regimen acc. to Bearman scale
研究概览
简要总结
The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation is a feasible and effective treatment for patients with primary myelofibrosis.
详细描述
The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from related or unrelated donors is a feasible and effective treatment for patients with primary myelofibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease: Histologically proven Myelofibrosis with myeloid metaplasia/MMM defined as per the Italian Consensus Conference on MMM diagnosis with either primary MMM or secondary to Polycythaemia vera or essential thrombocythaemia with
- •"intermediate risk" or "high risk" score according to the Lille Scoring System
- •OR "low risk" score according to the Lille Scoring System with constitutional symptoms (fever, night sweat, weight loss > 5% of body weight)
- •OR "high risk" score according to the Cervantes score
- •Patients between 50 and 70 years of age and no limited life expectancy for other reasons than MMM
- •Patients under 50 years of age who are not eligible for a standard myeloablative conditioning, (e.g., because of prior autologous stem cell, history of severe infections like fungal infections, history of cardiac toxicity or other reasons according to the treating physician)
- •HLA compatible or identical donor, related or unrelated (one mismatch allowed)
- •Written informed consent of the patient
排除标准
- •Positive search for bcr-abl on blood.
- •Serious irreversible renal, hepatic, pulmonary or cardiac disease
- •Central nervous involvement
- •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
结局指标
主要结局
Transplant-related mortality by day +100 and by one year post-transplant, hematopoietic recovery by day +100 post-transplant, myeloid and T-cell chimerism by day +100 posttransplant, toxicity of the regimen acc. to Bearman scale
时间窗: Follow-up until day +1095
次要结局
- VOD-Staging and VOD-Grading acc. to the McDonald-scale, incidence of GvHD, overall survival post-transplant, disease-free survival post-transplant(Follow-up until day +1095)
研究者
研究点 (2)
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