Prevention of Graft-versus-host Disease in Patients Treated With Allogeneic Stem Cell Transplantation: Possible Role of Extracorporeal Photophoresis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Reduce the frequency of GVHD by preventive treatment with ECP of patients undergoing allogeneic stem cell transplantation for hematological malignancies
研究概览
简要总结
The main aim is to test the preventive use of extracorporeal photophoresis (ECP) against development of graft-versus-host disease (GVHD) in patients undergoing allogeneic stem cell transplantation for hematological malignancy.
详细描述
Allogeneic stem cell transplantation represents the only available long-term control and possible cure of a number of hematological malignancies. A major obstacle to this treatment is the development of graft-versus-host disease (GVHD), affecting the majority of transplanted patients to some extent. Today, combinations of various cytotoxic and immunosuppressive drugs are used to prevent and treat GVHD, but many of them are associated with severe side-effects. Extracorporeal photophoresis (ECP) offers an alternative to chemo- and immunosuppressive therapy and confers apparently only mild side effects. The postulated rationale of ECP is to treat the patient's white blood cells ex vivo with ultraviolet irradiation after sensitization with 8-methoxypsoralen to dampen their immunoactivity. After engraftment the intervention group receives 2 consecutive ECP every week in 2 weeks then 1 ECP every week in 4 weeks ( a total of 8 ECP procedures).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written consent to participate
- •Understand Norwegian or English
- •No previous history of malignant disease
- •No contraindication to ECP-treatment or undergone previous ECP treatment
排除标准
- •(in addition to those regarding eligibility for transplantation itself):
- •Unwilling to provide written consent to participate
- •Unable to cooperate as judged by the responsible physician
- •ECOG status > 2 at time of inclusion
- •Using anti-inflammatory or cytotoxic drugs other than those that are part of the treatment of the current hematological malignancy
- •Known allergy to psoralens or citrate products
- •Splenectomy
- •Pregnancy/lactating
结局指标
主要结局
Reduce the frequency of GVHD by preventive treatment with ECP of patients undergoing allogeneic stem cell transplantation for hematological malignancies
时间窗: up to 1 year after allogeneic stamcell transplantation
GVHD is measured according to internationally recognized criteria
次要结局
- Number of survivors the first year after transplantation(Through study completion, and until 1 year after study start)
- Number of patients who relapsed the first year after transplantation Number of patients who relapsed the first year after transplantation Number of patients who relapsed the first year after transplantation(Through study completion, and until 1 year after study start)
- Quality of life (QoL) the first year after transplantation(Through study completion, and until 1 year after study start)
- Assessment of vitamin A derivatives(From randomization to 3 months after transplantation)
- Determination of microbiota(Through study completion, and until 1 year after study start)
- Determination of microbiota(Through study completion, and until 1 year after study start)
- Number of survivors the first year after transplantation(Through study completion, and until 1 year after study start)
- Number of patients who relapsed the first year after transplantation Number of patients who relapsed the first year after transplantation Number of patients who relapsed the first year after transplantation(Through study completion, and until 1 year after study start)
- Quality of life (QoL) the first year after transplantation(Through study completion, and until 1 year after study start)
- Assessment of vitamin A derivatives(From randomization to 3 months after transplantation)
研究者
Tobias Gedde-Dahl d.y.
Consultant hematologist MD,PhD
Oslo University Hospital