Dynamic of Immunocompetent Populations in Patients Treated With Extracorporeal Photopheresis in Chronic Graft Versus Host Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Changes in circulating immunocompetent subsets for responder and non-responder patients treated with ECP in inaugural cGVHD.
研究概览
简要总结
Extracorporeal photopheresis (ECP) is a cellular therapy indicated in the treatment of chronic GVHD (cGVHD). In this study protocol, patients suffering from inaugural cGVHD will be treated with the association of ECP and corticosteroid treatment. Treatment will start by an induction stage with 2 sessions of ECP per week until the 10th week followed by a maintenance stage including one session every other week until the 22th week. The objective of this study is to highlight the immunological mechanism of extracorporeal photopheresis treatment. Indeed, ECP is based on an immunomodulatory immunological effect and despite several hypotheses highlighted by different teams; clear mechanisms still need to be defined. This French multicenter study realize an immunological follow-up before and during treatment to elucidate the impact of ECP on immune system of responder patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients aged ≥18 years who had a first allo-CSH for hematological pathology
- •Body weight ≥ 40 kg.
- •Confirmed diagnosis of inaugural cGVHD requiring systemic treatment.
- •Any source of hematopoietic stem cells is allowed.
- •All conditioning treatments are allowed.
- •Patient validated by the local investigator as eligible for treatment with ECP according to the criteria of the investigating centers
- •Patient treated according to the study plan with a ECP in 2 steps
- •Patient having signed informed consent.
- •Prophylaxis of GVH maintained during the onset of cGVHD is accepted.
- •Effective contraception for men and women of childbearing age.
排除标准
- •cGVHD ≥ 2nd line of treatment
- •Exclusive pulmonary cGVHD
- •cGVHD before J100
- •cGVHD occurring after Donor Lymphocyte Injection (DLI)
- •Overlaps syndrome aGVHD-cGVHD
- •Late aGVHD
- •Relapsed patient or progressive disease
- •Non-controlled infection
- •Second Allograft
- •Leukopenia <0.5G / l at screening
结局指标
主要结局
Changes in circulating immunocompetent subsets for responder and non-responder patients treated with ECP in inaugural cGVHD.
时间窗: at 6-week follow-up
次要结局
- Changes in circulating immunocompetent subsets frequency for responder and non-responder patients treated with ECP in inaugural cGVHD.(at 22-week follow-up)
- Response rate (complete and partial response) according to NIH criteria(at 10 weeks and at 22 weeks)
- Comparison of serum and tissue biomarkers in responder and non-responder patients between the initial treatment and 6-week follow-up.(at baseline, at 6 week follow-up)
- QLQ-C30 version 3.0(between 10-week and 22-week follow-ups.)