A Multi-center Randomized Phase II Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporeal Photopheresis as First-line Treatment of Grade II Acute Graft-versus-host Disease With Skin Involvement Occuring After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Freedom from treatment failure
研究概览
简要总结
The goal of this clinical trial is to compare as a first line of grade II skin acute GVHD sconventional treatment with steroids alone to a combination of steroids and extracoporeal photopheresis (ECP)
The primary end point will compare Freedom from treatment failure at 6 months from randomization as defined by meeting all the following 4 conditions:
- to be alive
- without relapse of the hematological disease
- without having required a new line of treatment for acute GVHD
- without initiating a systemic treatment for chronic GVHD.
详细描述
A multi-center randomized phase II study comparing corticosteroids alone (standard of care) versus corticosteroids and extracorporeal photopheresis as first-line treatment of Grade II acute graft-versus-host disease with skin +/- upper gastrointestinal involvement occurring after allogeneic stem cell transplantation
Corticosteroids will be started at 2 mg/kg in both arms and will be tapered once acute GVHD achieves complete remission according to strict protocol guidelines (-20% of the daily dose per week until 1 mg/kg and then 10 mg twice a day in order to stop steroids within 2 to 3 months from randomization).
Extracorporeal Photopheresis (ECP) will be performed in the experimental arm : 2 sessions/week during 4 weeks then 1 session/week during 8 weeks), i.e. a total of 16 ECP sessions in 12 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years,
- •allogeneic hematopoietic stem cell transplantation received (from any type of graft and donor) after malignant or non malignant disease
- •patient suffering from Grade II acute GVHD with skin +/- high GI involvement (stage 2-3 skin + upper gastrointestinal tract or skin stage 3) in the 3 months following stem cell transplantation
- •patient requiring first line treatment for acute GVHD
- •patient able to start PCE therapy in the 3 days after randomization
- •validation of the presence of a peripheral or central venous access (its type should be conform to the recommendations described in the Therakos Cellex operator manual), allowing to perform PCE sessions weekly during 3 months. In the absence of appropriate preexisting central line at inclusion, peripheral access will be preferred.
- •leukocytes > 1.5 G/l, platelets > 30 G/l, hematocrit > 27% (blood transfusion are permitted), based on the last available blood testing results,
- •patient with French Health Insurance,
- •patient informed about the clinical trial content and organization,
- •informed consent form signed.
排除标准
- •- Grade 1 acute GVHD,
- •acute GVH grade > II or acute GVH with lower gastrointestinal tract or with liver involvement,
- •relapse of the hematologic disease at time of acute GVHD,
- •uncontrolled ongoing infection at time of inclusion: bacterial or fungal infections, CMV reactivation with increasing CMV viral load,
- •HIV positivity or replicative HBV or HCV infection (based on pre-transplant assessment),
- •patient with allergy or contraindications to UVADEX, extracorporeal photopheresis, steroids, or posaconazole (see details in the study protocol),
- •woman of childbearing age without efficient contraceptive method, pregnancy or breast feeding woman,
- •patient with history of profound venous thrombosis in the last 5 years,
- •patient included in another acute GVHD prospective clinical trial.
研究组 & 干预措施
Steroids alone
Steroids 2 mg/kg/day
干预措施: Steroids (Drug)
ECP + steroids
Steroids 2 mg/kg abd ECP x 2 per week for 1 months and once a week for 2 months
干预措施: Uvadex (Drug)
结局指标
主要结局
Freedom from treatment failure
时间窗: at 6 months from randomization
To be alive, without disease relapse, without second line treatment for acute GVHD and without systemic treatment for chronic GVHD
次要结局
- infections(at 6 months from randomization)
- overall survival(at 12 months from randomization)
- steroid cumulative dose(at 6 months from randomization)
- chronic GVHD(at 12 months from randomization)
- relapse(at 12 months from randomization)
- non-relapse mortality(at 12 months from randomization)
研究者
Marie-Thérèse RUBIO
PU-PH
Central Hospital, Nancy, France