Efficacy and Safety of UC-MSCS for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT: A Multicenter, Randomized, Open-label Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Rate of complete remission
研究概览
简要总结
Randomized, open-label, multicenter study to investigate the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSC) for the treatment of steroid-resistant acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a view to establishing an effective treatment protocol for steroid-resistant aGVHD.
详细描述
A total of 130 patients with steroid-resistant aGVHD after allo-HSCT are enrolled in this multicenter, randomized, controlled trial. Patients were randomized to UC-MSC + anti-CD25 monoclonal antibodies (mAb) group and anti-CD25 mAb group. The complete response (CR) rate after 4 weeks of treatment in the two groups will be compared. Adverse events are also recorded throughout the study.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Confirmed diagnosed steroid-resistant aGVHD after allo-HSCT.
- •Neutrophile granulocyte (ANC) ≥ 0.5 x 10^9/L.
- •Creatinine below 2 times normal upper limit .
- •Willing and able to sign written informed consent.
排除标准
- •Untoleratation of the treatment.
- •Primary disease are not effectively controlled or are progressing.
- •Active infection (Bacteria, fungi, viruses ).
- •Combined with dysfunction of multiple organ.
- •Female patients who are nursing or pregnant, or who contemplate pregnancy during the study period.
- •Patients who are deemed unsuitable for the study by the investigator.
研究组 & 干预措施
UC-MSC and anti-CD25 mAb
UC-MSC, iv, 1×10^6 cells/kg, once a week, for 4 weeks. Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, 4 weeks. Other treatment would replace it according to clinical experience if aGVHD continue to progress within 3 weeks of treatment or patients are lack of response after 4 weeks of treatment. The treatment would be repeated in another 4 weeks if patients receive partial response after the first 4 weeks of treatment.
干预措施: UC-MSC (Drug)
UC-MSC and anti-CD25 mAb
UC-MSC, iv, 1×10^6 cells/kg, once a week, for 4 weeks. Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, 4 weeks. Other treatment would replace it according to clinical experience if aGVHD continue to progress within 3 weeks of treatment or patients are lack of response after 4 weeks of treatment. The treatment would be repeated in another 4 weeks if patients receive partial response after the first 4 weeks of treatment.
干预措施: Anti-CD25 mAb (Drug)
Anti-CD25 mAb
Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks. Other treatment would replace it according to clinical experience if aGVHD continue to progress within 3 weeks of treatment or patients are lack of response after 4 weeks of treatment. The treatment would be repeated in another 4 weeks if patients receive partial response after first 4 weeks of treatment.
干预措施: Anti-CD25 mAb (Drug)
结局指标
主要结局
Rate of complete remission
时间窗: 4 weeks after treatment
Complete remission of aGVHD related symptoms and indicators
次要结局
- Rate of partial remission(4 weeks after treatment)
- Overall survival(At the end of Week 4 / 8 / 12 / 24 / 52.)
- Infusion toxicity(From the beginning of to four hours after every infusion of UC-MSC)
研究者
Xiao Hui Zhang
Vice president of Peking Univeristy Institute of Hematology
Peking University People's Hospital