Study on the Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease (cGVHD) of the Liver Following Allogeneic Hematopoietic Stem Cell Transplantation.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- overall response rate (ORR)
研究概览
简要总结
The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will receive a treatment regimen consisting of the Anti-CD25 rhMAb in combination with prednisone, cyclosporine, and ruxolitinib.The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 16 and 65 years
- •Received allogeneic hematopoietic stem cell transplantation
- •Developed chronic GVHD in the liver after transplantation
- •Ineffective prednisone treatment prior to screening
- •Received ≤4 lines of systemic therapy prior to screening
- •After informed consent, the patient agreed to receive anti-CD25 rhMAb treatment
排除标准
- •Elevation of bilirubin, ALT, or alkaline phosphatase due to reasons other than chronic GVHD
- •No prior treatment with prednisone
- •Overlap syndrome
- •Uncontrolled active infection
- •Organ failure
- •Early progression or recurrence of hematologic diseases
- •Allergy to anti-CD25 rhMAb
- •Received other interleukin-2 receptor monoclonal antibody treatment due to various reasons within one month after transplantation
- •Participated in other clinical studies within one month
研究组 & 干预措施
Anti-CD25 rhMAb + traditional therapy
干预措施: Ruxolitinib (Drug)
Anti-CD25 rhMAb + traditional therapy
干预措施: Cyclosporine (Drug)
Anti-CD25 rhMAb + traditional therapy
干预措施: anti-CD25 rhMAb (Drug)
Anti-CD25 rhMAb + traditional therapy
干预措施: Prednisone (Drug)
结局指标
主要结局
overall response rate (ORR)
时间窗: 56 days
ORR is defined as the percentage of complete response (CR) and partial response (PR).
次要结局
- duration of response（DOR）(1 year)
- disease-free survival (DFS)(1 year)
- failure-free survival (FFS)(1 year)
- non-relapse mortality (NRM)(1 year)
- overall survival （OS）(1 year)
- adverse drug reactions (ADR)(1 year)
- patient-reported outcomes (PRO)(1 year)
研究者
Xiao-Jun Huang
Director
Peking University People's Hospital