Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent Chronic Graft-versus-host-disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This study suggested that hydrogen has a potential as an effective and safe therapeutic agent on cGVHD.
详细描述
The investigators will evaluate clinical response rate, time to treatment Failure (TTF), overall survival (OS), and toxicity in cGVHD patients.
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
入排标准
- 年龄范围
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •not pregnant female
- •patients <65 years old
- •Diagnosis of cGVHD steroid refractory (no response after Prednisone ≥1mg/kg ) or steroid-dependent cGVHD (had an initial response followed by a cGVHD flare upon steroid taper)
- •Patient intolerant to steroid therapy
排除标准
- •Patients with stable disease, not well controlled by the current treatment
- •Pregnancy
- •HIV positive
- •Severe liver or renal impairment: serum creatinine >2.5 mg/dl; serum bilirubin>2.5 mg/dl (without evidence of hepatic cGVHD)
- •Uncontrolled malignancies including the persistence of the underlying malignancy before the Allogeneic Transplantation and the relapse of hematopoietic malignancy
- •Any other investigational agents administered within last four weeks
- •Cardiac insufficiency (>grade II, New York Heart Association classification)
- •Inability to comply with medical therapy or follow-up
研究组 & 干预措施
Hydrogen
Patients will receive hydrogen-rich water (4mL/kg three times one day, 0.8 ppm)
干预措施: Hydrogen (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 12 months after date of start of Hydrogen
Overall Response Rate (ORR) is defined as an Objective improvement at sixth month, and includes at least 1 of the following criteria: At least 50% reduction of body surface area involved; Reduction (at least 20%) of skin sclerosis, measured by Rodnan score Improvement\>1 point in functional pulmonary tests, evaluated by LFS score; \>50% steroid reduction (for at least 4 weeks)
次要结局
- Response Rate in each domain (RRD)(12 months after date of start of Hydrogen)
研究者
Liren Qian
Doctor
Navy General Hospital, Beijing