A Single-cohort, Phase II Study of Methotrexate Combined Corticosteroid in Chinese Patients With Acute Graft vs. Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR) for GVHD treatment at 7 days after treatment
研究概览
简要总结
The aim of the study is to identify the efficacy and safety of methotrexate (MTX) combined corticosteroid treatment for acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
详细描述
Allo-HSCT is an effective treatment of malignant hematopoietic diseases. However, aGVHD remains a major complication after allo-HSCT and the destruction of recipient tissues by alloantigen-activated T cells is a key event in the development of aGVHD. Corticosteroid is the standard first-line therapy for aGVHD due to their roles in suppressing T cell responses. However, the response rate of corticosteroid was approximate 50%, and the clinical outcomes of patients with corticosteroid refractory GVHD were poor. Thus far, no combination therapy had been prove to be superior to corticosteroid alone as initial therapy for aGVHD. The study hypothesis: MTX combined corticosteroid treatment could help to further ameliorate the activity of T cells and control aGVHD.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are fully informed and sign informed consent by themselves or their guardians;
- •Patients receiving allogeneic hematopoietic stem cell transplantation;
- •Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation;
- •Patients with stable implantation of granulocytes and platelets.
排除标准
- •Patients who have received more than one transplant;
- •Patients with overlap syndrome;
- •Patients within six months after the failure of the first transplantation;
- •Patients with uncontrollable active infection;
- •Patients with recurrence of primary malignant hematopathy;
- •Patients with DLI or induced graft-versus-host disease after first intervention;
- •Patients with serious respiratory diseases;
- •Patients with severe renal insufficiency;
- •Patients with serious and uncontrolled heart disease;
- •Patients with severe hepatobiliary diseases unrelated to graft-versus-host disease;
- •Within one week patients who need to use more than 1mg/kg/d methylprednisolone for reasons other than graft-versus-host disease;
- •patients who have participated in other clinical trials within 1 month;
- •The researcher judges that there are other factors that are not suitable for participating
研究组 & 干预措施
MTX and corticosteroid
Methylprednisolone 1 mg/kg/day MTX (10 mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II;
干预措施: Methotrexate (Drug)
结局指标
主要结局
Overall response rate (ORR) for GVHD treatment at 7 days after treatment
时间窗: 7 days
Overall response rate is defined as the proportion of patients demonstrating a complete response or partial response without requirement for additional systemic therapies for an earlier progression, mixed response or non-response.
次要结局
- Overall survival(1 year)
- Non-relapse mortality(1 year)
- Overall response rate (ORR) at 28 days after treatment(28 days)
- Disease free survival(1 year)
- Failure free survival(1 year)
- Relapse(1 year)
- Chronic GVHD(1 year)
研究者
Xiao-Jun Huang
Director
Peking University People's Hospital