Prospective Study of Combined 4-Day ATG Regimen for Prophylaxis of aGVHD in Matched Sibling Donor PBSCT
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants with severe cGVHD
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of combined ATG #antithymocyte globulin # regimen (5mg/kg divided from day -5 to day -2) for aGVHD(acute graft-versus-host disease ) prophylaxis in matched sibling donor peripheral blood stem cell transplantation (MSD-PBSCT).
详细描述
Transplantation with G-CSF #Granulocyte colony stimulating factor #mobilized peripheral blood stem cell (PBSCT) has been a stable transplant setting with matched sibling donor transplantation. Unmanipulated haploidentical donor PBSCT (haplo-PBSCT) has been applied in patients with hematologic malignancies. In our previous cohort study, haplo-PBSCT was associated with lower incidence of severe acute GVHD and extensive chronic GVHD compared with matched sibling donor PBSCT (MSD-PBSCT). Haplo-PBSCT has the same GVHD prophylaxis regimen with MSD-PBSCT, except ATG. It suggested the potential advantage of ATG in prophylaxis of GVHD and improvement of long term quality of life of the transplant recipients, which motivate us to observe the efficacy of combined ATG regimen for GVHD prophylaxis in MSD-PBSCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were aged from 14 to 65 years;
- •Patients were diagnosed of acute leukemia or MDS;
- •There were indications of MSD-PBSCT for these patients;
- •Patients without any uncontrolled infections or without severe pulmonary, renal, hepatic or cardiac diseases.
排除标准
- •Patients with any uncontrolled infections or with severe pulmonary,renal, hepatic or cardiac diseases;
- •AML patients with t (15;17).
研究组 & 干预措施
4-day ATG combined regimen
ATG combined regimen for prophylaxis of GVHD, includes ATG, MMF (Mycophenolate mofetil), CsA (cyclosporin A) and MTX (methotrexate). All recipients in this arm received ATG, CsA, mycophenolate mofetil, and short-term methotrexate for GVHD prophylaxis. ATG (Thymoglobuline, rabbit) was used as 1 mg/kg/d from day -5 to day -3 and 2 mg/kg/d on day -2. CsA (3 mg/kg, q12h, i.v.) was used from day -9, and the concentration was adjusted to 180-200 ng/mL. CsA was switched to oral administration when the patient's bowel function recovered. From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30. After graft infusion, MTX was given for all patients at 15 mg/m2 on day +1 and 10 mg/m2 on days +3, +6 and +11.
干预措施: Rabbit ATG (Drug)
结局指标
主要结局
Number of participants with severe cGVHD
时间窗: 1 year
Chronic graft versus host disease grading criteria (refer to NIH criteria)
次要结局
- Number of participants relapse as assessed by NCCN (National Comprehensive Cancer Network )criteria(1 year)
- NRM(1 year)
- OS(1 year)
- Number of participants with aGVHD as assessed by acute graft versus host disease grading criteria (refer to Glucksberg criteria)(100 days)
- DFS(1 year)
研究者
Daihong Liu
Director
Chinese PLA General Hospital