Prophylaxis Roles of Low Dose of IL-2 Treatment on GVHD After Haploidentical Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- II-IV acute graft-versus-host disease (aGVHD) post transplantation
研究概览
简要总结
The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow transplantation (HBMT) on hematological malignancies are well established.The aim of this prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be decreased with IL2 therapy post HBMT.
详细描述
The effects of haploidentical rhG-CSF-mobilized unmanipulated blood and marrow transplantation (HBMT) on hematological malignancies are well established.The aim of this prospective cohort trial is to determine if acute graft-versus-host disease (aGVHD) could be decreased with IL2 therapy post HBMT.low dose of IL-2 (40 million U/m2) will be administered from WBC engraftment to day 90 post haploidentical transplantation. IL-2 will be administered three times a week.
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
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 15-65 years old
- •Acute leukemia in complete remission (CR1/CR2) who received myeloablative haploidentical allo-HSCT
- •WBC engraftment (ANC>500/ul for continuous 3 days)
- •At least +7d
- •Less than or equal to +15d
- •no active II-IV aGVHD
- •no severe infections
- •Karnofsky score greater than or equal to 90%
- •Haploidentical donor from sibling, children or father
- •Ensure that informed consent signed and faxed to Research Coordinator
排除标准
- •Exposure to any other clinical trials prior to enrollment
- •Active malignant disease relapses or MRD positive
- •Active, uncontrolled infection
- •Inability to comply with IL-2 treatment regimen
- •Active, uncontrolled II-IV aGVHD
- •Haploidentical donor from mother or collateral donors
- •Clinical Signs of severe pulmonary dysfunction
- •Clinical Signs of sever cardiac dysfunction
- •Receiving corticosteroids as GVHD treatment
研究组 & 干预措施
Interleukin-2 interventions
Patients with standard risk hematologic malignancies undergoing an unmodified haploidentical HCT will be eligible. Once patients achieved neutrophil engraftment will be given IL-2, 0.4×10E+6/M2/d, 3 times a week (separated by at least 1 day between injections) until day +90 (+/- 7 days).
干预措施: Interleukin-2 (Drug)
结局指标
主要结局
II-IV acute graft-versus-host disease (aGVHD) post transplantation
时间窗: Day 100 post transplantation
cumultive incidence of II-IV acute graft-versus-host disease (aGVHD) post transplantation
次要结局
- Overall survival post transplantation(1 year)
- CMV infection post transplantation(Day 100 post transplantation)
- Measureable residual disease (MRD)-positive test post transplantation(1 year)
- Disease-free free survival post transplantation(1 year)
- Severe chronic GVHD post transplantation(1 year post transplantation)
- Hematological relapse post transplantation(1 year)
研究者
Xiaojun Huang,MD
Chief of Peking University Institute of Hematology
Peking University People's Hospital