NCT04686929已完成1 期
The Efficacy and Safety of Subcutaneous Abatacept in the Prevention of Acute Graft-versus-host Disease After Haplo-identical Donor Hematopoietic Cell Transplantation
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Incidence of overt aGVHD
研究概览
简要总结
Acute graft-versus-host disease (aGVHD) is a potentially fatal complication after allogeneic hematopoietic cell transplantation (HCT), particularly for that with a HLA-mismatched donor. Abatacept has been demonstrated as a potent drug to reduce the risk of aGVHD, but the efficacy of subcutaneous form has yet been investigated. This trial is designed to preliminarily determin the efficacy and saftey of subcutaneous abatacept in the prevention of aGVHD after haplo-identical HCT.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≧18 years
- •ECOG score 0-2 / Karnofsky score≧80
- •haplo-HCT is proposed
- •Conditioning with motified Bu/Cy+ATG regimen
- •Having the following hematologic malignancies with transplant indications:
- •Acute leukemia
- •Myelodysplastic syndrome
- •Aggressive lymphoma
- •Expected survival ≥ 3 months
- •Written informed Consent can be acquired
- •Agree to use effective contraception
排除标准
- •With a history of allo-HCT previously
- •Allergic/intolerant to Abatacept
- •Contraindications to the use of Abatacept
- •HIV infection, or active HBV infection or HCV infection
- •Uncontrolled active infection
- •Vital organ function intolerated to transplantation
- •Other malignancies except for the following diseases: malignant tumors that have been cured for at least 3 years without active lesions; adequete treated non-melanoma skin cancer, malignant amygdala, and carcinoma in situ without active lesions
- •Evidence of complications or medical conditions that may interfere with research or put the subjects at serious risk, including but not limited to severe cardiovascular disease (e.g. New York Heart Association grade III or IV heart disease, myocardial infarction in the past 6 months, unstable arrhythmia or unstable angina) and/or severe lung disease (e.g. history of severe obstructive lung disease and symptomatic bronchospasm)
- •Pregnant and lactational women
- •Any life-threatening disease, medical condition, or organ dysfunction unfit for participants, or may interfere with the absorption or metabolism of Abatacept
研究组 & 干预措施
Cohort 1
Experimental
The participants in Cohort 1 will receive abatacept s.c
干预措施: Abatacept s.c. (Drug)
结局指标
主要结局
Incidence of overt aGVHD
时间窗: 100 days post-HCT
The incidence of grade II-IV aGVHD post-transplantation
次要结局
- Incidence of severe aGVHD(100 days post-HCT)
- Early transplant-related mortality(100 days post-HCT)
- Incidence of aGVHD(100 days post-HCT)
- Relapse(100 days post-HCT)
研究者
CHEN Jia
M.D.
The First Affiliated Hospital of Soochow University
研究点 (1)
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