NCT06473909尚未招募2 期
An Exploratory Clinical Study on the Efficacy and Safety of Humanized CD25 Monoclonal Antibody Combined With Glucocorticoid in the First-line Treatment of Acute Graft-versus-host Disease (aGVHD) After Allo-HSCT
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- The remission rate of aGVHD
研究概览
简要总结
The first-line treatment of acute graft-versus-host disease with humanized CD25 monoclonal antibody combined with glucocorticoid was used to study the remission rate of acute graft-versus-host disease, the cumulative incidence and remission rate of severe acute graft-versus-host disease, GVHD-free survival rate, all-cause mortality and quality of life evaluation, and safety evaluation for prevention programs.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •( 1 ) Diagnosis of grade II to IV acute graft-versus-host disease after hematopoietic stem cell transplantation.
- •( 2 ) older than or equal to 18 years old. ( 3 ) Informed consent can be signed by themselves. ( 4 ) HIV negative, HBV, HCV negative. ( 5 ) Informed consent must be signed before the start of the study procedure. The informed consent must be signed by the patient himself or his immediate family. Considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent will be signed by the legal guardian or the patient 's immediate family.
排除标准
- •• (1) diagnosed as VOD/SOS.
- •(2) Uncontrolled infection at enrollment; requires mechanical ventilation or is hemodynamically unstable at the time of enrollment;
- •(3) has severe hepatic insufficiency (defined as Child-Pugh Class C; has serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 xthe upper limit of normal (ULN) or serum total bilirubin > 2.5 x ULN.
- •(4) has end-stage renal impairment with a creatinine clearance less than 10 mL/min.
- •(5) has both moderate hepatic insufficiency AND moderate renal insufficiency;
- •(6) has documented positive results for human immunodeficiency virus antibody (HIVAb), hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) within 90 days prior to enrollments;
- •(7) has active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas).
- •(8) Suffering from mental disorders or other conditions and unable to cooperate with the requirements of study treatment and monitoring;
- •(9) unable or unwilling to sign the consent form;
- •(10) patients with other special conditions assessed as unqualified by the investigator
研究组 & 干预措施
treatment arm
Experimental
干预措施: CD25 antibody combined glucocorticoid as first-line treatment (Drug)
结局指标
主要结局
The remission rate of aGVHD
时间窗: 28 days
次要结局
- Incidence rate of severe aGVHD(24 weeks)
- infection rate(24 weeks)
- overall survival(24 weeks)
- relapse rate(24 weeks)
- non-relapse mortality(24 weeks)
研究者
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