NCT05832216已完成1 期
Efficacy of Daratumumab to Overcome Platelet Transfusion Refractoriness in Patients with Aplastic Anemia
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年4月17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
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percentage of patients with platelet transfusion responsiveness
研究概览
简要总结
This is a phase 1, prospective, single-arm, open-label study. The aim of this study is to evaluate the transfusion responses of platelet increment by using Daratumumab among aplastic anemia patients with platelet transfusion refractoriness.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of aplastic anemia (AA)
- •Dependent on platelet transfusions, characterized by either PLT<10×10^9/L, or PLT<20×10^9/L with bleeding events.
- •Diagnosed with platelet transfusion refractoriness, characterized by Corrected count increment (CCI) <7500/ul at 60 min, or CCI <4500/ul at 24 hrs.
- •Male or female age ≥ 12 years
- •ECOG performance status ≤2
- •Willing and able to comply with the requirements for this study and written informed consent.
排除标准
- •The inherited bone marrow failure syndromes
- •The presence of hemolytic PNH clone
- •Combination of either radiotherapy or chemotherapy for solid tumors in recent 3 years, excluding the local tumor diagnosed 1 year ago and cured by surgical resection.
- •Cytopenia caused by other diseases, including liver cirrhosis, active rheumatic connective tissue disease, and persistence of infectious diseases, etc.
- •Uncontrolled infection
- •HIV, HCV or HBV active infection
- •The presence of any of the following bleeding events:
- •Gastrointestinal bleeding
- •Respiratory tract hemorrhage
- •Central nervous system bleeding
- •Abnormal liver function: ALT or AST > 2 ULN, or TBil > 2 ULN after treatment.
- •Abnormal kidney function: Creatinine clearance < 30 ml/min
- •Heart failure (NYHA class III or IV)
- •Poorly controlled diabetes, characterized by fasting blood glucose > 8.8mmol/L or post-meal blood glucose > 11.1mmol/L after therapy with insulin or oral hypoglycemic agents
- •History of congestive heart failure, unstable angina pectoris, myocardial infarction, arterial or venous thrombosis
- •Pregnant or breast-feeding patients
- •Had a history of any psychiatric diseases, cerebrovascular disease or cognitive sequelae of head injury.
- •Participation in another clinical trial within 4 weeks before the start of this trial
- •Have an allergy to Daratumumab or any other part of this medicine.
- •Previously treated with Daratumumab
- •Previously treated with ATG/ALG within 4 months before the start of this trial
- •Previously treated with the anti-CD20 monoclonal antibody within 2 months before the start of this trial
- •Currently treated with TPO-RA except for a minimum of 4 weeks for washout before the start of this trial
- •Patients considered to be ineligible for the study by the investigator for reasons other than above
研究组 & 干预措施
Daratumumab
Experimental
干预措施: Daratumumab (Drug)
结局指标
主要结局
Percentage of patients with platelet transfusion responsiveness
时间窗: 12 weeks
To evaluate the safety and efficacy of Daratumumab to increase the platelet increment, defined as Corrected Count Increment (CCI) ≥7500/μL at 60 min or CCI≥4500/μL at 24 hrs post transfusion, or platelet transfusion independence, i.e. PLT\>10×10\^9/L without any bleeding events.
次要结局
- Time to the platelet increment(12 weeks)
研究者
研究点 (1)
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