NCT04398459招募中2 期
A Phase II, Multicenter, Open-label Trial to Determine the Safety and Efficacy of Ibrutinib in Refractory/Relapsed Autoimmune Hemolytic
Institute of Hematology & Blood Diseases Hospital, China3 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Overall response rate
研究概览
简要总结
This is an open-label, single-arm study to evaluate the safety and efficacy of Ibrutinib in subjects with refractory/relapsed autoimmune hemolytic anemia.
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
- 6 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 6 to
- •Diagnosed with WAIHA or MAIHA.
- •Meets the criteria of relapsed / refractory AIHA.
- •Meets the criteria of DAT-negative AIHA without any other inherited or acquired hemolytic diseases, and previously treated effectively with glucocorticoids and rituximab.
- •Signed informed consent.
- •Organs in good function.
排除标准
- •Nursing woman
- •Active bacterial, virus, fungal or parasitic infection, including HIV infection, HbsAg and HBV DNA positive, HCV DNA positive, etc.
- •Diagnosed with cold agglutinin disease or cold agglutinin syndrome or paroxysmal cold hemoglobinuria.
- •Secondary AIHA caused by drugs or infection.
- •Received rituximab in 8 weeks before enrollment.
- •Previously received treatment with BTK inhibitor.
- •Previously received organ or stem cell transplantation.
- •Have a history of thrombosis or organ infarction.
- •Diagnosed with an active stage of connective tissue disease.
- •Have a history of lymphoproliferative tumors or any other malignant tumors.
- •Have other inherited or acquired hemolytic diseases.
- •Received low-molecular-weight heparin or warfarin within 1 week before enrollment or during the Ibrutinib treatment.
- •Received CYP3A4 Enzyme Inhibitors or Inducers within 1 week before enrollment or during the Ibrutinib treatment.
- •Have a history of mental illness.
- •Inability to understand or to follow study procedures.
研究组 & 干预措施
iBRIAN
Experimental
干预措施: Ibrutinib (Drug)
结局指标
主要结局
Overall response rate
时间窗: within 12 weeks
次要结局
- Incidence of adverse events and severe adverse events(within 48 weeks)
- Relapse free survival rate(within 48 weeks)
研究者
Jun Shi
Director, Regenerative Medicine Clinic Center
Institute of Hematology & Blood Diseases Hospital, China
研究点 (3)
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