NCT06021977招募中2 期
A Phase II, Single Center, Open-label Trial to Determine the Safety and Efficacy of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2023年9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
- 33
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
The sample size of this study is calculated based on Simon's two-stage design. The first stage of the study enrolled a cohort of 12 patients. If after 12 weeks at least 6 patients achieved a response, then enrollment was expanded to a total of 26 patients. The null hypothesis was unaccepted if more than 14 of 26 patients achieved the response. Accounting for a 20% dropout rate, the estimated final sample size was 33 patients.
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 70
- •Diagnosis of Coombs-negative AIHA
- •Diagnosis of warm AIHA, mixed AIHA or Evans syndrome.
- •Meets the criteria of relapsed / refractory AIHA
- •Willing and able to comply with the requirements for this study and written informed consent.
排除标准
- •Diagnosis of any of the following diseases: Cold agglutinin disease, cold agglutinin syndrome, mixed AIHA, paroxysmal cold hemoglobinuria (PCH).
- •Diagnosis of active stage of connective tissue disease.
- •History of lymphoproliferative tumors or any other malignant.
- •Diagnosis of other inherited or acquired hemolytic diseases.
- •Secondary AIHA caused by drugs or infection.
- •Previously received organ or stem cell transplantation.
- •History of thrombosis or organ infarction.
- •Received rituximab within 8 weeks before enrollment.
- •Previously treated with BTK inhibitor ≥ 2 weeks.
- •Received low-molecular-weight heparin or warfarin within 1 week before enrollment and need to continue the drug treatment.
- •Received CYP3A4 Enzyme Inhibitors or Inducers within 1 week before enrollment and need to continue the drug treatment.
- •Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment), known human immunodeficiency virus (HIV), known evidence of active infectious hepatitis B, and/or known evidence of active hepatitis C.
- •Any severe and/or uncontrolled medical conditions: refractory hypertension, clinically significant cardiac diseases, renal diseases, liver diseases and metabolic diseases, etc.
- •History of mental illness.
- •Participation in another clinical trial within 4 weeks before the start of this trial.
- •Pregnant or breast-feeding patients.
- •Patients considered ineligible for the study by the investigator for reasons other than the above.
研究组 & 干预措施
Zanubrutinib
Experimental
Each recruited subject will accept Zanubrutinib treatment.
干预措施: Zanubrutinib (Drug)
结局指标
主要结局
Overall response rate
时间窗: within 12 weeks
The percentage of patients achieved complete response, complete response with incomplete hemolysis recovery, and partial response.
次要结局
- Incidence of adverse events and severe adverse events(within 24 weeks)
- Relapse free survival rate(within 48 weeks)
研究者
Fang Liwei
Principal Investigator of Regenerative Medical Center
Institute of Hematology & Blood Diseases Hospital, China
研究点 (1)
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