NCT04423367已完成2 期
Safety and Efficacy of Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment: A Prospective Phase II Trial
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9月13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
- 已完成
- 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 bortezomib plus dexamethasone for acquired pure red cell aplasia failure or relapse after first-line treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to
- •Diagnosed with acquired pure red cell aplasia.
- •Meets the criteria of first-line treatment failure or relapse.
- •Organs in good function.
- •Signed informed consent.
排除标准
- •Nursing woman.
- •Active bacterial, virus, fungal or parasitic infection, including HIV infection, HBsAg or HBV DNA positive, HCV DNA positive, etc.
- •Secondary PRCA caused by lymphoproliferative disorders, including large granular lymphocytic leukemia, waldenström macroglobulinemia, small lymphocytic lymphoma/chronic lymphocytic leukemia, etc.
- •Secondary PRCA caused by either smoldering multiple myeloma or symptomatic multiple myeloma.
- •Secondary PRCA caused by either ABO major mismatched stem cell transplantation or organ transplantation.
- •Secondary PRCA caused by solid tumors except for thymoma.
- •Secondary PRCA caused by drugs or pregnancy.
- •Secondary PRCA caused by the B19 virus.
- •Have contraindications for glucocorticoids, or unable to tolerate glucocorticoids for comorbidities.
- •Previously received treatment in other trials within 4 weeks before enrollment.
- •Previously treated with the proteasome inhibitor.
- •Experience active hemorrhage condition, including gastrointestinal bleeding, respiratory tract bleeding and central nervous system bleeding within 2 months before enrollment or during bortezomib/dexamethasone treatment.
- •Have a history of malignant tumors.
- •Have a history of mental illness.
- •Inability to understand or to follow study procedures.
研究组 & 干预措施
bortezomib/dexamethasone
Experimental
Enrolled patients will receive the combination therapy of bortezomib and dexamethasone.
干预措施: bortezomib/dexamethasone (Drug)
结局指标
主要结局
Overall response rate
时间窗: within 12 weeks
次要结局
- Frequency and severity of adverse events and severe adverse events(within 12 weeks)
- Relapse free survival(within 24 and 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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