An Open-label Phase II Study to Determine the Efficacy and Safety of Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A
试验速览
- 阶段
- 2 期
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The time to attain first complete remission (CR)
研究概览
简要总结
The purpose of this prospective study is to determine the efficacy and safety of Rituximab plus Bortezomib in patients with newly diagnosed acquired hemophilia A.
详细描述
This is a prospective, single-arm, open-label clinical trial to evaluate the efficacy and safety the regimen of Bortezomib with rituximab as first-line treatment to eradicate anti-factor VIII antibodies in newly diagnosed acquired hemophilia A.
All of enrolled patients in this study will be injected Bortezomib plus rituximab. This study will be performed for about 2 years and approximately 22 patients will be enrolled in our insititution.
After obtaining the written informed consent from the patients, the information of demographic and medical history will be collected and laboratory tests will be performed.
Patients who meet the inclusion/exclusion criteria will be received the regimens: Bortezomib (1.3mg/m2 d1,4,8,11) with rituximab (375mg/m2 for one dose). The information of adverse events will be collected. In case that the evaluation of treatment response might be performed in regular clinical practice, those data will also be collected as well.
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
- •Must be ≥ 18 years;
- •Understand and voluntarily sign an ICD prior to any study related assessments/procedures are conducted;
- •Diagnosis of acquired hemophilia A；
- •acute bleeding episodes(≥once).
排除标准
- •Uncontrolled systemic infection;
- •Allergy to rituximab;
- •Positive for Lupus anticoagulant;
- •Life expectancy < 3 months;
- •Pregnant and breastfeeding women;
- •Neuropathy>Grade 1;
- •Positive for Hepatitis B surface antigen or hepatitis C antibody or human immunodeficiency virus（HIV）antibody;
- •Patients with poor compliance；
- •Patient who is considered by the investigator not suitable for clinical study.
研究组 & 干预措施
Bortezomib +Rituximab
Bortezomib +Rituximab
干预措施: Rituximab (Drug)
Bortezomib +Rituximab
Bortezomib +Rituximab
干预措施: Bortezomib (Drug)
结局指标
主要结局
The time to attain first complete remission (CR)
时间窗: Last day of the treatment regimen (up to 3 months)
Complete remission defined as titer FVIII inhibitor lower than 0.6 Bethesda unit, factor VIII level\> 50% and no bleeding events without bypass treatments for 24 hours
次要结局
- Adverse events(During 24 month)
- The time to durable treatment response(During 24 month)
- Overall survival(During 24 month)
研究者
Tienan Zhu
Associate chief physician
Peking Union Medical College Hospital