2 Cycles Rituximab Compared With Standard Regimen in Management of ITP
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Duration Response
研究概览
简要总结
The project was undertaking by Qilu Hospital, Shandong University and other several well-known hospitals in China. In order to report the efficacy and safety of Rituximab in different frequencies for the treatment of adults with steroid-resistant/relapsed immune thrombocytopenia (ITP).
详细描述
The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 60 refractory ITP adult patients from medical centers in China. One part of the participants are randomly selected to receive rituximab (given intravenously at a dose of 375mg/m(2) weekly for 2 weeks, i.e. Day 1, 8; the others are selected to receive standard rituximab treatment (given intravenously at a dose of 375 mg/m(2) weekly for 4 cycles, i.e. Day 1, 8, 15, 22). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of the combination therapy compared to conventional rituximab therapy for the treatment of adults with steroid-resistant/relapsed immune thrombocytopenia (ITP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for immune thrombocytopenia.
- •Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years.
- •To show a platelet count <30×10^9/L, and with bleeding manifestations.
- •Willing and able to sign written informed consent.
排除标准
- •Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- •Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
- •Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
- •Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- •Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- •Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- •Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
- •Patients who are deemed unsuitable for the study by the investigator.
研究组 & 干预措施
2 cycles
2 cycles RTX
干预措施: Rituximab (Drug)
standard 4 cycles
standard 4 cycles RTX
干预措施: Rituximab (Drug)
结局指标
主要结局
Duration Response
时间窗: 12 months
response rate (CR+R) at the 12st month from the initial injection of RTX. CR is defined as platelet count ≥ 100×10\^9/L, and R is defined as platelet count of \>30 × 10\^9/L with a least a doubling of the baseline value.
Early Response
时间窗: 3 months
response rate (CR+R) at the 3rd month from the initial injection of RTX. CR is defined as platelet count ≥ 100×10\^9/L, and R is defined as platelet count of \>30 × 10\^9/L with a least a doubling of the baseline value.
次要结局
- Safety(1 months)
研究者
Ming Hou
Professor and Director
Shandong University