Rituximab Plus Short-term Methylprednisolone Versus Standard Dose Methylprednisolone in Newly Diagnosed Participants With Immune Thrombocytopenia (ITP): A Multicenter, Randomized Phase II Study in China
试验速览
- 阶段
- 2 期
- 入组人数
- 112
- 主要终点
- Relapse free survival
研究概览
简要总结
a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China
详细描述
This is a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China. The investigators explore the efficacy and safety of Rituximab plus short-term methylprednisolone compare standard dose methylprednisolone in newly diagnosed ITP participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed
- •Platelet count less than 30×109/L on two occasions or Platelets above 30×109/L combined with bleeding manifestation
- •Subject is ≥ 18 years and ≤80years
- •Subject has signed and dated written informed consent.
- •Fertile patients must use effective contraception during treatment and observational period
- •Negative pregnancy test
排除标准
- •Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
- •Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or an aspartate aminotransaminase or alanine aminotransferase level > 3×upper limit of normal
- •Have a New York Heart Classification III or IV heart disease
- •Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
- •Have active hepatitis B or hepatitis C infection
- •Have a HIV infection
- •Have active infection requiring antibiotic therapy within 7 days prior to study entry
- •Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
- •Previous treatment with rituximab
- •Previous splenectomy
- •Had previous or concomitant malignant disease
- •Not willing to participate in the study.
- •Expected survival of < 2 years
- •Intolerant to murine antibodies
- •Immunosuppressive treatment within the last month
- •Connective tissue disease
- •Autoimmune hemolytic anemia
- •Patients currently involved in another clinical trial with evaluation of drug treatment
研究组 & 干预措施
Rituximab plus methylprednisolone
Combination therapy with rituximab （1000mg IV day1, week 3, week 17 , and week 19）plus short-term methylprednisolone (1mg/kg, oral or IV; reduce to 50% of base dose at week 4, then reduce 8mg every 1 week until stopped).
干预措施: Rituximab plus methylprednisolone (Drug)
Methylprednisolone
standard dose methylprednisolone alone (1mg/kg, oral or IV; begin to reduce at week 4, reduce 8mg every 2 weeks, then another 8 weeks later reduce 2-4mg every 2-4 weeks).
干预措施: methylprednisolone (Drug)
结局指标
主要结局
Relapse free survival
时间窗: From date of randomization until the date of relapse or death from any cause, whichever came first, assessed up to 1 year
Relapse was defined as a drop in platelet count to \<30 ×109/L following an initial best response (partial or complete response).
次要结局
- Cumulative complete response rate(1 year)
- Cumulative relapse rate(1 year)
- Cumulative response rate(1 year)
- adverse event/serious adverse event and cumulative rate of bleeding events(1 year)