Iguratimod Plus Low-dose Rituximab vs Low-dose Rituximab in Corticosteroid-resistant or Relapsed ITP
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- overall response
研究概览
简要总结
Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and Iguratimod in patients with steroid-resistant/relapsed ITP.
详细描述
Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of steroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. Rituximab has been shown to partly improve the complete remission rate of ITP. The small molecule compound iguratimod is widely used as a novel antirheumatic drug to treat several autoimmune diseases. According to studies involving ITP mice, iguratimod may represent a new approach for the prevention and treatment of anti-platelet antibody-mediated ITP by modulating T-cell differentiation.
A multicentre prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were randomized to the low-dose rituximab+iguratimod and the low-dose rituximab monotherapy groups. Platelet count, bleeding and other symptoms were evaluated before and after treatment.Adverse events are also recorded throughout the study, in order to assess the efficacy and safety of the combination of low-dose rituximab and iguratimod in patients with steroid-resistant/relapsed 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
- Single (Outcomes Assessor)
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
- •ITP confirmed by excluding other supervened causes of thrombocytopenia;
- •Platelet count of less than 30×10^9/L at enrollment;
- •Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
排除标准
- •Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus);
- •Congestive heart failure;
- •Severe arrhythmia;
- •Nursing or pregnant women;
- •Aspartate aminotransferase and alanine transaminase levels ≥ 3×the upper limit of the normal threshold criteria;
- •Creatinine or serum bilirubin levels each 1•5 times or more than the normal range;
- •Active or previous malignancy;
- •Patients with other diseases were undergoing treatment with immunosuppressants;
- •Patients with ITP had received rituximab;
研究组 & 干预措施
Iguratimod plus low-dose rituximab
Low-dose rituximab was used in combination with Iguratimod
干预措施: Iguratimod (Drug)
Iguratimod plus low-dose rituximab
Low-dose rituximab was used in combination with Iguratimod
干预措施: low-dose rituximab (Drug)
Low-dose rituximab
Low-dose rituximab alone
干预措施: low-dose rituximab (Drug)
结局指标
主要结局
overall response
时间窗: From the start of study treatment (Day 1) up to the end of Year 1
The number of participants (responders) with platelet count \>=30x10\^9/L and at least a 2-fold increase in the baseline count (PR) or a platelet count \>=100x10\^9/L (CR) and the absence of bleeding, without rescue medication at 1-year follow-up.
次要结局
- sustained response(From the start of study treatment (Day 1) up to the end of Year 1)
- complete response(From the start of study treatment (Day 1) up to the end of Year 1)
- time to response(From the start of study treatment (Day 1) up to the end of Year 1)
- duration of response(From the start of study treatment (Day 1) up to the end of Year 1)
- incidence of adverse events(All patients were assessed for adverse events every week during the first 4 weeks of treatment, and at 2-weeks interval for the following 5 months, and monthly thereafter. Adverse events were scaled according to CTCAE 5.0)
- Bleeding events(From the start of study treatment (Day 1) up to the end of Year 1)
- Health-related quality of life (HRQoL)(From the start of study treatment (Day 1) up to the end of Year 1)
研究者
Xiao Hui Zhang
Vice president of Peking Univeristy Institute of Hematology
Peking University People's Hospital