A Randomised Phase III Study of the Efficacy of High Dose Dexamethasone Versus High Dose Dexamethasone in Combination With Rituximab (MabThera®)in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 10
- 主要终点
- Number of patients with sustained partial response after 6 months
研究概览
简要总结
In this study we want to investigate if combination therapy with rituximab (R) + dexamethasone (DXM) is superior to monotherapy with DXM in patients with newly diagnosed idiopathic thrombocytopenic purpura (ITP). Before treatment molecular studies - gene expression profiling - are performed to characterize at the molecular level those patients responding adequately to the treatment as compared to those obtaining a minor or no responses.
The hypothesis is that combination therapy is superior to monotherapy as defined above. Using gene expression studies up-front the hypothesis is that this method may be able to predict the response to treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or over
- •Diagnosis = ITP + platelet count above or equal to 25 Mia/l or platelet count above or equal to 50 Mia/l and bleeding from the mucous membranes.
- •Adequate contraceptive measures within the last 3 months for women of childbearing potential.
排除标准
- •Performance status above or equal to 2
- •Previous treatment with rituximab
- •Immunosuppressive treatment within the last month except for not previously treated patients
- •Other serious disease
- •Pregnant women and nursing mothers
- •Contraindication for rituximab treatment.
- •Active infection requiring antibiotic treatment.
研究组 & 干预措施
1
Combination therapy with Dexamethasone and Rituximab
干预措施: Dexamethasone and Rituximab (Drug)
2
Dexamethasone as monotherapy
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of patients with sustained partial response after 6 months
时间窗: 6 months
次要结局
- Remission rates in the 2 arms at day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5(day 7, 10, 14,21, 28, month 2 - 12, year 2 - 5)
研究者
Forskningsenheden
Forskningsenhed
Copenhagen University Hospital at Herlev