Association of Rituximab to Plasma Exchange in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in patients treated with rituximab in association with plasma exchanges
研究概览
简要总结
Multicentric non-randomized phase II opened prospective study (10 centres involved).
Primary endpoint:
- To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in patients treated with rituximab in association with plasma exchanges.
Secondary endpoints:
- To evaluate the tolerance of rituximab, the volume of plasma and the number of plasma exchange sessions required to achieve a durable complete remission, and to determinate the duration of B-cell depletion.
- To evaluate the incidence of persistent severe acquired ADAMTS13 deficiency following treatment with rituximab, as well as the incidence of relapses.
详细描述
Duration of the study:
3 years and 2 months, including 1 year of inclusion and 2 years of participation for the patient.
Experimental plan:
Patients fulfilling the inclusion criteria of the study will be treated according to the recommendations of the Reference Centre for the management of thrombotic microangiopathies. If patients present refractory TTP, infusions of rituximab (375 mg/m2) will be added to this treatment at day 1, 4 and 15, immediately after plasma exchange sessions.On diagnosis, during treatment and after remission achievement, the following values will be explored: ADAMTS13 activity, ADAMTS13 inhibitors and anti-ADAMTS13 antibodies, B-cell lymphocytes quantification by immunophenotyping, and serum gammaglobulin level by serum protein electrophoresis. Rituximab will also be quantified.
Number of patients:
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
- •Microangiopathic hemolytic anemia (< 12 g/dL) with thrombocytopenia <50 G/L, and mild or no renal failure (Serum creatinine < 150 µmol/L),
- •negative Beta HCG and ongoing contraception during treatment and during the 24 months following the last infusion of rituximab,
- •refractory TTP (after 4 days of standard treatment)
- •> 18 year old
- •and signed written informed consent.
排除标准
- •Hemolytic uremic syndrome (platelet count ³ 50 G/L and serum creatinine ³ 150 micromol/L),
- •TTP associated with another condition (HIV infection, cancer and/or chemotherapy, transplantation),
- •previous treatment with vincristine or cyclophosphamide or other immunomodulatory drugs (except steroids), within 2 months before inclusion ;
- •ongoing or planned pregnancy, lactation
研究组 & 干预措施
1
Microangiopathic hemolytic anemia (< 12 g/dL) with thrombocytopenia (<50 G/L)
干预措施: rituximab (Drug)
结局指标
主要结局
To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in patients treated with rituximab in association with plasma exchanges
时间窗: at 1, 3, 6, 9, 12, 18 and 24 months
次要结局
- To evaluate the tolerance of rituximab, the volume of plasma and the number of plasma exchange sessions required to achieve a durable complete remission, and to determinate the duration of B-cell depletion(at 1, 3, 6, 9, 12, 18 and 24 months)
- To evaluate the incidence of persistent severe acquired ADAMTS13 deficiency following treatment with rituximab, as well as the incidence of relapses.(at 1, 3, 6, 9, 12, 18 and 24 months)