A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 4
- 主要终点
- overall response
研究概览
简要总结
The aim of this prospective study was to evaluate the activity, safety and the duration of the response of low dose rituximab associated with standard oral prednisone as first line therapy in newly diagnosed warm autoimmune hemolytic anemia and cold hemagglutinin disease, and as second line therapy in warm autoimmune hemolytic anemia relapsed after standard oral prednisone. Further aim was to correlate the clinical response to biological parameters (cytokine and anti-erythrocyte antibody production in cultures).
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
- •Newly diagnosed "warm" or "cold" AIHA, defined by symptomatic anemia and positive DAT, in the absence of underlying lymphoproliferative, infectious or neoplastic disease (according to the single Center diagnostic criteria).
- •Idiopathic "warm" or "cold" AIHA relapsed after first line treatment with oral prednisone.
- •Aged >18 years
- •ECOG performance status grade 0, 1 or 2
- •No psychiatric illness that precludes understanding concepts of the trial or signing informed consent
- •Patients who have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
排除标准
- •Cell or humoral immunologic deficit (congenital or acquired)
- •Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
- •Active bacterial, viral, or fungal infection requiring systemic therapy HIV or HbsAg positive (with HBV-DNA+) or HCV-Ab positive (with HCV-RNA+) patients
- •History of malignancies within 3 years prior to study entry
- •Concomitant immunosuppressive or cytotoxic treatment
- •Positive pregnancy test. Lactation.
- •The presence of associated organ-specific autoimmune diseases do not constitute exclusion criteria. Previous splenectomy does not constitute exclusion criteria
结局指标
主要结局
overall response
时间窗: month +2
Response will be evaluated at each clinic visit. Complete response (CR) will be defined as Hb increase \>2 g/dL and Hb \> 12 g/dL, normalization of all haemolytic markers and no transfusion requirement;Partial response (PR) will be defined as Hb increase \>2 g/dL and Hb 10-12 g/dL, and 50% reduction of transfusion. In the remaining cases there is no response.
次要结局
- Sustained response (SR)(month +6, month +12)