ISRCTN16619820已完成不适用
Anti-CD20 treatment of relapsed or refractory immune thrombocytopaenic purpura (ITP) after first line corticosteroid treatment
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands) - Data Centre0 个研究点目标入组 150 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age minimal 18 years
- •2. Subjects with relapsed or refractory ITP (fulfilling the diagnostic criteria given in appendix A) and platelet numbers less than 30 x 10^9/l
- •3. Having completed first line treatment with corticosteroids
- •4. Written informed consent
- •5. World Health Organization (WHO) performance status less than or equal to 2
排除标准
- •1. The presence of an accessory spleen in splenectomized patients
- •2. Use of anticoagulants or chemotherapy or known other disorders and/or treatments influencing the platelet number within 3 months of randomisation date (tranexaminic acid [Cyklokapron®] treatment is allowed)
- •3. Pulsed or high dose corticosteroids, IVIG or splenectomy within 3 weeks prior to randomisation. Maintenance corticosteroid therapy is allowed.
- •4. Prior therapy with rituximab
- •5. ITP treatments (other than corticosteroids, IVIG or splenectomy) within 3 months prior to randomisation (e.g. cyclosporin, vincristine). Stable treatment with non-immunosuppressive medication (i.e. danazol, dapson, vitamin C) is permitted.
- •6. Inadequate renal and liver function, i.e. creatinine or bilirubin greater than 25 x the upper normal value
- •7. Neutrophil count less than 15 x 10^9/l and haemoglobin level less than 62 mmol/l
- •8. Active bleeding (defined by grade 3 or 4 according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v3.0)
- •9. Pregnant or lactating
- •10. Systemic infections: active viral infections, including human immunodeficiency virus (HIV)
- •11. Seriously immunocompromised patients
- •12. Systemic autoimmune disorders (e.g. systemic lupus erythematosus [SLE])
- •13. Current malignant disease
- •14. Any experimental therapy within 30 days prior to randomisation
研究者
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