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The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia. (ITP-RITUX)

2012年3月20日更新者：Khellaf Mehdi、Henri Mondor University Hospital

The ITP-RITUX Cohort: An Observational Study on Rituximab Off-label Use for Immune ThrombocytoPenia.

The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for Immune Thrombocytopenia.

研究概览

地位

未知

条件

详细说明

Rituximab (RTX) is used in the treatment of malignant non-Hodgkin's indication for which it has been authorized since 1997 and why it is considered effective and well tolerated. Rituximab is also effective and well tolerated in combination with methotrexate in severe rheumatoid arthritis (RA) refractory to anti-TNF. To date, the RA is the only autoimmune disease in which rituximab has proven efficacy in randomized trials and has obtained authorization in this indication. There are also data from the literature, for the benefit of rituximab in other autoimmune diseases like Lupus, cryoglobulinemia associated to Hepatitis C or Sjogren's disease.

Immune Thrombocytopenia (ITP) is an autoimmune disease in which there is thrombocytopenia due in part to destruction of platelets by autoantibodies. In adults, the disease is most often chronic and in the most severe forms, the treatment of choice is splenectomy. Rituximab was suggested during chronic ITP when used with 4 weekly infusions of 375 mg/m2, 60% of patients achieve an immediate response and 30 to 40% a prolonged response. These encouraging results and the apparent good tolerance advocate for using rituximab as first-line treatment for patients refractory to splenectomy. In France, Afssaps - French Health Products Safety Agency has recently issued a temporary protocol processing to authorize rituximab in this indication. Nevertheless, many questions remain unresolved, including the tolerance of long-term treatment and the risk of late relapse in responders. This justifies the creation of this register, whose establishment is recommended by Afssaps - French Health Products Safety Agency.

研究类型

观察性的

注册 (预期的)

250

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

法国
- Val de Marne
  - Creteil、Val de Marne、法国、94010
    - 招聘中
    - Henri Mondor University Hospital
    - 接触：
      
      Mehdi KHELLAF, MD
      
      电话号码：0033149812076
      
      邮箱：mehdi.khellaf@hmn.aphp.fr
    - 副研究员：
      
      Mehdi KHELLAF, MD
  - Creteil、Val de Marne、法国、94010
    - 招聘中
    - National Reference Center for the Study of Auto Immune Cytopenia
    - 接触：
      
      Mehdi KHELLAF, MD
      
      电话号码：0033149812076
      
      邮箱：mehdi.khellaf@hmn.aphp.fr

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Immune ThrombocytoPenia (ITP) patients according to the American Society of Hematology (ASH).

描述

Inclusion Criteria:

ITP diagnosis according to the American Society of Hematology society
Secondary ITP if the underlying disease is an autoimmune disease(Lupus,Sjogren..)

Exclusion Criteria:

Previous treatment by rituximab
Secondary ITP associated to a hematologic disease (Chronic Lymphocytic Leukemia, Hodgkin Disease...)
Secondary ITP associated to a chronic infectious disease (Hepatitis B, C, HIV)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Occurrence of a serious adverse events (clinical or biological events) 大体时间：5 years	reaction during perfusions, hypogammaglobulinemia, neutropenia,etc...	5 years

次要结果测量

结果测量	措施说明	大体时间
Impact of rituximab on the natural history of ITP 大体时间：5 years	Number of patients in complete response (platelet count>100G/L), in partial response (platelet count>50G/L and at least doubling the baseline platelet count)or in failure. Rate of diminution for the concomittant therapies for ITP. Use of emergencies treatment for ITP.	5 years
Modality of the administration of rituximab 大体时间：5 years	number of perfusions, dosage, retreatment.	5 years
Characteristics of the patients receiving Rituximab 大体时间：5 years	age, sex, duration of ITP, previous used treatment	5 years
Evaluation of the Platelet count evolution 大体时间：5 years	Platelet count estimated at Month 1, 3 and then every 6 months during the 5 years of follow-up.	5 years
Rate of splenectomy in the cohort 大体时间：5 years		5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Henri Mondor University Hospital

合作者

Roche Pharma AG

调查人员

首席研究员：Bertrand GODEAU, MD、National Reference Center for Study of Cytopenia

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Khellaf M, Charles-Nelson A, Fain O, Terriou L, Viallard JF, Cheze S, Graveleau J, Slama B, Audia S, Ebbo M, Le Guenno G, Cliquennois M, Salles G, Bonmati C, Teillet F, Galicier L, Hot A, Lambotte O, Lefrere F, Sacko S, Kengue DK, Bierling P, Roudot-Thoraval F, Michel M, Godeau B. Safety and efficacy of rituximab in adult immune thrombocytopenia: results from a prospective registry including 248 patients. Blood. 2014 Nov 20;124(22):3228-36. doi: 10.1182/blood-2014-06-582346. Epub 2014 Oct 7.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年4月1日

初级完成 (预期的)

2012年4月1日

研究完成 (预期的)

2017年4月1日

研究注册日期

首次提交

2010年4月5日

首先提交符合 QC 标准的

2010年4月8日

首次发布 (估计)

2010年4月9日

研究记录更新

最后更新发布 (估计)

2012年3月21日

上次提交的符合 QC 标准的更新

2012年3月20日

最后验证

2012年3月1日