Study of the Effectiveness of Rituximab in Adults With Chronic and Severe Immune Thrombocytopenic Purpura and Candidate for a Splenectomy
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|ClinicalTrials.gov Identifier: NCT00225875|
Recruitment Status : Terminated
First Posted : September 26, 2005
Last Update Posted : October 27, 2005
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Thrombocytopenic Purpura||Drug: Mabthéra||Phase 2|
Adults immune thrombocytopenic purpura has an evolution which is generally chronic defined by the persistence of the thrombocytopenia 6 months after the diagnosis. The treatment is then based on the splenectomy which is proposed by the majority of the teams when the platelets are lower than 30x109/L. The splenectomy is effective at 70 to 80 % of the patients whereas no medicamentous treatment makes it possible to obtain a comparable result. Nevertheless, it exposes to immediate post-operative complications and to a risk of mortal fulminant infections by encapsulated germs, in particular the pneumococcus. However, its long-term effectiveness is discussed with a risk of relapse which would reach 50 % for certain teams.
The rituximab could be an alternative to the splenectomy because of its great frequency of effectiveness and its good tolerance in the short and medium term. None the medicamentous treatments usually suggested in alternative to the splenectomy (disulone, danazol, immunosuppressors) indeed makes it possible to obtain an answer prolonged after the stop of therapeutic in a significant number of cases. Moreover, the use of the immunosuppressors such as the cyclophosphamide, the azathioprine or the ciclosporine appears contestable at this stage of the disease because of potential severity their side effects.The primary endpoint is satisfactory response to one year, defined by a figure of plates >=50x109/L and at least 2 times superior in the initial, and persistent figure without treatment during one year after the stop of the treatment by rituximab. Secondary objectives are incomplete response to one year, defined by a figure of platelets >= 30x109/L and < 50x109/L and at least twice the figure initial or > 50x109/L but lower than twice the persistent initial figure without treatment during one year after the end of the treatment by rituximab. Splenectomy at one year satisfactory Response to 2 years incomplete Response to 2 years Splenectomies at 2 years Tolerance of the treatment.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation De l'Efficacité Du Rituximab (Mabthéra) Chez l'Adulte Atteint d'Un Purpura thrombopénique Auto-Immun Chronique Et sévère Et Candidat à La splénectomie|
|Study Start Date :||September 2003|
|Study Completion Date :||July 2007|
- Satisfactory response to one year, platelets >=50x109/L and at least 2 times superior in the initial, and persistent figure without treatment during one year after the stop of the treatment.
- Incomplete response to one year,platelets >= 30x109/L and < 50x109/L and at least twice the figure initial or > 50x109/L but lower than twice the persistent initial figure without treatment during one year after the end of the treatment.
- Splenectomy at one year satisfactory Response to 2 years Incomplete Response to 2 years Splenectomy at 2 years Tolerance of the treatment.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225875
|Hôpital Henri Mondor|
|Créteil, France, 94000|
|Principal Investigator:||Bertrand Godeau, Professor||Henri Mondor University Hospital|
|Principal Investigator:||Philippe Bierling, Professor||EFS|