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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
Sponsor:
Collaborator:
Etablissement Français du Sang
Information provided by:
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The goal of this study is to evaluate the clinical effectiveness of the rituximab at the adults with a chronic immune thrombocytopenic purpura (>=6 months of evolution) and severe (platelets <= 30x109/L) and candidate to a splenectomy. The objective is to obtain after a treatment by the rituximab a satisfactory response to one year, defined by a number of platelets higher than 50x109/L and at least 2 times superior with the persistent initial figure without treatment during one year after the end of the treatment.

Condition or disease Intervention/treatment Phase
Autoimmune Thrombocytopenic Purpura Drug: Mabthéra Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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





Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.
  2. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Platelets <= 30x109/L in the absence of agglutinat
  • Evolution of the PTAI >= 6 months starting from the date of the diagnosis
  • Myélogramme normal and rich in mégacaryocytes
  • Age >=18 years
  • Among patients at which the treatments prescribed before (and in particular corticoids or intravenous immunoglobulins) did not have any effectiveness, even transitory, the diagnosis of ITP will have to be confirmed by an isotopic study of the 1/2 life of the plates.

Exclusion Criteria:

  • Refusal of informed and enlightened assent written.
  • Intermittent ITP defined by which has occurred of transitory periods of remissions variable length of the thrombocytopenia.
  • Sick splenectomized whatever is the reason
  • Splénomégalie
  • Absence of vaccination against the pneumococcus
  • Absence of vaccination against Haemophilus influenzae
  • Previous of treatment by the rituximab
  • Administration of a treatment known as active during the ITP other than corticoids in the 30 days which precede inclusion
  • CIVD and/or weakens haemolytic with schizocytes
  • Serology VIH or positive VHC, Ag positive HBs
  • Rate of ALAT or ASAT higher than twice the higher limit of the normal of the laboratory
  • Associated autoimmune anomalies:

    • Anti DNA and/or anti ECT (ENA) and/or anti Ro (SSA)
    • The presence isolated from antibody anti cores (nuclear anti factors) is not a criterion of exclusion.
    • Anticoagulant circulating of lupic type and/or antibody anticardiolipines with antecedent of thrombosis or spontaneous miscarriages with repetition (their isolated presence is not a criterion of exclusion)
    • Other autoimmune diseases: lupus (with at least 4 criteria of the ACR), polyarthrite chronic evolutionary, disease of Biermer, affected thyroid, weakens haemolytic autoimmune.
  • Pregnant woman, breast feeding, woman in genital working life in the effective absence of contraception throughout treatment and 12 month after stop of the treatment.
  • Evolutionary or previous cancer of malignant hemopathy
  • Over-sensitiveness with murine proteins

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225875


Locations
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France
Hôpital Henri Mondor
Créteil, France, 94000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Etablissement Français du Sang
Investigators
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Principal Investigator: Bertrand Godeau, Professor Hôpital Henri Mondor
Principal Investigator: Philippe Bierling, Professor EFS

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00225875    
Other Study ID Numbers: PTAI
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: October 27, 2005
Last Verified: March 2005
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Autoimmune thrombocytopenic purpura
Rituximab
Additional relevant MeSH terms:
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Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents