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The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia.

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Henri Mondor University Hospital
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Khellaf Mehdi, Henri Mondor University Hospital
ClinicalTrials.gov Identifier:
NCT01101295
First received: April 5, 2010
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

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.


Condition
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Thrombocytopenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The ITP-RITUX Cohort: An Observational Study on Rituximab Off-label Use for Immune ThrombocytoPenia.

Resource links provided by NLM:


Further study details as provided by Henri Mondor University Hospital:

Primary Outcome Measures:
  • Occurrence of a serious adverse events (clinical or biological events) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    reaction during perfusions, hypogammaglobulinemia, neutropenia,etc...


Secondary Outcome Measures:
  • Impact of rituximab on the natural history of ITP [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    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.


  • Modality of the administration of rituximab [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    number of perfusions, dosage, retreatment.

  • Characteristics of the patients receiving Rituximab [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    age, sex, duration of ITP, previous used treatment

  • Evaluation of the Platelet count evolution [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Platelet count estimated at Month 1, 3 and then every 6 months during the 5 years of follow-up.

  • Rate of splenectomy in the cohort [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: April 2010
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101295

Contacts
Contact: Bertrand GODEAU, MD 0033149812900 bertrand.godeau@hmn.aphp.fr
Contact: Mehdi KHELLAF, MD 0033149812076 mehdi.khellaf@hmn.aphp.fr

Locations
France
Henri Mondor University Hospital Recruiting
Creteil, Val de Marne, France, 94010
Contact: Mehdi KHELLAF, MD    0033149812076    mehdi.khellaf@hmn.aphp.fr   
Sub-Investigator: Mehdi KHELLAF, MD         
National Reference Center for the Study of Auto Immune Cytopenia Recruiting
Creteil, Val de Marne, France, 94010
Contact: Mehdi KHELLAF, MD    0033149812076    mehdi.khellaf@hmn.aphp.fr   
Sponsors and Collaborators
Henri Mondor University Hospital
Roche Pharma AG
Investigators
Principal Investigator: Bertrand GODEAU, MD National Reference Center for Study of Cytopenia
  More Information

No publications provided

Responsible Party: Khellaf Mehdi, Medical Doctor, Henri Mondor University Hospital
ClinicalTrials.gov Identifier: NCT01101295     History of Changes
Other Study ID Numbers: GECAI
Study First Received: April 5, 2010
Last Updated: March 20, 2012
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Henri Mondor University Hospital:
Immune Thrombocytopenia
Rituximab
side effects
tolerance
safety
splenectomy
serum sickness

Additional relevant MeSH terms:
Thrombocytopenia
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Immune System Diseases
Pathologic Processes
Purpura
Signs and Symptoms
Skin Manifestations
Thrombotic Microangiopathies
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014