Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura

Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura

OBJECTIVES: I. Determine the response rate and response duration to rituximab in patients with immune thrombocytopenic purpura.

II. Evaluate the toxicity associated with this treatment regimen in these patients.

III. Evaluate the alteration in antiplatelet antibody with this treatment regimen in these patients.

PROTOCOL OUTLINE: Patients receive rituximab IV on days 1, 8, 15, and 22. Patients who achieve a clinical response lasting over 4 months may receive a second course of rituximab.

Patients are followed at 5, 6, 8, and 12 weeks, and then at 6 and 9 months.

Phase 2
Interventional
Primary Purpose: Treatment
  • Purpura, Thrombocytopenic, Idiopathic
Drugrituximab
    * Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
    Drug
    20
    December 2000
    August 2007

    PROTOCOL ENTRY CRITERIA:

    --Disease Characteristics--

    Clinically confirmed immune thrombocytopenic purpura (ITP) Platelet count less than 75,000/mm3 on two occasions at least 1 week apart within past month

    Normal to increased numbers of megakaryocytes on bone marrow examination within past 6 months

    Failed prior steroid therapy (i.e., unable to achieve sustained platelet count greater than 75,000/mm3)

    No drug associated ITP

    No B cell malignancies

    No evidence of disseminated intravascular coagulation (DIC)

    --Prior/Concurrent Therapy--

    Endocrine therapy: Concurrent steroids allowed as long as platelet count is less than 75,000/mm3 and dose is not changed within past 2 weeks or during study

    Other:

    • No other concurrent medical therapy for immune thrombocytopenia purpura (ITP)

    • At least 2 weeks since prior therapy for ITP (except steroids)

    • At least 4 weeks since prior cyclosporine

      --Patient Characteristics--

      Performance status: ECOG 0-2

      Life expectancy: At least 6 months

      Renal: Creatinine no greater than 2.0 mg/dL

      Cardiovascular: No congestive heart failure or symptomatic coronary insufficiency

      Other:

    • No clinically significant bleeding (i.e., other than mild mucosal bleeding or petechiae)

    • No sepsis or fever

    • No active infection requiring therapy

    • No active chronic viral infection

    • HIV negative

    • No other concurrent or prior malignancy within past 5 years except squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    Both
    18 Years - N/A
    No
    • , ,
    • , ,
    United States,
    NCT00005652
    199/15038
    UAB-9866
    ,
    University of Alabama at Birmingham
      Study Chair: Mansoor Noorali Saleh, University of Alabama at Birmingham
      Office of Rare Diseases (ORD)
      September 2008
      May 2, 2000
      September 8, 2008
      Required WHO trial registration data element.
      †† WHO trial registration data element that is required only if it exists.