Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura
|Brief Title †||Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura|
|Official Title †|
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.
|Study Phase||Phase 2|
|Study Type †||Interventional|
|Study Design †||Primary Purpose: Treatment|
|Primary Outcome Measure †|
|Secondary Outcome Measure †|
|Study Arms / Comparison Groups|
|* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.|
|Recruitment Status †||Drug|
|Estimated Enrollment †||20|
|Start Date †||December 2000|
|Primary Completion Date||August 2007|
|Eligibility Criteria †||
PROTOCOL ENTRY CRITERIA:
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)
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
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
|Location Countries †||United States,|
|NCT ID †||NCT00005652|
|Secondary IDs ††||UAB-9866|
|Study Sponsor †||University of Alabama at Birmingham|
|Investigators †||Study Chair: Mansoor Noorali Saleh, University of Alabama at Birmingham|
|Information Provided By||Office of Rare Diseases (ORD)|
|Verification Date||September 2008|
|First Received Date †||May 2, 2000|
|Last Updated Date||September 8, 2008|
†† WHO trial registration data element that is required only if it exists.