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.
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||December 2000|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
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.
|United States, Alabama|
|University of Alabama Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294|
|Study Chair:||Mansoor Noorali Saleh||University of Alabama at Birmingham|