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Home > "P" Clinical Trials Conditions > Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura  Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura
Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura
For Condition: Purpura, Thrombocytopenic, Idiopathic
Status: No longer recruiting
Sponsor(s): UAB Comprehensive Cancer Center ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
MansoorSaleh, Study Chair, UAB Comprehensive Cancer Center
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
Additional Information:
Study ID Numbers: 199/15038; UAB-BB-IND-8136,UAB-9866,UAB-F990224001
Study Start Date: December 2000
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005652
Other Purpura, Thrombocytopenic, Idiopathic Studies:
1. Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura
2. An Epidemiological Study of Subjects with Immune Thrombocytopenic Purpura to Evaluate the Relationship Between Platelet Counts, Endogenous Thrombopoietin Levels, Endogenous Anti-Thrombopoietin Antibodies, and Selected Autoimmune Markers
Related Studies:
Other Purpura, Thrombocytopenic, Idiopathic Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura
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