Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura
NCT ID: NCT00005652
Last Updated: 2008-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2000-12-31
Brief Summary
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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.
Detailed Description
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Patients are followed at 5, 6, 8, and 12 weeks, and then at 6 and 9 months.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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rituximab
Eligibility Criteria
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Inclusion 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
18 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Principal Investigators
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Mansoor Noorali Saleh
Role: STUDY_CHAIR
University of Alabama at Birmingham
Locations
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
Countries
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Other Identifiers
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UAB-9866
Identifier Type: -
Identifier Source: secondary_id
UAB-BB-IND-8136
Identifier Type: -
Identifier Source: secondary_id
UAB-F990224001
Identifier Type: -
Identifier Source: secondary_id
199/15038
Identifier Type: -
Identifier Source: org_study_id