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| Sponsored by: |
University of Alabama at Birmingham |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00005652 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Purpura, Thrombocytopenic, Idiopathic |
Drug: rituximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Estimated Enrollment: | 20 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
--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:
Contacts and Locations| United States, Alabama | |
| University of Alabama Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| Study Chair: | Mansoor Noorali Saleh | University of Alabama at Birmingham |
More Information
| Study ID Numbers: | 199/15038, UAB-9866, UAB-BB-IND-8136, UAB-F990224001 |
| Study First Received: | May 2, 2000 |
| Last Updated: | September 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005652 History of Changes |
| Health Authority: | Unspecified |
|
hematologic disorders immune thrombocytopenic purpura rare disease |
|
Purpura Autoimmune Diseases Immunologic Factors Rituximab Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Rare Diseases |
Hemostatic Disorders Purpura, Thrombocytopenic Signs and Symptoms Thrombocytopathy Thrombocytopenia Hemorrhagic Disorders Purpura, Thrombocytopenic, Idiopathic Antirheumatic Agents |
|
Purpura Skin Manifestations Autoimmune Diseases Immunologic Factors Immune System Diseases Antineoplastic Agents Hematologic Diseases Rituximab Blood Coagulation Disorders Blood Platelet Disorders |
Physiological Effects of Drugs Pharmacologic Actions Purpura, Thrombocytopenic Signs and Symptoms Thrombocytopenia Hemorrhagic Disorders Therapeutic Uses Purpura, Thrombocytopenic, Idiopathic Antirheumatic Agents |