Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura
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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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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:
- 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
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00005652 History of Changes |
| Other Study ID Numbers: | 199/15038, UAB-9866, UAB-BB-IND-8136, UAB-F990224001 |
| Study First Received: | May 2, 2000 |
| Last Updated: | September 8, 2008 |
| Health Authority: | Unspecified |
Keywords provided by Office of Rare Diseases (ORD):
|
hematologic disorders immune thrombocytopenic purpura rare disease |
Additional relevant MeSH terms:
|
Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia |
Blood Platelet Disorders Immune System Diseases Hemorrhagic Disorders Autoimmune Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013