Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura

NCT00005652 | Completed Phase 2

• 4 other identifiers: 199/15038UAB-9866UAB-BB-IND-8136UAB-F990224001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Purpura, Thrombocytopenic, Idiopathic

Keywords

hematologic disorders; immune thrombocytopenic purpura; rare disease

Interventions

rituximab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Hematologic Diseases; Rare Diseases

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Mansoor Noorali Saleh

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: May 3, 2000
• Study Start: December 1, 2000
• Primary Completion: August 1, 2007
• Last Updated: September 9, 2008

Record last verified: 2008-09

Locations

US (1)