Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Completed

CT.gov ID

NCT00005652

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

OBJECTIVES: I. Determine the response rate and response duration to rituximab in patients with immune thrombocytopenic purpura.

Evaluate the toxicity associated with this treatment regimen in these patients.
Evaluate the alteration in antiplatelet antibody with this treatment regimen in these patients.

Condition or Disease	Intervention/Treatment	Phase
Purpura, Thrombocytopenic, Idiopathic	Drug: rituximab	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Study Start Date :

Dec 1, 2000

Actual Primary Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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