Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura

September 8, 2008 updated by: University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Study Chair: Mansoor Noorali Saleh, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

May 2, 2000

First Posted (Estimate)

May 3, 2000

Study Record Updates

Last Update Posted (Estimate)

September 9, 2008

Last Update Submitted That Met QC Criteria

September 8, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/15038
  • UAB-9866
  • UAB-BB-IND-8136
  • UAB-F990224001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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