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Phase 2
18 Years
N/A
Not Enrolling
Both
Purpura, Thrombocytopenic, Idiopathic

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Trial Information


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Mansoor Noorali Saleh

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

Unspecified

Study ID:

199/15038

NCT ID:

NCT00005652

Start Date:

December 2000

Completion Date:

Related Keywords:

  • Purpura, Thrombocytopenic, Idiopathic
  • hematologic disorders
  • immune thrombocytopenic purpura
  • rare disease
  • Purpura
  • Purpura, Thrombocytopenic
  • Purpura, Thrombocytopenic, Idiopathic

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294