Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease

Autoimmune Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00010387
• Other study ID #: 199/15672
• Secondary ID: JHOC-J9881JHOC-9
• Status: Completed
• Phase: Phase 2
• First received: February 2, 2001
• Last updated: September 8, 2008
• Start date: March 1999

Study information

• Verified date: September 2008
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

OBJECTIVES:

I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.

Description:

PROTOCOL OUTLINE: Patients receive high-dose cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) starting on day 10 and continuing until blood counts recover.

Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Diagnosis of severe autoimmune hematologic disease Autoimmune hemolytic anemia OR Immune thrombocytopenia

• Failure of at least 2 standard treatment approaches (e.g., prednisone therapy, splenectomy, intravenous immunoglobulin, or other immunosuppressants)

• Inability to taper prednisone dose to less than 10 mg/day OR Autoimmune neutropenia including the following: Felty's syndrome OR Disorders of large granular lymphocytes with recurrent infections or absolute neutrophil count less than 200/mm3

--Prior/Concurrent Therapy--

• See Disease Characteristics

--Patient Characteristics--

• Age: Not specified

• Performance status: Not specified

• Hematopoietic: See Disease Characteristics

• Hepatic: Not specified

• Renal: Creatinine no greater than 2.5 mg/dL

• Cardiovascular: Ejection fraction at least 40%

• Pulmonary: FVC, FEV1, or DLCO at least 50% predicted

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Not preterminal or moribund

Study Design

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Autoimmune Diseases
• Felty Syndrome
• Purpura, Thrombocytopenic

Intervention

Drug:
• cyclophosphamide

• filgrastim

Locations

Country	Name	City	State
United States	Johns Hopkins Oncology Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States,