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

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Felty Syndrome; Anemia, Hemolytic, Autoimmune; Purpura, Thrombocytopenic; Autoimmune Diseases

Treatments: Drug: filgrastim; Drug: cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT00010387

JHOC-J9881

199/15672

JHOC-99012906

Details and patient eligibility

About

OBJECTIVES:

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

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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