I. Determine the response rate and 1-year event-free survival in patients with severe
autoimmune hematologic disease treated with high-dose cyclophosphamide.
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.
PROTOCOL ENTRY CRITERIA:
- Diagnosis of severe autoimmune hematologic disease Autoimmune hemolytic anemia OR
- 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
- See Disease 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
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Not preterminal or moribund