Baltimore, Maryland 21231

  • Autoimmune Diseases


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

Study summary:

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: --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



Primary Contact:

Study Chair
Robert A. Brodsky
Johns Hopkins University

Backup Contact:


Location Contact:

Baltimore, Maryland 21231
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source:

Date Processed: April 03, 2020

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