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

Johns Hopkins University32 enrolled

Overview

OBJECTIVES: 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Enrollment

Conditions

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

Interventions

cyclophosphamideDRUG

filgrastimDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins Oncology Center

Baltimore, Maryland, United States

Data from ClinicalTrials.gov

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