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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00010387

Enrollment

Registered

2001-02-02

Start date

1999-03-31

Completion date

Unknown

Last updated

2008-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Felty syndrome, autoimmune hemolytic anemia, autoimmune neutropenia, hematologic disorders, immune thrombocytopenic purpura, rare disease

Brief 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.

Detailed 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.

Interventions

DRUGcyclophosphamide

DRUGfilgrastim

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026