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

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT00010387

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

OBJECTIVES:

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

Condition or Disease	Intervention/Treatment	Phase
Anemia, Hemolytic, Autoimmune Felty Syndrome Purpura, Thrombocytopenic Autoimmune Diseases	Drug: cyclophosphamide Drug: filgrastim	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

N/A

Intervention Model:

Single Group Assignment

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 1999

Actual Primary Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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--