Not Signed In -
Autoimmune Diseases |
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Clinical Trial: Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
This study is no longer recruiting patients.
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Purpose
OBJECTIVES: I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Anemia, Hemolytic, Autoimmune Felty Syndrome Purpura, Thrombocytopenic Autoimmune Diseases | Drug: cyclophosphamide Drug: filgrastim | Phase II |
MedlinePlus related topics: Anemia; Autoimmune Diseases; Bleeding Disorders; Immune System and Disorders; Rheumatoid Arthritis
Study Type: Interventional
Study Design: Treatment, Single Group Assignment
Expected Total Enrollment: 32
Study start: March 1999
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.
Eligibility
Genders Eligible for Study: Both
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
Location Information
Robert A. Brodsky, Study Chair, Johns Hopkins Oncology Center
More Information
Record last reviewed: October 2003
Last Updated: October 13, 2004
Record first received: February 2, 2001
ClinicalTrials.gov Identifier: NCT00010387
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Alopecia Areata: Frequently Asked Questions (National Alopecia Areata Foundation)
- American Autoimmune Related Diseases Association
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