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Home > "P" Clinical Trials Conditions > Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease  Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
For Condition: Anemia, Hemolytic, Autoimmune,Felty Syndrome,Purpura, Thrombocytopenic,Autoimmune Diseases
Status: No longer recruiting
Sponsor(s): Johns Hopkins Oncology Center ,
Synopsis: OBJECTIVES: I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.
Details: 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:
Study Type: Interventional, Treatment, Single Group Assignment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 32
Location and Contact Information:
Overall Study Official:
RobertBrodsky, Study Chair, Johns Hopkins Oncology Center
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
Additional Information:
Study ID Numbers: 199/15672; JHOC-99012906,JHOC-J9881
Study Start Date: March 1999
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010387
Other Felty Syndrome Studies:
1. Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
2. Study of Silicone-Associated Connective Tissue Diseases
3. Genetic and Immune Studies of Rheumatoid Arthritis and Related Conditions
4. Treatment of Childhood Onset Psychiatric Disorders with Intravenous Immunoglobulin (IVIg)
5. Study of Oral Bacteria in Patients with Dry Mouth
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Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
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