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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 Anemia, Hemolytic, Autoimmune Studies:
1. Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide, Anti-thymocyte Globulin, and Autologous CD34-Selected Peripheral Blood Stem Cell Transplantation in Children With Refractory Autoimmune Disorders
2. Treatment of Childhood Onset Psychiatric Disorders with Intravenous Immunoglobulin (IVIg)
3. Study of Silicone-Associated Connective Tissue Diseases
4. Treatment of Multiple Sclerosis with Copaxone and Albuterol
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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