Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease (NCT00010387) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
United States32 participantsStarted 1999-03
Plain-language 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.
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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