Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
NCT ID: NCT00010387
Last Updated: 2008-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
1999-03-31
Brief Summary
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I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.
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Detailed Description
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Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
Interventions
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cyclophosphamide
filgrastim
Eligibility Criteria
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Inclusion 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
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Principal Investigators
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Robert A. Brodsky
Role: STUDY_CHAIR
Johns Hopkins University
Locations
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Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Countries
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Other Identifiers
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JHOC-J9881
Identifier Type: -
Identifier Source: secondary_id
JHOC-99012906
Identifier Type: -
Identifier Source: secondary_id
199/15672
Identifier Type: -
Identifier Source: org_study_id
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