Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome
NCT ID: NCT00010400
Last Updated: 2005-06-24
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
NA
35 participants
INTERVENTIONAL
1997-04-30
Brief Summary
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I. Determine the induction of durable remission in patients with life-threatening systemic lupus erythematosus or antiphospholipid antibody syndrome treated with cyclophosphamide.
II. Determine the toxicity of this drug in these patients.
Detailed Description
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Patients receive cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) beginning on day 10 and continuing until blood counts recover.
Patients are followed monthly for 6 months, and then every 3 months thereafter.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
Interventions
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Cyclophosphamide
filgrastim
Eligibility Criteria
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Inclusion Criteria
--Disease Characteristics--
Diagnosis of life-threatening systemic lupus erythematosus (SLE); must show at least 4 American College of Rheumatology criteria for SLE; must have severe organ damage in 1 or more organs; must have 1 or more of the following indications of ongoing disease activity: disease activity score (SLEDAI) at least 4, hospitalization for disease activity within 12 months, life-threatening disease not captured on SLEDAI
OR
Diagnosis of antiphospholipid antibody syndrome by the Hughes criteria; must show severity by ongoing symptoms or signs of hypercoagulability in spite of warfarin therapy
--Patient Characteristics--
Hepatic: Bilirubin no greater than 2.0 mg/dL; transaminases no greater than 2.0 times normal
Renal: Creatinine no greater than 3.0 mg/dL
Cardiovascular: Ejection fraction at least 45%
Pulmonary: FVC, FEV1, or DLCO at least 50% predicted
Other: Not preterminal or moribund; not pregnant or nursing; fertile patients must use effective contraception
18 Years
70 Years
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 University School of Medicine
Baltimore, Maryland, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Countries
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References
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Petri M, Brodsky RA, Jones RJ, Gladstone D, Fillius M, Magder LS. High-dose cyclophosphamide versus monthly intravenous cyclophosphamide for systemic lupus erythematosus: a prospective randomized trial. Arthritis Rheum. 2010 May;62(5):1487-93. doi: 10.1002/art.27371.
Other Identifiers
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JHOC-J9717
Identifier Type: -
Identifier Source: secondary_id
JHOC-97022128
Identifier Type: -
Identifier Source: secondary_id
199/15673
Identifier Type: -
Identifier Source: org_study_id