An interventional study of Cyclophosphamide and filgrastim in Systemic Lupus Erythematosus and Antiphospholipid Antibody Syndrome, sponsored by Johns Hopkins University. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
OBJECTIVES:
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.
PROTOCOL OUTLINE:
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.
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's enrollment of 35 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
PROTOCOL ENTRY 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
This study is completed, as verified in Jul 2004. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic→
Johns Hopkins University