Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome
Status
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Treatments
Details and patient eligibility
About
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.
Full description
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.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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