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Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 2, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Office of Rare Diseases (ORD)


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.

Condition Intervention
Systemic Lupus Erythematosus Antiphospholipid Antibody Syndrome Drug: Cyclophosphamide Drug: filgrastim

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 35
Study Start Date: April 1997
Detailed Description:


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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


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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010400

United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Johns Hopkins University
Study Chair: Robert A. Brodsky Johns Hopkins University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00010400     History of Changes
Other Study ID Numbers: 199/15673
First Submitted: February 2, 2001
First Posted: February 2, 2001
Last Update Posted: December 9, 2005
Last Verified: July 2004

Keywords provided by Office of Rare Diseases (ORD):
antiphospholipid antibody syndrome
arthritis & connective tissue diseases
immunologic disorders and infectious disorders
rare disease
systemic lupus erythematosus

Additional relevant MeSH terms:
Antiphospholipid Syndrome
Antibodies, Antiphospholipid
Lupus Erythematosus, Systemic
Pathologic Processes
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists