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

This study has been completed.

First Received: February 2, 2001 Last Updated: June 23, 2005 History of Changes

Sponsor:	Johns Hopkins University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00010400

Purpose

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.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized

Resource links provided by NLM:

MedlinePlus related topics: Lupus

Drug Information available for: Cyclophosphamide Filgrastim Immunoglobulins Globulin, Immune

U.S. FDA Resources

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

Estimated Enrollment:	35
Study Start Date:	April 1997

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010400

Locations

United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

Johns Hopkins University

Investigators

Study Chair:

Robert A. Brodsky

Johns Hopkins University

More Information

No publications provided

Study ID Numbers:	199/15673, JHOC-J9717, JHOC-97022128
Study First Received:	February 2, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00010400 History of Changes
Health Authority:	Unspecified

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:

Autoimmune Diseases
Disease
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Immunosuppressive Agents
Pharmacologic Actions
Pathologic Processes

Lupus Erythematosus, Systemic
Therapeutic Uses
Syndrome
Myeloablative Agonists
Connective Tissue Diseases
Antineoplastic Agents, Alkylating
Antiphospholipid Syndrome
Antibodies, Antiphospholipid
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on November 27, 2009