search
Back to results

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

Primary Purpose

Systemic Lupus Erythematosus, Antiphospholipid Antibody Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide
filgrastim
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring antiphospholipid antibody syndrome, arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University School of Medicine
  • Johns Hopkins Oncology Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
June 23, 2005
Sponsor
Johns Hopkins University
search

1. Study Identification

Unique Protocol Identification Number
NCT00010400
Brief Title
Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2004
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Johns Hopkins University

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Antiphospholipid Antibody Syndrome
Keywords
antiphospholipid antibody syndrome, arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Non-Randomized
Enrollment
35 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
filgrastim

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A. Brodsky
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20131296
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs