Immune Ablation and Hematopoietic Stem Cell Support in Patients With Systemic Lupus Erythematosus: A Phase II Study - Full Text View

Sponsor:	Richard Burt
Information provided by (Responsible Party):	Richard Burt, Northwestern University
ClinicalTrials.gov Identifier:	NCT00271934

Purpose

In patients with systemic lupus erythematosus, immunosuppressive therapy to the point of complete immune ablation and hematopoietic stem cell recovery.

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Procedure: Immune ablation and hematopoietic stem cell support.	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Immune Ablation and Hematopoietic Stem Cell Support in Patients With Poor Prognostic Indicators and Systemic Lupus Erythematosus:A Phase II Study

Resource links provided by NLM:

MedlinePlus related topics: Lupus

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

SLEDAI [ Time Frame: 5 years after transplant ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	September 2002
Study Completion Date:	May 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Autologous hematopoietic stem cell transplant

Detailed Description:

Systemic lupus erythematosus is a multisystem, inflammatory disorder characterized by the production of antibodies that react with many different self-antigens. Defects in immune regulation underlie the breakdown in self-tolerance.(1) The clinical course of lupus is variable. Aggressive intervention is reserved for disease with characteristic high risk features including diffuse, proliferative glomerulonephritis, pulmonary hemorrhage, cerebritis and other life-threatening manifestations of vasculitis. In patients with SLE and high risk features, we propose extension of current immunosuppressive therapy to the point of complete immune ablation and hematopoietic stem cell recovery.

Eligibility

Ages Eligible for Study:	up to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Less than age of 60 year at the time of pretransplant evaluation.
An established clinical diagnosis of systemic lupus erythematosus with one of the following features:
1. Lupus nephritis-WHO class III or IV (or V when coexistent III or IV) lupus nephritis, failing NIH short course cyclophosphamide therapy (10mg/kg q month for 6 months). Failure will be defined as failure of creatinine to return to normal or pre-exacerbation level.
2. Vasculitis/Immune complex deposition- causing end organ signs or symptoms e.g. cerebritis, transverse myelitis, pulmonary hemorrhage, cardiac failure, renal failure.
3. Cytopenias that are immune-mediated and not controlled by conservative measures including danzole, prednisone, and alkylating agents (cyclophosphamide or vincristine); and any one of the following: transfusion dependant anemia with untransfused hemoglobin less than 8 grams/dl, or platelets less than 40,000/ul without transfusions,or granulocytes less than 1000/ul.
4. Catastrophic Anti-phospholipid Syndrome

4. Ability and willingness to provide informed consent.

Exclusion Criteria:

Human immunodeficiency virus (HIV)positive status.
History of unstable angina.
Uncontrolled diabetes mellitus, or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemoradiotherapy.
Prior history of malignancy except for localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as head and neck cancer, or stage I breast cancer will be considered on an individual basis.
Positive serum pregnancy test, inability or unwillingness to pursue effective means of birth control or failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.
Psychiatric illness or mental deficiency not due to active lupus cerebritis making compliance with treatment or informed consent impossible.
FEV1/FVC<50% of predicted, DLCO <50%of predicted.
Resting left ventricular ejection fraction(LVEF)<35% or lupus induced myocarditis.
Known hypersensitivity to Escherichia coli.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271934

Locations

United States, Illinois
Northwestern University, feinberg School of Medicine
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Richard Burt

Investigators

Principal Investigator:

Richard Burt, MD

Northwestern University

More Information

Publications:

Burt RK, Traynor A, Statkute L, Barr WG, Rosa R, Schroeder J, Verda L, Krosnjar N, Quigley K, Yaung K, Villa Bs M, Takahashi M, Jovanovic B, Oyama Y. Nonmyeloablative hematopoietic stem cell transplantation for systemic lupus erythematosus. JAMA. 2006 Feb 1;295(5):527-35.

Responsible Party:	Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier:	NCT00271934 History of Changes
Other Study ID Numbers:	NU95LU1
Study First Received:	January 2, 2006
Last Updated:	August 29, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012