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

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. Identifier: NCT00271934
Recruitment Status : Completed
First Posted : January 4, 2006
Last Update Posted : April 11, 2012
Information provided by (Responsible Party):
Richard Burt, MD, Northwestern University

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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: Immune ablation and hematopoietic stem cell support. Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2002
Actual Primary Completion Date : November 2007
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Intervention Details:
  • Biological: Immune ablation and hematopoietic stem cell support.
    Autologous hematopoietic stem cell transplant

Primary Outcome Measures :
  1. SLEDAI [ Time Frame: 5 years after transplant ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Less than age of 60 year at the time of pretransplant evaluation.
  2. 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:

  1. Human immunodeficiency virus (HIV)positive status.
  2. History of unstable angina.
  3. 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.
  4. 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.
  5. 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.
  6. Psychiatric illness or mental deficiency not due to active lupus cerebritis making compliance with treatment or informed consent impossible.
  7. FEV1/FVC<50% of predicted, DLCO <50%of predicted.
  8. Resting left ventricular ejection fraction(LVEF)<35% or lupus induced myocarditis.
  9. Known hypersensitivity to Escherichia coli.

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 identifier (NCT number): NCT00271934

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United States, Illinois
Northwestern University, feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Richard Burt, MD
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Principal Investigator: Richard Burt, MD Northwestern University
Publications of Results:
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Responsible Party: Richard Burt, MD, MD, Northwestern University Identifier: NCT00271934    
Other Study ID Numbers: NU95LU1
First Posted: January 4, 2006    Key Record Dates
Last Update Posted: April 11, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases