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

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

Tracking Information
First Submitted Date  ICMJE January 2, 2006
First Posted Date  ICMJE January 4, 2006
Last Update Posted Date April 11, 2012
Study Start Date  ICMJE September 2002
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2008)
SLEDAI [ Time Frame: 5 years after transplant ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2006)
  • SLEDAI
  • Response of pretransplant abnormalities
Change History Complete list of historical versions of study NCT00271934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immune Ablation and Hematopoietic Stem Cell Support in Patients With Systemic Lupus Erythematosus: A Phase II Study
Official Title  ICMJE Immune Ablation and Hematopoietic Stem Cell Support in Patients With Poor Prognostic Indicators and Systemic Lupus Erythematosus:A Phase II Study
Brief Summary In patients with systemic lupus erythematosus, immunosuppressive therapy to the point of complete immune ablation and hematopoietic stem cell recovery.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE Biological: Immune ablation and hematopoietic stem cell support.
Autologous hematopoietic stem cell transplant
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2012)
52
Original Enrollment  ICMJE
 (submitted: January 3, 2006)
50
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00271934
Other Study ID Numbers  ICMJE NU95LU1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Burt, MD, Northwestern University
Study Sponsor  ICMJE Richard Burt, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Burt, MD Northwestern University
PRS Account Northwestern University
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP