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Allogeneic Stem Cell Transplantation in Systemic Lupus Erythematosus

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier:
NCT00278590
First received: January 16, 2006
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

This trial is designed to evaluate the safety of treating systemic lupus erythematosus participants with cyclophosphamide and CAMPATH-1H followed by allogeneic stem cell transplant. There will be no randomization in this study. All subjects who are determined to be eligible for the study treatment will receive cyclophosphamide and CAMPATH-1H followed by allogeneic stem cell transplant. The purpose of the intense chemotherapy is to destroy the cells in the immune system which may be causing this disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack body. The study purpose is to examine whether this treatment will result in improvement in the lupus disease.


Condition Intervention Phase
Systemic Lupus Erythematosus
Biological: Allogeneic Stem Cell Transplantation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Allogeneic Stem Cell Transplantation in Patients With Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Survival, disease free survival, number of relapses, organ function [ Time Frame: Evaluation of response will be performed for 5 years. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: July 2004
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: allogeneic stem cell transplantation
allogeneic stem cell transplantation will be performed
Biological: Allogeneic Stem Cell Transplantation
Allogeneic stem cell transplantation will be performed.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18 to 50 years old.
  • Meet at least 4 of 11 American College of Rheumatology (ACR) Classification criteria for SLE (see Appendix 1).
  • Able to give informed consent.
  • HLA matched sibling donor available.
  • Meet one of following three:

    1. For lupus nephritis, participants must fail pulse cyclophosphamide (500 to 1000 mg/m2 monthly for a minimum of 6 months). Failure is defined as meeting criteria to be considered as BILAG (Appendix 4) renal category A. If indication for HSCT is nephritis, a renal biopsy must be obtained and document either class III or IV glomerulonephritis.
    2. For visceral organ involvement other than nephritis, participants must be BILAG cardiovascular/respiratory category A, vasculitis category A, or neurologic category A and must fail at least 3 months of oral or IV cyclophosphamide and be corticosteroid dependent. Steroid dependence being defined as at least 3 months of steroid therapy and inability to wean corticosteroid to less than 20 mg/day of prednisone or equivalent.
    3. For cytopenias that are immune mediated, participants must be BILAG hematologic category A. Participants must have an inability to maintain platelets > 15,000, an inability to prevent active bleeding without transfusion, an inability to maintain hemoglobin > 7.0, or an inability to prevent cardiovascular disease without transfusion. In addition, participants must fail corticosteroids (either oral prednisone > 0.5 mg/kg/day for more than 6 months or pulse methylprednisolone for at least one cycle of three days), be refractory to IVIG, and at least one of the following: azathioprine at 2 mg/kg/day for at least 3 months, mycophenolate mofetil 2 grams daily for more than 3 months, cyclophosphamide intravenously or orally for at least 3 months, or cyclosporine at least 3 mg/kg/day for at least 3 months, danazol for at least 3 months, or splenectomy.

Exclusion Criteria:

  • HIV positive.
  • Ongoing malignancy except localized basal cell or squamous skin cancer. Other malignancies for which the participant is judged to be cured by local surgical therapy, such as head and neck cancer, or stage I or II breast cancer will be considered on an individual basis by the investigators doing the final screening for participant qualification.
  • Positive pregnancy test, inability or unwillingness to pursue effective means of birth control, failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.
  • Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
  • DLCO < 45% of predicted unless attributed solely to active lupus.
  • Resting LVEF < 40% unless due to active lupus.
  • Known hypersensitivity to E. Coli derived proteins.
  • Transaminases greater than 2 times normal unless due to active lupus.
  • Any illness that in the opinion of the investigator would jeopardize the ability of the patient to tolerate this treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278590

Contacts
Contact: Dzemila Spahovic, MD 312-695-4960 d-spahovic@northwestern.edu

Locations
United States, Illinois
Northwestern University, Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Richard Burt, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Richard Burt, MD Northwestern University
  More Information

No publications provided

Responsible Party: Richard Burt, MD, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00278590     History of Changes
Other Study ID Numbers: DI SLE.Allo2004
Study First Received: January 16, 2006
Last Updated: September 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on November 25, 2014