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Sponsored by: |
Northwestern University |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00278590 |
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 |
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Systemic Lupus Erythematosus |
Procedure: Stem Cell Transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Allogeneic Stem Cell Transplantation in Patients With Systemic Lupus Erythematosus |
Estimated Enrollment: | 10 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Ages 18 to 50 years old. 2. Meet at least 4 of 11 American College of Rheumatology (ACR) Classification criteria for SLE (see Appendix 1).
3. Able to give informed consent. 4. HLA matched sibling donor available. 5. Meet one of following three:
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:
1. HIV positive. 2. 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.
3. 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.
4. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
5. DLCO < 45% of predicted unless attributed solely to active lupus. 6. Resting LVEF < 40% unless due to active lupus. 7. Known hypersensitivity to E. Coli derived proteins. 8. Transaminases greater than 2 times normal unless due to active lupus. 9. Any illness that in the opinion of the investigator would jeopardize the ability of the Patient to tolerate this treatment.
Contact: Dzemila Spahovic, MD | 312-908-0059 | d-spahovic@northwestern.edu |
United States, Illinois | |
Northwestern University, Feinberg School of Medicine | Recruiting |
Chicago, Illinois, United States, 60611 | |
Principal Investigator: Richard Burt, MD | |
Sub-Investigator: Mihai Gheorghiade, MD | |
Sub-Investigator: John Varga, MD |
Principal Investigator: | Richard Burt, MD | Northwestern University |
Responsible Party: | Northwestern University ( Richard Burt, MD ) |
Study ID Numbers: | DI SLE.Allo2004 |
Study First Received: | January 16, 2006 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00278590 |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases |
Immune System Diseases |