Status:
COMPLETED
Immune Ablation and Hematopoietic Stem Cell Support in Patients With Systemic Lupus Erythematosus: A Phase II Study
Lead Sponsor:
Northwestern University
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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:
- 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.
- Vasculitis/Immune complex deposition- causing end organ signs or symptoms e.g. cerebritis, transverse myelitis, pulmonary hemorrhage, cardiac failure, renal failure.
- 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.
- Catastrophic Anti-phospholipid Syndrome
- 4\. Ability and willingness to provide informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00271934
Start Date
September 1 2002
End Date
April 1 2012
Last Update
November 9 2023
Active Locations (1)
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1
Northwestern University, feinberg School of Medicine
Chicago, Illinois, United States, 60611