Status:
TERMINATED
Allogeneic Blood Stem Cell Transplantation for Patients With Life-Threatening Systemic Lupus Erythematosus
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
City of Hope National Medical Center
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
The Stanford Medical Center Division of Immunology and Rheumatology and the Division of Blood and Marrow Transplantation (BMT) are enrolling patients with severe systemic lupus erythematosus (SLE) tha...
Detailed Description
The purpose of this study is to evaluate the effectiveness of allogeneic blood stem cell transplantation in individuals with life-threatening SLE. A non-bone marrow ablative regimen consisting of tota...
Eligibility Criteria
Inclusion
- Meet the American College of Rheumatology (ACR) criteria for classification of SLE (i.e., at least 4 of the 11 criteria; see Appendix 2 of the protocol for more information)
- SLE disease activity index (SLEDAI) greater than 20 (i.e., active, multi-system SLE; see Appendix 3 of the protocol for more information)
- History of one or more of the following conditions that have not responded to conventional therapy with pulse intravenous or oral cyclophosphamide and corticosteroids:
- Lupus pneumonitis with a progressive decline in lung function tests and evidence of oxygen desaturation on effort in which the lung CT scans and chest X-rays show active disease without irreversible extensive scarring
- Diffuse alveolar hemorrhage associated with oxygen desaturation with persistent abnormalities of the lung CT scan or X-rays that have not resolved after conventional therapy
- Central nervous system lupus that has resulted in neurological deficits requiring hospitalization with a brain CT scan and/or brain MRI and shows evidence of lupus activity without extensive irreversible lesions
- Lupus nephritis with a progressive decline in the creatinine clearance that has not fallen below 25 ml/min in which a biopsy shows active disease without irreversible extensive scarring
- Refractory disease, as determined by failure of the following two conditions:
- Trial of corticosteroids (equivalent to prednisone 0.5 mg/kg/day for 2 months and/or at least 3 pulses of methylprednisolone 1,000 mg over 3 days) on at least one occasion within the 6 months prior to study entry
- Trial of cyclophosphamide of at least 500 mg/m² IV pulse at least 3 times or oral cyclophosphamide for at least 30 days
- Must have a fully HLA identical sibling or a matched unrelated donor
- Willing to use contraception throughout the study and for 12 months following treatment
Exclusion
- Allergic to rabbit ATG
- Score of less than 60% on Karnofsky Performance Scale
- Organ dysfunction, defined as follows:
- Cardiac function ejection fraction less than 40% or uncontrolled malignant arrhythmias or clinical evidence of congestive heart failure (New York Class 3-4, see Appendix 4 of the protocol for more information)
- Pulmonary diffusion capacity (DLCO) less than 30% of predicted
- Liver function abnormalities with direct bilirubin levels greater than 3.0 mg/dL on two repeated tests and/or transaminases greater than 4 times the upper limit of normal
- Measured creatinine clearance of less than 40 ml/min (24 hour urine collection)
- Pregnant
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00325741
Start Date
June 1 2004
End Date
October 1 2015
Last Update
August 15 2023
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305