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View Clinical Trial (Medical Research Study)
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Cyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus - NCT00278538-60611B (Clinical Trial 136125)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy136125.aspx
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| City: |
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Chicago |
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State:
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IL |
| Zip Code: |
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60611 |
| Conditions: |
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Systemic Lupus Erythematosus |
| Purpose: |
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This study is designed to examine whether treating patients with lupus with high dose
cyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immune
system), followed by return of their previously collected stem cells will result in
improvement in the disease. Stem cells are undeveloped cells that have the capacity to grow
into mature blood cells, which normally circulate in the blood stream. 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.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Ages 16 to 60 years old
- Meet at least 4 of 11 American College of Rheumatology (ACR) Classification criteria
for SLE (see Appendix 16.2)
- Meet one of following five:
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 renal category A.
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 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), 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.
4. For mucocutaneous disease, participants must meet BILAG mucocutaneous category
A, be unable to be weaned from prednisone to less than 0.5 mg/kg/day for more
than 6 months and obvious cushingoid habitus, and have received at least one of
the following: azathioprine at 2 mg/kg/day for at least 3 months, methotrexate
at 15mg/week for at least 3 months, cyclophosphamide intravenously or orally for
at least 3 months, or cyclosporine at least 3 mg/kg/day for at least 3 months.
5. For arthritis/myositis, participants must meet BILAG musculoskeletal category A,
be unable to be weaned from prednisone to less than 0.5 mg/kg/day for more than
6 months and obvious cushingoid habitus, and have received at least one of the
following: azathioprine at 2 mg/kg/day for at least 3 months, methotrexate at
15mg/ week for at least 3 months, cyclophosphamide intravenously or orally for
at least 3 months, or cyclosporine at least 3 mg/kg/day for at least 3 months.
- Able to give informed consent.
- If indication for HSCT is nephritis, a renal biopsy must demonstrate the potential of
a reversible (non-fibrotic) component indicating that if successful the participant
would not be likely to be permanently dialysis-dependent after transplant.
- Since the BILAG is only one of multiple indices for SLE, patients may also be
candidates if despite prior immune suppression therapy as described above, patients
are still on active immune suppression (more than 10mg a day of prednisone).
- Patients with SLE whose major manifestation is Antiphospholipid syndrome (APS) may be
candidates without prior immune suppression therapy if they have had a visceral organ
thrombotic or embolic event despite anticoagulation
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 to active lupus.
- Resting LVEF < 40% unless attributed to active lupus.
- Known hypersensitivity to E Coli derived proteins.
- Transaminases greater than 2 times normal unless attributed to active lupus.
- Positive tuberculosis skin test
- Any active infection
- Any co-morbid illness that in the opinion of the investigator would jeopardize the
ability of the subject to tolerate the study.
- Failure to collect at least 2.0 x 106 CD34+ cells/kg |
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| Study is available at: |
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Northwestern University
Chicago, IL 60611
United States
Primary Contact:
Dzemila Spahovic, MD
Email: d-spahovic@northwestern.edu
Phone: 312-908-0059 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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