Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00004643 |
Date of registration:
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24/02/2000 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
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Scientific title:
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Date of first enrolment:
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February 1995 |
Target sample size:
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10 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00004643 |
Study type:
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Interventional |
Study design:
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Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Contacts
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Name:
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Bruce Richardson |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Michigan |
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Key inclusion & exclusion criteria
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PROTOCOL ENTRY CRITERIA:
Disease Characteristics
- Clinically documented active systemic lupus erythematosus demonstrating at least 4
revised diagnostic criteria
- Unresponsive to conventional therapy with nonsteroidal anti-inflammatory drugs
(NSAIDs), topical corticosteroids, and antimalarials
- Intolerable side effects from corticosteroids or other immunosuppressive drugs
Failure on immunosuppressives not required
- No life-threatening disease, e.g.: Lupus cerebritis Rapidly progressive
glomerulonephritis
Prior/Concurrent Therapy
- No concurrent other DNA synthesis inhibitors, NSAIDs, and prednisone continued on
study
Patient Characteristics
- Hematopoietic: WBC at least 2000; Platelets at least 100,000
- Renal: Creatinine clearance at least 20 mL/min
- Other: No major infection within 2 weeks prior to entry
- Negative pregnancy test required of fertile women
- Effective contraception required of fertile women. Advised for men during and for 75
days after therapy
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lupus Erythematosus, Systemic
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Intervention(s)
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Drug: cytarabine
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Secondary ID(s)
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199/11685
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UMMC-91208
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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