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Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT00004643
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
University of Michigan
Information provided by:
Office of Rare Diseases (ORD)

February 24, 2000
February 25, 2000
June 24, 2005
February 1995
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Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
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OBJECTIVES: I. Evaluate the toxicity of cytarabine in patients with refractory systemic lupus erythematosus.

II. Evaluate objective disease parameters, including serum complement levels, anti-DNA antibody titers, sedimentation rate, and the systemic lupus activity measure in these patients.


Subcutaneous cytarabine is given for 5 days. Patients are re-treated every 4 weeks for a maximum of 3 courses; those who relapse prior to the second course are re-treated every 3 weeks.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Lupus Erythematosus, Systemic
Drug: cytarabine
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Yung RL, Richardson BC. Cytarabine therapy for refractory cutaneous lupus. Arthritis Rheum. 1995 Sep;38(9):1341-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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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
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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National Center for Research Resources (NCRR)
University of Michigan
Study Chair: Bruce Richardson University of Michigan
Office of Rare Diseases (ORD)
March 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP