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Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00017641
Recruitment Status : Unknown
Verified November 2003 by Office of Rare Diseases (ORD).
Recruitment status was:  Active, not recruiting
First Posted : June 6, 2001
Last Update Posted : June 24, 2005
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:


I. Determine the safety of immune ablation with high-dose cyclophosphamide and anti-thymocyte globulin followed by peripheral blood stem cell support in patients with systemic lupus erythematosus.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: filgrastim Procedure: CD34+ Peripheral Blood Stem Cell Reinfusion Phase 1

Detailed Description:

PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1 hour for 2 doses. Patients receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours after completion of cyclophosphamide and continuing until leukapheresis is complete. Leukapheresis continues daily until target number of cells is harvested. CD 34+ cells are isolated from peripheral blood stem cells (PBSC) in vitro.

Patients then receive cyclophosphamide IV over 1 hour on days -5 to -2, anti-thymocyte globulin IV over 10 hours on days -4 to -2, and G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients undergo reinfusion of CD34+ PBSC on day 0.

Patients are followed weekly for 90 days, monthly for 1 year, and at 2 years.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Primary Purpose: Treatment
Study Start Date : April 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--Disease Characteristics--

Diagnosis of systemic lupus erythematosus with 1 of the following malignant features:

  • Nephritis (WHO class III or IV)
  • Failed NIH short-course cyclophosphamide therapy
  • Vasculitis/immune complex deposition causing end organ signs or symptoms (e.g., cerebritis, transverse myelitis, pulmonary hemorrhage, cardiac failure, or renal failure)
  • Hematologic cytopenias that are immune mediated and uncontrolled by conservative measures with any of the following:

Transfusion-dependent anemia with untransfused hemoglobin less than 8 g/dL

Platelet count less than 40,000/mm3 (without transfusions)

Granulocyte count less than 1,000/mm3

Catastrophic anti-phospholipid syndrome

--Patient Characteristics--


  • LVEF at least 35%
  • No lupus-induced myocarditis
  • No history of unstable angina


  • FEV1/FVC at least 50% predicted
  • DLCO at least 50% predicted


  • HIV negative
  • No prior or concurrent malignancy except localized basal cell or squamous cell skin cancer
  • No uncontrolled diabetes mellitus
  • No medical illness that would preclude study
  • No psychiatric illness or mental deficiency that would preclude study
  • No known hypersensitivity to E. coli-derived proteins
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017641

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United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792-0001
Sponsors and Collaborators
Northwestern Memorial Hospital
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Study Chair: Ann Traynor Northwestern Memorial Hospital
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ClinicalTrials.gov Identifier: NCT00017641    
Other Study ID Numbers: 199/14976
First Posted: June 6, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 2003
Keywords provided by Office of Rare Diseases (ORD):
arthritis & connective tissue diseases
immunologic disorders and infectious disorders
rare disease
systemic lupus erythematosus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists