- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00017641
Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
OBJECTIVES:
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
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Wisconsin
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Madison, Wisconsin, United States, 53792-0001
- University of Wisconsin Hospital and Clinics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PROTOCOL ENTRY CRITERIA:
--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--
Cardiovascular:
- LVEF at least 35%
- No lupus-induced myocarditis
- No history of unstable angina
Pulmonary:
- FEV1/FVC at least 50% predicted
- DLCO at least 50% predicted
Other:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ann Traynor, Northwestern Memorial Hospital
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Connective Tissue Diseases
- Lupus Erythematosus, Systemic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Antilymphocyte Serum
Other Study ID Numbers
- 199/14976
- NU-95LU1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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