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Sponsored by: |
Northwestern Memorial Hospital |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00017641 |
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.
Condition | Intervention | Phase |
---|---|---|
Systemic Lupus Erythematosus |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: filgrastim Procedure: CD34+ Peripheral Blood Stem Cell Reinfusion |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Estimated Enrollment: | 10 |
Study Start Date: | April 2001 |
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.
Ages Eligible for Study: | up to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of systemic lupus erythematosus with 1 of the following malignant features:
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:
Pulmonary:
Other:
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 |
Study Chair: | Ann Traynor | Northwestern Memorial Hospital |
Study ID Numbers: | 199/14976, NU-95LU1 |
Study First Received: | June 6, 2001 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00017641 |
Health Authority: | Unspecified |
arthritis & connective tissue diseases immunologic disorders and infectious disorders rare disease systemic lupus erythematosus |
Antilymphocyte Serum Autoimmune Diseases Lupus Erythematosus, Systemic Arthritis |
Rare Diseases Connective Tissue Diseases Cyclophosphamide |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Immunosuppressive Agents Pharmacologic Actions |