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Sponsored by: |
Fred Hutchinson Cancer Research Center |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00010335 |
OBJECTIVES: I. Determine the safety and long term complications of total body irradiation in combination with cyclophosphamide, anti-thymocyte globulin, and autologous CD34-selected peripheral blood stem cell (PBSC) transplantation in children with refractory autoimmune disorders.
II. Determine the efficacy of this treatment regimen in these patients. III. Determine the reconstitution of immunity after autologous CD34-selected PBSC transplantation in these patients.
IV. Determine engraftment of autologous CD34-selected PBSC in these patients.
Condition | Intervention | Phase |
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Systemic Sclerosis Systemic Lupus Erythematosus Dermatomyositis Juvenile Rheumatoid Arthritis Autoimmune Diseases |
Procedure: Stem Cell Transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of High-Dose Immunosuppression Followed by Infusion of CD34-Selected Autologous or Syngeneic Peripheral Blood Stem Cells for Treatment of Refractory Autoimmune Disorders |
Estimated Enrollment: | 20 |
Study Start Date: | November 2000 |
Estimated Study Completion Date: | December 2020 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive a stem cell transplant.
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Procedure: Stem Cell Transplantation
Participants will receive a stem cell transplantation along with irradiation and the drugs anti-thymocyte globulin, cyclophosphamide, and filgrastim as noted in the text of this record.
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PROTOCOL OUTLINE: This is a multicenter study. Patients receive filgrastim (G-CSF) subcutaneously daily until peripheral blood stem cell (PBSC) collection is completed. CD34+ cells are separated from the rest of the PBSCs.
Patients undergo total body irradiation twice daily on days -5 and -4. Patients receive anti-thymocyte globulin IV on days -5, -3, -1, 1, 3, and 5 and cyclophosphamide IV on days -3 and -2. CD34-selected PBSCs are reinfused on day 0. Patients receive G-CSF IV daily beginning on day 0 and continuing until blood counts recover.
Patients are followed annually for 5 years and then every 5 years thereafter.
Ages Eligible for Study: | 2 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
Other:
--Patient Characteristics--
Other:
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Ann Woolfrey 206-667-4453 | |
Contact: Carol A. Wallace, MD 206-987-4448 cwallace@u.washington.edu |
Study Chair: | Ann Woolfrey | Fred Hutchinson Cancer Research Center |
Principal Investigator: | Carol A. Wallace, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Ann E. Woolfrey, MD / Associate Member ) |
Study ID Numbers: | 199/15575, FHCRC-1353.00 |
Study First Received: | February 2, 2001 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00010335 |
Health Authority: | United States: Food and Drug Administration |
arthritis & connective tissue diseases dermatomyositis immunologic disorders and infectious disorders juvenile rheumatoid arthritis |
rare disease systemic lupus erythematosus systemic sclerosis |
Arthritis, Juvenile Rheumatoid Autoimmune Diseases Skin Diseases Joint Diseases Arthritis, Rheumatoid Rare Diseases Sclerosis Cyclophosphamide Rheumatic Diseases Antilymphocyte Serum Myositis |
Dermatomyositis Muscular Diseases Neuromuscular Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases Arthritis Polymyositis Connective Tissue Diseases Idiopathic myopathy Scleroderma, Systemic |
Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Pathologic Processes Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |