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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: | NCT00010361 |
OBJECTIVES: I. Determine the safety of total body irradiation and fludarabine followed by allogeneic peripheral blood stem cell or bone marrow transplantation in combination with cyclosporine and mycophenolate mofetil for establishing mixed chimerism in patients with inherited disorders.
II. Determine whether this regimen can establish mixed chimerism in these patients.
III. Determine whether mixed chimerism is sufficient to reverse disease symptoms in these patients.
IV. Determine the safety of donor lymphocyte infusions to eliminate persistent disease in these patients with mixed chimerism.
Condition | Intervention |
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Metabolism, Inborn Errors Granulomatous Disease, Chronic |
Drug: cyclosporine Drug: fludarabine Drug: mycophenolate mofetil |
Study Type: | Interventional |
Study Design: | Treatment |
Estimated Enrollment: | 20 |
Study Start Date: | November 2000 |
PROTOCOL OUTLINE: Patients receive fludarabine IV over 2 hours on days -4 to -2 followed by total body irradiation and peripheral blood stem cell or bone marrow transplantation on day 0. Patients also receive oral or IV cyclosporine 2-3 times daily on days -3 to 50 (related donor) or 100 (unrelated donor) and oral mycophenolate mofetil twice daily on days 0 to 28 (related donor) or 40 (unrelated donor).
Patients may also receive donor lymphocyte infusion for continued treatment of symptoms in the event of mixed chimerism and in the absence of graft-versus-host disease.
Patients are followed weekly for 1 month, monthly for 2 years, and then annually thereafter.
Ages Eligible for Study: | up to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109 |
Study Chair: | Ann Woolfrey | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | 199/15577, FHCRC-1475.00 |
Study First Received: | February 2, 2001 |
Last Updated: | August 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00010361 |
Health Authority: | Unspecified |
Cyclosporine Metabolic Diseases Clotrimazole Hematologic Diseases Miconazole Tioconazole Mycophenolic Acid Leukocyte Disorders Fludarabine monophosphate Granuloma Cyclosporins Immunologic Deficiency Syndromes |
Metabolism, Inborn Errors Lymphatic Diseases Genetic Diseases, Inborn Granulomatous Disease, Chronic Mycophenolate mofetil Genetic Diseases, X-Linked Chronic Disease Fludarabine Metabolic disorder Lymphoproliferative Disorders Chronic granulomatous disease |
Antimetabolites Phagocyte Bactericidal Dysfunction Anti-Infective Agents Disease Attributes Antimetabolites, Antineoplastic Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs |
Enzyme Inhibitors Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Pathologic Processes Antifungal Agents Therapeutic Uses Antirheumatic Agents Dermatologic Agents |