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Study of Total Body Irradiation and Fludarabine Followed By Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation in Combination With Cyclosporine and Mycophenolate Mofetil in Patients With Inherited Disorders
This study is currently recruiting patients.
Sponsored by: | Fred Hutchinson Cancer Research Center |
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Information provided by: | Office of Rare Diseases (ORD) |
Purpose
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 | Treatment or Intervention |
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Metabolism, Inborn Errors Granulomatous Disease, Chronic |
Drug: cyclosporine Drug: fludarabine Drug: mycophenolate mofetil |
MedlinePlus related topics: Genetic Disorders; Immune System and Disorders; Metabolic Disorders
Study Type: Interventional
Study Design: Treatment
Expected Total Enrollment: 20
Study start: 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.
Eligibility
Ages Eligible for Study: up to 55 Years, Genders Eligible for Study: Both
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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