Bone Marrow Transplantation in Treating Children With Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT00004485|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : September 10, 2008
RATIONALE: Sickle cell disease is an inherited disorder in which abnormal, crescent-shaped red blood cells interfere with the ability of the blood to carry oxygen through the body and can cause severe pain, stroke, and organ damage. Bone marrow transplantation, is a procedure in which the soft, sponge-like tissue in the center of bones producing white blood cells, red blood cells, and platelets is replaced by bone marrow from a another person. Bone marrow transplantation may be an effective treatment in relieving the symptoms of sickle cell disease.
PURPOSE: Phase I/II trial to study the effectiveness of bone marrow transplantation in treating children who have sickle cell disease.
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Anemia||Drug: cyclosporine Drug: fludarabine Drug: mycophenolate mofetil Procedure: Bone Marrow Transplantation||Phase 1 Phase 2|
PROTOCOL OUTLINE: This is a multicenter study. Patients undergo total body irradiation on day 0, followed by allogeneic bone marrow transfusion. Patients also receive fludarabine IV daily and cyclosporine IV twice a day on days -1 to 1. Patients then receive oral cyclosporine on days 1-90, and oral mycophenolate mofetil twice a day on days 0-27.
Patients are followed for 100 days, monthly for 6 months and then annually for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||50 participants|
|Official Title:||Phase I/II Study of Induction of Stable Mixed Chimerism After Bone Marrow Transplantation From HLA-Identical Donors in Children With Sickle Cell Disease|
|Study Start Date :||December 1999|
|Actual Primary Completion Date :||August 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004485
|United States, California|
|Children's Hospital of Oakland|
|Oakland, California, United States, 94609|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Chair:||Mark Walters||Children's Hospital of Oakland|