Stem Cell Transplantation With Identical Donors for Patients With Sickle Cell Disease
NCT ID: NCT00186810
Last Updated: 2009-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
1992-12-31
2007-10-31
Brief Summary
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The primary aim of the study was to evaluate how well the donated cells migrated to the bone marrow and begin producing healthy red blood cells, white blood cells and platelets (engrafted), how well the recipients immune system recovered, and assess any regimen related toxicities including a potentially life-threatening transplant related complication called graft-versus-host-disease or GVHD.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Busulfan, Cyclophosphamide, Horse ATG
Transplant recipients received a myeloablative conditioning regimen of cyclophosphamide, Anti-Thymocyte Globulin (horse), and Busulfan. Cyclosporine and methotrexate were administered for GVHD prophylaxis.
Allogeneic stem cell transplant
Allogeneic stem cell transplant Matched sibling donor transplant Cord blood transplant
Interventions
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Busulfan, Cyclophosphamide, Horse ATG
Transplant recipients received a myeloablative conditioning regimen of cyclophosphamide, Anti-Thymocyte Globulin (horse), and Busulfan. Cyclosporine and methotrexate were administered for GVHD prophylaxis.
Allogeneic stem cell transplant
Allogeneic stem cell transplant Matched sibling donor transplant Cord blood transplant
Eligibility Criteria
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Inclusion Criteria
* Previous central nervous system vaso-occlusive episode with or without residual neurologic findings or
* Frequent painful vaso-occlusive episodes with significant interference with normal life activities and which necessitates chronic transfusion therapy or
* Recurrent SCD chest syndrome events which necessitate chronic transfusion therapy.
Exclusion Criteria
* Patient with severe renal dysfunction defined as creatinine clearance \< 40 ml/min/1.73m2.
* Patient with severe cardiac dysfunction defined as echocardiogram shortening fraction \< 25%.
* Patient with HIV infection.
* Pregnant or lactating.
* Patient with unspecified chronic toxicity that in the opinion of the Principal Investigator is serious enough to detrimentally affect the patient's capacity to tolerate SCT.
* Patient or patient's guardian(s) unable to understand the nature and risks inherent in the BMT process
21 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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St. Jude Children's Research Hospital
Principal Investigators
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Gregory Hale, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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References
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Dallas MH, Triplett B, Shook DR, Hartford C, Srinivasan A, Laver J, Ware R, Leung W. Long-term outcome and evaluation of organ function in pediatric patients undergoing haploidentical and matched related hematopoietic cell transplantation for sickle cell disease. Biol Blood Marrow Transplant. 2013 May;19(5):820-30. doi: 10.1016/j.bbmt.2013.02.010. Epub 2013 Feb 14.
Related Links
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St. Jude Children's Research Hospital
Other Identifiers
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SCALLO
Identifier Type: -
Identifier Source: org_study_id