Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004485
Status:
COMPLETED
Last Update Posted:
2008-09-10
First Post:
1999-10-18
Brief Title:
Bone Marrow Transplantation in Treating Children With Sickle Cell Disease
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
Phase III Study of Induction of Stable Mixed Chimerism After Bone Marrow Transplantation From HLA-Identical Donors in Children With Sickle Cell Disease
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 III trial to study the effectiveness of bone marrow transplantation in treating children who have sickle cell disease
PURPOSE Phase III trial to study the effectiveness of bone marrow transplantation in treating children who have sickle cell disease
Detailed Description:
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
Patients are followed for 100 days monthly for 6 months and then annually for 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FHCRC-137300 | None | None | None |