Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010361
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2001-02-02
Brief Title:
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
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-08
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:
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
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
Detailed Description:
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
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
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-147500 | None | None | None |