Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008450
Status:
COMPLETED
Last Update Posted:
2019-07-29
First Post:
2001-01-06
Brief Title:
Total-Body Irradiation Followed By Cyclosporine and Mycophenolate Mofetil in Treating Patients With Severe Combined Immunodeficiency Undergoing Donor Bone Marrow Transplant
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Induction of Mixed Hematopoietic Chimerism in Patients With Severe Combined Immunodeficiency Disorders Using Allogeneic Bone Marrow and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil
Status:
COMPLETED
Status Verified Date:
2019-07
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:
This pilot clinical trial studies total-body irradiation followed by cyclosporine and mycophenolate mofetil in treating patients with severe combined immunodeficiency SCID undergoing donor bone marrow transplant Giving total-body irradiation TBI before a donor bone marrow transplant using stem cells that closely match the patients stem cells helps stop the growth of abnormal cells It may also stop the patients immune system from rejecting the donors stem cells The donated stem cells may mix with the patients immune cells and help destroy any remaining abnormal cells Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To safely establish partial lymphoid chimerism 1-95 donor cluster of differentiation CD3 cells using a non-lethal conditioning regimen in patients with severe combined immunodeficiency syndrome
II To define the kinetics of immune reconstitution following a non-lethal conditioning regimen in patients with immunodeficiency diseases
OUTLINE
Patients receive cyclosporine orally PO or intravenously IV on days -3 to 100 followed by a taper until day 180 and mycophenolate mofetil PO or IV on days 0-40 with a taper until day 96 in the absence of unacceptable toxicity Unrelated donor recipients also undergo TBI on day 0 Patients undergo bone marrow transplant on day 0
After completion of study treatment patients are followed up at 6 months and then yearly for 5 years
I To safely establish partial lymphoid chimerism 1-95 donor cluster of differentiation CD3 cells using a non-lethal conditioning regimen in patients with severe combined immunodeficiency syndrome
II To define the kinetics of immune reconstitution following a non-lethal conditioning regimen in patients with immunodeficiency diseases
OUTLINE
Patients receive cyclosporine orally PO or intravenously IV on days -3 to 100 followed by a taper until day 180 and mycophenolate mofetil PO or IV on days 0-40 with a taper until day 96 in the absence of unacceptable toxicity Unrelated donor recipients also undergo TBI on day 0 Patients undergo bone marrow transplant on day 0
After completion of study treatment patients are followed up at 6 months and then yearly for 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA015704 | NIH | Fred HutchUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |
| NCI-2010-02045 | REGISTRY | None | None |
| 122700 | OTHER | None | None |
| P01HL036444 | NIH | None | None |