Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352976
Status:
COMPLETED
Last Update Posted:
2021-11-24
First Post:
2006-07-14
Brief Title:
TBI Dose De-escalation for Fanconi Anemia
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Total Body Irradiation Dose De-escalation Study in Patients With Fanconi Anemia Undergoing Alternate Donor Hematopoietic Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2021-10
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 is a single arm total body irradiation TBI trial All patients will be prescribed TBI 300 cGy with the goal of evaluating secondary endpoints
Detailed Description:
Study Treatment Patients will receive voriconazole antifungal therapy by mouth beginning 1 month prior to conditioning therapy if possible 1 The subject is to receive total body irradiation 300 cGy with thymic shielding it will be given six days before the stem cells are given day -6 2 Day -5 through Day -2 subjects will receive a chemotherapy regimen of Fludarabine and Cyclophosphamide via central line ie Hickman or Broviac Starting Day -3 patients will receive sirolimus therapy with a taper commencing on day 180 and also mycophenolate mofetil MMF through day 30 or for 7 days after engraftment whichever day is later if no acute graft-versus-host disease GVHD 4 If the subject is receiving bone marrow or peripheral stem cells cells collected from the donors arm via a cell separator on the day of transplantation the stem cells taken from the donor will be put into a machine which will separate the lymphocytes the cells that cause graft-versus-host disease GVHD from the stem cells If the subject is receiving an umbilical cord blood the lymphocytes will not be removed because the risk of GVHD is not as high Otherwise all patients will receive the same treatment The stem cells are given as an infusion into the subjects existing catheter over 1-2 hours on day 05 On the day after transplant day 1 subjects will be given G-CSF to stimulate the growth of the transplanted cells 6 While receiving treatment and until the subjects blood counts recover heshe will have daily blood tests and several bone marrow biopsies and aspirates After recovery subjects will be seen once a month for a health assessment and blood tests until at least 3 months after the cells have been infused Additional blood tests or assessments may be done as medically indicated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 0605M85788 | OTHER | IRB University of Minnesota | None |