Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304720
Status:
UNKNOWN
Last Update Posted:
2008-02-08
First Post:
2006-03-17
Brief Title:
Tacrolimus and MMF as Post Grafting Immunosuppression After Conditioning With Flu TBI for HLA Matched Family Donor
Sponsor:
Colorado Blood Cancer Institute
Organization:
Colorado Blood Cancer Institute
Study Overview
Official Title:
Tacrolimus and Mycophenolate Mofetil as Post-Grafting Immunosuppression After Conditioning With Fludarabine and Low-Dose Total Body Irradiation for Recipients of HLA-Matched Family Donor Hematopoietic Cell Transplants
Status:
UNKNOWN
Status Verified Date:
2004-03
Last Known Status:
RECRUITING
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:
Primary Objective
A To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients receiving a non-myeloablative allogeneic SCT from a matched sibling donor with fludarabine and low-dose TBI with pre- and post-transplant immunosuppression with tacrolimus and MMF
B To evaluate the incidence of grade II-IV GVHD associated with this treatment
A To determine whether stable allogeneic hematopoietic engraftment can be safely established in patients receiving a non-myeloablative allogeneic SCT from a matched sibling donor with fludarabine and low-dose TBI with pre- and post-transplant immunosuppression with tacrolimus and MMF
B To evaluate the incidence of grade II-IV GVHD associated with this treatment
Detailed Description:
Conditioning regimen
1 Days - 4 to -2 Fludarabine 30 mgm2day IV
2 Day 0 TBI 20 Gy at 6-7 cGymin from a linear accelerator followed by stem-cell infusion TBI will preferably be administered between 700 am and 100 pm to avoid proximity to tacrolimusMMF administration
Immunosuppression
Day -3 Start tacrolimus at 006 mgkg PO BID Day 0 Start MMF at 15 mgkg PO bid from day 0 PM dose only
1 Days - 4 to -2 Fludarabine 30 mgm2day IV
2 Day 0 TBI 20 Gy at 6-7 cGymin from a linear accelerator followed by stem-cell infusion TBI will preferably be administered between 700 am and 100 pm to avoid proximity to tacrolimusMMF administration
Immunosuppression
Day -3 Start tacrolimus at 006 mgkg PO BID Day 0 Start MMF at 15 mgkg PO bid from day 0 PM dose only
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