Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360685
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2006-08-03
Brief Title:
Tacrolimus and Mycophenolate Mofetil MMF in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate MTX
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Safety of Tacrolimus And Methotrexate MTX Versus Tacrolimus And Mycophenolate Mofetil MMF As Graft Versus Host Disease Prophylaxis In Allogeneic Hematopoietic Cell Transplants HCT
Status:
COMPLETED
Status Verified Date:
2013-03
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:
A comparative trial where all patients will receive daily doses of tacrolimus TAC until day 60 when tapering will begin in the absence of graft-versus-host disease GVHD and discontinued by day 180 In addition patients will be randomized to methotrexate MTX or mycophenolate mofetil MMF and again in the absence of GVHD a tapering schedule will begin on day 240 and be completed on day 360 Doses will be adjusted to maintain blood levels
Detailed Description:
The randomization for this comparative trial will be stratified by conditioning regimen and for those patients enrolled on MCC-14178 by busulfan AUC level
All patients will receive daily doses of TAC beginning day -3 day 0 being the day of hematopoietic stem cell transplant HCT and will be given until day 60 when tapering will begin in the absence of GVHD Provided no GVHD develops TAC should be discontinued by day 180 Doses will be adjusted to maintain blood levels
In addition to TAC patients will be randomized to one of the following additional anti-GVHD medications MTX or MMF beginning day 0 at least 2 hours after the end of the HCT In the absence of GVHD a tapering schedule will begin on day 240 and be completed on day 360
Study participants will be extensively monitored as inpatients and then weekly as outpatients Some tests will be conducted at least twice weekly blood tests toxicity data GVHD and physical exams one-month post-transplant and during the tapering off periods for up to 2 years
All patients will receive daily doses of TAC beginning day -3 day 0 being the day of hematopoietic stem cell transplant HCT and will be given until day 60 when tapering will begin in the absence of GVHD Provided no GVHD develops TAC should be discontinued by day 180 Doses will be adjusted to maintain blood levels
In addition to TAC patients will be randomized to one of the following additional anti-GVHD medications MTX or MMF beginning day 0 at least 2 hours after the end of the HCT In the absence of GVHD a tapering schedule will begin on day 240 and be completed on day 360
Study participants will be extensively monitored as inpatients and then weekly as outpatients Some tests will be conducted at least twice weekly blood tests toxicity data GVHD and physical exams one-month post-transplant and during the tapering off periods for up to 2 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