Ignite Creation Date:
2024-05-06 @ 1:03 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01713400
Status:
COMPLETED
Last Update Posted:
2020-03-04
First Post:
2012-10-22
Brief Title:
Tacrolimus Sirolimus and Ustekinumab vs Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Tacrolimus Sirolimus and Ustekinumab vs Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2020-03
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:
Ustekinumab
Brief Summary:
To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell Tregtotal cluster of differentiation 4 CD4 cells in peripheral blood at day 30 post-hematopoietic cell transplantation HCT
Detailed Description:
This is a comparative study to assess the biologic and clinical activity of the agent ustekinumab when given in concert with our established regimen of SIRTAC Patients will be randomly assigned between the standard regimen of tacrolimussirolimus TACSIR placebo vs the investigational regimen of tacrolimussirolimusustekinumab TACSIRU in a 11 scheme
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