Clinical Trial: Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease Following Allogeneic Hematopoietic Cell Transplant
Brief Summary: To determine whether treatment with ustekinumab will alter the ratio of T Regulatory Cell (Treg)/total cluster of differentiation 4 (CD4)+ cells in peripheral blood at day 30 post-hematopoietic cell transplantation (HCT).
Detailed Summary: 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 SIR/TAC. Patients will be randomly assigned between the standard regimen of tacrolimus/sirolimus (TAC/SIR + placebo) vs. the investigational regimen of tacrolimus/sirolimus/ustekinumab (TAC/SIR/U) in a 1:1 scheme.
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Current Primary Outcome: T Regulatory Cell (Treg)/Total Cluster of Differentiation 4 (CD4)+ Ratio [ Time Frame: 30 days post transplant ]
Original Primary Outcome: Treg/total CD4+ ratio [ Time Frame: 30 days post transplant ]
Current Secondary Outcome: Incidence of Acute Graft vs. Host Disease (AGVHD) [ Time Frame: 100 days post transplant ]
Original Secondary Outcome: Incidence of Acute Graft vs. Host Disease [ Time Frame: 100 days post transplant ]
Information By: H. Lee Moffitt Cancer Center and Research Institute
Dates:
Date Received: October 22, 2012
Date Started: February 2013
Date Completion: January 2018
Last Updated: March 28, 2017
Last Verified: March 2017