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 ]

Median Blood Treg/Total CD4+ Ratio at day 30 following hematopoietic cell transplantation (HCT). Comparison between study arms: Ustekinumab vs. Placebo. From NCI Dictionary: "T reg" - A type of immune cell that blocks the actions of some other types of lymphocytes, to keep the immune system from becoming over-active. T regs are being studied in the treatment of cancer. A T reg is a type of white blood cell and a type of lymphocyte. Also called regulatory T cell, suppressor T cell, and T-regulatory cell.


Original Primary Outcome: Treg/total CD4+ ratio [ Time Frame: 30 days post transplant ]

Treg/total CD4+ ratio at day 30 following HCT


Current Secondary Outcome: Incidence of Acute Graft vs. Host Disease (AGVHD) [ Time Frame: 100 days post transplant ]

Cumulative incidence of Grade II - IV AGVHD to be characterized weekly from day of transplant to day 100 using the 1995 updated grading scheme for Graft vs. Host Disease (GVHD) developed by Glucksberg, et al.


Original Secondary Outcome: Incidence of Acute Graft vs. Host Disease [ Time Frame: 100 days post transplant ]

Incidence of acute graft vs. host disease will be characterized weekly from day of transplant to day 100 using the 1995 updated grading scheme for GVHD developed by Glucksberg, et al.


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