Tacrolimus, Sirolimus and Ustekinumab vs. Tacrolimus and Sirolimus for the Prevention of Acute Graft-Versus-Host Disease — Ustekinumab  

Graft vs. Host Disease Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft vs. Host Disease

• NCT number: NCT01713400
• Study type: Interventional
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Status: Completed
• Phase: Phase 2
• Start date: February 25, 2013
• Completion date: June 14, 2018