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In Vivo Treg Expansion and Graft-Versus-Host Disease Prophylaxis

Graft-Versus-Host-Disease Clinical Trial

Official title:
In Vivo Treg Expansion and Graft-Versus-Host Disease Prophylaxis With IL-2, Sirolimus, and Tacrolimus Following Allogeneic Hematopoietic Cell Transplantation

Clinical Trial Summary

IL-2 add-back post allogeneic hematopoietic stem cell transplant (HSCT), combined with Sirolimus (SIR), Tacrolimus (TAC) will optimize Treg reconstitution and prevent graft versus host disease (GVHD).

Clinical Trial Description

1) Determine if a GVHD prophylaxis regimen of IL-2/SIR/TAC enhances in vivo Treg differentiation and growth; 2) Study the safety and effects of IL-2/SIR/TAC on the incidence of acute and chronic GVHD; 3) Evaluate the influence of dual IL-2 supplementation and mammalian target of rapamycin (mTOR) inhibition on T cell-specific signaling pathways and the polarization of emerging T helper cells. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01927120
Study type Interventional
Source H. Lee Moffitt Cancer Center and Research Institute
Contact
Status Active, not recruiting
Phase Phase 2
Start date March 25, 2014
Completion date January 2018
View Details
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