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

NCT01927120 ↗

Phase 2 Completed 20 enrolled H. Lee Moffitt Cancer Center and Research Institute

NaSingle-groupOpen-labelPrevention

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).

Timeline

Start: 2014-03-25
Primary completion: 2016-08-25
Completion: 2017-03-09

Publications

Betts BC, Pidala J, Kim J, Mishra A, Nishihori T, Perez L, Ochoa-Bayona JL, Khimani F, Walton K, Bookout R, Nieder M, Khaira DK, Davila M, Alsina M, Field T, Ayala E, Locke FL, Riches M, Kharfan-Dabaja M, Fernandez H, Anasetti C. IL-2 promotes early Treg reconstitution after allogeneic hematopoietic cell transplantation. Haematologica. 2017 May;102(5):948-957. doi: 10.3324/haematol.2016.153072. Epub 2017 Jan 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sirolimus	Small molecule	12 mg	Oral
Subject	Tacrolimus	Small molecule	0.01 mg/kg	Intravenous
Subject	aldesleukin	Protein / enzyme biologic	200000 unknown	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications