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

Phase 2 Completed 54 enrolled H. Lee Moffitt Cancer Center and Research Institute Gateway for Cancer Research · collab

RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start: 2013-02-25
Primary completion: 2014-10-27
Completion: 2018-06-14

Publications

Pidala J, Beato F, Kim J, Betts B, Jim H, Sagatys E, Levine JE, Ferrara JLM, Ozbek U, Ayala E, Davila M, Fernandez HF, Field T, Kharfan-Dabaja MA, Khaira D, Khimani F, Locke FL, Mishra A, Nieder M, Nishihori T, Perez L, Riches M, Anasetti C. In vivo IL-12/IL-23p40 neutralization blocks Th1/Th17 response after allogeneic hematopoietic cell transplantation. Haematologica. 2018 Mar;103(3):531-539. doi: 10.3324/haematol.2017.171199. Epub 2017 Dec 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ustekinumab	Monoclonal antibody	45 mg	Subcutaneous
Subject	Ustekinumab	Monoclonal antibody	90 mg	Subcutaneous
Background	Sirolimus	Small molecule	—	Oral
Background	Tacrolimus	Small molecule	—	—

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

Summary

Timeline

Publications

Drugs

Indications