Infliximab for the Prevention of Graft-versus-Host Disease Following Allogenic Hematopoietic Stem Cell Transplantation

NCT00201799 ↗

Phase 2 Completed 19 enrolled Ohio State University Comprehensive Cancer Center

NaSingle-groupOpen-labelPrevention

Summary

This study will evaluate the efficacy of infliximab in reducing the incidence of grade II-IV acute graft versus host disease by day +100 post-transplant in patients undergoing allogeneic hematopoietic stem cell transplant.

Timeline

Start: 2004-02
Primary completion: 2006-08
Completion: 2008-03

Outcome

Missed primary endpoint

paper The cumulative incidences of grades II-IV aGVHD in the infliximab and control groups were 36.8% and 36.6%, respectively (P = .77). PMID 18541197 ↗

paper The addition of infliximab to standard GVHD prophylaxis did not lower the risk of GVHD PMID 18541197 ↗

Publications

Results Hamadani M, Hofmeister CC, Jansak B, Phillips G, Elder P, Blum W, Penza S, Lin TS, Klisovic R, Marcucci G, Farag SS, Devine SM. Addition of infliximab to standard acute graft-versus-host disease prophylaxis following allogeneic peripheral blood cell transplantation. Biol Blood Marrow Transplant. 2008 Jul;14(7):783-9. doi: 10.1016/j.bbmt.2008.04.006.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Infliximab	Monoclonal antibody	10 mg/kg	Intravenous