drugset

drugset / Trial / NCT04128319

T-Guard as Treatment for Steroid Refractory Acute GVHD (BMT CTN 1802)

NCT04128319 ↗

Phase 3 Terminated 3 enrolled Xenikos Blood and Marrow Transplant Clinical Trials Network · collab National Cancer Institute (NCI) · collab National Heart, Lung, and Blood Institute (NHLBI) · collab National Marrow Donor Program · collab

NaSingle-groupOpen-labelTreatment

Summary

The study is designed as an open-label, single arm Phase III, multicenter trial to evaluate the efficacy and safety of T-Guard treatment in patients with Steroid-Refractory acute Graft versus Host Disease (SR-aGVHD).

Timeline

Start: 2019-11-21
Primary completion: 2020-02-17
Completion: 2020-02-17

Publications

Results Meyers G, Hamadani M, Martens M, Ali H, Choe H, Dawson P, Harris AC, van Hooren E, Klaassen W, Leifer E, MacMillan ML, van Oosterhout Y, Perez L, Pusic I, Vo P, Levine JE. Lessons learned from early closure of a clinical trial for steroid-refractory acute GVHD. Bone Marrow Transplant. 2022 Feb;57(2):302-303. doi: 10.1038/s41409-021-01529-x. Epub 2021 Nov 23. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	T-Guard	Protein / enzyme biologic	4 mg/m2	Intravenous

Indications