A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)

Phase 3 Terminated 12 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

RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, randomized, Phase 3, multicenter trial, which has been designed to compare the efficacy and safety of T-Guard to ruxolitinib in patients with Grade III or IV Steroid-Refractory acute Graft-Versus-Host Disease (SR-aGVHD). The primary hypothesis is that T-Guard treatment will improve the Day 28 complete response (CR) rate in patients with Grades III and IV SR-aGVHD compared to ruxolitinib.

Timeline

Start: 2022-06-16
Primary completion: 2022-11-10
Completion: 2023-01-19

Publications

Results Meyers G, Hamadani M, Martens M, Ali H, Chevallier P, Choe H, Harris AC, Holler E, van Hooren E, Klaassen W, Leifer E, van Oosterhout Y, Perez L, Pusic I, Stelljes M, van der Velden W, Ammatuna E, Beauvais D, Cornillon J, Maziarz RT, Schetelig J, Romeril J, MacMillan ML, Levine JE, Socie G. Anti-CD3/CD7 immunoconjugate (T-Guard) for severe, steroid-refractory GVHD: final report of BMT CTN 2002. Bone Marrow Transplant. 2023 Dec;58(12):1416-1418. doi: 10.1038/s41409-023-02110-4. Epub 2023 Sep 25. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ruxolitinib	Small molecule	10 mg	Oral
Subject	T-Guard	Protein / enzyme biologic	4 mg/m2	Intravenous

A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)

Summary

Timeline

Publications

Drugs

Indications