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

PHASE3TerminatedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

June 16, 2022

Primary Completion Date

November 10, 2022

Study Completion Date

January 19, 2023

Conditions
Steroid-Refractory Acute Graft Versus Host Disease
Interventions
DRUG

T-Guard

T-Guard will be administered intravenously inpatient over 4 hours every 2 calendar days on Days 0, 2, 4, and 6, at a dose of 4mg/m2 Body Surface Area (BSA).

DRUG

Ruxolitinib

Ruxolitinib will be administered orally twice a day starting on Day 0 through Day 56, at a dose of 10mg. Ruxolitinib taper can be initiated starting on Day 56 for participants responding to treatment, tapering will be done according to institutional practices.

Trial Locations (48)

10029

Mount Sinai Medical Center, New York

27109

Wake Forest University, Winston-Salem

27710

Duke University Medical Center, Durham

33612

H. Lee Moffitt Cancer Center, Tampa

35294

University of Alabama, Birmingham

37203

Sarah Cannon Research Institute, Nashville

43210

Ohio State University, Columbus

53705

University of Wisconsin, Madison

63110

Washington University St. Louis, St Louis

84112

University of Utah, Salt Lake City

91010

City of Hope National Medical Center, Duarte

97239

Oregon Health & Science University, Portland

Unknown

Site BE300, Brussels

Site BE301, Brussels

Site BE307, Ghent

Site BE305, Leuven

Site BE302, Liège

Site BE303, Yvoir

Site HR320, Zagreb

Site FR341, Angers

Site FR345, Créteil

Site FR346, La Tronche

Site FR355, Lille

SiteFR354, Nantes

SiteFR342, Paris

SiteFR348, Paris

Site FR356, Pierre-Bénite

Site FR351, Saint-Priest-en-Jarez

Site FR352, Toulouse

Site DE367, Dresden

Site DE364, Essen

Site DE371, Hanover

Site DE368, Heidelberg

Site DE360, Leipzig

Site DE362, Mainz

Site DE361, Münster

Site IT384, Milan

Site NL461, Groningen

Site NL460, Maastricht

Site NL463, Nijmegen

Site ES447, Barcelona

Site ES446, Madrid

Site ES442, Salamanca

Site ES451, Santander

Site ES452, Seville

Site ES453, Valencia

Site ES454, Valencia

Site GB483, Cardiff

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Blood and Marrow Transplant Clinical Trials Network

NETWORK

collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Marrow Donor Program

OTHER

lead

Xenikos

INDUSTRY

NCT04934670 - A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002) | Biotech Hunter | Biotech Hunter