A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.

Active:	Yes
Cancer Type:	Unknown Primary	NCT ID:	NCT06143891
Trial Phases:	Phase III	Protocol IDs:	EFC17757 (primary) NCI-2023-10169 2023-505394-32 U1111-1280-4918
Eligibility:	12 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Sanofi Aventis
NCI Full Details:	http://clinicaltrials.gov/show/NCT06143891

Summary

This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate
or severe chronic GVHD.

The study duration for a participant includes up to 4 weeks for screening; a treatment
period until clinically meaningful cGVHD progression (defined as progression requiring
addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying
disease, participant starts new systemic treatment for cGVHD or experiences an
unacceptable toxicity, at the request of the participants or the investigators, or until
the end of study is reached, whichever comes first; at least 30 days follow-up of adverse
events (AEs) after the last dose until resolution or stabilization, if applicable; and
long-term follow-up until death or study close-out, whichever comes first.

Objectives

Up to 5 years

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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