Overview

A Study to Evaluate Steroid-free Treatment for Standard-Risk aGVHD (BMT CTN 1501)

Status:
Completed
Trial end date:
2019-02-19
Target enrollment:
Participant gender:
Summary
The study is a Phase II randomized, open label, multicenter trial designed to identify whether sirolimus is a potential alternative to prednisone as an up-front treatment for patients with standard-risk acute GVHD defined according to clinical and biomarker-based risk stratification. This trial incorporates both a novel up front GVHD therapy (sirolimus) as well as a novel BMT CTN developed acute GVHD biomarker test.
Phase:
Phase 2
Details
Lead Sponsor:
Medical College of Wisconsin
Collaborators:
Blood and Marrow Transplant Clinical Trials Network
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Marrow Donor Program
Treatments:
Everolimus
Prednisone
Sirolimus