BMT Tandem Meetings | Study design of the REACH-3 trial using ruxolitinib in steroid refractory GvHD

The GvHD Hub was pleased to attend the 2018 BMT Tandem Meetings in Salt Lake City, Utah. Wednesday February 21, study design was presented from Robert Zieser of the Medical University of Freiburg in Germany regarding a prospective trial of ruxolitinib compared to best available therapy (BAT) in patients with steroid refractory chronic graft versus host disease (SR-cGvHD). The REACH-3 trial will review safety and efficacy of ruxolitinib in this population of pediatric and adult patients.

Ruxolitinib is a janus-associated kinase 1 and 2 inhibitor (JAK1, JAK2). The implications of JAK 1 and 2 inhibition, lead to decreased signaling of inflammatory mediators associated with cGvHD, such as tumor necrosis factor and interleukins. 

This study will allow patients to continue therapy with steroids or calcineurin inhibitors, while on ruxolitinib and compare to patients receiving standard cGVHD therapies alone. The primary outcome measure will be overall response rate at 6 months. Multiple secondary analyses will be conducted, including relapse of primary disease, non-relapse mortality, a need to add therapies in addition to steroids or calcineurin inhibitors, decrease in corticosteroid dose, duration of response, adverse events and overall survival.

Ruxolitinib has shown great promise as a therapy for SR-cGVHD based on responses from a retrospective survey.  The upcoming data from this prospective clinical trial are anticipated to provide data leading to promising survival outcomes for patients with cGVHD.