Ruxolitinib In GvHD

Phase 2 Terminated 22 enrolled Prof. Dr. Nikolas von Bubnoff Clinical Trials Unit Freiburg · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The preliminary data demonstrate potent activity of Ruxolitinib in steroid-refractory aGvHD. In this phase 2 trial the efficacy of Ruxolitinib and best available treatment (BAT) versus BAT in steroid-refractory acute GvHD in approximately 12 transplantation centers in Germany will be compared. The response by monitoring the clinical GvHD grade, requirement of alternative GvHD active agents and serum levels of pro-inflammatory cytokines will be determined.

Timeline

Start: 2017-06-29
Primary completion: 2019-11-15
Completion: 2019-11-15

Outcome

Outcome not reported

Stopped (Enrollment): “impossibility to recruit in the BAT arm”

Publications

von Bubnoff N, Ihorst G, Grishina O, Rothling N, Bertz H, Duyster J, Finke J, Zeiser R. Ruxolitinib in GvHD (RIG) study: a multicenter, randomized phase 2 trial to determine the response rate of Ruxolitinib and best available treatment (BAT) versus BAT in steroid-refractory acute graft-versus-host disease (aGvHD) (NCT02396628). BMC Cancer. 2018 Nov 19;18(1):1132. doi: 10.1186/s12885-018-5045-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ruxolitinib	Small molecule	10 mg	Oral