Multicentre Phase 2 Trial to Evaluate the Efficacy of Ruxolitinib in Steroid-refractory Acute 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)
Phase of Trial: Phase II
Latest Information Update: 04 Oct 2017
At a glance
- Drugs Ruxolitinib (Primary)
- Indications Graft-versus-host disease
- Focus Therapeutic Use
- Acronyms RIG
- 03 May 2017 Treatment arms has been changed from 1 to 2. Treatment with Ruxolitinib at a dose of 10 mg BID orally addition to BAT according DGHO-Onkopedia guidelines has been added and primary endpoint has changed from Proportion of patients with response to efficacy of Ruxolitinib and BAT as compared to BAT alone at day 28 after treatment start. patients number increases and official title also amended.
- 03 May 2017 Planned number of patients changed from 92 to 148.
- 03 May 2017 Planned End Date changed from 1 Dec 2020 to 1 Jan 2021.