Ruxolitinib for Steroid-refractory GVHD

PHASE2CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

December 31, 2018

Study Completion Date

April 30, 2019

Conditions
Graft Vs Host Disease
Interventions
DRUG

Ruxolitinib Oral Tablet

"Dose reduction criteria for acute GVHD: grade 4 neutropenia or grade 4 thrombocytopenia related to ruxolitinib administration based on the decision of attending physician.~Dose reduction criteria for chronic GVHD: grade 3 neutropenia, grade 3 thrombocytopenia or anemia requiring transfusion, related to ruxolitinib administration based on the decision of attending physician.~Reduced dose schedule: 5 mg bid for adults and children with body weight \> 40 kg, 0.08 mg/kg bid for children with body weight \< 40 kg.~Treatment discontinuation criteria: complete response; absence of response after 28 days or progressive disease after 7 days for acute GVHD; absence of response after 84 days or progressive disease after 28 days for chronic GVHD; life-threatening complications."

Trial Locations (1)

197089

First Pavlov State Medical University of St. Petersburg, Saint Petersburg

All Listed Sponsors
collaborator

Ministry of Health, Russian Federation

OTHER_GOV

lead

St. Petersburg State Pavlov Medical University

OTHER

NCT02997280 - Ruxolitinib for Steroid-refractory GVHD | Biotech Hunter | Biotech Hunter