75
Participants
Start Date
August 31, 2016
Primary Completion Date
December 31, 2018
Study Completion Date
April 30, 2019
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."
First Pavlov State Medical University of St. Petersburg, Saint Petersburg
Ministry of Health, Russian Federation
OTHER_GOV
St. Petersburg State Pavlov Medical University
OTHER