212
Participants
Start Date
March 25, 2019
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2024
Bosutinib
Bosutinib, provided by Pfizer, starting dose of 200mg QD and stepwise dose escalation (\> 300 mg/d \> 400 mg/d) during the first three months. A pharmacological study will be performed in the French cohort (BOSUSTEP Substudy). BOS residual plasma concentration (Cmin) will be checked after initiation, before each dose step in the French cohort, and at M3 also for Nordic patients in ancillary studies.
Ropeginterferon
Ro-Peg-Interferon α2b will be supplied by AOP Orphan to be administered by subcutaneous injections from prefilled injection pens. RoPegIFN will be given in an open-label fashion. Patients assigned to RoPegIFN will start with 50 μg injected subcutaneously every 14 days, in combination with Bosutinib.
Aalborg university hospital, Aalborg
Aarhus ..., Aarhus
Copenhagen ..., Copenhagen
Odense Universitetshospital, Odense
Comprehensive Cancer Center, Hematology, Helsinki
Haukeland Universitetssjukehus, Bergen
Oslo Universitetssykehus, Oslo
Stavanger Universitetssjukehus, Stavanger
Universitetssykehuset Nord Norge, Tromsø
St Olavs Hospital, Trondheim
Göteborg ...., Gothenburg
Universitetssjukhuset Linköping, Linköping
Skåne University Hospital, Lund
Universitetssjukhuset Örebro, Örebro
Karolinska Universitetssjukhus, Stockholm
Sundsvall ..., Sundsvall
Norrlands Universitetssjukhus, Umeå
University Hospital, Uppsala
Haukeland University Hospital
OTHER
Oslo University Hospital
OTHER
University Hospital of North Norway
OTHER
Helse Stavanger HF
OTHER_GOV
Henri Mondor University Hospital
OTHER
Hôpital René Huguenin
UNKNOWN
Hôpital Mignot, Versailles Paris
UNKNOWN
Uppsala University Hospital
OTHER
Odense University Hospital
OTHER
St. Olavs Hospital
OTHER