Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis

PHASE2CompletedINTERVENTIONAL
Enrollment

212

Participants

Timeline

Start Date

March 25, 2019

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Chronic Myeloid Leukemia
Interventions
DRUG

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.

DRUG

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.

Trial Locations (18)

Unknown

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

All Listed Sponsors
collaborator

Haukeland University Hospital

OTHER

collaborator

Oslo University Hospital

OTHER

collaborator

University Hospital of North Norway

OTHER

collaborator

Helse Stavanger HF

OTHER_GOV

collaborator

Henri Mondor University Hospital

OTHER

collaborator

Hôpital René Huguenin

UNKNOWN

collaborator

Hôpital Mignot, Versailles Paris

UNKNOWN

collaborator

Uppsala University Hospital

OTHER

collaborator

Odense University Hospital

OTHER

lead

St. Olavs Hospital

OTHER

NCT03831776 - Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis | Biotech Hunter | Biotech Hunter