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

Summary

To study the efficacy and safety of combination of Ro-Peg-interferon-α2b (RoPegIFN) with Bosutinib (BOS) in comparison to BOS monotherapy, as frontline therapy for newly diagnosed chronic myeloid leukemia patients, and to estimate efficacy of the addition of RoPegIFN to BOS in terms of deep molecular response with the aim of increasing the proportion of patients who may achieve treatment free remission. (NCMLSG study #NordCML012)

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.

Sponsors & Collaborators

• Haukeland University Hospital

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• University Hospital of North Norway

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• Henri Mondor University Hospital

  collaborator OTHER

• Hôpital René Huguenin

  collaborator UNKNOWN

• Hôpital Mignot, Versailles Paris

  collaborator UNKNOWN

• Uppsala University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• St. Olavs Hospital

  lead OTHER

Principal Investigators

• Tom Christian Martinsen, md phd · St Olavs Hospital, Clinical of Internal Medicine

• Henrik Hjorth-Hansen, md phd · St. Olavs Hospital

• Lydia Roy, md phd · Centre Hospitalo-Universitaire Henri Mondor, Service d'Hematologie Clinique

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-25

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Denmark
• Finland
• Norway
• Sweden

Study Locations