<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03831776</url>
  </required_header>
  <id_info>
    <org_study_id>BosuPeg TRIAL</org_study_id>
    <secondary_id>2018-001044-54</secondary_id>
    <nct_id>NCT03831776</nct_id>
  </id_info>
  <brief_title>Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis</brief_title>
  <acronym>BosuPeg</acronym>
  <official_title>A Study of Efficacy and Safety of Long-acting Low Dose Ropeginterferon in Patients With Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis: a Randomized Prospective Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Henri Mondor University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital René Huguenin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital Mignot, Versailles Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Uppsala University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Olavs Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the efficacy and safety of combination of Ro-Peg-interferon-α2b (RoPegIFN) with&#xD;
      Bosutinib (BOS) in comparison to BOS monotherapy, as frontline therapy for newly diagnosed&#xD;
      chronic myeloid leukemia patients, and to estimate efficacy of the addition of RoPegIFN to&#xD;
      BOS in terms of deep molecular response with the aim of increasing the proportion of patients&#xD;
      who may achieve treatment free remission. (NCMLSG study #NordCML012)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Anticipated">March 2028</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of molecular response 4 (MR4)</measure>
    <time_frame>12 months</time_frame>
    <description>Molecular response 4 (MR4) is defined by either a positive BCR-ABL/ABL ratio ≤ 0.01% on the international scale (IS) or by undetectable BCR-ABL with the analysis of at least 10000 copies of ABL or 24000 copies of GUS (according to the ELN recommendations by N. Cross et al., Leukemia 2015)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of molecular response MR2, MR3, MR4, MR4.5 from 1 month up to 24 months and every 6 months thereafter</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of molecular response MR3, MR4, MR4.5</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of complete cytogenetic response (CCyR) up to 12 months</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of undetectable molecular response for patients who achieved molecular response MR4 and MR4.5</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to and duration of CCyR, MR3, MR4, MR4.5</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of patients eligible for randomization after 3 months of Bosutinib</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate and characteristics of severe adverse events (SAE)</measure>
    <time_frame>2 years</time_frame>
    <description>type and grade according to the NCI CTCAE v4.03</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose intensity of RoPegIFN and Bosutinib</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of discontinuation of the therapies, incl. reasons for discontinuation</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment by QLQC30 questionnaire up to 6 years at key time point (Day 1, month 3, month 6, month 12, month 24, month 48, month 54, month 72)</measure>
    <time_frame>6 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment by CML24 questionnaire up to 6 years at key time point (Day 1, month 3, month 6, month 12, month 24, month 48, month 54, month 72)</measure>
    <time_frame>6 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients achieving a durable deep molecular response and being eligible for treatment discontinuation at month 48</measure>
    <time_frame>4 years</time_frame>
    <description>Sustained deep molecular response (MR) criteria will be defined according updated data and ELN guidelines before the first patient will achieve month 48 (at least a MR4 over a 12 months period and confirmed on the last centralized measurement at month 48</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">212</enrollment>
  <condition>Chronic Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Bosutinib-Ropeginterferon combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Bosutinib monotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bosutinib</intervention_name>
    <description>Bosutinib, provided by Pfizer, starting dose of 200mg QD and stepwise dose escalation (&gt; 300 mg/d &gt; 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.</description>
    <arm_group_label>Bosutinib monotherapy</arm_group_label>
    <arm_group_label>Bosutinib-Ropeginterferon combination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropeginterferon</intervention_name>
    <description>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.</description>
    <arm_group_label>Bosutinib-Ropeginterferon combination</arm_group_label>
    <other_name>RoPegIFN</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed written informed consent form (ICF) before any procedure related to the study&#xD;
&#xD;
          -  Newly diagnosed (≤ 3 months) BCR-ABL positive chronic myeloid leukemia (CML) in&#xD;
             chronic phase&#xD;
&#xD;
          -  Major BCR-ABL transcripts (p210 b2a2(e13a2) and/or b3a2 (e14a2)&#xD;
&#xD;
          -  Not previously treated for CML except with hydroxyurea or anagrelide&#xD;
&#xD;
          -  ECOG Performance Status (ECOG PS) ≤ 2&#xD;
&#xD;
          -  Adequate organ function: Total bilirubin &lt; 1,5 times the institutional Upper Limit of&#xD;
             Normal (ULN); Hepatic enzymes ASAT and ALAT &lt; 2 times the institutional ULN; Serum&#xD;
             Creatinine &lt; 1.5 time the institutional ULN; Lipase &lt; 1.5 time the institutional ULN&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) must be using an adequate method of&#xD;
             contraception to avoid pregnancy throughout the study.&#xD;
&#xD;
          -  WOCBP must have a negative serum or urine pregnancy test at screening.&#xD;
&#xD;
          -  Free subject, without guardianship nor subordination&#xD;
&#xD;
          -  Health insurance coverage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with BCR-ABL transcript other than M-BCR-ABL&#xD;
&#xD;
          -  Patients previously treated with tyrosine kinase inhibitors (TKIs).&#xD;
&#xD;
          -  Inability to freely provide consent through judiciary or administrative condition.&#xD;
&#xD;
          -  Ongoing participation to another clinical investigational study.&#xD;
&#xD;
          -  Medical history and concurrent diseases: a) Hypersensitivity to any of the excipients&#xD;
             of BOS or RoPegIFN, b) Prior treatment with Interferon-α, contraindication to&#xD;
             interferon-α, c) Autoimmune disorder, concomitant immunosuppressive treatment or&#xD;
             corticosteroids, d) Pre-existing thyroid disease unless controlled with conventional&#xD;
             treatment, auto-immune thyroiditis, e) Chronic liver disease, f) Prior or ongoing&#xD;
             severe psychiatric disease, g) HIV positivity, chronic hepatitis B or C, h)&#xD;
             Uncontrolled or severe cardiac (NYHA Class III or IV) or pulmonary disease,&#xD;
             echocardiography with LVF &lt; 45% or LLN, peak velocity of tricuspid regurgitant flow &gt;&#xD;
             2,8 m/s, pulmonary arterial hypertension (PAH), QTc&gt;450 ms (by Barrets correction)&#xD;
&#xD;
          -  Other malignant disease during the last 5 years prior to the inclusion except&#xD;
             non-melanoma skin carcinoma or carcinoma in situ of the cervix,&#xD;
&#xD;
          -  History of significant bleeding disorder unrelated to CML or diagnosed congenital&#xD;
             bleeding disorder,&#xD;
&#xD;
          -  Subjects with an uncontrolled undercurrent illness or any concurrent condition that,&#xD;
             in the investigator's opinion, would jeopardize the safety of the subject or&#xD;
             compliance with the protocol.&#xD;
&#xD;
          -  Prohibited treatments and/or therapies: strong inhibitors/inducers of the CYP 3A4,&#xD;
&#xD;
          -  History / any condition for poor compliance to medical treatment.&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding are not eligible for this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tom Christian Martinsen, md phd</last_name>
    <role>Study Director</role>
    <affiliation>St Olavs Hospital, Clinical of Internal Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Henrik Hjorth-Hansen, md phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Olavs Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lydia Roy, md phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalo-Universitaire Henri Mondor, Service d'Hematologie Clinique</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Henrik Hjorth-Hansen, md phd</last_name>
    <phone>0047 73598673</phone>
    <email>henrik.hjorth-hansen@ntnu.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lydia Roy, md phd</last_name>
    <phone>0033 0149812111</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Aalborg university hospital</name>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Rie Sander Bech</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aarhus ...</name>
      <address>
        <city>Aarhus</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jesper Stentoft</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Copenhagen ...</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christen Lykkegård Andersen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Odense Universitetshospital</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Andreja Dimitrijevic</last_name>
    </contact>
    <contact_backup>
      <last_name>Marianne Augustenborg</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Center, Hematology</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Perttu M Koskenvesa</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Haukeland Universitetssjukehus</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bjørn Tore Gjertsen</last_name>
    </contact>
    <contact_backup>
      <last_name>Øystein Sefland</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Oslo Universitetssykehus</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kristin H Låstad</last_name>
    </contact>
    <investigator>
      <last_name>Eivind Galteland</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tobias Gedde-Dahl</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stavanger Universitetssjukehus</name>
      <address>
        <city>Stavanger</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Margrete Friestad</last_name>
    </contact>
    <investigator>
      <last_name>Mohammed Waleed Majeed</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitetssykehuset Nord Norge</name>
      <address>
        <city>Tromsø</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mats I Olsen</last_name>
    </contact>
    <contact_backup>
      <last_name>Anders Vik</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Henrik Hjorth-Hansen, md phd</last_name>
      <email>henrik.hjorth-hansen@ntnu.no</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Göteborg ....</name>
      <address>
        <city>Göteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitetssjukhuset Linköping</name>
      <address>
        <city>Linköping</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kourosh Lotfi</last_name>
    </contact>
    <contact_backup>
      <last_name>Arta Dreimane</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Skåne University Hospital</name>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Johan Richter</last_name>
    </contact>
    <contact_backup>
      <last_name>Anna Lubking</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Karolinska Universitetssjukhus</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Leif Stenke</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sundsvall ...</name>
      <address>
        <city>Sundsvall</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anders Själander</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Norrlands Universitetssjukhus</name>
      <address>
        <city>Umeå</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Berit Markevärn</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ulla Olsson-Strömberg</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitetssjukhuset Örebro</name>
      <address>
        <city>Örebro</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Erik Ahlstrand</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Norway</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bosupeg</keyword>
  <keyword>Ropeginterferon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03831776
org study id: BosuPeg TRIAL
secondary id: 2018-001044-54
nct id: NCT03831776
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of molecular response 4 (MR4)
time frame: 12 months
description: Molecular response 4 (MR4) is defined by either a positive BCR-ABL/ABL ratio ≤ 0.01% on the international scale (IS) or by undetectable BCR-ABL with the analysis of at least 10000 copies of ABL or 24000 copies of GUS (according to the ELN recommendations by N. Cross et al., Leukemia 2015)
measure: Rate of molecular response MR2, MR3, MR4, MR4.5 from 1 month up to 24 months and every 6 months thereafter
time frame: 2 years
measure: Cumulative incidence of molecular response MR3, MR4, MR4.5
time frame: 2 years
measure: Rate of complete cytogenetic response (CCyR) up to 12 months
time frame: 12 months
measure: Rate of undetectable molecular response for patients who achieved molecular response MR4 and MR4.5
time frame: 2 years
measure: Time to and duration of CCyR, MR3, MR4, MR4.5
time frame: 2 years
measure: proportion of patients eligible for randomization after 3 months of Bosutinib
time frame: 3 months
measure: rate and characteristics of severe adverse events (SAE)
time frame: 2 years
description: type and grade according to the NCI CTCAE v4.03
measure: Dose intensity of RoPegIFN and Bosutinib
time frame: 2 years
measure: Cumulative incidence of discontinuation of the therapies, incl. reasons for discontinuation
time frame: 2 years
measure: Quality of life assessment by QLQC30 questionnaire up to 6 years at key time point (Day 1, month 3, month 6, month 12, month 24, month 48, month 54, month 72)
time frame: 6 years
measure: Quality of life assessment by CML24 questionnaire up to 6 years at key time point (Day 1, month 3, month 6, month 12, month 24, month 48, month 54, month 72)
time frame: 6 years
measure: The proportion of patients achieving a durable deep molecular response and being eligible for treatment discontinuation at month 48
time frame: 4 years
description: Sustained deep molecular response (MR) criteria will be defined according updated data and ELN guidelines before the first patient will achieve month 48 (at least a MR4 over a 12 months period and confirmed on the last centralized measurement at month 48
arm group label: Bosutinib-Ropeginterferon combination
arm group type: Experimental
arm group label: Bosutinib monotherapy
arm group type: Active Comparator
intervention type: Drug
intervention name: Bosutinib
description: 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.
arm group label: Bosutinib monotherapy
arm group label: Bosutinib-Ropeginterferon combination
intervention type: Drug
intervention name: Ropeginterferon
description: 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.
arm group label: Bosutinib-Ropeginterferon combination
other name: RoPegIFN
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Tom Christian Martinsen, md phd
role: Study Director
affiliation: St Olavs Hospital, Clinical of Internal Medicine
last name: Henrik Hjorth-Hansen, md phd
role: Principal Investigator
affiliation: St. Olavs Hospital
last name: Lydia Roy, md phd
role: Principal Investigator
affiliation: Centre Hospitalo-Universitaire Henri Mondor, Service d'Hematologie Clinique
last name: Henrik Hjorth-Hansen, md phd
phone: 0047 73598673
email: henrik.hjorth-hansen@ntnu.no
last name: Lydia Roy, md phd
phone: 0033 0149812111
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country: Denmark
country: Finland
country: Norway
country: Sweden
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive