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    Summary
    EudraCT Number:2018-001044-54
    Sponsor's Protocol Code Number:Bosupeg
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-03-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2018-001044-54
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of effect and safety of a new combination of drugs for chronic myeloid leukemia in chronic phase. Bosutinib is the basis treatment and patients will be randomized to receive or not to receive a long-acting low dose of Ropeginterferon.
    A.3.2Name or abbreviated title of the trial where available
    BosuPeg
    BosuPeg
    A.4.1Sponsor's protocol code numberBosupeg
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSt Olavs Hospital -Trondheim University Hospital
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Norge AS
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportAOP Orphan Pharmaceuticals AG
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSt Olavs Hospital
    B.5.2Functional name of contact pointHenrik Hjorth-Hansen
    B.5.3 Address:
    B.5.3.1Street AddressPB 3250 Sluppen
    B.5.3.2Town/ cityTrondheim
    B.5.3.3Post code7006
    B.5.3.4CountryNorway
    B.5.4Telephone number4772825176
    B.5.6E-mailhenrik.hjorth-hansen@ntnu.no
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Bosulif (bosutinib)
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Inc., 445 Eastern Point Road, MS 8260-1118, 06340 Groton, CT, USA
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBOSUTINIB
    D.3.9.1CAS number 380843-75-4
    D.3.9.4EV Substance CodeSUB29176
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Besremi
    D.2.1.1.2Name of the Marketing Authorisation holderAOP Orphan Pharmaceuticals AG
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/11/932
    D.3 Description of the IMP
    D.3.1Product namePegylated proline-interferon alpha 2b
    D.3.2Product code AOP2014
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGINTERFERON ALFA-2B
    D.3.9.1CAS number 215647-85-1
    D.3.9.4EV Substance CodeSUB12549MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic myeloid leukemia at diagnosis-chronich phase
    E.1.1.1Medical condition in easily understood language
    Chronic myeloid leukemia, a type of blood cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10009015
    E.1.2Term Chronic myeloid leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    Å vurdere effekten av å legge til RoPeginterferon til bosutinib for å oppnå meget god respons med målsetning å øka andel pasienter som kan slutte med medisin uten å få tilbakefall (behandlingsfri remisjon)
    E.2.2Secondary objectives of the trial
    • To compare cytogenetic and molecular response including kinetics through the treatment course.
    • To assess the proportion of patients eligible for randomization after the initial 3 months of BOS.
    • To determine and to compare safety and tolerability of the treatment in each arm.
    • To estimate reasons and cumulative rates of RoPegIFN and BOS discontinuation and the median dose of each drug by study arm.
    • To evaluate the tolerability, of a step-by-step dose schedule for BOS initiation (BOSUSTEP substudy)
    • To estimate the progression free, event-free and overall survival in each arm.
    • To estimate the proportion of patients achieving a durable deep molecular response and secondary eligibility for treatment discontinuation.
    • To compare the measurement of deep molecular response (by standard RTQPCR and digital droplet PCR (ddPCR),
    • To estimate and compare the rate of successful treatment discontinuation after M48 in each arm
    Se engelsk tekst
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A substudy of immunological parameters and a proteomic approach for identification of tumour markers is planned
    Se engelsk tekst
    E.3Principal inclusion criteria
    1) Signed written informed consent form (ICF) before any procedure related to the study
    2) Target Population
    a) Men and women, ages 18 to 75 years
    b) Newly diagnosed (≤ 3 months) BCR-ABL positive chronic myeloid leukemia in chronic phase
    c) Major BCR-ABL transcripts (p210 b2a2(e13a2) and/or b3a2(e14a2))
    d) Not previously treated for CML except with hydroxyurea or anagrelide
    e) ECOG Performance Status (ECOG PS) ≤ 2
    f) Adequate organ function.
    i. Total bilirubin < 1,5 times the institutional Upper Limit of Normal (ULN)
    ii. Hepatic enzymes ASAT and ALAT < 2 times the institutional ULN
    iii. Serum Creatinine < 1.5 time the institutional ULN
    iv. Lipase < 1.5 time the institutional ULN
    3) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
    4) WOCBP must have a negative serum or urine pregnancy test at screening.
    5) A male subject of fathering potential must use an adequate method of contraception to avoid conception throughout the study to minimize the risk of pregnancy.
    6) Free subject, without guardianship nor subordination
    7) Health insurance coverage.
    Se engelsk tekst
    E.4Principal exclusion criteria
    1) Patients with BCR-ABL transcript other than M-BCR-ABL
    2) Patients previously treated with tyrosine kinase inhibitors (TKIs).
    3) Medical history and concurrent diseases:
    a) Hypersensitivity to any of the excipients of BOS or RoPegIFN
    b) Prior treatment with Interferon-α, contraindication to interferon-α,
    c) Autoimmune disorder, concomitant immunosuppressive treatment or corticosteroids,
    d) Pre-existing thyroid disease unless controlled with conventional treatment, auto-immune thyroiditis
    e) Chronic liver disease,
    f) Prior or ongoing severe psychiatric disease
    g) HIV positivity, chronic hepatitis B or C
    h) Uncontrolled or severe cardiac (NYHA Class III or IV) or pulmonary disease,
    Echocardiography with LVF < 45% or LLN, peak velocity of tricuspid regurgitant flow > 2,8 m/s
    Pulmonary arterial hypertension (PAH),
    QTc>450 ms (by Barrets correction)
    i) Other malignant disease during the last 5 years prior to the inclusion except non-melanoma skin carcinoma or carcinoma in situ of the cervix,
    j) History of significant bleeding disorder unrelated to CML or diagnosed congenital bleeding disorder,
    k) Subjects with an uncontrolled undercurrent illness or any concurrent condition that, in the investigator’s opinion, would jeopardize the safety of the subject or compliance with the protocol.
    4) Prohibited treatments and/or therapies: strong inhibitors/inducers of the CYP 3A4,
    5) History / any condition for poor compliance to medical treatment.
    6) Women who are pregnant or breastfeeding are not eligible for this study
    7) Inability to freely provide consent through judiciary or administrative condition.
    8) Ongoing participation to another clinical investigational study.
    se engelsk tekst
    E.5 End points
    E.5.1Primary end point(s)
    To compare the rate of molecular response 4 (MR4) at 12 months in each treatment arm.
    Å sammenligne andel av pasienter, i hver studiearm for seg, vedrørende oppnåelse av molekylærrespons 4 (MR4) 12 måneder etter oppstart i studien
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months of treatment
    Etter 12 mnd behandling
    E.5.2Secondary end point(s)
    • The rates of molecular responses MR2, MR3, MR4, MR4.5, at 1, 2, 3, 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter in each arm.
    • The cumulative incidence of MR3, MR4, MR4.5 within the same periods in each arm.
    • The rates of complete cytogenetic response (CCyR) at 3, 6, 12 months.
    • The rates of undetectable molecular responses for the patients who achieved an MR4 and an MR4.5 in each arm.
    • The rates of MR4 and MR4.5 by standard RTQPCR IS and digital droplet PCR (ddPCR) on the centralized molecular samples, for the patients who achieve an MR4 or better: comparison for sensitivity and accuracy of the 2 methods at key time points to be decided (ie Month 12 and Month 48)
    • Time to and duration of CCyR, MR3, MR4, MR4.5.
    • The proportion of patients eligible for randomization after 3 months of BOS
    • The rates and characteristics of severe adverse events (SAE) and adverse events (AE) related to BOS and RoPegIFN, from clinical and biological assessments: type and grade according to the NCI CTCAE v4.03.
    • The dose intensity of RoPegIFN and BOS administered during the first two years of study treatment. The cumulative incidence of discontinuation of the therapies. Reasons of discontinuation.
    • Other endpoints for the BOSUSTEP substudy within the first three months of BOS:
    - Any grade of diarrhea and GI toxicity
    - Other AE > grade 1 related to BOS
    - The final dose level of BOS by 3 months
    - The proportion of patients with transient treatment discontinuation
    - The proportion of patients with permanent treatment discontinuation
    - Cytogenetic and Molecular responses assessed by BCR-ABL IS at M3 and M6
    - The relationship between plasma residual concentration (Cmin) after dose escalation steps and tolerance / efficacy of BOS in a subset of patients (French cohort), and at M3 for Nordic patients who take part in ancillary projects.
    • The progression free survival, the event-free survival and the overall survival. Occurrence and type of BCR-ABL TK mutation
    • Quality of life assessment by QLQC30 and CML24 questionnaires at key time point (Day 1, M3, M6, M12, M24, M48, M54, M72)
    • The proportion of patients achieving a durable deep molecular response and being eligible for treatment discontinuation at month 48. Sustained deep molecular response 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 M48)
    • The proportion of patients in treatment free remission after 6, 12, 24 and 36 months of BOS discontinuation, from M48.
    Se engelsk tekst
    E.5.2.1Timepoint(s) of evaluation of this end point
    See text above in E5.2.Many time points
    Se E5.2
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    Bosutinib alone
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV q3 2028
    Sidste lægebesøg i studiet q3 2028
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 145
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 67
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 212
    F.4.2.2In the whole clinical trial 212
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Treatment according to guidelines in the patient's countries by advice of their treating physicians.
    Behandling gis etter gjengse retningslinjer i pasientens land og etter råd fra pasientens behandlende hematolog.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Nordic CML Study group
    G.4.3.4Network Country Norway
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation France Intregroupe LMC
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-15
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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