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    Summary
    EudraCT Number:2013-004974-82
    Sponsor's Protocol Code Number:2013.837
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2013-004974-82
    A.3Full title of the trial
    PETALS study : PEgylated interferon-alpha2a and TAsigna® for first Line therapy of Philadelphia chromosome-positive chronic phase CML patientS
    Etude randomisée de phase III, comparant le taux de réponse moléculaire 4.5 à 12 mois chez des patients atteints de leucémie myéloïde chronique en phase chronique (LMC PC), de novo, chromosome Philadelphie positive, traités par nilotinib 600mg par jour versus nilotinib 600mg par jour plus Interféron-alpha 2a pégylé (PEG-IFN)
    Protocole PETALS
    PEgylated interferon-alpha2a and TAsigna® for first Line therapy of chronic phase CML patientS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study comparing treatment with nilotinib 600mg daily versus nilotinib 600 mg daily plus pegylated interferon-alpha 2a (PEG-IFN) in patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase de novo
    Etude clinique comparant le traitement par nilotinib 600mg par jour versus nilotinib 600mg par jour plus Interféron-alpha 2a pégylé (PEG-IFN) chez des patients atteints de leucémie myéloïde chronique en phase chronique (LMC PC), de novo, chromosome Philadelphie positive
    A.3.2Name or abbreviated title of the trial where available
    PETALS
    PETALS
    A.4.1Sponsor's protocol code number2013.837
    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 SponsorHospices Civils de Lyon
    B.1.3.4CountryFrance
    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 supportNOVARTIS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointD.R.C.I
    B.5.3 Address:
    B.5.3.1Street Address3 quai des célestins
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69229
    B.5.3.4CountryFrance
    B.5.4Telephone number+33472115296
    B.5.5Fax number+33472115190
    B.5.6E-mailfiorella.portis@chu-lyon.fr
    D. IMP Identification
    D.IMP: 1
    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 Pegasys 135 microgrammes solution injectable.
    D.2.1.1.2Name of the Marketing Authorisation holderRoche
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.1Product namePegasys
    D.3.4Pharmaceutical form Solution for injection
    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-2A
    D.3.9.1CAS number 198153-51-4
    D.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number135
    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 Yes
    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 phase chronic myeloid leukaemia with Philadelphia chromosome positive or BCR-ABL positive
    leucémie myéloïde chronique en phase chronique avec chromosome Philadelphie positif ou BCR-ABL positif
    E.1.1.1Medical condition in easily understood language
    Chronic phase chronic myeloid leukaemia
    leucémie myéloïde chronique
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10034877
    E.1.2Term Philadelphia chromosome positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10052065
    E.1.2Term Chronic phase chronic myeloid leukaemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this test is to determine the molecular 4.5 cumulative response rate (RM 4.5) at 12 months and confirmed three months later after treatment with nilotinib compared to those induced by a combination of nilotinib + PEG-low-dose IFN in patients with CML in newly diagnosed chronic phase (<3 months).
    L’objectif principal de cet essai est de déterminer les taux cumulatifs de réponse moléculaire 4,5 (RM 4,5) à 12 mois et confirmé 3 mois plus tard après traitement par nilotinib comparé à ceux induits par une association de nilotinib + PEG-IFN à faible dose, chez des patients présentant une LMC en phase chronique nouvellement diagnostiquée (< 3 mois).
    E.2.2Secondary objectives of the trial
    Compare between the 2 treatment groups:
    1 - kinetics of obtaining RM 4.5 to 1 , 2, 3 , 6, 9 and 12 months and the stability of the RM 4.5 during the 2nd and 3rd year of treatment (15, 18, ​​24, 30 and 36 months).
    2 - The kinetics of obtaining RMM 1, 2 , 3, 6 , 9 and 12 months and the stability of the MMR during the 2nd and 3rd year of treatment (15, 18, ​​24 , 30, and 36 months) .
    3 - The rate of patients with a BCR-ABL/ABL ( SI ) ≥ 10 % at 3 and 6 months .
    4 - The cumulative rate of complete cytogenetic response ( CCyR) at 3, 6 and 12 months.
    5 - Tolerance (haematological adverse events and non -haematological ranking according to the NCI CTC AE v4) of the association nilotinib -PEG- IFN .
    6 - the quality of life of treated patients.
    7 - The rate of dose reduction or interruption of each treatment.
    8 - The compliance to treatment in the 2 arms assessed by the Morisky questionnaire .
    9 - The event-free survival .
    10 - Progression-free survival .
    11 - Overall survival .
    Comparer entre les 2 groupes de traitement :
    1- la cinétique d’obtention de la RM 4,5 à 1, 2, 3, 6, 9 et 12 mois et la stabilité de la RM 4,5 durant la 2eme et 3eme année de traitement (15, 18, 24, 30, et 36 mois).
    2- La cinétique d’obtention de la RMM à 1, 2, 3, 6, 9 et 12 mois et la stabilité de la RMM durant la 2ème et 3ème année de traitement (15, 18, 24, 30, et 36 mois).
    3- Le taux de patients avec un BCR-ABL/ABL (IS) ≥ 10% à 3 et 6 mois.
    4- Le taux cumulé de réponse cytogénétique complète (RCyC) à 3, 6 et 12 mois.
    5- La tolérance (évènements indésirables hématologiques et non-hématologiques gradés selon le NCI CTC AE v4) de l’association nilotinib-PEG-IFN.
    6- la qualité de vie des patients traités.
    7- Le taux de réduction de dose ou d’interruption de chaque traitement.
    8- La compliance aux traitements dans les 2 bras évalué par le questionnaire de Morisky.
    9- La survie sans événement.
    10- La survie sans progression.
    11- La survie globale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Chronic Myelogenous Leukemia - Chronic phase positive to the Philadelphia chromosome or BCR-ABL diagnosed less than 3 months prior to study entry
    Patient for whom treatment with Nilotinib is planned
    men and women patients age ≥ 18 years
    ECOG score 0-2
    No other CML treatment except for hydroxyurea and/or anagrelide
    Without prior treatment with IFN or ITK (same for other purposes),
    AST and ALT <2.5 x ULN.
    Serum creatinine <2 x ULN
    No planned allogeneic stem cell transplantation
    Informed consent signed
    Leucémie Myéloide Chronique - Phase chronique chromosome philadelphie positif ou BCR-ABL positive diagnostiquée depuis moins de 3 mois avant l’inclusion dans l'étude
    Patient pour lequel un traitement par Nilotinib est prévu
    Patients hommes ou femmes d’âge ≥ à 18 ans
    ECOG score 0 à 2
    Sans traitement préalable par ITK ou IFN (même à d’autres fins) ; hydroxyurée et/ou anagrélide acceptées.
    ASAT et ALAT < 2.5 x LNS.
    Créatininémie < 2 x LSN
    Pas de greffe de cellules souches allogéniques planifiée
    Consentement éclairé signé
    E.4Principal exclusion criteria
    Transcripts other than M- Bcr
    Contra-indications to IFN including in particular ,
    Severe psychiatric / neurological disease (history or concomitant )
    Known concomitant autoimmune disease, including rheumatoid arthritis
    Uncontrolled thyroid disease
    Pregnancy, lactation
    HIV positivity, chronic hepatitis B or C
    History or concurrent malignancy other than CML , except if it is currently not clinically significant in terms of the investigator and requires no treatment .
    History of peripheral arterial disease or peripheral arterial disease , stroke , myocardial infarction or severe coronary artery disease.
    Diabetic patients with target organ damage .
    Permanent elevation of total cholesterol and triglycerides despite treatment
    Other product in the current study
    Current immunosuppressive therapy
    Patients receiving treatment may induce torsades de pointes.
    QTc ( Fredericia ) > 450 ms despite the correction of predisposing factors , congenital long QT syndrome
    No health insurance coverage
    Transcrits autres que M-Bcr
    Contre-indication à l’IFN incluant en particulier,
    Maladie psychiatrique / neurologique sévère (antécédent ou concomitante)
    Maladie auto-immune concomitante connue incluant la polyarthrite rhumatoïde
    Thyroïdopathie non contrôlée
    Grossesse, allaitement
    Positivité HIV, hépatite chronique B ou C
    Antécédent ou affection maligne concomitante autre que le LMC, sauf si celle-ci n’est actuellement pas cliniquement significative du point de vue de l’investigateur et ne nécessite pas de traitement.
    Antécédent d’artériopathie oblitérante ou artériopathie périphérique, accident vasculaire cérébral, infarctus du myocarde ou de maladie coronarienne sévère.
    Patients diabétiques avec atteinte des organes cibles.
    Elévation permanente du cholestérol total et des triglycérides malgré un traitement
    Autre produit à l’étude en cours
    Traitement immunosuppresseur en cours
    Patients recevant un traitement à risque d’induire des torsades de pointes.
    QTc (Fredericia) > 450 ms en dépit de la correction des facteurs prédisposants ; un syndrome QT long congénital
    Aucune couverture d’assurance maladie
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the cumulative rate of patients RM 4.5 to 12 months, and confirmed at 15 months, analyzed by molecular biology centralized RT-qPCR. The molecular response RM being defined by a 4.5 undetectable residual disease with a copy number of ABL or ≥ 32 000 copies of a rate BCR-ABL/ABL <0.0032% IS14.
    Le critère de jugement principal de l’étude est le taux cumulé de patients en RM 4,5 à 12 mois et confirmé à 15 mois, analysé par biologie moléculaire en RT-qPCR centralisée. La réponse moléculaire RM 4,5 étant définie par une maladie résiduelle indétectable avec un nombre de copies d’ABL ≥ 32 000 copies ou un taux de BCR-ABL/ABL <0.0032% IS14.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    E.5.2Secondary end point(s)
    1 - kinetics of obtaining RM 4.5 to 1 , 2, 3 , 6, 9 and 12 months and the stability of the RM 4.5 during the 2nd and 3rd year of treatment (15, 18, ​​24, 30 and 36 months).
    2 - The kinetics of obtaining RMM 1, 2 , 3, 6 , 9 and 12 months of nilotinib and the stability of the MMR during the 2nd and 3rd year of treatment (15, 18, ​​24 , 30, and 36 months ) .
    3 - The rate of patients with a BCR-ABL/ABL ( SI ) ≥ 10 % at 3 and 6 months .
    4 - The cumulative rate of complete cytogenetic response ( CCyR) at 3, 6 and 12 months
    5 - The deadline for obtaining the RMM (this period represents the interval between the date of initiation of nilotinib and the date of obtaining the MMR) .
    6 - The deadline for obtaining the RM 4.5 (this period represents the interval between the date of initiation of nilotinib and the date of obtaining the RM 4.5 ) .
    7 - The safety profile ( hematologic adverse events and non -haematological graded according to the NCI CTC AE v4)
    8 - The quality of life of treated patients
    9 - The rate of dose reduction or interruption of each treatment and the mean daily doses of nilotinib and PEG -IFN administered.
    10 - The compliance to treatment
    11 - Event-free survival .
    12 - Progression-free survival .
    13 - Overall survival .
    1- la cinétique d’obtention de la RM 4,5 à 1, 2, 3, 6, 9 et 12 mois et la stabilité de la RM 4,5 durant la 2ème et 3ème année de traitement (15, 18, 24, 30, et 36 mois).
    2- La cinétique d’obtention de la RMM à 1, 2, 3, 6, 9 et 12 mois de nilotinib et la stabilité de la RMM durant la 2ème et 3ème année de traitement (15, 18, 24, 30, et 36 mois).
    3- Le taux de patients avec un BCR-ABL/ABL (IS) ≥ 10% à 3 et 6 mois.
    4- Le taux cumulé de réponse cytogénétique complète (RCyC) à 3, 6 et 12 mois
    5- Le délai d’obtention de la RMM (ce délai représentant l’intervalle entre la date d’initiation du nilotinib et la date d’obtention de la RMM).
    6-Le délai d’obtention de la RM 4,5 (ce délai représentant l’intervalle entre la date d’initiation du nilotinib et la date d’obtention de la RM 4,5).
    7- Le profil de tolérance (évènements indésirables hématologiques et non-hématologiques gradés selon le NCI CTC AE v4)
    8- La qualité de vie des patients traités
    9- Le taux de réduction de dose ou d’interruption de chaque traitement ainsi que les doses moyennes quotidiennes de nilotinib et PEG-IFN administrées.
    10-La compliance aux traitements
    11- La survie sans événement.
    12- La survie sans progression.
    13- La survie globale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 months
    36 mois
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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.8.2.4Number 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 concerned24
    E.8.5The trial involves multiple Member States No
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state200
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    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)
    none
    Non
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-10-21
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