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    Summary
    EudraCT Number:2012-003389-42
    Sponsor's Protocol Code Number:DASA-PEGIFN
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-05-21
    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 number2012-003389-42
    A.3Full title of the trial
    A phase II study to assess the efficacy and safety of frontline combination of dasatinib (SPRYCEL®) and pegylated-interferon alpha 2b (Peg-IFNα2b) therapy in patients newly diagnosed with chronic phase chronic myeloid leukaemia (CP-CML)
    Etude de phase II évaluant l’efficacité et la tolérance de l’association dasatinib (Sprycel®) et Peg-Interféron alpha 2b (PegIFN-α2b) comme première ligne de traitement des patients atteints de Leucémie Myéloïde Chronique en phase chronique (LMC-PC) nouvellement diagnostiquée
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Etude évaluant l’efficacité et la tolérance de l’association Sprycel® et PegIFN-α2b comme premier traitement des patients atteints de Leucémie Myéloïde Chronique en phase chronique nouvellement diagnostiquée
    A.3.2Name or abbreviated title of the trial where available
    DASA-PEGIFN
    A.4.1Sponsor's protocol code numberDASA-PEGIFN
    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 SponsorCHU DE POITIERS
    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 supportCHU DE POITIERS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU DE POITIERS
    B.5.2Functional name of contact pointFanny ABRIAT
    B.5.3 Address:
    B.5.3.1Street AddressDirection de la Recherche-2 rue de la Miletrie
    B.5.3.2Town/ cityPOITIERS
    B.5.3.4CountryFrance
    B.5.4Telephone number0549443796
    B.5.5Fax number0549443058
    B.5.6E-mailfanny.abriat@chu-poitiers.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 SPRYCEL® 100mg
    D.2.1.1.2Name of the Marketing Authorisation holderEU/1/06/363/011 ; CIP 3400939159584
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.11 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 VIRAFERONPEG®, 50 µg
    D.2.1.1.2Name of the Marketing Authorisation holderEU/1/00/132/031 ; CIP 3400935941930
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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.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
    Patients with newly diagnosed chronic phase Chronic Myeloid Leukemia (CP-CML), not previously treated with Tyrosine Kinase Inhibitors (TKIs). First line therapy.
    E.1.1.1Medical condition in easily understood language
    Patients with newly diagnosed chronic phase Chronic Myeloid Leukemia (CP-CML), not previously treated with Tyrosine Kinase Inhibitors (TKIs). First line therapy.
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054352
    E.1.2Term Chronic phase chronic myeloid leukemia
    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 primary objective of this study is to assess the efficacy of dasatinib combined to Peg-interferon-α2b on the cumulative rate of molecular response 4.5 (MR4.5) at 12 months, as frontline therapy for newly diagnosed CP-CML patients.
    E.2.2Secondary objectives of the trial
    •To assess the rates of complete cytogenetic response (CCgR) at 3, 6, 12, 18, 24 months, and every 12 months thereafter.
    •To assess the rates of major molecular responses (MMR) at 3, 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter.
    •To assess the rate of molecular response 4.5 (MR4.5) at 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter.
    •To assess the rates of molecular responses 5.0 (MR5.0) at 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter, for the patients who achieved MR4.5.
    •To estimate the cumulative rates of CCR, MMR, MR4.5, MR5.0 within the same periods.
    •Kinetics and duration of CCR, MMR, MR4.5MR5.0.
    •To determine the safety and tolerability of the combination of PegIFN-α2b and dasatinib.
    •To estimate the rate of PegIFN-α2b and dasatinib discontinuation, and dose reduction.
    •To analyse the residual plasmatic levels (Cmin) of dasatinib.
    •To estimate the progression free survival, event-free and overall survival.
    .
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Principal inclusion criteria
    1) Signed Written Informed Consent: All patients must have read and sign the informed consent form (ICF) before any procedure related to the study, registration/inclusion in the study.
    2) Target Population
    a) Men and women, ages 18 to 69 years
    b) Newly diagnosed (≤ 3 months) Philadelphia chromosome positive chronic phase chronic myeloid leukemia (CP-CML)
    c) Major BCR-ABL transcripts (p210 b2a2 or b3a2)
    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 < 2.0 times the institutional Upper Limit of Normal (ULN)
    ii) Hepatic enzymes (AST, ALT ) ≤ 2.5 times the institutional ULN
    iii) Serum Na, K+, Mg2+, Phosphate and Ca2+ > Lower Limit of Normal (LLN)
    iv) Serum Creatinine < 1.5 time the institutional ULN
    g) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study. WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:
    • Amenorrhea that has lasted for  12 consecutive months without another cause, or
    • For women with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL.
    Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or who are practicing abstinence or where their partner is sterile (e.g. vasectomy) should be considered to be of childbearing potential.
    WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of the investigational product.
    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.
    3) Expected compliance to the treatment.
    4) Health insurance coverage.
    E.4Principal exclusion criteria

    1) Patients with BCR-ABL other than M-BCR-ABL, Philadelphia negative CML.
    2) Patients previously treated with Tyrosine Kinase Inhibitors (TKIs).
    3) Medical history and concurrent diseases:
    a) Prior treatment with Interferon-α / Contraindication to interferon-α,
    b) Concomitant immunosuppressive treatment or corticosteroids,
    c) Preexisting thyroid disease unless it is controlled with conventional treatment, Auto-immune thyroiditis,
    d) Autoimmune disorder, Chronic liver disease,
    e) Prior or ongoing severe psychiatric disease,
    f) Epilepsy or compromised central nervous system(CNS) function,
    g) HIV positivity, chronic hepatitis B or C,
    h) Uncontrolled or significant cardio vascular disease,
    i) Uncontrolled angina, congestive heart failure or MI within 6 months,
    ii) Echocardiography with LVF <45% or LLN,
    iii) Pulmonary arterial hypertension (PAH),
    iv) Any history of clinically significant ventricular or supraventricular arrhythmias,
    v) Diagnosed congenital long QT syndrome,
    vi) Prolonged QTc interval > 450 msec (Fredericia) on 3 pre-entry electrocardiogram,
    vii) Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib,
    i) Other malignant disease during the last 5 years prior to the inclusion except basal cell carcinoma of the skin or carcinoma in situ of the cervix,
    j) History of significant bleeding disorder unrelated to CML, including:
    i) Diagnosed congenital bleeding disorders (e.g. von Willebrand’s disease),
    ii) Diagnosed acquired bleeding disorder within one year (e.g. acquired anti-factor VIII antibodies),
    iii) Ongoing or recent ( 3 months) significant gastrointestinal bleeding.
    k) Another severe or life –threatening medical disease.
    4) Women who are pregnant or breastfeeding, WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after the last dose of study drug.
    5) Prohibited treatments and/or therapies:
    a) strong inhibitors of the CYP 3A4,
    b) category I drugs that are generally accepted to have a risk of causing “Torsades de Pointes”. Patients must discontinue the drug minimum 7 days prior to starting dasatinib.
    6) History /any condition for poor compliance to the treatment.
    7) Inability to freely provide consent through judiciary or administrative condition.
    8) Ongoing participation to another clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the cumulative rate of molecular responses 4.5 (MR4.5) achieved at 12 months.
    Centralized analyses of molecular response by RTQPCR will be performed for all molecular assessments in this study.
    Molecular response 4.5 (MR4.5) is defined by either a positive BCR-ABL/ABL ratio ≤0.0032 on the international scale or by undetectable BCR-ABL with the analysis of at least 32000 copies of ABL (according to the ELN recommendations by N. Cross et al., leukemia 2012[26]).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months since enrolment
    E.5.2Secondary end point(s)
    • The rates of complete cytogenetic response (CCgR) at 3, 6, 12, 18, 24 months and every 12 months thereafter.
    • The rates of major molecular responses (MMR) at 3, 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter.
    • The rate of molecular response 4.5 (MR4.5) at 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter.
    • The rates of the molecular responses 5.0 (MR5.0) at 6, 9, 12, 15, 18, 21, 24 months and every 6 months thereafter, for the patients who achieved MR4.5.
    • The cumulative rates of CCR, MMR, MR4.5, MR5.0 within the same periods.
    • Time to and duration of CCR, MMR, MR4.5MR5.0.
    • Incidence and characteristics of severe adverse events (SAE) and adverse events (AE) related to the therapy, from clinical and biological assessments: type and grade according to the NCI CTCAE v4.0.
    • The cumulative incidence of discontinuation for PegIFN-α2b or dasatinib during the first two years of study treatment. Time to and duration of discontinuation
    • The dose intensity of PegIFN-α2b and dasatinib administered during the first two years of study treatment.
    • The relationship between residual (Cmin) plasmatic levels and SAE related to dasatinib at M1, M6.
    • The progression free survival, the event-free survival and the overall survival.
    • Quality of life questionnaire (EORTC QLQ-C30) with PegIFN-α2b and dasatinib at Day 1, M3, M6, M12 and at the end of the study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months since enrolment
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned22
    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 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
    Duration of the study for one patient: four to five years including 24 months study therapy and 24 months follow-up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    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 state70
    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)
    At the conclusion of the study, the patients will receive the usual medical treatement for their pathology
    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 Decision2012-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-26
    P. End of Trial
    P.End of Trial StatusOngoing
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