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    Summary
    EudraCT Number:2021-002042-32
    Sponsor's Protocol Code Number:CPX-351-TA-SMP
    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:2021-07-20
    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 number2021-002042-32
    A.3Full title of the trial
    A phase II study of CPX-351 monotherapy in Acute Myeloid Leukemia secondary to Myeloproliferative neoplams
    Étude de phase ii d’une monothérapie par cpx-351 dans les leucémies aiguës secondaires à un syndrome myéloprolifératif
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study of CPX-351 monotherapy in Acute Myeloid Leukemia secondary to Myeloproliferative neoplams
    Étude de phase II d’une monothérapie par cpx-351 dans les leucémies aiguës secondaires à un syndrome myéloprolifératif
    A.3.2Name or abbreviated title of the trial where available
    CPX-351 TA-SMP
    A.4.1Sponsor's protocol code numberCPX-351-TA-SMP
    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 SponsorFILO
    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 supportFILO
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportJAZZ PHARMACEUTICAL
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFILO
    B.5.2Functional name of contact pointFILO Desk
    B.5.3 Address:
    B.5.3.1Street AddressCHRU DE TOURS Hôpital Bretonneau Hématologie 2 Boulevard Tonnellé
    B.5.3.2Town/ cityTOURS cedex 9
    B.5.3.3Post code37044
    B.5.3.4CountryFrance
    B.5.4Telephone number330247391896
    B.5.5Fax number330247373512
    B.5.6E-mailsecretariat@filo-leucemie.org
    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 CPX-351, VYXEOS
    D.2.1.1.2Name of the Marketing Authorisation holderJAZZ PHARMACEUTICALS
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameVyxeos
    D.3.2Product code CPX-351
    D.3.4Pharmaceutical form Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    newly secondary AML according to WHO 2016 classification following an antecedent of Myeloproliferative Neoplasm including Essential Thrombocythemia (ET), Polycythemia Vera (PV), primary or secondary Myelofibrosis
    Premier diagnostic de LAM secondaires selon la classification OMS 2016 avec un antécédent de néoplasie myeloproliferative (NMP) incluant une thrombocytémie essentielle (TE), une polyglobulie primitive (PV), une myélofibrose primitive ou secondaire
    E.1.1.1Medical condition in easily understood language
    newly secondary AML following an antecedent of Myeloproliferative Neoplasm including Essential Thrombocythemia (ET), Polycythemia Vera (PV), primary or secondary Myelofibrosis
    Premier diagnostic de LAM secondaires selon la classification OMS 2016 avec un antécédent de néoplasie myeloproliferative (NMP) incluant une TE, une PV, ou une myélofibrose primitive ou secondaire
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10000880
    E.1.2Term Acute myeloid leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the Complete Remission (CR/CRi) rate after treatment with CPX-351 in post-MPN AML
    Evaluer le taux de rémission complète (RC/RCi) après un traitement par CPX-351 dans les LAM secondaires à un syndrome myéloprolifératif
    E.2.2Secondary objectives of the trial
    Overall response rate (CR, CRi, PR), Time to CR, response duration, Event-Free Survival and overall survival
    -Early mortality (Day-30 and Day-60 mortality)
    -Rate of allogeneic SCT
    -Safety and toxicity profile of CPX-351 in this population
    -Duration of cytopenias
    -Post-induction MRD
    -Impact of pretreatment gene mutations on outcome (EFS)
    • Taux de réponse globale (RC, RCi, RP), temps pour obtenir la RC, durée de réponse, survie sans évènement et survie globale
    • Mortalité précoce (mortalité à J30 et à J60)
    • Taux de greffe allo génique
    • Sécurité et profil de toxicité du CPX-351 dans cette population
    • Durée des cytopénies
    • Impact des mutations génétiques avant traitement sur la survie sans évènement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of newly secondary AML according to WHO 2016 classification following an antecedent of Myeloproliferative Neoplasm including Essential Thrombocythemia (ET), Polycythemia Vera (PV), primary or secondary Myelofibrosis
    2. Age > 18 years.
    3. Performance status < 2 (ECOG grading).
    4. Eligible for standard intensive chemotherapy
    5. Absence of concomitant severe cardiovascular disease which would make intensive chemotherapy impossible, i.e. arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease, reduced left ventricular function assessed by multigated acquisition (MUGA) scan or echocardiogram.
    “Cardiac ejection fraction ≥ 50% by echocardiography ou MUGA”
    6. Patient must have adequate organ function as indicated by the following laboratory values:
    Renal
    Serum creatinine: < 2 mg/dl OR calculated creatinine clearance*: ≥ 30 mL/min by MDRD for patients with creatinine levels > 1.5 X institutional ULN
    Hepatic
    Serum total bilirubin: ≤ 2.5 X ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels ≥ 2 mg/dL
    AST (SGOT) and ALT (SGPT): ≤ 2.5 times ULN
    Alkaline Phosphatase: ≤ 5 X ULN, if > 2.5 X ULN, then liver fraction should be ≤ 2.5 X ULN
    *Creatinine clearance should be calculated per institutional standard
    7. Life expectancy should be of 12 weeks at least according to investigator evaluation.
    8. Female patients of childbearing potential must have a negative serum pregnancy test (β-hCG) within 72 hours prior to receiving the first dose of CPX-351. Female patients who are not post-menopausal, free from menses for > 2 years or surgically sterilized, will have to use adequate barrier methods of contraception to prevent pregnancy or agree to abstain from becoming pregnant throughout the study, starting with Visit 1.
    9. Male patients agree to use an adequate method of contraception for the duration of the study. Men should be advised not to father a child while receiving CPX-351 and for 3 months post study.
    10. Patients have the ability to understand and willingness to sign an informed consent form indicating the investigational nature of the study.
    1. Premier diagnostic de LAM secondaires selon la classification OMS 2016 avec un antécédent de néoplasie myeloproliferative (NMP) incluant une thrombocytémie essentielle (TE), une polyglobulie primitive (PV), une myélofibrose primitive ou secondaire
    2. Age  18 ans.
    3. ECOG 2.
    4. Eligible pour la chimiothérapie standard intensive
    5. Absence de maladies cardio-vasculaires sévères concomitantes qui pourraient rendre impossible la chimiothérapie intensive, comme une arythmie nécessitant un traitement chronique, insuffisance cardiaque congestive ou une maladie cardiaque ischémique, réduction de la fonction ventriculaire gauche évaluée par scintigraphie ou échographie cardiaque.
    Fraction d’éjection ventriculaire ≥50%.
    6. Patient doit avoir un fonctionnement d’organe adéquat et défini par les valeurs biologiques suivantes :
    • Rénal
    Créatinine sérique : < 2 mg/dl ou clairance de la créatinine calculée*: ≥ 30 ml/min selon MDRD pour les patients avec des taux de créatinine > 1.5 X ULN institutionnel
    • Hépatique
    o Bilirubine totale sérique : ≤ 2.5 X ULN ou bilirubine directe ≤ ULN pour les patients avec une bilirubine totale ≥ 2 mg/dL
    o AST (SGOT) and ALT (SGPT): ≤ 2.5 X ULN
    o Alcaline Phosphatase : ≤ 5 X ULN, si > 2.5 X ULN, la fraction hépatique doit être ≤ 2.5 X ULN
    *Clairance de la créatinine doit être calculée par les standards institutionnels
    7. L’espérance de vie doit être d’au moins 12 semaines selon l’évaluation de l’investigateur
    8. Les femmes en âge de procréer doivent avoir un test sérique de grossesse négatif (β-hCG) dans les 72 heures avant la première dose de CPX-351. Les femmes qui ne sont pas ménopausées, sans règles depuis plus de 2 ans ou ménopausées de façon chirurgicale doivent utiliser un moyen de contraception adapté pour éviter une grossesse ou accepter une abstinence à partir de la visite d’inclusion et tout au long de l’étude.
    9. Les hommes doivent utiliser un moyen de contraception adapté pour toute la durée de l’étude. Les hommes ne doivent pas concevoir d’enfant sous traitement par CPX-351 et ce jusqu’à 3 mois après la fin de l’étude.
    10. Les patients doivent avoir les capacités de comprendre et la volonté de signer un consentement éclairé indiquant la nature expérimentale de l’étude.
    E.4Principal exclusion criteria
    Exclusion criteria
    1. MPN/MDS mixed types
    2. Prior therapy for AML transformation except for Hydroxyurea
    3. Prior treatment with growth factors such as erythropoietin alfa (EPO) or granulocyte colony-stimulating factor (G-CSF), low-dose oral chemotherapy or Hypomethylating agents chemotherapy given in the chronic phase of MPN in the 30 days before inclusion, except for hydroxyurea.
    4. Uncontrolled undercurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pancreatitis, or psychiatric or social conditions that may interfere with patient compliance.
    5. Active and uncontrolled infection.
    6. Current participation or participation in a study with an investigational compound or device within 30 days of initial dosing with study drug.
    7. Patients with acute promyelocytic leukemia
    8. Known human immunodeficiency virus (HIV) infection or HIV-related malignancy.
    9. Clinically active hepatitis B or hepatitis C infection.
    10. Known allergy or hypersensitivity to any component of CPX-351.
    11. "Currently active" second malignancy, other than non-melanoma skin cancer and in situ carcinoma of the cervix. Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for >3 years or are considered by their physician to be at less than 30% risk of relapse.
    12. Clinical evidence of CNS leukemia.
    13. Pregnancy or breastfeeding during the projected duration of the study.
    Critères d’inclusion
    1. Premier diagnostic de LAM secondaires selon la classification OMS 2016 avec un antécédent de néoplasie myeloproliferative (NMP) incluant une thrombocytémie essentielle (TE), une polyglobulie primitive (PV), une myélofibrose primitive ou secondaire
    2. Age  18 ans.
    3. ECOG 2.
    4. Eligible pour la chimiothérapie standard intensive
    5. Absence de maladies cardio-vasculaires sévères concomitantes qui pourraient rendre impossible la chimiothérapie intensive, comme une arythmie nécessitant un traitement chronique, insuffisance cardiaque congestive ou une maladie cardiaque ischémique, réduction de la fonction ventriculaire gauche évaluée par scintigraphie ou échographie cardiaque.
    Fraction d’éjection ventriculaire ≥50%.
    6. Patient doit avoir un fonctionnement d’organe adéquat et défini par les valeurs biologiques suivantes :
    • Rénal
    Créatinine sérique : < 2 mg/dl ou clairance de la créatinine calculée*: ≥ 30 ml/min selon MDRD pour les patients avec des taux de créatinine > 1.5 X ULN institutionnel
    • Hépatique
    o Bilirubine totale sérique : ≤ 2.5 X ULN ou bilirubine directe ≤ ULN pour les patients avec une bilirubine totale ≥ 2 mg/dL
    o AST (SGOT) and ALT (SGPT): ≤ 2.5 X ULN
    o Alcaline Phosphatase : ≤ 5 X ULN, si > 2.5 X ULN, la fraction hépatique doit être ≤ 2.5 X ULN
    *Clairance de la créatinine doit être calculée par les standards institutionnels
    7. L’espérance de vie doit être d’au moins 12 semaines selon l’évaluation de l’investigateur
    8. Les femmes en âge de procréer doivent avoir un test sérique de grossesse négatif (β-hCG) dans les 72 heures avant la première dose de CPX-351. Les femmes qui ne sont pas ménopausées, sans règles depuis plus de 2 ans ou ménopausées de façon chirurgicale doivent utiliser un moyen de contraception adapté pour éviter une grossesse ou accepter une abstinence à partir de la visite d’inclusion et tout au long de l’étude.
    9. Les hommes doivent utiliser un moyen de contraception adapté pour toute la durée de l’étude. Les hommes ne doivent pas concevoir d’enfant sous traitement par CPX-351 et ce jusqu’à 3 mois après la fin de l’étude.
    10. Les patients doivent avoir les capacités de comprendre et la volonté de signer un consentement éclairé indiquant la nature expérimentale de l’étude.

    Critères d’exclusion
    1. MPN/MDS (types mixtes)
    2. Traitement antérieur pour la transformation en LAM hormis l’Hydroxyurée.
    3. Traitement antérieur avec des facteurs de croissance comme érytropoïetine alpha (EPO) ou facteur de croissance granuleux (G-CSF), chimiothérapie orale faible dose ou agents hypométhylants donné en phase chronique de la NMP dans les 30 jours avant l’inclusion, hormis l’hydroxyurée.
    4. Maladie intercurrente non contrôlée ou circonstances qui pourraient perturber la compliance de l’étude, comprenant mais non limité aux situations suivantes : insuffisance cardiaque congestive symptomatique, angine de poitrine instable, arythmie cardiaque non contrôlée, pancréatite, ou conditions psychiatriques ou sociales qui pourraient interférer avec la compliance du patient.
    5. Infection évolutive et non contrôlée.
    6. Participation en cours ou participation dans une étude avec un produit ou un dispositif expérimental dans les 30 jours de la dose initiale de l’étude.
    7. Patient avec une LAM3
    8. Infection connue par le virus de l’immunodéficience humaine (VIH) ou cancer relié au VIH.
    9. Infection active par le virus de l’hépatite B ou C.
    10. Allergie ou hypersensibilité connue à un composant du CPX-351.
    11. Second cancer "actuellement actif" hormis cancer cutané autre que mélanome et cancer du col utérin in situ. Les patients ne sont pas considérés comme ayant un cancer actif s’ils ont fini leur traitement pour un cancer préalable, sont sans maladie depuis plus de 3 ans ou sont considérés par leur médecin d’être à moins de 30% de risque de rechute.
    12. Atteinte clinique du SNC.
    13. Grossesse ou allaitement pendant la durée prévue de l’étude.
    E.5 End points
    E.5.1Primary end point(s)
    - Rate of CR and CRi
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation after induction or consolidation
    E.5.2Secondary end point(s)
    CR, CRi, PR according to ELN 2017 criteria, time from treatment start to first response, time from response to relapse or progression
    • Proportion of patients receiving an allo-SCT
    • Rate of day- 30 and day-60 mortality
    • Overall Survival, Event-Free Survival (EFS)
    • Toxicity profile, including duration of cytopenias, life threatening or fatal cytopenias, time spent in hospital for induction cycle and consolidation cycles
    • Pretreatment gene mutations and outcome (CR/CRi, EFS, OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    after induction or consolidation périod
    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) 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 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) 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 concerned40
    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 years
    E.8.9.1In the Member State concerned months45
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 No
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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
    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 Decision2021-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
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