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    Summary
    EudraCT Number:2020-005866-32
    Sponsor's Protocol Code Number:LAMSA2020
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-25
    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 number2020-005866-32
    A.3Full title of the trial
    A phase II randomized study to assess the efficacy on outcome of Venetoclax combined with Cytarabine versus Idarubicin combined with Cytarabine administered as post-remission therapy to elderly patients with acute myeloid leukemia in first remission
    Etude de phase II randomisée évaluant l’efficacité de l’association Venetoclax + Cytarabine versus Idarubicine + Cytarabine en traitement de post-rémission chez des patients âgés en première rémission de Leucémie Aigue Myéloblastique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy of Venetoclax combined with Cytarabine versus Idarubicin combined with Cytarabine administered as post-remission therapy to elderly patients with acute myeloid leukemia in first remission
    Etude évaluant l’efficacité de l’association Venetoclax + Cytarabine versus Idarubicine + Cytarabine en traitement de post-rémission chez des patients âgés en première rémission de Leucémie Aigue Myéloblastique
    A.3.2Name or abbreviated title of the trial where available
    LAMSA 2020
    A.4.1Sponsor's protocol code numberLAMSA2020
    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 supportABBVIE
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportFILO
    B.4.2CountryFrance
    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 pointFENOLL Cindy
    B.5.3 Address:
    B.5.3.1Street AddressCHRU Tours, Hôpital Bretonneau, 2 boulevard Tonnellé, B47, 1er etage
    B.5.3.2Town/ cityTOURS
    B.5.3.3Post code37044
    B.5.3.4CountryFrance
    B.5.4Telephone number33247391896
    B.5.5Fax number33247373512
    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 VENCLYXTO
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG Knollstrasse 67061 Ludwigshafen Allemagne
    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 nameVenclyxto
    D.3.2Product code ABT-199
    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.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
    elderly patients (> = 60 years) with Acute Myeloid Leukemia
    Patients âgés de 60 ans et plus, atteints d'une Leucémie Aigue Myéloïde
    E.1.1.1Medical condition in easily understood language
    elderly patients (> = 60 years) with Acute Myeloid Leukemia
    Patients âgés de 60 ans et plus, atteints d'une Leucémie Aigue MyéloïdeLeucémie Aigue Myéloïde
    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 compare the Relapse free survival (RFS) at 2 years after follow-up between the two arms: Venetoclax with Cytarabine versus Idarubicin with Cytarabine.
    Comparer le taux de survie sans rechute à 2 ans de suivi entre les deux bras, Venetoclax + Cytarabine versus Idarubicine + Cytarabine
    E.2.2Secondary objectives of the trial
    - Overall survival (OS) at 2 years
    - Event Free Survival (EFS) at 2 years
    - Cumulative incidence of relapse and death in first remission
    - Impact of treatment on measurable minimal residual disease (MRD)
    - Toxicity of Venetoclax in combination with Cytarabine according to NCI-CTCAE v5.0
    - Death rate during consolidation
    - Impact of Venetoclax in allografted patients and in non-allografted patients
    - Evaluation of quality of life using the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionnaire
    - Adverse events reported according to the descriptions and grading scale found in version 5.0 of the NCI-CTCAE.
    - Survie globale à 2 ans
    - Survie sans évènement à 2 ans
    - Incidence cumulée des rechutes et décès en première rémission
    - Impact du traitement sur la maladie résiduelle (MRD)
    - Toxicité de l’association Venetoclax-Cytarabine selon le NCI-CTCAE V5.0
    - Taux de décès durant la consolidation
    - Impact du Venetoclax chez les patients allogreffés et non allogreffés
    - Evaluation de la qualité de vie à l’aide du questionnaire FACT-Leu
    - Evènements indésirables reportés selon le NCI-CTCAE Version 5.0
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Principal inclusion criteria (pre-induction) :
    - ≥ 60 years of age.
    - AML de novo according to the WHO 2016 classification
    - AML with favorable or intermediate cytogenetic risk according to ELN 2017
    - Subjects should be eligible for intensive chemotherapy by Idarubicin, Cytarabine and Lomustine (standard induction for FILO)
    - SORROR < 3
    - AML secondary to MDS and chemotherapy are eligible, unless adverse cytogenetics
    - ECOG < 3
    - Adequate baseline organ function
    - Adequate cardiac function with LVEF ≥ 50 %
    - Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule
    - Females must be menopausal to be pre-enrolled
    - Patient must be affiliated to the French Social Security (health insurance)
    - Signed written informed consent for LAMSA 2020-VENETOCLAX study

    Principal randomization criteria (after induction phase)
    - Subject must have been registered at diagnosis
    - Subject must have received intensive induction by Idarubicin, Cytarabine and Lomustine
    - Patients in CR/CRi post induction according to ELN 2017 criteria
    - Randomization should be performed no more than D+60 after induction
    - ECOG < 3
    - Adequate baseline organ function
    - Adequate cardiac function with LVEF ≥ 50 %
    - Male subject who are sexually active must agree, from Study Day 1 through at least 180 days after the last dose of study drug, to practice protocol-specified methods of contraception
    - Female subject must be postmenopausal defined as with no menses for 12 or more months without an alternative medical cause
    Principaux Critères d’inclusion: (en pré-induction)
    - ≥ 60 ans
    - LAM de novo selon la classification OMS 2016
    - LAM avec un risque cytogénétique favorable ou intermédiaire selon ELN 2017
    - Sujet éligible pour une chimiothérapie intensive par Idarubicine, Cytarabine et Lomustine (selon les standards du FILO)
    - SORROR < 3
    - LAM secondaire à un syndrome myélodysplasique ou à une chimiothérapie peut être inclus, sauf en cas de cytogénétique défavorable
    - ECOG < 3
    - Fonctions des organes adéquates s
    - Fonction cardiaque adéquate avec FEVG ≥ 50 %
    - Absence de conditions psychologiques, familiales, sociales ou géographiques qui potentiellement empêcheraient la compliance avec le protocole et le calendrier protocolaire.
    - Les femmes devront être ménopausées.
    - Affilié à la sécurité sociale française.
    - Le patient doit avoir donné son consentement écrit du LAMSA 2020-Venetoclax

    Principaux Critères de randomisation : (en post-induction)
    - Patient doit avoir été enregistré dans l’étude au diagnostic
    - Patient doit avoir reçu une chimiothérapie intensive par Idarubicine, Cytarabine et Lomustine
    - Patient en RC/RCi post-induction selon les critères ELN 2017
    - La randomisation doit être réalisée dans les 60 jours après induction
    - ECOG < 3
    - Fonctions des organes adéquates
    - Fonction cardiaque adéquate avec FEVG ≥ 50 %
    - Les hommes sexuellement actifs doivent être d’accord pour avoir une méthode de contraception définie selon le protocole, du J1 de l’étude jusqu’à 180 jours après la dernière dose de traitement à l’étude.
    -Les femmes devront être ménopausées, définies par l’absence de menstruation pendant 12 mois ou plus, sans autre cause médicale.
    E.4Principal exclusion criteria
    Principal exclusion criteria (at diagnosis, before induction) :
    - Diagnosis of APL
    - AML with adverse cytogenetics according to ELN 2017
    - AML with BCR-ABL1 translocation
    - Subject with an antecedent of myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocytosis, polycythemia vera or chronic myelogenous leukemia (CML) with or without BCR-ABL1 translocation
    - Clinical symptoms suggesting active central nervous system leukemia, or presence of isolated extramedullary leukemia
    - Previous exposure to Anthracycline ≥ 550mg/m² (Daunorubicin equivalence)
    - Previous AML treatment other than Hydroxyurea
    - Treatment with an investigational drug within 30 days or 5 half-life whichever is longer, preceding the initiation study and/or previous treatment with Venetoclax
    - History of another malignancy within the past 3 years except basal cell carcinoma of the skin or cervix in situ carcinoma
    - Any serious medical condition, laboratory abnormalities or psychiatric illness that would place the participant at an unacceptable risk or prevent them from giving informed consent or precluding the administration of protocol treatments
    - Other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy which must be reviewed and approved by the study medical monitor before study enrolment
    12. Subject with known HIV infection (due to potential drug-drug interactions between antiretroviral medications and Venetoclax).. Subject known to be positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; Inactive hepatitis carrier status with undetectable PCR viral load on antivirals (non-exclusionary medications) are not excluded

    Principal non-randomization criteria (after induction phase) :
    - Patient in PR, or failure to follow one induction course by Idarubicin, Cytarabine and Lomustine, according to ELN 2017 criteria
    - Uncontrolled infection
    - Subject with cardiovascular disability status as per the New York Heart Association Class > 2.
    - Subject has a malabsorption syndrome or other condition that precludes enteral route of administration
    - Any serious medical condition, laboratory abnormality, or psychiatric illness that would place the participant at an unacceptable risk or prevent them from giving informed consent
    - Treatment with any of the following within 7 days prior to the first dose of study drug :
    a. Strong or moderate CYP3A inducers
    b. Steroid therapy for anti-neoplastic intent
    - Subject having consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to the initiation of study treatment
    - Subject having chronic respiratory disease that requires continuous oxygen, or a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition that in the opinion of the investigator would adversely affect his/her participating in this study
    - Previous treatment with Venetoclax and/or current participation in any other research study with investigational products
    - Known hypersensitivity to the study medication
    Principaux critères d’exclusion (au diagnostic, avant induction) :
    - Sujet avec un diagnostic de LAM 3
    - LAM avec une cytogénétique défavorable selon ELN 2017
    - LAM avec translocation BCR-ABL1
    - Sujet avec un antécédent d’hémopathie myéloproliférative incluant la myélofibrose, la thrombocytémie essentielle, la maladie de Vaquez ou la Leucémie Myéloïde Chronique (LMC) avec ou sans translocation BCR-ABL1
    - Symptômes cliniques qui suggèrent la présence de la Leucémie au niveau du système nerveux central ou présence de LAM extra-médullaire isolée
    - Exposition préalable à des anthracyclines ≥ 550 mg/m² (équivalent Daunorubicine).
    - Traitements préalables pour la LAM en dehors de l’Hydréa
    - Traitement avec un médicament expérimental dans les 30 jours ou 5 fois le temps de demi-vie (si elle est plus longue) précédent le début de l’étude et/ou traitement antérieur par Venetoclax
    - Histoire d’un autre cancer dans les 3 dernières années à l’exception de carcinome basocellulaire de la peau ou carcinome in situ du cervix
    - Conditions médicales sévères, anomalies de laboratoires, ou maladies psychiatriques qui placeraient le patient dans un risque inacceptable ou qui empêcheraient la signature du consentement ou l’administration du traitement à l’étude.
    - Autres comorbidités qui pourraient selon l’investigateur être incompatibles avec un traitement de chimiothérapie intensive. L’inclusion de ces patients doit être revue et validée par le médecin coordonnateur de l’étude avant tout traitement.
    - Patient présentant une infection VIH (car potentielle interaction médicamenteuse entre les traitements antiviraux et le venetoclax).
    Patients connus pour avoir une infection active hépatite B ou C ; les patients avec une charge virale par PCR indétectable sous antiviraux (médicaments non exclusifs) ne sont pas exclus.

    Principaux critères de non randomisation (en post-induction) :
    - Patient en Réponse Partielle ou en échec après induction par Idarubicine, Cytarabine et Lomustine, selon les critères ELN 2017
    - Infection active non contrôlée
    - Maladie cardio-vasculaire pré-existante (New York Heart Association [NYHA] de Grade > 2).
    - Sujet avec un syndrome de malabsorption ou toute autre condition qui empêcherait une administration par voie entérale
    - Conditions médicales sévères, anomalies de laboratoires, ou maladies psychiatriques qui placeraient le patient dans un risque inacceptable ou qui empêcheraient la signature du consentement.
    -Sujet ayant reçu un des traitements suivants dans les 7 jours avant le début du traitement à l’étude :
    a. Inducteur fort ou modéré du CYP3A
    b. Stéroïdes à visée antinéoplasique
    -Sujet ayant consommé du pamplemousse, des produits dérivés du pamplemousse, des oranges de Séville (incluant la confiture contenant des oranges de Séville) ou des caramboles dans les 3 jours avant le début du traitement à l’étude
    -Sujet ayant une maladie respiratoire chronique nécessitant de l’oxygène en continu, ou un antécédent significatif de maladie rénale, neurologique, psychiatrique, endocrinologique, métabolique, immunologique, hépatique, cardiovasculaire, ou toute autre condition médicale, qui selon l’investigateur pourraient affecter sa participation à l’étude
    - Traitement antérieur par Venetoclax et/ou participation dans une autre étude clinique avec médicament expérimental.
    - Hypersensibilité connue au traitement à l’étude
    E.5 End points
    E.5.1Primary end point(s)
    Relapse free survival (RFS) at 2 years according to ELN 2017 criteria
    Survie Sans Rechute mesurée de la date de rémission jusqu’à la date de rechute ou de décès quel que soit la cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 2 years post-treatment
    A 2 ans post-traitement
    E.5.2Secondary end point(s)
    - Overall survival (OS) at 2 years
    - Event Free Survival (EFS) at 2 years
    - Cumulative incidence of relapse and death in first remission
    - Impact of treatment on measurable minimal residual disease (MRD)
    - Toxicity of Venetoclax in combination with Cytarabine according to NCI-CTC criteria v5.0
    - Death rate during consolidation
    - Impact of Venetoclax in allografted patients and in non-allografted patients
    - Evaluation of quality of life using the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionnaire
    - Adverse events reported according to the descriptions and grading scale found in version 5.0 of the NCI-CTCAE.
    - Survie globale à 2 ans, définie par le temps entre la date de randomisation et la date de décès ou de dernières nouvelles
    - Survie sans évènement à 2 ans, définie par le temps entre la date de randomisation et la date d'échec ou de première rechute après RC ou RCi, ou la date décès
    - Incidence cumulée des rechutes et décès en première remission, définie pour tous les patients ayant eu une RC/RCi ; et mesurée de la date de la remission jusqu’à la date de rechute (date du dernier examen si absence de rechute, patient décédé sans rechute est compté comme un échec)
    - Impact du traitement sur la maladie résiduelle (MRD)
    - Toxicité du Venetoclax associé à la Cytarabine selon le NCI-CTCAE V5.0
    - Taux de décès durant la consolidation
    - Impact du Venetoclax chez les patients allogreffés et non allogreffés
    - Evaluation de la qualité de vie à l’aide du questionnaire FACT-Leu
    - Evènements indésirables reportés, avec description et grade selon le NCI-CTCAE V5.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of study
    A la fin de l'étude
    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 Yes
    E.6.13.1Other scope of the trial description
    Survival
    Survie
    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.8.2.4Number 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 concerned26
    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
    LVLS
    Dernière Visite du Dernier Patient
    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 months81
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state134
    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
    Aucun
    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 Decision2021-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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