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    Summary
    EudraCT Number:2017-004860-36
    Sponsor's Protocol Code Number:DEXAML-02
    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:2018-03-20
    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 number2017-004860-36
    A.3Full title of the trial
    A phase II study of dexamethasone added to induction and post-remission therapy in older patients with newly diagnosed AML. A French Innovative Leukemia Organization (FILO) study.
    Etude de phase II évaluant la dexaméthasone ajoutée au traitement d’induction et de consolidation des sujets âgés ayant une leucémie aiguë myéloïde nouvellement diagnostiquée. Une étude du groupe FILO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II study of dexamethasone added to induction and post-remission therapy in older patients with newly diagnosed AML. A French Innovative Leukemia Organization (FILO) study.
    Etude de phase II évaluant la dexaméthasone ajoutée au traitement d’induction et de consolidation des sujets âgés ayant une leucémie aiguë myéloïde nouvellement diagnostiquée. Une étude du groupe FILO
    A.3.2Name or abbreviated title of the trial where available
    DEXAML-02
    A.4.1Sponsor's protocol code numberDEXAML-02
    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 SponsorFrench Innovative Leukemia Organization (FILO)
    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 supportForce Hemato
    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 pointFILO study central office
    B.5.3 Address:
    B.5.3.1Street AddressCHRU DE TOURS - Hôpital Bretonneau B47 - 1er étage 2 Bd Tonnellé
    B.5.3.2Town/ cityTOURS
    B.5.3.3Post code37044
    B.5.3.4CountryFrance
    B.5.4Telephone number33247 39 18 96
    B.5.5Fax number33247 37 35 12
    B.5.6E-mailfilo@univ-tours.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 DEXAMETHASONE
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN SAS
    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 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
    Elderly patients > 60 years with untreated acute myeloid leukemia
    Patients agés de plus de 60 ans avec une leucémie aigue myéloblastique non traitée.
    E.1.1.1Medical condition in easily understood language
    Elderly patients > 60 years with untreated acute myeloid leukemia
    Patients agés de plus de 60 ans avec une leucémie aigue myéloblastique non traitée.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000835
    E.1.2Term Acute 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
    To determine whether adding dexamethasone to ICL induction and IC post-remission therapy results in significant improvement of event-free survival (EFS) in patients >60 years with newly diagnosed AML as compared with a historical cohort of the FILO LAM-SA 2007 trial.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of adding dexamethasone to ICL induction and IC post-remission therapy on response to therapy, presence of minimal residual disease (MRD), allogeneic stem-cell transplantation, relapse from complete remission (CR) or CR with incomplete hematologic recovery (CRi), relapse-free survival (RFS), overall survival (OS), in patients >60 years with newly diagnosed AML.
    To evaluate the effect of adding dexamethasone to ICL induction and IC post-remission therapy on EFS, response to therapy, relapse from CR or CRi, OS, according to AML heterogeneity and post-remission therapy. AML heterogeneity includes leukocytosis (white blood cells (WBC) ≥30 G/L versus <30 G/L), molecular subgroups (NPM1, FLT3-ITD, RUNX1, DNMT3A mutations), and cytogenetic subgroups (favorable, intermediate and adverse). Post-remission therapy includes allogeneic stem cell transplantation.
    To assess the safety of adding dexamethasone to ICL induction and IC post-remission therapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. > 60 years of age.
    2. Newly diagnosed AML according to the World Health Organization (WHO) 2016 either de novo AML or therapy-related AML (i.e; AML arising after previous cytotoxic therapy or radiation)
    3. AML with favorable or intermediate cytogenetic risk according to MRC 2010 classification
    4. Subjects should be eligible for intensive chemotherapy by Idarubicine, cytarabine, Lomustine.
    5. ECOG < 3
    6. SORROR ≤ 3
    7. Adequate baseline organ function defined by the criteria below:
    - Total bilirubin ≤ 1.5xULN except cases clearly not indicative of inadequate liver function
    - ALAT and ASAT ≤ 3xULN
    - Creatinine ≤ 2.5xULN
    Unless considered due to leukemic organ involvement.
    8. Adequate cardiac function with LVEF ≥50%
    9. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
    10. Women will be menopausal to be enrolled
    11. The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient and before the start of induction chemotherapy.
    12. Affiliated to the French Social Security (Health Insurance).
    E.4Principal exclusion criteria
    1. Acute promyelocytic leukemia (APL) or acute megakaryocytic leukemia (AML-FAB M7).
    2. AML with adverse cytogenetic risk according to the MRC 2010 classification.
    3. AML arising from myelodysplastic syndromes, myeloproliferative disorders or chronic myelo-monocytic leukemia according to WHO classification (2016).
    4. AML with Philadelphia chromosome or with BCR-ABL1.
    5. Known active central nervous system leukemia
    6. Previous anti-AML treatment other than hydroxyurea.
    7. Cumulative anthracycline dose equivalent to ≥550 mg/m².
    8. Treatment with an investigational drug within 30 days or 5 half-life whichever is longer, preceding the first dose of study medication.
    9. Prior history of cancer unless controlled for at least 2 years and except for basal cell carcinoma, non-melanoma skin cancer and in situ cervical carcinoma.
    10. Severe medical or mental condition precluding the administration of protocol treatments
    11. Any sign of active uncontrolled disease including but not restricted to cardiac disease, infections, hepatitis.
    12. Any severe chronic disease potentially interfering with the protocol including HIV infection, active hepatitis B or C.
    13. Any severe conditions inducing contra-indications to dexamethasone including uncontrolled diabetes, infections, hypertension, stomach ulcer, mental illness, myasthenia or glaucoma.
    14. 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.
    15. Known active HIV, Hepatitis B or C infection.
    16. Pregnancy or breastfeeding.
    17. Patients who are incapacitated, under wardship, legal guardianship, or under the protection of the courts.
    18. Patients under State Medical Assistance (AME).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the EFS defined as the time from the date of inclusion to the date of induction failure, relapse from CR or CRi, or death from any cause, whichever occurs first. CR, CRi, relapse from CR or CRi and induction failure are defined according to the 2017 European Leukemia Net (ELN) recommendations.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    E.5.2Secondary end point(s)
    Response to therapy after induction therapy defined as CR according to the 2017 ELN recommendations.

    Response to therapy after induction therapy defined as CR or CRi according to the 2017 ELN recommendations.

    Presence of MRD after induction therapy and after post-remission therapy, measured by either quantitative PCR or flow cytometry.

    Allogeneic stem cell transplantation during post-remission therapy course.

    Remission duration (relapse from CR or CRi) defined as the time from the date of CR or CRi to the date of relapse according to the 2017 ELN recommendations.

    RFS defined as the time from the date of CR or CRi to the date of relapse or death from any cause, whichever occurs first, according to the 2017 ELN recommendations.

    Overall survival defined as the time from the date of randomization to the date of death from any cause.

    Adverse events reported according to the descriptions and grading scale found in the version 4.0 of the NCI-CTCAE.
    E.5.2.1Timepoint(s) of evaluation of this end point
    80 months
    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 No
    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 concerned25
    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 years6
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned 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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 state120
    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)
    According to standard care in the center
    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 Decision2018-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-10-19
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