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    Summary
    EudraCT Number:2016-000327-10
    Sponsor's Protocol Code Number:SAMBA
    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:2017-06-27
    Trial results View 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 number2016-000327-10
    A.3Full title of the trial
    SINGLE AGENT JNJ-56022473 IN MDS AND AML PATIENTS FAILING HYPOMETHYLATING AGENT BASED THERAPY
    Etude de phase II avec JNJ-56022473 en monothérapie chez les patients présentant un syndrome myélodysplasique de haut risque (IPSS int 2 et élevé) ou une leucémie aigue myéloblastique en échec d'un agent hypométhylant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of efficacy of the antibody JNJ-56022473 in MDS and AML patients, in which the treamtment with hypomethylating agents fails or the treatment with hypomethylating agents results in a relapse.
    Etude de phase II avec JNJ-56022473 en monothérapie chez les patients présentant un syndrome myélodysplasique de haut risque (IPSS int 2 et élevé) ou une leucémie aigue myéloblastique en échec d'un agent hypométhylant
    A.3.2Name or abbreviated title of the trial where available
    SAMBA-trial
    A.4.1Sponsor's protocol code numberSAMBA
    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 SponsorGWT-TUD GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Pharmaceutica NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGroupe Francophone des Myélodysplasies (GFM)
    B.5.2Functional name of contact pointGFM
    B.5.3 Address:
    B.5.3.1Street Addressservice Hématologie Séniors/Hôpital Saint Louis/1 avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33171207056
    B.5.5Fax number33171207038
    B.5.6E-mailyuliya.sedletska@aphp.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 No
    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 nameJNJ-56022473 (CSL-62) 100 mg
    D.3.2Product code JNJ-56022473 (CSL-62) 100 mg
    D.3.4Pharmaceutical form Concentrate for solution for 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 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) Yes
    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
    AML and MDS patients failing or being refractory to hypomethylating agent (HMA) treatment.
    patients atteins de MDS ou de LAM réfractaires ou en rechute de traitement par les agents hypomethylants
    E.1.1.1Medical condition in easily understood language
    Patients with MDS or AML, who are failing hypomethylating agents.
    patients atteins de MDS ou de LAM réfractaires ou en rechute de traitement par les agents hypomethylants
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10067096
    E.1.2Term 5q minus myelodysplastic syndrome
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of JNJ-56022473 for the treatment of MDS and AML patients who have relapsed after or are refractory to treatment with HMAs
    Evaluer l’efficacité du JNJ-56022473 dans le traitement des LAM et des MDS de «risque» IPSS élevé ou intermédiaire 2 en échec de traitement par les agents hyméthylants.
    E.2.2Secondary objectives of the trial
    Safety, quality of life, Pharmacodymancs, AML evolution, progression
    Evaluer :
    1. La sécurité ;
    2. La qualité de vie
    3. La pharmacodynamique ;
    4. Le taux de progression vers LAM ;
    5. Le taux de progression.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - signed informed consent
    - ≥ 18 years of age
    - Must be able to adhere to the study visit schedule and other protocol requirements
    - Diagnosis of AML or MDS
    - At least one cytopenia (ANC < 1800/µL or platelet count < 100,000/µL or hemoglobin < 10 g/dL)
    - Failure to achieve complete or partial response or hematological improvement after at least six (azacitidine) or four (decitabine) 4-week treatment cycles administered during the past two years OR
    - Relapse after initial complete or partial response or hematological improvement observed after at least six (azacitidine) or four (decitabine) 4-week treatment cycles administered during the past two years OR
    - Intolerance to treatment with HMAs defined by drug-related ≥ Grade 3 liver or renal toxicity leading to treatment discontinuation during the past two years
    - Failed to respond to, relapsed following, not eligible, or opted not to participate in bone marrow transplantation
    - Off all other treatments for AML/MDS for at least four weeks; Filgrastim (G-CSF) and erythropoietin are allowed before and during the study as clinically indicated
    - No medical need for or patient opted not to receive induction chemotherapy
    - ECOG performance status of 0-2
    - Willing to adhere to the prohibitions and restrictions specified in the protocol
    - Age ≥ 18 ans
    - LAM ou MDS
    - blastes médullaires ≥ 5 %
    - Au moins une cytopénie (PNN < 1800/µl ou plaquettes < 100 000/µl ou hémoglobine < 10 g/dl)
    - Traitement préalable par au moins 6 cures d’Azacitidine ou 4 cure de Décitabine sans obtention de réponse hématologique (RC, RP, RC médullaire ou HI) effectué dans les 2 dernières années OU

    Rechute après réponse OU

    Intolérance au traitement par les agents hypomethylants définie par une toxicité hépatique de grade ≥ 3 reliée au traitement dans les deux dernières années.
    - Non-éligibilité, échec ou rechute après une greffe de moelle osseuse.
    - Aucun traitement contre LAM/MDS depuis au moins 4 semaines ; G-CSF et EPO sont autorisés avant et pendant l’étude selon les indications cliniques
    - Absence d’indication médicale ou refus de recevoir la chimiothérapie intensive
    - ECOG 0-2
    - Adhésion au programme de suivi de l’étude
    - Le patient doit comprendre et signer un consentement éclairé

    E.4Principal exclusion criteria
    - Previous treatment with a CD123 agent or T- or NK cell redirecting therapy
    - Patients having received intensive chemotherapy to treat HMA failure
    - Diagnosis of acute APL
    - WBC > 15 GPT/L
    - Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
    - Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
    - Active infection not adequately responding to appropriate therapy
    - Total bilirubin > 1.5 mg/dL not related to hemolysis or Gilbert’s disease
    - ALT/AST > 2.5 x upper limit of normal
    - Serum creatinine > 2.0 mg/dL
    - Female patients who are pregnant or lactating
    - Patients who are unwilling to follow highly effective contraception requirements (including condom use for males with sexual partners, and for females: prescription of oral contraceptives, contraceptive injections, intrauterine device, contraceptive patch, surgical sterilization or true sexual abstinence) at least at screnning, throughout the study and within 3 months after last study drug administration.
    - Female patients with child-bearing potential who do not have a negative urine ß-HCG pregnancy test at screening and prior to the first study drug administration at visit 1 (day 0 of JNJ-56022473 treatment period)
    - Female patients who are lactating
    - Known hypersensitivity to the study drugs or active substances or excipients of the preparations
    - Suspicion of drug or alcohol abuse
    - Antécédent de traitement par le CD123 ou traitement par un agent modulant l’activité des cellules T- ou NK.
    - Antécédent de traitement par la chimiothérapie intensive après l’échec de traitement par agents hypomethylants.
    - Leucémie aiguë promyélocytaire (LAP)
    - Leucocytes > 15 G/l
    - Cancer actif, ou tout cancer durant l’année précédant l’inclusion, à l’exception d’un carcinome baso-cellulaire ou d’un carcinome in situ du col de l’utérus ou du sein
    - Toute affection non-contrôlée, dont l’insuffisance cardiaque congestive symptomatique, l’angine de poitrine instable ou l’arythmie cardiaque.
    - Toute infection active non-répondante au traitement approprié.
    - Bilirubine totale > 1.5 mg/dl non liée à l’hémolyse ou la maladie de Gilbert.
    - ASAT/ALAT > 2.5 fois à la limite supérieure de la normale.
    - Créatinine sanguine > 2 mg/dl.
    - Refus d’utiliser une contraception efficace entre le screening et jusqu’à 3 mois après l’arrêt de traitement.
    - Femmes enceintes ;
    - Femmes allaitantes
    E.5 End points
    E.5.1Primary end point(s)
    - Overall hematological response rate at 3 months (either CR, PR, marrow-CR, HI, SD)
    réponse globale après 3 mois de traitement (rémission complète, rémission partielle, rémission complète médullaire, réponse hématologique, stabilité de la maladie)
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 3 month of treatment
    après 3 mois de traitement
    E.5.2Secondary end point(s)
    - Toxicity as measured by NCI CTCAE 4.03
    - Overall survival at 1 year
    - Progression-free-survival at 1 year
    - Overall hematological response rate at 12 months (either CR, PR, marrow-CR, HI, SD). Remission assessment according to Döhner et al. (AML patients) and Cheson et al. (MDS patients) - Quality of life as measured by EORTC-QLQ30
    - Time to treatment failure
    - Duration of response (best overall response)
    - Association of response to molecular signature and immune cell function (additional translational project)
    - survie globale à 1 an
    - survie sans progression à 1 an
    - réponse globale hématologique à 12 mois (rémission complète, rémission partielle, rémission complète médullaire, réponse hématologique, stabilité de la maladie). évaluation de la rémission complète d'après Döhner et al. (patients atteints de LAM) and Cheson et al. (patients atteints de SMD)
    - temps jusqu'à la perte de réponse au traitement
    - durée de la réponse (meilleure réponse)
    -association d ela réponse avec la signature moléculaire et la fonction des cellules immunitaires
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 1 year after enrollment
    1 an après l'inclusion
    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 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    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 months37
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months37
    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: 43
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 43
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 43
    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)
    After conclusion of the clinical trial, patients will receive further standard medical care at the discretion of the treating physician.
    après la fin de l'étude les patients recevrons le meilleur traitement disponible. le choix du traitement est à la discrétion du médecin traitant
    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 Decision2017-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-31
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