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    Summary
    EudraCT Number:2017-000409-19
    Sponsor's Protocol Code Number:TOTAL
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-01
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-000409-19
    A.3Full title of the trial
    A phase II study of brentuximab vedotin in patients with relapsed or refractory peripheral T-cell lymphoma treated with gemcitabine followed by brentuximab vedotin maintenance
    Etude de phase II du brentuximab vedotin chez des patients atteints de lymphome T périphérique récidivant ou réfractaire traités par gemcitabine suivi d'une maintenance par brentuximab vedotin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of brentuximab vedotin in patients with T lymphoma
    Etude du brentuximab vedotin chez des patients atteints d'un lymphome T
    A.3.2Name or abbreviated title of the trial where available
    TOTAL
    A.4.1Sponsor's protocol code numberTOTAL
    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 SponsorLYSARC
    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 supportMillennium Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLYSARC
    B.5.2Functional name of contact pointProject Manager J. Diou-Lefort
    B.5.3 Address:
    B.5.3.1Street AddressCH LYON SUD - Ste Eugénie - Pav 6D
    B.5.3.2Town/ cityPIERRE BENITE CEDEX
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number+33472 66 93 33
    B.5.5Fax number+33426 07 40 55
    B.5.6E-mailaffaires-reglementaires@lysarc.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 ADCETRIS
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    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 nameBrentuximab vedotin
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrentuximab vedotin
    D.3.9.1CAS number 914088-09-8
    D.3.9.2Current sponsor codeSGN-35
    D.3.9.3Other descriptive nameBRENTUXIMAB VEDOTIN
    D.3.9.4EV Substance CodeSUB32397
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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
    Relapsed or refractory peripheral T-cell lymphoma
    lymphome T périphérique récidivant ou réfractaire
    E.1.1.1Medical condition in easily understood language
    T lymphoma
    lymphome T
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10042980
    E.1.2Term T-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10042979
    E.1.2Term T-cell lymphoma recurrent
    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 determine the efficacy of brentuximab vedotin (BV) in patients treated by gemcitabine for relapsed or refractory peripheral T-cell lymphoma in term of overall response rate assessed after 4 cycles of treatment according to the international response criteria for malignant lymphoma (Lugano Classification 2014 – CT-Based Response).
    Déterminer l'efficacité du brentuximab vedotin (BV) chez des patients traités par gemcitabine pour un lymphome T périphérique récidivant ou réfractaire par le taux de réponse globale évaluée après 4 cycles de traitement selon les critères de réponse internationale du lymphome (Critères de Lugano 2014 – Réponse basée sur le CT-scan).
    E.2.2Secondary objectives of the trial
    To determine :
    ‐the efficacy of BV in patients with relapsed or refractory peripheral T-cell lymphoma treated with gemcitabine, in term of progression free survival (PFS), complete response rate (CRR), duration of response for responding patients (DR), time to treatment failure (TTF), time to next treatment (TTNT) and overall survival (OS)
    ‐ the efficacy of maintenance with BV in terms of PFS, DR and OS
    ‐ the overall response rate (ORR) according to FDG-PET scan assessment
    ‐ the toxicity of BV in patients with relapsed or refractory peripheral T-cell lymphoma treated with gemcitabine according to the NCICTCAE v4.03
    ‐the toxicity of maintenance with BV according to the NCICTCAE v4.03
    Déterminer :
    - l'efficacité du BV chez des patients traités par gemcitabine pour un lymphome T périphérique récidivant ou réfractaire par le taux de survie sans progression (PFS), le taux de réponse complète (CRR), la durée de réponse (DR) pour les patients répondeurs, le délai avant échec du traitement (TTF) , le délai avant le prochain traitement (TTNT) et la survie globale (OS)
    - l’efficacité du BV en entretien évaluée par la PFS, La DR, l'OS
    - le taux de réponse global (ORR) selon l'évaluation de la TEP
    - la toxicité du BV chez les patients atteints de lymphome T
    périphérique récidivant ou réfractaire traités par gemcitabine selon la
    terminologie NCI-CTCAE v4.03;
    - la toxicité du traitement de maintenance par BV selon la
    terminologie NCI-CTCAE v4.03.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Males and females of 18 years to 80 years of age
    - Understand and voluntarily sign an informed consent document prior to any study related assessment or procedure
    - Patients able to adhere to the study visit schedule and protocol requirements
    - Patients with histologically proven, CD30 positive (at least 5% of cells
    according to local examination) peripheral T-cell lymphoma (PTCL) according to the 2016 WHO classification for whom gemcitabine treatment is expected. A biopsy at relapse is highly recommended
    - Patients who have evidence of relapsed disease after at least one line (and no more than three lines) of treatment or who were refractory to a first or subsequent line of treatment
    - Patients with Ann Arbor stage I – IV
    - Patients with ECOG performance status of 0 - 2
    - Patients with at least one measurable disease, i.e. one nodal or extra-nodal lesion of 1.5 cm or more
    - Negative pregnancy test for females of childbearing potential (FCBP)
    - Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 6 months thereafter
    - Males must use an effective method of birth control during treatment period and 6 months thereafter
    - Hommes et femmes de 18 à 80 ans
    - Comprendre et signer volontairement le document de consentement éclairé avant toute évaluation ou procédure liée à l'étude
    - Patients capables de se conformer au calendrier des visites de l'étude et aux exigences du protocole
    - Lymphome T périphérique (Classification OMS 2016), CD30+ (au minimum 5% de cellules en lecture locale) pour lesquels un traitement par gemcitabine est une option ; une biopsie à la rechute est fortemment recommandée
    - Maladie récidivante après au moins une (et pas plus de trois) ligne de
    traitement ou qui étaient réfractaires à une première ligne de traitement ou à une ligne suivante
    - Stade Ann Arbor de I à IV
    - Performance status ≤ 2 selon l’échelle ECOG
    - Au moins une lésion mesurable, nodale ou extra-nodale de 1,5 cm ou plus
    - Test de grossesse négatif pour les femmes en âge de procréer
    - Les femmes en âge de procréer doivent utiliser une méthode efficace de contraception (hormonale, dispositif intra-utérin, diaphragme avec spermicide, préservatif avec spermicide ou abstinence) pendant toute la période de traitement et jusqu’à 6 mois après la fin du traitement
    - Les hommes doivent utiliser une méthode efficace de contraception pendant la période de traitement et jusqu’à 6 mois après la fin du traitement
    E.4Principal exclusion criteria
    - Any significant medical condition or laboratory abnormality unrelated to PTCL, or psychiatric illness that would prevent the patient from participating in the study and from signing the informed consent form
    - Any condition that confounds the ability to interpret data from the study
    - Other types of lymphomas, e.g. B-cell lymphoma
    - Central nervous system and/or meningeal involvement by PTCL
    - Signs or symptoms of Progressive Multifocal Leukoencephalopathy
    - Preexistent peripheral neuropathy ≥ grade 2, whatever the cause
    - Contraindication to any drug contained in the chemotherapy regimen
    - Subjects with HIV or HTLV1 positivity
    - Subjects with active hepatitis B or C. Chronic carriers of hepatitis B without HBV DNA positive blood are eligible. Subjects with non-active hepatitis C (with normal transaminases) are eligible
    - Chronic or acute, clinically significant, untreated bacterial, viral or fungal infection
    - Any of the following laboratory abnormalities:
    a. Absolute neutrophil count (ANC) < 1500 cells/mm3 (1.5 x 109/L);
    b. Platelet count <75,000/mm3 (75 x 109/L);
    c. Serum SGOT/AST or SGPT/ALT ≥ 3.0 x upper limit of normal (ULN).
    SGOT/AST or SGPT/ALT may be elevated up to 5 x ULN if their elevation can be ascribed to the presence of hematologic/solid tumor in the liver
    d. Serum total bilirubin > 1.5 x ULN
    e. Serum lipase level > 2 x ULN
    f. Serum creatinine > 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance < 40 mL/minute
    g. Hemoglobin < 8g/dL
    - Active malignancies other than PTCL requiring systemic treatment
    - Previous treatment with brentuximab vedotin
    - Previous treatment with gemcitabine
    - Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study
    - Known history of any of the following cardiovascular conditions:
    o Myocardial infarction within 2 years of enrollment
    o New York Heart Association (NYHA) Class III or IV heart failure
    o Evidence of current uncontrolled cardiovascular conditions,
    including cardiac arrhythmias, congestive heart failure (CHF),
    angina, or electrocardiographic evidence of acute ischemia or
    active conduction system abnormalities
    o Recent evidence (within 6 months before first dose of study drug) of
    a left-ventricular ejection fraction <50%
    - Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment
    - Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
    - Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
    - Toute condition médicale significative ou anomalie de laboratoire non liée au lymphome T périphérique, ou une maladie psychiatrique qui empêcherait le patient de participer à l'étude et de signer le formulaire de consentement éclairé
    - Toute condition qui modifie la capacité d'interprétation des données de l'étude
    - Autres types de lymphomes, par exemple lymphome à cellules B
    - Envahissement du système nerveux central et / ou méningé par le lymphome T périphérique
    - Signes ou symptômes de leucoencéphalopathie multifocale progressive
    - Contre-indication à l’un des produits utilisés dans la chimiothérapie
    - Neuropathie périphérique préexistante de grade ≥ 2, quelle que soit la cause
    - Sérologies HIV ou HTLV1 positives
    - Hépatite B ou C active ; les porteurs chroniques de l’hépatite B sans
    présence d’ADN du VHB circulant sont éligibles ; les patients atteints
    d’hépatite C non active (transaminases normales) sont éligibles
    - Infection bactérienne, virale ou fongique, chronique ou aiguë, cliniquement significative, non traitée
    - L'une des anomalies de laboratoire suivantes :
    a. Polynucléaires neutrophiles (valeur absolue) < 1500/mm3 (1.5 x 109/L)
    b. Plaquettes <75 000/mm3 (75 x 109/L)
    c. ASAT (SGOT) ou ALAT (SGPT) ≥ 3.0 x la normale supérieure
    Les ASAT (SGOT) ou ALAT (SGPT) peuvent atteindre jusqu'à 5 x la
    normale supérieure si leur élévation peut être attribuée à la présence d'une tumeur hématologique / solide dans le foie
    d. Bilirubine totale > 1.5 x la normale supérieure
    e. Lipase sérique > 2 x la normale supérieure
    f. Créatinine sérique > 2.0 mg/dL et / ou clairance de la créatinine ou
    clairance de la créatinine calculée < 40 mL/minute
    g. Hémoglobine < 8 g/dL
    - Tumeur maligne autres que le lymphome T périphérique nécessitant un traitement systémique
    - Traitement antérieur par brentuximab vedotin
    - Traitement antérieur par gemcitabine
    - Femmes enceintes ou allaitantes, ou femmes en âge de procréer qui ne veulent pas utiliser une méthode adéquate de contraception pendant la durée de l'étude
    - Antécédents connus de l'une des affections cardiovasculaires suivantes :
    o Infarctus du myocarde dans les 2 ans avant l’inclusion
    o Insuffisance cardiaque de classe III ou IV selon les critères de la
    New York Heart Association (NYHA)
    o Preuve d’une maladie cardiovasculaire non contrôlée en cours, y
    compris : arythmie cardiaque, insuffisance cardiaque congestive,
    angine de poitrine ou signes électrocardiographiques d'ischémie
    aiguë ou de trouble de la conduction
    o Preuve récente (dans les 6 mois avant la première dose de
    traitement de l'étude) d'une fraction d'éjection du ventricule gauche <
    50%
    - Patients qui n'ont pas terminé un traitement antérieur de chimiothérapie et /ou d'autres agents expérimentaux depuis au moins 5 demi-vies de la dernière dose de ce traitement antérieur
    - Diagnostic ou traitement pour un cancer dans les 3 ans précédant la
    première dose de traitement à l’étude ou diagnostic précédant pour un autre cancer et présentant des signes de maladie résiduelle ; les patients atteints de cancer de la peau autre que mélanome ou de carcinome in situ de tout type ne sont pas exclus s'ils ont bénéficié d’une résection complète .
    - Hypersensibilité connue au protéines recombinantes, protéines murines et à tout excipient contenu dans la formulation du brentuximab vedotin
    E.5 End points
    E.5.1Primary end point(s)
    ORR according to Lugano Classification 2014 – CT-Based Response
    ORR selon les Critères de Lugano 2014 – Réponse basée sur le CT-scan
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 4 cycles of treatment
    après 4 cycles de traitement
    E.5.2Secondary end point(s)
    - Response rates (RR) according to the response criteria for malignant lymphoma 2014
    - Overall Metabolic Response Rate (OMRR) according to FDG-PET scan assessment
    - Progression Free Survival (PFS)
    - Duration of response (DR)
    - Time to Treatment Failure (TTF)
    - Time to next treatment (TTNT)
    - Overall Survival (OS)
    - Safety
    - Taux de réponse (RR) selon les critères de réponse de lymphome malin de 2014
    - Taux de réponse métabolique globale (OMRR) selon évaluation par FDG-PET scan
    - Survie sans progression (PFS)
    - Durée de réponse (DR)
    - Délai avant échec du traitement (TTF)
    - Délai avant prochain traitement (TTNT)
    - Survie globale (OS)
    - Sécurité
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Efficacy assessments
    Tumor assessment will be performed at baseline, after the second cycle and at the end of GBv treatment or at permanent treatment
    discontinuation.
    During BV maintenance : every three cycles of BV.

    Follow-up assessment : every 3 months the first 2 years and every 6 months thereafter.

    2. Safety assessments throughout the study.
    1. Les objectifs secondaires d'efficacité:
    Evaluation de la tumeur après le deuxième cycle et à la fin du traitement GBV ou lors de l'arrêt prématuré du traitement

    Pendant le traitement d'entretien de BV : tous les trois cycles de
    BV.

    Pendant la période de suivi : tous les 3 mois
    durant les 2 premières années et tous les 6 mois par la suite.

    2. Evaluations de sécurité : tout au long 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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    Subjects will be followed according to the standard of care in the
    center.
    Les patients seront suivis selon les soins standards du centre
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation LYSA
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-10-08
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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