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    Summary
    EudraCT Number:2020-002336-74
    Sponsor's Protocol Code Number:SGN35-032
    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:2020-09-30
    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 number2020-002336-74
    A.3Full title of the trial
    A dual-cohort, open-label, phase 2 study of brentuximab vedotin and CHP (A+CHP) in the frontline treatment of subjects with peripheral T-cell lymphoma (PTCL) with less than 10% CD30 expression
    Étude de phase 2 à double cohorte, en ouvert portant sur le brentuximab védotine et le CHP (A+CHP) dans le traitement de première ligne de patients atteints de lymphome à cellules T périphérique (LCTP) avec moins de 10 % d’expression de CD30
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, phase 2 study of brentuximab vedotin and Chemotherapy agents in the frontline treatment of subjects with peripheral T-cell lymphoma (PTCL)
    Étude en ouvert, de phase 2 à double cohorteportant sur le brentuximab védotine et les agents de chimiothérapie dans le traitement de première ligne de patients atteints de lymphome à cellules T périphérique (LCTP)
    A.4.1Sponsor's protocol code numberSGN35-032
    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 SponsorSeattle Genetics, Inc.
    B.1.3.4CountryUnited States
    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 supportSeattle Genetics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSeattle Genetics, Inc.
    B.5.2Functional name of contact pointSeagen Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address21621- 30th Drive SE, Building 4
    B.5.3.2Town/ cityBothell
    B.5.3.3Post code98021
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@seagen.com
    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 holderSeattle Genetics, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/08/596; EU/3/08/595
    D.3 Description of the IMP
    D.3.1Product nameBrentuximab vedotin
    D.3.2Product code SGN-35
    D.3.4Pharmaceutical form Powder for concentrate for solution for 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.3.9.4EV Substance CodeSUB32397
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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
    Non-sALCL PTCL and CD30 expression <10%
    LCTP non LAGCs et expression du CD30 <10%
    E.1.1.1Medical condition in easily understood language
    T-cell Lymphoma
    Lymphome à cellules T
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10034624
    E.1.2Term Peripheral T-cell lymphoma unspecified NOS
    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 evaluate the objective response rate (ORR) per blinded independent central review (BICR) using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007)
    Évaluer le taux de réponse objective (TRO) par un examen central indépendant en aveugle (ECIA) en utilisant les critères de réponse révisés pour le lymphome malin (Cheson 2007)
    E.2.2Secondary objectives of the trial
    ● To evaluate the complete response (CR) following completion of study treatment (Cheson 2007)
    ● To evaluate progression-free survival (PFS) (Cheson 2007)
    ● To evaluate overall survival (OS)
    ● To evaluate duration of response (DOR) (Cheson 2007)
    ● To evaluate ORR per BICR using modified Lugano criteria (Cheson 2014)
    ● To evaluate safety and tolerability
    ● Évaluer la réponse complète (RC) après la fin du traitement à l’étude (Cheson 2007)
    ● Évaluer la survie sans progression (SSP) (Cheson 2007)
    ● Évaluer la survie globale (SG)
    ● Évaluer la durée de la réponse (DDR) (Cheson 2007)
    ● Évaluer le TRO d’après l’ECIA à l’aide des critères modifiés de Lugano (Cheson 2014)
    ● Évaluer la sécurité d’emploi et la tolérance
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age 18 years or older.
    2.Newly diagnosed PTCL, excluding systemic anaplastic large cell lymphoma (sALCL), per the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification.
    3.The following non-sALCL PTCL subtypes are eligible:
    a.PTCL – not otherwise specified (PTCL-NOS)
    b.Angioimmunoblastic T-cell lymphoma (AITL)
    c.Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukemia virus 1)
    d.Enteropathy-associated T-cell lymphoma (EATL)
    e.Hepatosplenic T-cell lymphoma
    f.Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL)
    g.Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract
    h.Follicular T-cell lymphoma
    i.Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype
    4.CD30 expression <10% by local assessment
    5.Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT, as assessed by the site radiologist.
    6.An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

    Other protocol defined inclusion criteria may apply.
    E.4Principal exclusion criteria
    1.Current diagnosis of any of the following:
    a.sALCL
    b.Primary cutaneous T-cell lymphoproliferative disorders and lymphomas
    c.Mycosis fungoides (MF), including transformed MF
    2.History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
    3.History of progressive multifocal leukoencephalopathy (PML).
    4.Cerebral/meningeal disease related to the underlying malignancy.
    5.Prior treatment with brentuximab vedotin.

    Other protocol defined exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    ORR per BICR following the completion of study treatment using Revised Response Criteria for Malignant Lymphoma criteria (Cheson 2007)
    TRO par ECIA après la du traitement à l'étude, à l’aide des critères de réponse révisés pour le lymphome malin (Cheson 2007)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after last subject enrolled
    6 mois après le dernier patient inclus
    E.5.2Secondary end point(s)
    ● Complete response rate per BICR (Cheson 2007)
    ● PFS per BICR (Cheson 2007)
    ● Overall survival (OS)
    ● Duration of response (DOR) per BICR
    ● ORR per BICR, using modified Lugano criteria (Cheson 2014)
    ● Type, incidence, severity, seriousness, and relatedness of adverse events
    ● Laboratory abnormalities
    ● taux de réponse complète d'après l'ECIA (Cheson 2007)
    ● SSP d'après l'ECIA (Cheson 2007)
    ● Survie globale (SG)
    ● Durée de la réponse (DDR) d'après l'ECIA
    ● TRO d'après l'ECIA, à l'aide des critères modifiés de Lugano (Cheson 2014)
    ● Type, fréquence, gravité, sévérité et imputabilité des évènements indésirables
    ● anomalies dans les analyses de laboratoire
    E.5.2.1Timepoint(s) of evaluation of this end point
    ● 1 year after last subject enrolled
    ● 1 year after last subject enrolled
    ● 1 year after last subject enrolled
    ● 1 year after last subject enrolled
    ● 1 year after last subject enrolled
    ● 1 year after last subject enrolled
    ● 1 an après l'inclusion du dernier patient
    ● 1 an après l'inclusion du dernier patient
    ● 1 an après l'inclusion du dernier patient
    ● 1 an après l'inclusion du dernier patient
    ● 1 an après l'inclusion du dernier patient
    ● 1 an après l'inclusion du dernier patient
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolérance
    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 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) 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 No
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Czech Republic
    France
    Italy
    Spain
    United Kingdom
    United States
    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
    The study will be closed 2 years after enrollment of the last subject, or when no subjects remain in long-term follow-up, whichever occurs first. Additionally, the sponsor may terminate the study at any time.
    The date the subject met criteria for study discontinuation and the reason for study discontinuation will be collected.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 80
    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)
    No further treatment or ASCT for patients who achieve CR; salvage therapy or clinical trial for patients who don’t respond or relapse
    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 Decision2020-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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