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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-000719-17
    Sponsor's Protocol Code Number:PIVeR
    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:2017-12-05
    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 number2017-000719-17
    A.3Full title of the trial
    A multicentre, phase II, open label, single arm study of pixantrone in patients with CD20-positive relapsed or refractory aggressive non-Hodgkin lymphoma treated with rituximab, ifosfamide and etoposide.
    Etude multicentrique de phase II, en ouvert, avec un bras de traitement, évaluant la pixantrone chez des patients traités par du rituximab, de l’ifosfamide et de l’étoposide ayant un lymphome non hodgkinien B agressif CD20 positif, réfractaire ou en rechute.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of pixantrone in patients with lymphoma.
    Etude évaluant la pixantrone chez des patients ayant un lymphome
    A.3.2Name or abbreviated title of the trial where available
    PIVeR
    PIVeR
    A.4.1Sponsor's protocol code numberPIVeR
    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 supportLES LABORATOIRES SERVIER INDUSTRIE
    B.4.2CountryFrance
    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 pointClinical Project Manager L. MELGAR
    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+33 (0)427 01 27 38
    B.5.5Fax number+33 (0)421 59 84 16
    B.5.6E-mailpiver@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 Pixuvri
    D.2.1.1.2Name of the Marketing Authorisation holderCTI Life Sciences Limited
    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 namePixantrone
    D.3.2Product code EMEA/H/C/002055
    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 INNpixantrone
    D.3.9.1CAS number 144675-97-8
    D.3.9.3Other descriptive namePIXANTRONE DIMALEATE
    D.3.9.4EV Substance CodeSUB31562
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.8
    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
    Patients with CD20-positive relapsed or refractory aggressive non-Hodgkin lymphoma
    Patients ayant un lymphome non hodgkinien B agressif CD20 positif, réfractaire ou en rechute.
    E.1.1.1Medical condition in easily understood language
    Patients with non-Hodgkin lymphoma
    Patients ayant un lymphome non hodgkinien
    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 HLT
    E.1.2Classification code 10029608
    E.1.2Term Non-Hodgkin's lymphomas unspecified histology aggressive
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the efficacy of Pixantrone with rituximab, ifosfamide and etoposide as measured by the overall metabolic response (OMR) rate after 2 cycles of treatment or at permanent treatment discontinuation, whichever occurs first.
    L’objectif principal est d’évaluer l’efficacité de la Pixantrone administrée avec l’association rituximab, ifosfamide et étoposide, mesuré par le taux de réponse métabolique globale (OMR) après 2 cycles de traitement ou à l’arrêt définitif du traitement, en fonction de ce qui surviendra en premier.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of Pixantrone with rituximab, ifosfamide and etoposideas measured by the OMR and complete metabolic response (CMR), PFS and OS
    - To assess the safety of pixantrone with rituximab, ifosfamide and etoposide
    - To assess the transformation rate from PMR into CMR at the end of treatment for patients in PMR after 2 cycles who have not received transplant
    - To assess the feasibility of performing an autologous stem cell transplantation afterPixantrone with rituximab, ifosfamide and etoposide in patients who intend to undergo ASCT
    - To assess the success of stem cell collection after treatment
    - Évaluer l’efficacité de la Pixantrone avec le rituximab, l’ifosfamide et l’étoposide mesurée par le taux de réponse métabolique globale (OMR) et la réponse métabolique complète (CMR), la survie sans progression (PFS) et la survie globale (OS)
    - Evaluer la sécurité de la pixantrone avec le rituximab, l’ifosfamide et l’étoposide
    - Evaluer le taux de conversion d’une réponse métabolique partielle en une réponse métabolique complète à la fin du traitement pour les patients en réponse métabolique partielle après deux cycles qui n’ont pas été greffés
    - Evaluer la faisabilité de faire une autogreffe de cellules souches hématopoïétiques après un traitement par pixantrone administrée avec le rituximab, l’ifosfamide et l’étoposide chez des patients éligibles à une autogreffe
    - Evaluer le taux de succès de la collecte de cellules souches hématopoïétiques après traitement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 - Histologically proven CD20+ aggressive non-Hodgkin lymphoma (diffuse large B-cell lymphoma (DLBCL), de novo or transformed DLBCL from previously untreated low grade non-Hodgkin lymphoma or grade 3b follicular lymphoma) as per the WHO 2016 criteria

    2 - Relapsed or refractory disease, defined as follows:
    a. Patients eligible for ASCT who failed to achieve a CR after at least one salvage therapy (eg, R-ICE, R-ESHAP, or R-DHAP)
    b. Or patients in first relapse after ASCT
    c. Or patients not eligible for ASCT who failed to achieve a CR after at least one prior treatment (and no more than 4 previous lines) or in relapse after at least one prior treatment (and no more than 4 previous lines).

    3 - Age 18 years old and older

    4 - Eastern Cooperative Oncology Group (ECOG) performance status under or equal to 2

    5 - Subjects must have evaluable disease based on PET-CT scan

    6 - Minimum life expectancy of 6 months

    7 - Signed written informed consent

    8 - Patient covered by any social security system

    9 - Men must agree to use a barrier method of contraception during the treatment period and until 3 months after the last dose of chemotherapy

    10 - Women of childbearing potential must agree to use an adequate method of contraception, such as oral contraceptives, intrauterine device, or barrier method of contraception during the treatment period and until 12 months after the last dose of chemotherapy

    1 - Patients atteints d’un lymphome B non hodgkinien agressif confirmé histologiquement (CD20+) (lymphome diffus à grandes cellules B de novo ou transformation d’un lymphome non hodgkinien de bas grade, ou lymphome folliculaire de grade 3b) selon les critères de l’OMS de 2016

    2 - Maladie réfractaire ou en rechute, selon la définition suivante :
    a - Patients éligibles pour une autogreffe de cellules souches qui n’ont pas obtenu de réponse complète après au moins un traitement de rattrapage (i.e. R-ICE, R-ESHAP ou R-DHAP)
    b - OU patients en première rechute après une autogreffe de cellules souches
    c - OU patients non éligibles pour une autogreffe de cellules souches qui n’ont pas obtenu une réponse complète après au moins une ligne de traitement (et pas plus de quatre lignes de traitement), ou en rechute après au moins une ligne de traitement (et pas plus de quatre lignes de traitement).

    3 - Age 18 ans et plus

    4 - Indice de performance status ≤ 2 selon l’ECOG

    5 - Patients devant avoir une maladie mesurable sur un TEP-TDM

    6 - Espérance de vie au minimum de 6 mois

    7 - Consentement écrit libre et éclairé signé

    8 - Patient couvert par un système de sécurité sociale

    9 - Les hommes doivent accepter d’utiliser une méthode de contraception mécanique pendant le traitement et jusqu’à 3 mois après la dernière administration de la chimiothérapie

    10 - Les femmes en âge de procréer doivent accepter d’utiliser une méthode de contraception efficace, comme un contraceptif oral, un dispositif intra-utérin ou une méthode mécanique de contraception pendant le traitement et jusqu’à 12mois après la dernière dose de la chimiothérapie
    E.4Principal exclusion criteria
    1 - Any other histological type of lymphoma (Burkitt lymphoma, mantle-cell lymphoma…)
    2 - Any history of previously treated indolent non-Hodgkin lymphoma
    3 - Symptomatic central nervous system or meningeal involvement by the lymphoma
    4 - Contraindication to any drug contained in the Pixantrone with rituximab, ifosfamide and etoposide regimen
    5 - Treatment with any investigational drug within 28 days before the first study drug administration
    6 - Any of the following lab abnormalities unless related to the lymphoma or bone marrow infiltration:
    a. Absolute neutrophil count (ANC) < 1.0 G/L
    b. Platelet count < 100 G/L
    c. Creatinine clearance < 40 mL/min for patients < 70 y, or creatinine clearance < 60 mL/min for patients ≥ 70 y., by MDRD method
    d. Total bilirubin level > 1,5xULN
    e. Serum AST/SGOT or ALT/SGPT > 2,5x ULN
    7 - Known HIV positive
    8 - Active hepatitis C (Positive HCV serology with positive PCR for HCV RNA)
    9 - Active hepatitis B :
    a. HBsAg positive
    b. HBsAg negative, Ac anti-HBs positive and/or Ac anti-HBc positive (Patients who are seropositive due to a history of hepatitis B vaccine are eligible. Patients with Ac anti-HBs positive and/or Ac anti-HBc positive and no history of hepatitis B vaccine are eligible only if PCR for VHB DNA is negative)
    10 - Cumulative dose of doxorubicine or equivalent > 450mg/m2
    11 - Left ventricular ejection fraction (LVEF) < 45% measured by echocardiography or isotopic method
    12 - Congestive heart failure NYHA stage III or IV
    13 - History of a myocardial infarction within 6 months prior to enrolment
    14 - Pregnant or lactating females
    15 - Prior history of malignancies with the exception of non-melanoma skin tumors (basal cell or squamous cell carcinoma) or in situ cervical carcinoma
    16 - Any serious active disease or co-morbid medical condition according to the investigator’s decision
    17 - Adult person unabled to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
    18 - Use of any standard or experimental anti-cancer drug therapy within 28 days before the first study drug administration
    19 - Use of corticosteroids prior to baseline PET-CT
    1 -Tout autre type histologique de lymphome (Lymphome de Burkitt, lymphome du manteau, …)
    2 -Tout antécédent de lymphome non hodgkinien indolent précédemment traité
    3 - Symptômes évoquant un envahissement neuro-méningé
    4 - Contre-indication à l’un des composants de la pixantrone, du rituximab, de l’ifosfamide et de l’étoposide
    5 - Traitement avec un produit expérimental dans les 28 jours avant la première administration du traitement
    6 -Toute anomalie biologique suivante, sauf si liée au lymphome ou à l’envahissement médullaire :
    a -Neutrophiles < 1.0 G/l
    b -Plaquettes < 100 G/L
    c -Clairance de la créatinine < 40 mL/min pour les patients < 70 ans, ou clairance de la créatinine < 60 mL/min pour les patients ≥ 70 y, par la méthode MDRD.
    d -Bilirubine totale > 1,5 x limite normale supérieure (LNS)
    e -Alanine aminotransferase (ALT) et aspartate aminotransferase (AST) > 2,5x limite normale supérieure (LNS)
    7 -Séropositivité au VIH connue (infection par le virus de l’immunodéficience humaine)
    8 -Infection active par le virus de l’hépatite C (sérologie VHC positive avec ARN viral détectable)
    9 -Infection active par le virus de l’hépatite B (VHB) :
    a -HBsAg positif
    b -HBsAg négatif, anti-HBs positif et/ou anti-HBc positif (les patients qui sont séropositifs en raison d’une précédente vaccination contre l’hépatite B sont éligibles. Les patients avec anti-HBs positif et/ou anti-HBc positif et sans antécédent de vaccination contre l’hépatite B sont éligibles seulement si l’ADN du VHB est indétectable)
    10 - Dose cumulée de doxorubicine (ou équivalent) > 450mg/m²
    11 - Fraction d’éjection ventriculaire gauche (FEVG) < 45%
    12 - Insuffisance cardiaque de grade II ou IV de la New York Heart Association (NYHA)
    13 - Infarctus du myocarde dans les 6 mois précédents l’inclusion
    14 - Femmes enceintes ou allaitant
    15 - Patients avec un antécédent d’un autre cancer, à l’exception d’un cancer cutané hors mélanome (carcinome baso-cellulaire ou épidermoïde) ou un cancer in situ du col de l’utérus
    16 - Toute maladie grave active ou co-morbidité selon le jugement de l’investigateur
    17 - Adulte dans l’incapacité de donner un consentement éclairé en raison d’une déficience intellectuelle, d'une affection médicale grave, d'une anomalie biologique ou d'une maladie psychiatrique
    18 - Utilisation de traitement anti-cancéreux, standard ou expérimental, dans les 28 jours avant la première administration du traitement
    19 - Utilisation de corticostéroïdes avant le TEP-TDM de baseline
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the assessment of the Overall Metabolic Response (OMR) rate by local investigator based on PET-CT scan according to Lugano classification (Cheson B. et al, JCO 2014)
    Le critère principal d’efficacité est l’évaluation par l’investigateur local du taux de réponse métabolique globale (OMR) basé sur le TEP-TDM selon les critères de Lugano (Cheson B. et al, JCO 2014)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 2 cycles or at permanent treatment discontinuation, whichever occurs first.
    Après 2 cycles ou à l’arrêt définitif du traitement, en fonction de ce qui surviendra en premier.
    E.5.2Secondary end point(s)
    - Complete Metabolic Response (CMR) rate according to the local investigator
    - OMR and CMR rate according to the central review
    - PET results according to local investigator and central review
    - Progression-free survival (PFS)
    - Overall survival (OS)
    - Rate of ASCT
    - Rate of successful stem cell collection
    - Adverse Events (AEs) and Serious Adverse Events (SAEs)
    - taux de CMR selon l'investigateur local
    - taux d'OMR et de CMR selon la revue centralisée
    - résultats du TEP la revue centralisée
    - survie sans progression (PFS)
    - survie globale (OS)
    - taux de réalisation d’une autogreffe de cellules souches
    - taux de succès de collecte de cellules souches
    - évènements indésirables et les évènements indésirables graves
    E.5.2.1Timepoint(s) of evaluation of this end point
    - CMR rate :
    - after 2 cycles or at permanent treatment discontinuation according to the local investigator
    - after 2 cycles or at permanent treatment discontinuation and at the end of the study according to the central review
    - at the end of treatment according to the local investigator

    - OMR rate :
    - after 2 cycles or at permanent treatment discontinuation and at the end of the study according to the central review
    - at the end of treatment according to the local investigator

    - PET and central review : after 2 cycles and at the end of treatment

    - PFS, OS, Rate of ASCT, Rate of successful stem cell collection, AEs and SAEs: end of study
    - taux de CMR
    - après 2 cycles ou à l’arrêt définitif du traitement selon l'investigateur
    - après 2 cycles ou à l’arrêt définitif du traitement selon la revue centralisée
    - à la fin de traitement selon l'investigateur

    - taux de OMR
    - après 2 cycles ou à l’arrêt définitif du traitement selon la revue centralisée
    - à la fin de traitement selon l'investigateur

    - TEP et revue centralisée : après 2 cycles et à la fin du traitement
    - PFS, OS, taux de réalisation d’une autogreffe de cellules souches,EI et EIG: en fin d'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 concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 years6
    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 years6
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 89
    F.4.2.2In the whole clinical trial 89
    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 Decision2018-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
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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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