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    Summary
    EudraCT Number:2020-005515-51
    Sponsor's Protocol Code Number:202000814
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-28
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-005515-51
    A.3Full title of the trial
    An explorative and feasibility study of Venetoclax combined with Tamoxifen in patients with relapsed/refractory Diffuse Large B-cell Lymphoma
    Een verkennend en haalbaarheidsonderzoek van Venetoclax in combinatie met Tamoxifen bij patiënten met recidiverend / refractair diffuus grootcellig B-cellymfoom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tamoxifen and Venetoclax in R/R DLBCL
    Tamoxifen en Venetoclax in R/R DLBCL
    A.3.2Name or abbreviated title of the trial where available
    TamVen
    TamVen
    A.4.1Sponsor's protocol code number202000814
    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 SponsorMedical University Medical Center Groningen
    B.1.3.4CountryNetherlands
    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 supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointTrial Data Center Hematology
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310503610468
    B.5.6E-mailtrialbureauhematologie@onco.umcg.nl
    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 Venclyxto
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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.IMP: 2
    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 Tamoxifen
    D.2.1.1.2Name of the Marketing Authorisation holderWockhardt UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    relapsed/refractory Diffuse Large B-cell Lymphoma
    recidiverend / refractair diffuus grootcellig B-cellymfoom
    E.1.1.1Medical condition in easily understood language
    lymphoma
    lymfoom kanker
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the safety of Tamoxifen added to Venetoclax. Venetoclax will be dosed at 800 mg once daily. After 2 days of venetoclax, tamoxifen will be orally administrated in a ramp-up phase (2 days 10mg, 2 days 20mg, to a final dose of 40 once daily, see study scheme)
    • Om de veiligheid van Tamoxifen toegevoegd aan Venentoclax te beoordelen. Venetoclax wordt gedoseerd in een dosis van 800 mg eenmaal daags. Na 2 dagen venetoclax, zal tamoxifen oraal worden toegediend in een opstartfase (2 dagen 10 mg, 2 dagen 20 mg, tot een laatste dosis van 40 eenmaal daags, zie onderzoeksschema)
    E.2.2Secondary objectives of the trial
    ● To assess the efficacy of Tam added to Ven. An FDG PET /CT scan will be performed at day +28 and day +90 of the treatment
    ● To assess the duration of response (DOR)
    ● To assess the progression free survival (PFS)
    ● To assess the overall survival (OS)
    ● Op dag +28 en +90 van de behandeling wordt een FDG PET / CT-scan gemaakt.
    ● Om de responsduur (DOR) te beoordelen
    ● Om de progressievrije overleving (PFS) te beoordelen
    ● Om de algehele overleving (OS) te beoordelen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients of 18 years and older and under the age of 70 with a diagnosis of Diffuse Large B-cell lymphoma (according WHO 2016) and refractory after 2 lines of therapy for patients ineligible for CAR T-cell therapy and after CAR T-cell therapy (hence after 3rd line of therapy). Patients with relapsed/refractory DLBCL older than 70 years after at least 1 line of conventional chemotherapy or after CAR T-cell therapy.
    • Written informed consent.
    • No known allergy to Ven or Tam.
    • Patiënten van 18 jaar en ouder en jonger dan 70 met de diagnose diffuus grootcellig B-cellymfoom (volgens de WHO 2016) en refractair na 2 therapielijnen voor patiënten die niet in aanmerking komen voor CAR T-celtherapie en na CAR T-celtherapie (dus na 3e therapielijn). Patiënten met recidiverende / refractaire DLBCL ouder dan 70 jaar na ten minste 1 lijn conventionele chemotherapie of na CAR T-celtherapie.
    • Schriftelijke geïnformeerde toestemming.
    • Geen bekende allergie voor Ven of Tam.
    E.4Principal exclusion criteria
    • Eastern Cooperative Oncology Group (ECOG) performance status >2
    • Absolute neutrophil count (ANC) <1,000/µL
    • Platelet count <50,000/µL
    • Absolute lymphocyte count <100/µL
    • Primary CNS lymphoma
    • Active systemic fungal, viral or bacterial infection
    • CrCl <30 mL/min calculated according to the modified formula of Cockcroft and Gault or by direct urine collection
    • Pregnant or breast-feeding woman
    • Eastern Cooperative Oncology Group (ECOG) prestatiestatus> 2
    • Absoluut aantal neutrofielen (ANC) <1.000 / µL
    • Aantal bloedplaatjes <50.000 / µL
    • Absoluut aantal lymfocyten <100 / µL
    • Primair CZS-lymfoom
    • Actieve systemische schimmel-, virale of bacteriële infectie
    • CrCl <30 ml / min berekend volgens de aangepaste formule van Cockcroft en Gault of door directe urinecollectie
    • Zwangere vrouw of vrouw die borstvoeding geeft
    E.5 End points
    E.5.1Primary end point(s)
    ● Descriptive analyses of safety and toxicity (using SAE grade 3 and 4 listing) of tamoxifen and venetoclax.
    ● Beschrijvende analyses van veiligheid en toxiciteit (gebruikmakend van SAE-graad 3 en 4-lijst) van tamoxifen en venetoclax
    E.5.1.1Timepoint(s) of evaluation of this end point
    at entry, prior to first administration, and 24h, 72h, 7 days, 28 days and 90 days after first administration
    bij binnenkomst, voorafgaand aan de eerste toediening, en 24 uur, 72 uur, 7 dagen, 28 dagen en 90 dagen na de eerste toediening
    E.5.2Secondary end point(s)
    • To assess the effectivity of the combination Tam and Ven as measured by the day + 28 and +90 response as measured by FDG PET CT scan.
    • To assess the duration of response (DOR)
    • To assess the progression free survival (PFS) after 3 months (after the first dose of TAM)
    • To assess the overall survival (OS) after 3 months
    • Om de effectiviteit van de combinatie Tam en Ven te beoordelen, zoals gemeten aan de hand van de dag + 28 en +90 respons, zoals gemeten met een FDG PET CT-scan.
    • Om de responsduur (DOR) te beoordelen
    • Om de progressievrije overleving (PFS) na 3 maanden (na de eerste dosis TAM) te beoordelen
    • Om de algehele overleving (OS) na 3 maanden te beoordelen
    E.5.2.1Timepoint(s) of evaluation of this end point
    at entry, prior to first administration, and 24h, 72h, 7 days, 28 days and 90 days after first administration
    bij binnenkomst, voorafgaand aan de eerste toediening, en 24 uur, 72 uur, 7 dagen, 28 dagen en 90 dagen na de eerste toediening
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state6
    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)
    standard of care
    standaard zorg
    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 Decision2021-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-22
    P. End of Trial
    P.End of Trial StatusOngoing
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