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    Summary
    EudraCT Number:2020-002935-30
    Sponsor's Protocol Code Number:20-01434
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-002935-30
    A.3Full title of the trial
    Venetoclax in combination with the BTK inhibitor Ibrutinib and Rituximab or conventional chemotherapy (Bendamustine) and Ibrutinib and Rituximab in patients with treatment naive Mantle Cell Lymphoma not eligible for high dose therapy.
    Venetoclax in Kombination mit dem BTK Inhibitor Ibrutinib und Rituximab oder konventionelle Chemotherapie (Bendamustin) und Ibrutinib und Rituximab zur Behandlung eines unbehandelten Mantelzell-Lymphoms bei Patienten, die nicht für eine Hochdosistherapie geeignet sind.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Venetoclax in combination with Ibrutinib and Rituximab or conventional chemotherapy (Bendamustine) and Ibrutinib and Rituximab in patients with Mantle Cell Lymphoma.
    Venetoclax in Kombination mit Ibrutinib und Rituximab oder konventionelle Chemotherapie (Bendamustin) und Ibrutinib und Rituximab bei Patienten mit Mantelzell-Lymphoms.
    A.3.2Name or abbreviated title of the trial where available
    MCL elderly III
    MCL elderly III
    A.4.1Sponsor's protocol code number20-01434
    A.5.4Other Identifiers
    Name:EU CTNumber:2022-501808-96-00
    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 SponsorUniversity Medical Center of the Johannes Gutenberg-University Mainz
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportJanssen Pharmaceutica NV
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center of the Johannes Gutenberg-University Mainz
    B.5.2Functional name of contact pointUniv.-Prof. Dr. med. Georg Hess
    B.5.3 Address:
    B.5.3.1Street AddressLangenbeckstr. 1
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55131
    B.5.3.4CountryGermany
    B.5.4Telephone number+496131175040
    B.5.5Fax number+49613117475040
    B.5.6E-mailSPO@izks-mainz.de
    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 IMBRUVICA®140 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIbrutinib
    D.3.9.1CAS number 936563-96-1
    D.3.9.3Other descriptive nameImbruvica
    D.3.9.4EV Substance CodeSUB120863
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 Yes
    D.3.11.13.1Other medicinal product typeAntineoplastic agents, protein kinase inhibitors
    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 Venclyxto® 10 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVenetoclax
    D.3.9.3Other descriptive nameVenclyxto
    D.3.9.4EV Substance CodeSUB176260
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeother antineoplastic agents
    D.IMP: 3
    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® 50 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVenetoclax
    D.3.9.3Other descriptive nameVenclyxto
    D.3.9.4EV Substance CodeSUB176260
    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 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 Yes
    D.3.11.13.1Other medicinal product typeother antineoplastic agents
    D.IMP: 4
    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® 100 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVenetoclax
    D.3.9.3Other descriptive nameVenclyxto
    D.3.9.4EV Substance CodeSUB176260
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.3.11.13.1Other medicinal product typeother antineoplastic agents
    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
    Mantle Cell Lymphoma
    Mantelzell-Lymphom
    E.1.1.1Medical condition in easily understood language
    malignant lymph node disease
    bösartige Lymphknotenerkrankung
    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 10026799
    E.1.2Term Mantle cell lymphoma 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 efficacy in both treatment arms:
    - Failure-Free Survival (FFS) at 30 months
    Beurteilung der Wirksamkeit in beiden Behandlungsarmen:
    - Eventfreies Überleben (FFS) nach 30 Monaten
    E.2.2Secondary objectives of the trial
    To evaluate efficacy, safety, tolerability, and quality of life in both treatment arms:
    - Failure-free survival (continuous observation)
    - Progression-free survival
    - Complete Remission rate (CR) and overall response rate (ORR: CR, PR) four weeks after the end of induction therapy
    - best response, time to best response, time to first response
    - overall survival
    - Overall survival of patients divided according to the geriatric categories and treatment received
    - Safety: adverse events, tolerability
    - Quality of life during induction and maintenance therapy (assessed using the EORTC QLQ-C30 and the EORTC QLQ-NHL-HG29)
    - Molecular remission after induction and conversion during maintenance (exploratory)
    - Immune reconstitution, e.g. persistence of anti-Covid19 immunity
    - safety and efficacy in different geriatric categories
    Beurteilung der Wirksamkeit, Sicherheit, Verträglichkeit und Lebensqualität in beiden Behandlungsarmen:
    - Eventfreies Überleben (kontinuierliche Beobachtung)
    - Progressionsfreies Überleben
    - Komplette Remissionsrate (CR) und Gesamtansprechrate (ORR: CR, PR) vier Wochen nach Ende der Induktionstherapie
    - Bestes Ansprechen, Zeit bis zum besten Ansprechen, Zeit bis zum ersten Ansprechen
    - Gesamtüberlebensdauer
    - Sicherheit: unerwünschte Ereignisse, Verträglichkeit
    - Lebensqualität während der Induktions- und Erhaltungstherapie (bewertet mit dem EORTC QLQ-C30 und dem EORTC QLQ-NHL-HG29)
    - Molekulare Remission nach Induktion und Konversion während der Erhaltungstherapie (explorativ)
    - Immunrekonstitution, z. B. Persistenz der Anti-Covid19-Immunität
    - Wirksamkeit und Sicherheit in verschiedenen geriatrischen Kategorien
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed diagnosis of MCL according to WHO classification
    - previously untreated stage II-IV (Ann Arbor)
    - ≥ 60 years and not suitable for autologous SCT
    - At least 1 measurable lesion; in case of bone marrow infiltration only, bone marrow aspiration and biopsy is mandatory for all staging evaluations.
    - ECOG performance status ≤ 2
    The following laboratory values at screening (unless related to MCL):
    - Absolute neutrophil count (ANC) ≥ 1000 cells/μL
    - Platelets ≥75.000 cells/μL
    - Transaminases (AST and ALT) ≤3 x ULN
    - Total bilirubin ≤ 2 x ULN unless other reason known (Gilbert-Meulengracht-Syndrome)
    - Creatinine ≤ 2 mg/dL or eGFR ≥ 50 mL/min
    - Written informed consent form according to ICH/EU GCP and national regulations
    - Sexually active men with female partners of child-bearing potential potential must agree to use highly effective contraceptives
    - Histologisch bestätigte Diagnose von MCL gemäß WHO-Klassifikation
    - Bisher unbehandeltes Stadium II-IV (Ann Arbor)
    - ≥ 60 Jahre und nicht für eine autologe ASZT geeignet
    - Mindestens 1 messbare Läsion; ausschließlich im Falle einer Knochenmarkinfiltration ist eine Knochenmarkaspiration und -biopsie für alle Staging-Bewertungen obligatorisch.
    - ECOG ≤ 2
    Die folgenden Laborwerte beim Screening (sofern nicht auf MCL bezogen):
    - Absolute Neutrophilenzahl (ANC) ≥ 1000 Zellen/µL
    - Thrombozyten ≥75.000 Zellen/µL
    - Transaminasen (AST und ALT) ≤3 x ULN
    - Gesamtbilirubin ≤ 2 x ULN, sofern kein anderer Grund bekannt ist (Gilbert-Meulengracht-Syndrom)
    - Kreatinin ≤ 2 mg/dL oder eGFR ≥ 50 mL/min
    - Schriftliche Einverständniserklärung gemäß ICH/EU GCP und nationalen Vorschriften
    - Sexuell aktive Männer mit Partnerinnen im gebärfähigen Alter müssen sich verpflichten, hochwirksame Verhütungsmittel zu verwenden .

    E.4Principal exclusion criteria
    - Major surgery within 4 weeks prior to first dose
    - Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon)
    - History of stroke or intracranial hemorrhage within 6 months prior to first dose
    - Treatment with strong or moderate CYP3A4/5 inhibitors/inducers within 7 days before first dose and during Venetoclax and Ibrutinib intake
    - Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of Ibrutinib capsules, or put the study outcomes at undue risk
    - Vaccinated with live, attenuated vaccines within 4 weeks prior to first dose
    - Known CNS involvement of MCL
    - Known bleeding disorder (e.g. von Willebrand disease; hemophilia)
    Serious concomitant disease interfering with a regular therapy according to the study protocol:
    - Cardiac (Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification or LVEF below LLN)
    - Pulmonary (e.g. chronic lung disease with hypoxemia, e.g. DLCO ≤ 65% or FEV1 ≤ 65%)
    - Endocrinological (e.g. severe, not sufficiently controlled diabetes mellitus)
    - Patients with unresolved hepatitis B or C infection or known HIV positive infection (mandatory test)
    Concomitant or previous malignancies within the last 3 years other than basal cell skin cancer, Prostate cancer in remission with PSA within normal range or in situ uterine cervix cancer.
    - Schwerwiegende Operation innerhalb von 4 Wochen vor erster Dosis
    - Erforderte Antikoagulation mit Warfarin oder gleichwertigen Vitamin-K-Antagonisten (z. B. Phenprocoumon)
    - Vorgeschichte eines Schlaganfalles oder einer intrakraniellen Blutung innerhalb der letzten 6 Monate vor erster Dosis
    - Behandlung mit starken oder moderaten CYP3A4/5-Inhibitoren/Induktoren innerhalb der letzten 7 Tage vor Gabe der ersten Dosis und während der Einnahme von Venetoclax und Ibrutinib
    - Jede lebensbedrohliche Krankheit, jede Erkrankung oder jede Funktionsstörung eines Organsystems, die nach Ansicht des Prüfarztes, die Sicherheit des Probanden gefährden, die Absorption oder den Metabolismus von Ibrutinib-Kapseln beeinträchtigen oder die Ergebnisse der Studie in unangemessener Weise gefährden könnte
    - Geimpft mit abgeschwächten Lebendimpfstoffen innerhalb der letzten 4 Wochen vor erster Dosis
    - Bekannte ZNS-Beteiligung von MCL
    - Bekannte Blutungsstörung (z. B. von-Willebrand-Krankheit, Hämophilie)
    Schwerwiegende Begleiterkrankung, die eine reguläre Therapie gemäß dem Studienprotokoll beeinträchtigen:
    - Kardial (klinisch signifikante kardiovaskuläre Erkrankungen wie unkontrollierte oder symptomatische Arrhythmien, kongestive Herzinsuffizienz oder Myokardinfarkt innerhalb der letzten 6 Monate vor dem Screening oder eine Herzerkrankung der Klasse 3 (mittelschwer) oder Klasse 4 (schwer) gemäß der funktionellen Klassifikation der New York Heart Association oder ein LVEF unter LLN)
    - Pulmonal (z. B. chronische Lungenerkrankung mit Hypoxämie, z. B. DLCO ≤ 65 % oder FEV1 ≤ 65 %)
    - Endokrinologisch (z. B. schwerer, nicht ausreichend eingestellter Diabetes mellitus)
    - Patienten mit ungeklärter Hepatitis-B- oder -C-Infektion oder bekannter HIV-Infektion (obligatorischer Test)
    Begleitende oder frühere bösartige Erkrankungen innerhalb der letzten 3 Jahre, ausgenommen Basalzell-Hautkrebs, Prostatakrebs in Remission mit PSA im Normbereich oder In-situ-Gebärmutterhalskrebs.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate efficacy in both treatment arms:
    - Failure-Free Survival (FFS) at 30 months
    Beurteilung der Wirksamkeit in beiden Behandlungsarmen:
    - Eventfreies Überleben (FFS) nach 30 Monaten
    E.5.1.1Timepoint(s) of evaluation of this end point
    Failure-Free Survival (FFS) at 30 months
    Eventfreies Überleben (FFS) nach 30 Monaten
    E.5.2Secondary end point(s)
    To evaluate efficacy, safety, tolerability, and quality of life in both treatment arms:
    - Failure-free survival (continuous observation)
    - Progression-free survival
    - Complete Remission rate (CR) and overall response rate (ORR: CR, PR) four weeks after the end of induction therapy
    - best response, time to best response, time to first response
    - overall survival
    - Overall survival of patients divided according to the geriatric categories and treatment received
    - Safety: adverse events, tolerability
    - Quality of life during induction and maintenance therapy (assessed using the EORTC QLQ-C30 and the EORTC QLQ-NHL-HG29)
    - Molecular remission after induction and conversion during maintenance (exploratory)
    - Immune reconstitution, e.g. persistence of anti-Covid19 immunity
    - safety and efficacy in different geriatric categories
    Beurteilung der Wirksamkeit, Sicherheit, Verträglichkeit und Lebensqualität in beiden Behandlungsarmen:
    - Eventfreies Überleben (kontinuierliche Beobachtung)
    - Progressionsfreies Überleben
    - Komplette Remissionsrate (CR) und Gesamtansprechrate (ORR: CR, PR) vier Wochen nach Ende der Induktionstherapie
    - Bestes Ansprechen, Zeit bis zum besten Ansprechen, Zeit bis zum ersten Ansprechen
    - Gesamtüberlebensdauer
    - Sicherheit: unerwünschte Ereignisse, Verträglichkeit
    - Lebensqualität während der Induktions- und Erhaltungstherapie (bewertet mit dem EORTC QLQ-C30 und dem EORTC QLQ-NHL-HG29)
    - Molekulare Remission nach Induktion und Konversion während der Erhaltungstherapie (explorativ)
    - Immunrekonstitution, z. B. Persistenz der Anti-Covid19-Immunität
    - Wirksamkeit und Sicherheit in verschiedenen geriatrischen Kategorien
    E.5.2.1Timepoint(s) of evaluation of this end point
    Failure-Free Survival (FFS) at 30 months
    Eventfreies Überleben (FFS) nach 30 Monaten
    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 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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    letzter Visit, letzter 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 months66
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months66
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    Any choice of subsequent treatment is up to the decision of the treating physician. Type/regimen used and response to subsequent treatment should be reported in the eCRF. Patients should be offered to take part in the registry of the European Mantle Cell Lymphoma network, in which subsequent treatment lines can be registered for better understanding of treatment, response and survival patterns.
    Die Wahl der nachfolgenden Behandlung liegt im Ermessen des behandelnden Arztes. Art/Anwendung und Ansprechen auf die nachfolgende Behandlung sollten im eCRF angegeben werden. Den Patienten sollte angeboten werden, am Register des Europäischen Mantelzell-Lymphom-Netzes teilzunehmen, in dem nachfolgende Behandlungslinien zum besseren Verständnis von Behandlung, Ansprechen und Überleben registriert werden können.
    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 Decision2022-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-20
    P. End of Trial
    P.End of Trial StatusOngoing
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