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    EudraCT Number:2014-001363-12
    Sponsor's Protocol Code Number:TRIANGLE
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-10-30
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedPortugal - INFARMED
    A.2EudraCT number2014-001363-12
    A.3Full title of the trial
    Autologous Transplantation after a Rituximab/Ibrutinib/Ara-c containing iNduction in Generalized mantle cell Lymphoma – a randomized European MCL Network trial
    Transplantação autóloga após um regime de Indução com Rituximab, Ibrutinib e Citosina Arabinosido em doentes com Linfoma do Manto generalizado – um Ensaio aleatorizado do European MCL Network
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Autologous Transplantation after a Rituximab/Ibrutinib/Ara-c containing iNduction in Generalized mantle cell Lymphoma – a randomized European MCL Network trial
    Transplantação autóloga após um regime de Indução com Rituximab, Ibrutinib e Citosina Arabinosido em doentes com Linfoma do Manto generalizado – um Ensaio aleatorizado do European MCL Network
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberTRIANGLE
    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 SponsorKlinikum der Universität München, Medizinische Klinik und Poliklinik III
    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 supportJanssen Pharmaceutica NV
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinikum der Universität München, Medizinische Klinik und Poliklinik III
    B.5.2Functional name of contact pointHead of Study Center for Hematology
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistr. 15
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81377
    B.5.4Telephone number+4989440074900
    B.5.5Fax number+4989440077900
    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. name Imbruvica
    D. of the Marketing Authorisation holderJanssen Research & Development, LCC and Pharmacyclics, LCC
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/12/984 and EU/3/13/1115
    D.3 Description of the IMP
    D.3.1Product nameIbrutinib
    D.3.2Product code PCI-32765
    D.3.4Pharmaceutical form Capsule, hard
    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 nameIBRUTINIB
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Generalized mantle cell Lymphoma
    E.1.1.1Medical condition in easily understood language
    Generalized mantle cell Lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10026805
    E.1.2Term Mantle cell lymphoma stage IV
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10026804
    E.1.2Term Mantle cell lymphoma stage III
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10026803
    E.1.2Term Mantle cell lymphoma stage II
    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 establish one of three study arms, R-CHOP/R-DHAP followed by ASCT (control arm A), R-CHOP+ibrutinib /R-DHAP followed by ASCT and ibrutinib maintenance (experimental armA+I), and R-CHOP+ibrutinib /R-DHAP followed by ibrutinib maintenance (experimental arm I) as future standard based on the comparison of the investigator-assessed failure-free survival (FFS).
    Estabelecer um dos três braços do estudo, R-CHOP/R-DHAP seguido de TACE (braço controlo A), R-CHOP + ibrutinib /R-DHAP seguido de TACE e manutenção com ibrutinib (braço experimental A+I), e R- CHOP + ibrutinib /R-DHAP seguido de manutenção com ibrutinib (braço experimental I) como padrão de tratamento futuro baseado na comparação do failure-free survival (FFS) avaliada pelo investigador.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of the three treatment arms in terms of secondary efficacy endpoints.
    To determine the safety and tolerability of ibrutinib during induction immuno-chemotherapy and during maintenance and to compare the safety profile of the three treatment arms in terms of secondary toxicity endpoints.
    Comparar a eficácia dos três braços de tratamento relativamente aos objetivos secundários de eficácia.
    Determinar a segurança e tolerabilidade de ibrutinib durante a imunoquimioterapia de indução e durante a manutenção e comparar o perfil de segurança dos três braços de tratamento relativamente aos endpoints secundários de toxicidade.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed diagnosis of MCL according to WHO classification
    2. suitable for high-dose treatment including high-dose AraC
    3. Stage II-IV (Ann Arbor)
    4. Age >= 18 years and <= 65 years
    5. Previously untreated MCL
    6. At least 1 measurable lesion; in case of bone marrow infiltration only, bone marrow aspiration and biopsy is mandatory for all staging evaluations.
    7. ECOG/WHO performance status <= 2
    8. The following laboratory values at screening (unless related to MCL):
    - Absolute neutrophil count (ANC) >=1000 cells/uL
    - Platelets >=100,000 cells/uL
    - Transaminases (AST and ALT) <= 3 x upper limit of normal (ULN)
    - Total bilirubin <= 2 x ULN unless due to known Morbus Meulengracht [Gilbert-Meulengracht-Syndrome])
    - Creatinine <=2 mg/dL or calculated creatinine clearance >= 50 mL/min
    9. Written informed consent form according to ICH/EU GCP and national regulations
    10. Sexually active men and women of child-bearing potential must agree to use one of the highly effective contraceptive methods (combined oral contraceptives using two hormones, contraceptive implants, injectables, intrauterine devices, sterilized partner) together with one of the barrier methods (latex condoms, diaphragms, contraceptive caps) while on study; this should be maintained for 90 days after the last dose of study drug and 12 months after the last dose of rituximab.
    1. Diagnóstico histológico confirmado de LCM de acordo com a classificação da OMS
    2. Candidato a terapêutica com doses elevadas, incluindo doses elevadas de Ara-C e quimioterapia de alta dose
    3. Estadio II-IV (Ann Arbor)
    4. Idade >= 18 anos e <= 65 anos
    5. LCM não previamente tratado
    6. Pelo menos 1 lesão mensurável; no caso de existir apenas infiltração da medula óssea, é obrigatório o aspirado e biópsia da medúla óssea em todas as avaliações de estadiamento e resposta.
    7. Performance status ECOG/OMS <= 2
    8. Os seguintes valores laboratoriais no screening (a menos que relacionados com o LCM):
    - Contagem absoluta de neutrófilos (ANC) >= 1000 células/uL
    - Plaquetas >= 100.000 células/uL
    - Transaminases (AST e ALT) <= 3 x limite superior do normal (ULN)
    - Bilirrubina total <= 2 x ULN, a menos que se deva a diagnóstico de Síndrome de Gilbert-Meulengracht
    - Creatinina <= 2 mg/dL ou clearance da creatinina calculada >= 50 mL/min
    9. Consentimento informado, por escrito, de acordo com as ICH/GCP e os regulamentos nacionais.
    10. Indivíduos do sexo masculino e feminino sexualmente ativos, em idade fértil, devem concordar em usar, durante o estudo, um dos métodos contracetivos altamente eficazes (contracetivos orais combinados que contêm duas hormonas, implantes contracetivos, injetáveis, dispositivos intrauterinos, parceiro esterilizado), juntamente com um dos métodos barreira (preservativos de látex, diafragmas, cápsulas contracetivas), método que deverá ser mantido durante 90 dias após a última dose do fármaco do estudo e 12 meses após a última dose de rituximab.
    E.4Principal exclusion criteria
    1. Major surgery within 4 weeks prior to randomization.
    2. Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon).
    3. History of stroke or intracranial hemorrhage within 6 months prior to randomization.
    4. Requires treatment with strong CYP3A4/5 inhibitors.
    5. 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.
    6. Vaccinated with live, attenuated vaccines within 4 weeks prior to randomization.
    7. Known CNS involvement of MCL.
    8. Clinically significant hypersensitivity (e.g., anaphylactic or anaphylactoid reactions to the compound of ibrutinib itself or to the excipients in its formulation).
    9. Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies.
    10. Previous lymphoma therapy with radiation, cytostatic drugs, anti-CD20 antibody or interferon except prephase therapy according to trial protocol.
    11. 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),
    - Endocrinological (e.g. severe, not sufficiently controlled diabetes mellitus),
    - Renal insufficiency (unless caused by the lymphoma): creatinine > 2x normal value and/or creatinin clearance < 50 ml/min),
    - Impairment of liver function (unless caused by the lymphoma): transaminases > 3x normal or bilirubin > 2,0 mg/dl unless due to Morbus Meulengracht (Gilbert-Meulengracht-Syndrome).
    12. Positive test results for chronic HBV infection (defined as positive HBsAg serology) (mandatory testing)
    Patients with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA is undetectable, provided that they are willing to undergo monthly DNA testing. Patients who have protective titers of hepatitis B surface antibody (HBSAb) after vaccination are eligible.
    13. Positive test results for hepatitis C (mandatory hepatitis C virus [HCV] antibody serology testing). Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
    14. Patients with known HIV positive infection (mandatory test).
    15.Prior organ, bone marrow or peripheral blood stem cell transplantation.
    16. Concomitant or previous malignancies within the last 3 years other than basal cell skin cancer or in situ uterine cervix cancer.
    17.Pregnancy or lactation.
    18. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow up schedule.
    19. Subjects not able to give consent.
    20. Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial.
    21. Participation in another clinical trial within 30 days before randomization in this study.
    1. Cirurgia major nas 4 semanas que antecedem a aleatorização.
    2. Requeira anticoagulação com varfarina ou antagonistas da vitamina K equivalentes (p. ex:, femprocumona).
    3. História de acidente vascular cerebral ou hemorragia intracraniana nos 6 meses que antecedem a aleatorização.
    4. Requeira terapêutica com inibidores potentes do CYP3A4/5.
    5. Qualquer doença que implique risco de vida, situações clínicas ou disfunção do sistema orgânico que, na opinião do investigador, possa comprometer a segurança do indivíduo, ou interferir com a absorção ou o metabolismo do ibrutinib, ou colocar em risco os resultados do estudo.
    6. Vacinação com vacinas vivas atenuadas, nas 4 semanas que antecedem a aleatorização.
    7. Envolvimento conhecido do Sistema Nervoso Central por LCM.
    8. Hipersensibilidade clinicamente significativa (por exemplo, reações anafiláticas ou anafilatóides ao próprio ibrutinib ou aos excipientes da sua formulação)
    9. Hipersensibilidade conhecida a proteínas murinas ou presença conhecida de de anticorpos anti-murinos (HAMA)
    10. Tratamento prévio do linfoma com radioterapia, citostáticos, anticorpos anti-CD20 ou interferão, exceto a pré-fase de tratamento prevista no protocolo do ensaio.
    11. Doença concomitante grave, que interfira com o tratamento preconizado no protocolo do estudo:
    - Cardíaca (doença cardiovascular clinicamente significativa, como arritmia não controlada ou sintomática, insuficiência cardíaca congestiva ou enfarte do miocárdio, nos 6 meses antes do screening, ou qualquer falência cardíaca de Classe 3 (moderada) ou de classe 4 (grave), conforme definido pela Classificação Funcional da New York Heart Association, ou fração de ejeção ventricular esquerda (FEVE) abaixo do limite inferior da normalidade (LIN)
    - Pulmonar (por exemplo, doença pulmonar crónica com hipoxemia)
    - Endocrinológica (por exemplo, diabetes mellitus grave não controlada)
    - Insuficiência renal (a menos que causada pelo linfoma): creatinina > 2 x o valor normal e/ou clearance da creatinina < 50 ml/min
    - Insuficiência hepática (a menos que causada pelo linfoma): transaminases > 3 x o valor normal, ou bilirrubina > 2,0 mg/dl, a menos que seja devida a síndrome de Gilbert-Meulengracht
    12. Resultados positivos dos testes para infeção crónica por VHB (definido como serologia positiva para o AgHBs) (teste obrigatório)
    Doentes com infeção oculta ou prévia por VHB (definido como negativo para Ag-HBs e positivo para Anticorpo HBc total) podem ser incluídos se o ADN do VHB for indetetável, e estejam dispostos a realizar testes mensais para determinação da carga vital (ADN do VHB). Doentes que possuam título de proteção do anticorpo de superfície da hepatite B (anticorpo-HBs) após vacinação também são elegíveis
    13. Resultados positivos a testes para hepatite C (obrigatório teste serológico de pesquisa do anticorpo contra o vírus da hepatite C [VHC]. Doentes positivos para o anticorpo contra o VHC são elegíveis se a carga viral for indetectável (PCR for negativa para o ARN do VHC)
    14. Doentes com infeção VIH conhecida (teste obrigatório)
    15. Transplante prévio de órgãos, medula óssea ou células estaminais do sangue periférico
    16. Neoplasias malignas concomitantes ou prévias, nos últimos 3 anos, excepto carcinoma basocelular da pele ou cancro do colo do útero in situ
    17. Gravidez ou aleitamento.
    18. Qualquer situação psicológica, familiar, social ou geográfica que prejudique potencialmente o cumprimento do protocolo do estudo e o cronograma de follow-up
    19. Indivíduos que não deem o seu consentimento
    20. Indivíduos sem capacidade legal para consentir, incapazes de compreender a natureza, o alcance, a importância e as consequências deste ensaio clínico.
    21. Terapia realizada no âmbito de outro ensaio clínico nos 30 dias prévios à aleatorização para este estudo
    E.5 End points
    E.5.1Primary end point(s)
    FFS defined as time from randomization to stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause.
    FFS é definido como o tempo desde a aleatorização até doença estável no final da imunoquimioterapia, progressão da doença ou morte por qualquer causa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of immuno-chemotherapy, progressive disease, or death from any cause
    No final da imunoquimioterapia, progressão da doença ou morte por qualquer causa
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    1. Overall survival (OS).
    2. Progression-free survival (PFS) from randomization, from end of induction immuno-chemotherapy in patients with CR or PR at end of induction immuno-chemotherapy, and from the staging 6 weeks after end of induction assessment (at month 6).
    3. Overall response and complete remission rates at midterm, at end of induction, 3 months after end of induction immunochemotherapy (at month 6).
    4. PR to CR conversion rate during follow-up after end of induction immuno-chemotherapy.
    Secondary Toxicity Endpoints:
    1. Rates of AEs, SAEs, and SUSARs by CTC grade (Version 4.03) during induction immuno-chemotherapy and during periods of follow-up after response to immune-chemotherapy.
    2. Cumulative incidence rates of SPMs.
    Endpoints Secundários de Eficácia:
    1. Sobrevida Global (OS)
    2. Sobrevida livre de progressão (PFS) desde a aleatorização, desde o fim da imunoquimioterapia de indução em doentes com remissão completa (CR) ou remissão parcial (PR) no final da imunoquimioterapia de indução, e desde o estadiamento 6 semanas após o fim da avaliação de indução (no mês 6)
    3. Resposta global e taxas de CR na avaliação intercalar, no final da indução e 3 meses após o fim da imunoquimioterapia de indução (no mês 6).
    4. Taxa de conversão de PR para CR durante o follow-up após o fim da imunoquimioterapia de indução

    Endpoints secundários de Toxicidade:
    1. Taxas de EA, SAE e SUSAR pelo grau de toxicidade CTC (versão 4.03) durante a imunoquimioterapia de indução e durante os períodos de follow-up após a resposta à imunoquimioterapia.
    2. Taxas de incidência cumulativa de SPMs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See E.5.2
    Ver E.5.2
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    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 Yes
    E. description
    Six alternating courses of R-CHOP/RDHAP followed by ASCT
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA230
    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
    United Kingdom
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 870
    F.1.3Elderly (>=65 years) No
    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 800
    F.4.2.2In the whole clinical trial 870
    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)
    Patients will be treated according to the local standard care.
    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 Deutsche Studiengruppe Niedrig Maligne Lymphome e.V. (GLSG), Klinikum Großhadern, Medizinische Klinik
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Phase I/II platform e.V. of the European Mantle Cell Lymphoma Network, Klinikum der Universität München, Med. Klinik III
    G.4.3.4Network Country European Union
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-04
    P. End of Trial
    P.End of Trial StatusOngoing
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