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    Summary
    EudraCT Number:2019-002373-59
    Sponsor's Protocol Code Number:19-00153
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-21
    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 - PEI
    A.2EudraCT number2019-002373-59
    A.3Full title of the trial
    A prospective, multicenter randomized phase II trial investigating Gemcitabine/Oxaliplatin/Rituximab with or without Tafasitamab (MOR208) for patients
    with relapsed/refractory Aggressive Lymphoma (GOAL II).
    Eine prospektive multizentrische randomisierte Phase-II-Studie zur Untersuchung von Gemcitabin/Oxaliplatin/Rituximab mit oder ohne Tafasitamab (MOR-208) bei Patienten mit rezidiviertem/refraktärem Aggressivem Lymphom (GOAL II).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II trial investigating Gemcitabine/Oxaliplatin/Rituximab with or without Tafasitamab (MOR208) for patients aggressive Lymphoma.
    Eine Phase-II-Studie zur Untersuchung von Gemcitabin/Oxaliplatin/Rituximab mit oder ohne Tafasitamab (MOR-00208) bei Patienten mit aggressivem Lymphom.
    A.3.2Name or abbreviated title of the trial where available
    GOAL II
    GOAL II
    A.4.1Sponsor's protocol code number19-00153
    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 supportIncyte Corporation
    B.4.2CountryUnited States
    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-mailgeorg.hess@unimedizin-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 No
    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 nameTafasitamab
    D.3.2Product code MOR00208
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTAFASITAMAB
    D.3.9.2Current sponsor codeMOR00208
    D.3.9.4EV Substance CodeSUB197699
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Malignant B-cell lymphoma
    Aggressives B-Zell Lymphom
    E.1.1.1Medical condition in easily understood language
    Malignant Lymphoma
    Aggressives Lymphom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10003903
    E.1.2Term B-cell lymphoma refractory
    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
    Improvement of ORR in the experimental arm versus the standard Treatment (Analysis will be based on Lugano -Criteria ).
    Verbesserung der ORR im experimentellen Arm gegenüber der Standardbehandlung (Die Analyse basiert auf Lugano-Kriterien).


    E.2.2Secondary objectives of the trial
    Improvement of CR-Rate, PFS, OS
    Improvement ORR based on Cheson 2007-criteria
    Improvement of QoL (global QoL, physical functioning, Fatigue)
    Verbesserung der CR-Rate, PFS, OS
    ORR basierend auf Cheson 2007-Kriterien
    Verbesserung der Lebensqualität (global QoL, körperliche Funktionsfähigkeit, Fatigue)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting all of the following criteria will be considered for enrollment to the trial:
    - Histologically proven diagnosis of
    a) diffuse large cell B-cell lymphoma, and other aggressive B-cell lymphomas according to the WHO 2016 revision (specified in detail in the protocol)
    b) follicular lymphoma grade 3B and
    c) transformed indolent B-cell lymphoma (not more than 20 % of the patient population) according to the WHO classification (central pathology review)
    - Relapsed disease or refractory disease, at least one but no more than two prior treatment lines
    - age ≥ 18 years
    - No curative option available (age ≥ 65yr and/or HCT-CI Score > 2) or s.p. HDT
    - At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
    - Adequate bone marrow reserve:
    a) Platelets of at least 100 000/μl
    b) absolute neutrophil count of at least 1000/μl
    - Adequate hepatic and renal function:
    a) Alanine aminotransferase (ALT) <2.5 x upper limit of normal (ULN)
    b) Aspartate aminotransferase (AST) <2.5 x upper limit of normal (ULN)
    c) Total bilirubin <1.5 x upper limit of normal (ULN) unless related to lymphoma
    - Measured or calculated eGFR >50 ml/min (institutional standard)
    - Eastern Cooperative Oncology Group (ECOG) performance Status ≤2, unless tumor associated and expected to improve on treatment
    - Signed informed consent
    - Adequate contraception (if needed)
    Patienten, die alle folgenden Kriterien erfüllen, können in diese klinische Prüfung eingeschlossen werden:
    - Histologisch gesicherte Diagnose von
    a) diffusem großzelligem B-Zell-Lymphom und anderen aggressiven B-Zell-Lymphomen
    gemäß der WHO- Klassifikation 2016
    b) follikulärem Lymphom Grad 3B und
    c) transformiertem indolentem Lymphom (nicht mehr als 20% der Patientenpopulation)
    nach der WHO-Klassifikation (Review durch zentrale Pathologie)
    - rezidivierte oder refraktäre Erkrankung, mindestens eine, jedoch nicht mehr als zwei Vortherapien
    - ≥ 18 Jahre alt
    - Keine curativen Optionen verfügbar (Alter ≥ 65 Jahre und/oder HCT-CI-Score > 2) oder Status post HDT
    - Mindestens eine messbare Tumormasse (> 1,5 cm x > 1,0 cm) oder Knochenmarkinfiltration
    - Angemessene Knochenmarksreserve:
    a) Thrombozyten von mindestens 100 000 / µl
    b) absolute Neutrophilenzahl von mindestens 1000 / µl
    - Angemessene Leber- und Nierenfunktion:
    a) Alaninaminotransferase (ALT) < 2,5-fache Obergrenze des Normalwerts (ULN)
    b) Aspartataminotransferase (AST) < 2,5-fache Obergrenze des Normalwerts (ULN)
    c) Gesamtbilirubin < 1,5 x ULN, sofern kein Zusammenhang mit dem Lymphom besteht
    - Gemessene oder berechnete eGFR > 50 ml / min (lokaler Standard)
    - Eastern Cooperative Oncology Group (ECOG)–Score ≤2, sofern nicht tumorassoziiert und eine Verbesserung unter der Studienbehandlung zu erwarten ist
    - Unterzeichnete Einverständniserklärung
    - Angemessene Verhütung (falls zutreffend)
    E.4Principal exclusion criteria
    - CNS involvement (brain MRI is required only in cases of clinically suspicious involvement)
    - no adequate pretreatment (R-CHOP-like)
    - systemic treatment within last 6 weeks, steroids for bridging are allowed
    - prior allogeneic transplantation and prior anti CD19 CAR T-cell therapy
    - pregnant or breast-feeding women
    - severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinemia)
    - Prolongation of QTc interval > 450 ms, demonstrated in electrocardiogramm (two separate or one in triplicate) or family history for Long QT-syndrome
    - active uncontrolled infections
    - HIV positivity
    - Hepatitis C
    - active Hepatitis B, patients with HBs-Ag positivity and no measurable HBV-DNA are eligible
    - Medical or psychological condition that would not permit completion of the trial or signing of informed consent
    - Diagnosed or treated for a malignancy other than NHL except:
    a) adequately treated non-melanoma skin cancer
    b) curatively treated in-situ cancer of the cervix
    c) ductal carcinoma in situ (DCIS) of the breast
    d) other solid tumors curatively treated with no evidence of disease for >2 years
    e) prostate cancer with a life expectancy of more than 2 years
    - Concurrent treatment with another investigational agent or within the last 6 weeks prior to treatment initiation. Concurrent participation in non-treatment studies is not excluded.
    - Known intolerance to any of the study drugs or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
    Patienten, die mindestens eines der folgenden Kriterien erfüllen, werden nicht in diese klinische Prüfung eingeschlossen:
    - ZNS-Beteiligung (MRT ist nur bei klinischem Verdacht auf Lymphombefall des Hirns erforderlich)
    - keine ausreichende Vorbehandlung (R-CHOP-like)
    - vorangegangene systemische Behandlung innerhalb der letzten 6 Wochen (Steroidetheapie zur Überbrückung ist erlaubt)
    - vorherige allogenen Stammzelltransplantation oder anti CD19 CAR T-cell therapy
    - Schwangere oder stillende Frauen
    - schwere Begleiterkrankung (z. B. unkontrollierte arterielle Hypertonie, Herzinsuffizienz (NYHA III-IV), unkontrollierter Diabetes mellitus, Lungenfibrose, unkontrollierte Hyperlipoproteinämie)
    - Verlängertes QTc interval > 450ms (bestätigung durch 2 EKGS oder einem als Triplikat) oder Familiengeschichte für Long-QT-Syndrom
    - aktive unkontrollierte Infektionen
    - HIV-Positivität
    - Hepatitis C
    - aktiver Hepatitis B
    - Medizinische oder psychologische Gründe, die gegen eine Teilnahme an einer klinischen Studie sprechen oder eine schriftliche Einwilligung nicht ermöglichen
    - Diagnose oder Behandlung einer anderen Malognomst als NHL mit Ausnahme von:
    a) angemessen behandelter Nicht-Melanom -Hautkrebs
    b) kurativ behandeltem in situ Gebärmutterhalskrebs
    c) duktalem Carcinoma in situ (DCIS) der Brust
    d) andere kurativ behandelte solide Tumoren, welche seit > 2 Jahren keine Anzeichen der Erkrankung zeigen
    e) Prostatakrebs mit einer Lebenserwartung von > 2 Jahren
    - Gleichzeitige Behandlung mit einem anderen Prüfprodukt oder innerhalb der letzten 6 Wochen. Die gleichzeitige Teilnahme an Studien ohne Behandlung ist nicht ausgeschlossen.
    - Bekannte Unverträglichkeit oder Kontraindikation gegenüber dem Studienmedikament oder R-Gem/Ox oder anderen Substanzen mit ähnlicher chemischer Struktur oder anderen Inhaltstoffen der pharmazeutischen Zubereitung der Studienmedikation
    E.5 End points
    E.5.1Primary end point(s)
    ORR of the regimen within the first 8 treatment cycles, tested in the entire cohort of patients.
    ORR des Behandlungsregimes innerhalb von 8 Behandlungszyklen, getestet in der gesamten Patientenkohorte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 8 treatment cycles
    innerhalb von 8 Behandlungszyklen
    E.5.2Secondary end point(s)
    - ORR (Cheson 2007-criteria)
    - Progression free survival (Lugano)
    - Overall survival
    - Improvement of CR-Rate (Lugano)
    - Best response (Lugano)
    - Quality of Life measured with EORTC QLQ C30 and NHL-HG29 (global QoL, physical functioning, fatigue)
    - ORR in separate GCB vs. non GCB-analysis is planned

    Safety Endpoints: Safety and tolerability as measured by rate of AE, SAE compared between Arm A and B
    - ORR (Cheson 2007 criteria)
    - Progressionsfreies Überleben (PFS)
    - Gesamtüberleben (OS)
    - Verbesserung der CR rate (Lugano)
    - Bestes Ansprechen (Lugano)
    - Lebensqualität gemessen mit EORTC QLQ C30 und NHL-HG29 (global QoL, physical functioning, fatigue)
    - ORR in separater GCB versus non GCB-Analyse

    Sicherheitsendpunkte: Sicherheit gemessen anhand der AE- und SAE-Rate im Vergleich zwischen Arm A und B
    E.5.2.1Timepoint(s) of evaluation of this end point
    The complete Remission after 1 year
    Die komplette Remission nach 1 Jahr
    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 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 Yes
    E.8.1.7.1Other trial design description
    prospektiv
    prospective
    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.8.2.3.1Comparator description
    Gemcitabin, Oxaplatin, Rituximab
    Gemcitabine, Oxaplatin, Rituximab
    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 concerned21
    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
    Last visit last subject (LVLS)
    Letzter Studienbesuch letzter Patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 26
    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 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 state126
    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.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-16
    P. End of Trial
    P.End of Trial StatusOngoing
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