Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36603   clinical trials with a EudraCT protocol, of which   6045   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-000755-27
    Sponsor's Protocol Code Number:GABe2016
    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:2016-07-07
    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 number2016-000755-27
    A.3Full title of the trial
    FIRST LINE THERAPY OF ADVANCED STAGE FOLLICULAR LYMPHOMA
    IN PATIENTS < 60 YEARS NOT ELIGIBLE FOR
    STANDARD IMMUNOCHEMOTHERAPY AND ALL PATIENTS ≥ 60 YEARS
    Prospective randomized evaluation of single agent
    GA101 versus GA101 plus Bendamustine followed by GA101
    Primärtherapie fortgeschrittener Follikulärer Lymphome bei Patienten < 60 Jahren die für eine Standard-Immunochemotherapie nicht in Frage kommen und für alle Patienten ≥ 60 Jahre
    Eine prospektive randomisierte Untersuchung einer GA101- Monotherapie und GA101 plus Bendamustin jeweils gefolgt von GA101 bei Patienten in höherem Lebensalter bzw. bei Patienten mit Komorbiditäten und/oder Einschränkungen von Organfunktionen und/oder schlechtem Allgemeinzustand
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    First line therapy of patients < 60 years suffering from advanced follicular lymphoma who are not in the state of health for the standard immunochemotherapy or for all patients ≥ 60 years. It is a forward-looking comparison of two therapy schemes wherein the patients are assigned to the particular test group according to a special mathematical based principle. In arm 1 only GA 101 and in arm 2 GA 101 and Bendamustin is administered. After the initial therapy only GA 101 is given in both arms.
    Therapie bei Patienten < 60 Jahren mit Erstdiagnose eines fortgeschrittenen FL, deren allgemeiner Gesundheitszustand eine Standard- Immunchemotherapie nicht zulässt oder bei Patienten ≥ 60 Jahren. Die Studie untersucht prospeltiv zwei therapeutischer Ansätze, wobei die Testpatienten der jeweiligen Testgruppe gemäß dem Zufallsprinzip zugeordnet werden: in Arm 1 wird GA 101 allein und in Arm 2 GA 101 plus Bendamustin verabreicht. In der Folgetherapie wird in beiden Armen nur GA 101 verabreicht.
    A.3.2Name or abbreviated title of the trial where available
    GABe2016
    GABe2016
    A.4.1Sponsor's protocol code numberGABe2016
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03492775
    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
    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 supportRoche Pharma AG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportMundipharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinikum der Universität München, Med Klinik III
    B.5.2Functional name of contact pointStudienzentrale für Hämatologie
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistr. 15
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number004989440074900
    B.5.5Fax number004989440077900
    B.5.6E-mailstudyce@med.uni-muenchen.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 Gazyvaro®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma AG
    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 nameGazyvaro®, Obinutuzumab®
    D.3.4Pharmaceutical form Concentrate 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 INNOBINUTUZUMAB
    D.3.9.1CAS number 949142-50-1
    D.3.9.3Other descriptive nameOBINUTUZUMAB
    D.3.9.4EV Substance CodeSUB32751
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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) No
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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 Levact®
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma GmbH, Munich
    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.3.1Product nameLevact®, Ribomustine®
    D.3.2Product code Bendamustin
    D.3.4Pharmaceutical form Powder for concentrate 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 INNBENDAMUSTINE HYDROCHLORIDE
    D.3.9.1CAS number 3543-75-7
    D.3.9.4EV Substance CodeSUB00696MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    Evaluation of the efficacy and toxicity of GA 101 versus GA 101 plus Bendamustin, followed by GA 101 in medically non-fit patients < 60 years and in all patients ≥ 60 years as first line therapy of advanced stage follicular lymphoma
    Untersuchung der Monotherapie von GA 101 gegen GA 101 plus Bendamustin in der Erstlinie bei gesundheitlich beeinträchtigten Patienten < 60 Jahren und bei allen Patienten ≥ 60 Jahren mit fortgeschrittenem follikulären Lymphom
    E.1.1.1Medical condition in easily understood language
    Evaluation of GA 101 versus GA 101 plus Bendamustin followed by GA 101 in patients < 60 y not eligible for standard immunochemotherapy and in all patients ≥ 60 y suffering from an advanced stage FL
    Untersuchung der Einzeltherapie von GA 101 gegen GA 101 plus Bendamustin als Ersttherapie bei Patienten < 60 J mit schlechtem Allgemeinzustand und bei allen Patienten ≥ 60 J mit fortgeschrittenem FL
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10016908
    E.1.2Term Follicle centre lymphoma, follicular grade I, II, III stage II
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10016910
    E.1.2Term Follicle centre lymphoma, follicular grade I, II, III 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10016909
    E.1.2Term Follicle centre lymphoma, follicular grade I, II, III stage III
    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
    Primary objective:
    The objective of this study is to test the efficacy and toxicity of a combined OBINUTUZUMAB/bendamustine therapy or single agent OBINUTUZUMAB in younger (< 60 years) medically non-fit, ‘compromised’ patients and in all older patients (≥ 60 years) i. For the assessment of the anti-lymphoma activity the “overall response rate (ORR)” will be applied as primary endpoint. Overall response is defined as complete or partial response after 19 – 21 weeks
    E.2.2Secondary objectives of the trial
    Secondary objectives are to compare OBINUTUZUMAB/bendamustine with single agent OBINUTUZUMAB in terms of additional measures of anti-lymphoma activity, treatment related toxicities, treatment compliance, quality of life, and comorbidities, and the evaluation of geriatric and co-morbidity scores in the included medically non-fit FL population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - „Medically non-fit“ patients < 60 years defined by
    ECOG > 2 or ECOG 0-2 with co-morbidities excluding intensive therapy according to local investigator’s discretion
    - All patients ≥ 60 years in case of decision of investigator and patient to apply a reduced Treatment


    - Documentation of the CIRS-G, G8, IADL and ECOG Scores before start of treatment

    - Histologically confirmed follicular lymphoma grade I, II or IIIa with material available for central pathology review.

    - Stage III/IV and stage II without the option of curative radiotherapy

    - Age > 18 years

    - No prior therapy

    - Presence of at least one of the following symptoms or conditions requiring initiation of treatment:

    - Bulky disease according to the GELF criteria: nodal or extranodal mass > 7cm in its greater diameter

    - B symptoms (fever, drenching night sweats, or unintentional weight loss of >10% of normal body weight over a period of 6 months or less)

    - Hematopoietic insufficiency (at least one of the following: granulocytopenia < 1.500 cells/µl, Hb < 10 g/dl, thrombocytopenia < 100.000 cells/µl)

    - Compressive syndrome

    - Pleural/peritoneal effusion

    - Symptomatic nodal or extranodal manifestations

    - At least one bi-dimensionally measurable lesion (> 1,5 cm in its largest dimension by CT scan or MRI)

    - Adequate hematologic function (unless abnormalities are related to NHL), defined as follows:

    --hemoglobin ≥ 9.0 g/dl

    --absolute neutrophil count ≥ 1500 /µL

    --platelet count ≥75000 /µl

    - Women who are not breast feeding, are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 18 months thereafter.

    - Men who agree not to father a child during participation in the trial and during the 18 months thereafter.

    - Written informed consent form
    E.4Principal exclusion criteria
    - Medically fit” patient < 60 years with the option for more intensive induction therapy such as R-CHOP

    - Transformation to high-grade lymphoma (secondary to “low-grade” follicular lymphoma)

    - Grade IIIb follicular lymphoma

    - Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis).

    - Regular use of corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 20 mg/day prednisone.

    - Prior (< 3 years) or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer.

    - Major surgery (excluding lymph node biopsy) within 28 days prior to registration.

    - Necessity of rapid cytoreduction

    - Serious underlying medical conditions, which could impair the ability of the patient to tolerate the therapy offered in this trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).

    - Severe hepatic impairment (serum bilirubin > 3.0 mg/dl)

    - Known sensitivity or allergy to murine products

    - Known hypersensitivity to any of the study drugs

    - Treatment within a clinical lymphoma trial within 30 days prior to trial entry

    - 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 or prior but cured hepatitis B are eligible.

    - 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.

    - Known history of HIV seropositive status.

    - Patients with a history of confirmed PML

    - Vaccination with a live vaccine within 28 days prior to registration

    - Prior organ, bone marrow or peripheral blood stem cell transplantation

    - Any other co-existing medical or psychological condition that will preclude participation in the study or compromise the ability to understand its nature, meaning and implications
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR) defined as complete or partial response after 19-21 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Staging at week 19-21


    E.5.2Secondary end point(s)
    ● event free survival (EFS)
    ● CR Rate Time to Treatment Failure (TTF)
    ● Progression-free survival (PFS)
    ● Duration of Remission (RD)
    ● Time to next anti-lymphoma treatment
    ● Overall Survival (OS)
    ● Toxicities
    ● Frequency and Duration of Hospitalization
    ● Supportive Care
    ● Incidence of secondary transformation to aggressivelymphoma
    ● Incidence of secondary malignancies
    ● Treatment Compliance
    ● Quality of Life analysis (QoL)
    ● Geriatric and Comorbidity Scores
    lymphoma
    Incidence of secondary malignancies
    Treatment Compliance
    Quality of Life analysis (QoL)
    Geriatric and Comorbidity Scores
    E.5.2.1Timepoint(s) of evaluation of this end point
    Staging at week 19-21 and 4-6 weeks after completion of the last OBINUTUZUMAB application (week 49-51).

    Follow-Up evaluation every three months during the first year and then every 6 months the subsequent years until documentation of disease progression or death.
    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 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 Yes
    E.8.2.3.1Comparator description
    Monotherapie versus Kombinationstherapie
    monotherapy versus combination
    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 concerned65
    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
    observation until end of trial,
    max. duration: 78 months
    Beobachtung bis zum Ende der Studie (maximale Dauer: 78 Monate)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    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 state170
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 170
    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)
    Follow-up treatment according local standard of care for this patient group.
    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 GLSG Studienzentrale, Klinikum der Universität
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-17
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA