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    Summary
    EudraCT Number:2008-005859-16
    Sponsor's Protocol Code Number:NHL7-2008/A
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-05-27
    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 ConcernedAustria - BASG
    A.2EudraCT number2008-005859-16
    A.3Full title of the trial
    Prospektiv randomisierte Studie zur Therapieoptimierung (Primärtherapie) fortgeschrittener progredienter follikulärer und anderer niedrig maligner sowie Mantelzell Lymphome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospektiv randomisierte Studie zur Therapieoptimierung (Primärtherapie) fortgeschrittener progredienter follikulärer und anderer niedrig maligner sowie Mantelzell Lymphome
    A.3.2Name or abbreviated title of the trial where available
    NHL 7-2008/A
    A.4.1Sponsor's protocol code numberNHL7-2008/A
    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 SponsorStiL Forschungs-GmbH
    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 supportStiL Forschungs-GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStiL Forschungs-GmbH
    B.5.2Functional name of contact pointStiL Studienzentrale
    B.5.3 Address:
    B.5.3.1Street AddressKlinikstrasse 36
    B.5.3.2Town/ cityGießen
    B.5.3.3Post code35392
    B.5.3.4CountryGermany
    B.5.4Telephone number+49641985-42600
    B.5.5Fax number+49641985-42609
    B.5.6E-mailstil-info@innere.med.uni-giessen.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 Bendamustin
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma GmbH
    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 nameBendamustin
    D.3.2Product code LA01AA09
    D.3.4Pharmaceutical form Powder and solvent 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
    D.3.9.1CAS number 16506-27-7
    D.3.9.4EV Substance CodeSUB05707MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number90
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registartion Limited, UK
    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 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number375
    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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 MabThera® SC/Rituxan® SC
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 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
    Therapieoptimierung (Primärtherapie) fortgeschrittener progredienter follikülärer und anderer niedrigmaligner sowie Mantelzell Lymphome
    E.1.1.1Medical condition in easily understood language
    Therapieoptimierung (Primärtherapie) fortgeschrittener progredienter follikülärer und anderer niedrigmaligner sowie Mantelzell Lymphome
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10029635
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology low grade 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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10066703
    E.1.2Term Non-Hodgkin's lymphoma progression
    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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10029632
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology low grade stage I
    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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10029633
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology low grade 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 23.0
    E.1.2Level LLT
    E.1.2Classification code 10029634
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology low grade 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
    Bei den follikulären Lymphomen
    Ermittlung und Vergleich des progressionsfreien Überlebens beider Therapien Bendamustin plus Rituximab und 2 Jahre Rituximab Erhaltungstherapie vs. Bendamustin plus Rituximab und 4 Jahre Erhaltungstherapie
    Bei den anderen Lymphomen Immunozytom, Marginalzonen-, Mantelzell: Ermittlung und Vergleich des progressionsfreien Überlebens beider Therapien Bendamustin plus Rituximab ohne Erhaltungstherapie versus Bendamustin plus Rituximab und 2 Jahre Rituximab Erhaltungstherapie
    E.2.2Secondary objectives of the trial
    ekundäre Studienziele der Studie sind
    - Ermittlung der Remissionsraten nach Bendamustin- Rituximab
    - Ermittlung der SAE und SUSAR während der Induktion mit Bendamustin-Rituximab
    - Vergleich der Remissionsratender Lymphomentitäten nach Bendamustin-Rituximab
    - Vergleich der Gesamtüberlebenszeiten der Patienten beider Therapiearme
    - Vergleich der Remissionsdauer, EDS, DFS, TTTF, TTNT der Patienten beider Therapien
    - Erfassung und Vergleich der Akut- und Langzeit- Tox NHL-izitäten, der infektiösen Komplikationen, der Dauer des immunsuppressiven Effekts, der Verlängerung der Impftiter und der Nebenwirkungen beider Therapiearme
    - Kohortenvergleich bezüglich Toxizität, Remissionsdauer, PFS, EFS, DFS, TTTF, TTnt, OS zwischen den Patientengruppen Bendamustin- Rituximab und 2 Jahre Rituximab aus dieser Studie und Bendamustin-Rituximab (ohneErhaltungstherapie) aus der vorausgegangenen StiL-NHL I-2003
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patienten mit histologisch verifiziertem CD20+ C-Zell-Lymphomen folgender Entitäten:
    a) Follikuläres Lymphom Grad 1 und 2
    b) Lymphozytoplasmatisches Lymphom/Immunozytom (Morbus Waldenström) und kleinzelliges lymphozytisches Lymphom (CLL ohne leukämisches Blutbild)
    c) Marginalzonen Lymphom, nodales und generalisiertes (nodal und extranodal)
    d) Mantelzell Lymphom
    •Keine Vorbehandlung mit Zytostatika, Interferonen oder monoklonalen Antikörpern
    •Therapiebedürftigkeit, außer bei Mantelzell Lymphomen
    •Stadium III oder IV oder Stadium II bulky disease (> 7cmDurchmesser, oder 3 Läsionen > 5 cm)
    •Allgemeinzustand nach WHO 0 - 2
    •Alter mindestens 18, höchstens 80 Jahre
    •Negativer Schwangerschaftstest und Antikonzeption bei Frauen im gebärfähigen Alter
    •Eine aktuelle Histologie, die nicht älter als 6 Monate sein sollte, ist erforderlich.
    •Schriftliche Einverständniserklärung des Patienten.
    E.4Principal exclusion criteria
    Möglichkeit einer primären, potentiell kurativen Strahlentherapie
    •Vorbehandlung, außer mit einer einmaligen lokal begrenzten Strahlentherapie (Strahlenfeld nicht größer als zwei benachbarte Lymphknotenregionen)
    •Begleiterkrankungen, die eine studiengerechte Therapiedurchführung ausschliessen: schwere medikamentös nicht einstellbare Hypertonie, schwere Funktionseinschränkungen des Herzens NYHA III oder IV, der Lunge WHO-Grad III oder IV, der Leber und der Niere (Kreatinin > 2mg/dl, GOT und GPT oder Bilirubin über 3-faches der Norm), außer wenn lymphombedingt; schwerer, nicht einstellbarer Diabetes mellitus, aktive Autoimmunerkrankung, aktive Infektion, die eine antibiotische Behandlung erforderlich machen
    •Patienten mit nachgewiesener HIV-Infektion
    •Aktive replizierende Hepatitis - Infektionen
    •Schwere psychiatrische Erkrankungen
    •Fehlende oder nicht zu erwartende Compliance
    •Bekannte Überempfindlichkeit gegen einen der Wirkstoffe oder einen der sonstigen Bestandteile oder gegen Maus-Proteine
    •Schwangere oder stillende Frauen
    •Patienten mit einem Zweitmalignom oder einer malignen Erkrankung in der Vorgeschichte, wenn nicht von einer sicheren chirurgischen Kuration ausgegangen werden kann.
    E.5 End points
    E.5.1Primary end point(s)
    Progressionsfreies Überleben
    E.5.1.1Timepoint(s) of evaluation of this end point
    Die progressionsfrei Überlebenszeit ist definiert als die Zeit vor Eintritt in die Studie bis zum Fortschreiben des Lymphoms oder bis zum Tod aus jeglicher Ursache.
    E.5.2Secondary end point(s)
    Therapieoptimierung (Primärtherapie) fortgeschrittener progredienter follikülärer und anderer niedrigmaligner sowie Mantelzell Lymphome
    E.5.2.1Timepoint(s) of evaluation of this end point
    Zeit bis zum Therapieversagen, Zeit bis zur nächsten Therapie und Gesamtüberlebenszeit werden erfasst und verglichen.
    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) 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 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
    different duration of therapy
    E.8.2.4Number of treatment arms in the trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA250
    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
    Nachbeobachtung der Patienten bis zur Prgression oder zum Tod
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1272
    F.4.2.2In the whole clinical trial 1272
    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)
    best standard of care
    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 Decision2009-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-08
    P. End of Trial
    P.End of Trial StatusOngoing
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