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    Summary
    EudraCT Number:2013-001088-22
    Sponsor's Protocol Code Number:CLLR3
    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:2014-04-29
    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 number2013-001088-22
    A.3Full title of the trial
    A PROSPECTIVE, MULTICENTER, PHASE-II TRIAL EVALUATING EFFICACY AND SAFETY OF BENDAMUSTINE + GA101 (BG) IN PATIENTS WITH RELAPSED CLL FOLLOWED BY MAINTENANCE
    THERAPY WITH GA101 FOR RESPONDING PATIENTS.
    Eine prospektive, multizentrische, zwei-armige, Phase-II Studie zur Beurteilung der Effektivität und Sicherheit von Bendamustin + GA101 (BG) bei Patienten mit rezidivierender oder refraktärer CLL mit anschliessender GA101-Erhaltungstherapie für Patienten, die auf die Therapie ansprechen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A PROSPECTIVE, MULTICENTER, PHASE-II TRIAL EVALUATING EFFICACY AND SAFETY OF BENDAMUSTINE + GA101 (BG) IN PATIENTS WITH RELAPSED CLL FOLLOWED BY MAINTENANCE
    THERAPY WITH GA101 FOR RESPONDING PATIENTS.
    Eine prospektive, multizentrische, zwei-armige, Phase-II Studie zur Beurteilung der Effektivität und Sicherheit von Bendamustin + GA101 (BG) bei Patienten mit rezidivierender oder refraktärer CLL mit anschliessender GA101-Erhaltungstherapie für Patienten, die auf die Therapie ansprechen.
    A.3.2Name or abbreviated title of the trial where available
    CLLR3
    CLLR3
    A.4.1Sponsor's protocol code numberCLLR3
    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 SponsorStädtisches Klinikum München 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 supportF. Hoffmann- La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDeutsche CLL Studiengruppe
    B.5.2Functional name of contact pointEmily van der Poel-Holmes
    B.5.3 Address:
    B.5.3.1Street AddressKerpener Str. 62
    B.5.3.2Town/ cityKöln
    B.5.3.3Post code50935
    B.5.3.4CountryGermany
    B.5.4Telephone number004922147896118
    B.5.5Fax number004922147888688
    B.5.6E-mailemily.van-der-poel-holmes@uk-koeln.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 Fludara
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Europe B.V.
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 Endoxan
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Oncology 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 nameCyclophosphamide
    D.3.2Product code 1001995601
    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.3.11 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: 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 Levact
    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 nameBendamustine hydrochloride
    D.3.4Pharmaceutical form Concentrate and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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: 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 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 nameObinutuzumab
    D.3.2Product code R05072759
    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.3.9.2Current sponsor codeRO5072759
    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 typeRO5072759 is a humanized and glycoengineered monoclonal antibody (mAB)
    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
    Relapsed Chronic lymphocytic leukaemia (CLL)
    Rezidivierte Chronische Lymphatische Leukämie (CLL)
    E.1.1.1Medical condition in easily understood language
    Patients with relapsed Chronic lymphcytic leukaemia (CLL)
    Patienten mit einer rezidiverten Chronisch Lymphatischen Leukämie (CLL)
    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 10008958
    E.1.2Term Chronic lymphocytic leukaemia
    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
    Main objective of the trial ist to evaluate the efficacy of two regimens of immunochemotherapy, i.e. Fludarabine, Cyclophosphamide plus GA101 (FCG) and Bendamustine plus GA101 (BG), in patients with relapsed or refractory CLL.
    Primäres Studienziel ist die Beurteilung der Effektivität des Immunchemotherapie-Regimes, d.h. Bendamustin plus GA101 (BG) bei Patienten mit rezidivierter oder refraktärer CLL.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety of the regime of immunochemotherapies, i.e. Bendamustine plus GA101 (BG) in patients with relapsed or refractory CLL followed by maintenance therapy with GA101 for responding patients.
    - To investigate the feasibility of a maintenance therapy with GA101 following either a regimen of BG for responding patients.
    - To evaluate descriptively safety and efficacy of the BG regimen in patients with relapsed or refractory CLL.
    - Beurteilung der Sicherheit der beiden Immunchemotherapie-Regime, Bendamustin plus GA101 (BG) bei Patienten mit rezidivierter oder refraktärer CLL gefolgt von einer GA101-Erhaltungstherapie bei Patienten mit Therapieansprechen.
    - Überprüfung der Durchführbarkeit einer Erhaltungstherapie mit GA101 nach einer Induktion BG für Patienten mit Therapieansprechen.
    - Evaluation der Sicherheit und Wirksamkeit der Therapieregime BG bei Patienten mit rezidivierter oder refraktärer CLL.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of CLL in need of treatment according to the iwCLL guidelines 8
    2. Relapsed or refractory disease after at least one, but no more than 3 prior regimens for CLL
    3. Medically fit patients without relevant comorbidity, defined as total CIRS score ≤6 (single score < 4 for one organ category)
    4. ECOG performance status of 0 - 2
    5. Hematology values within the following limits unless cytopenia is caused by the underlying disease, i.e. no evidence of additional bone marrow dysfunction (e.g. myelodysplastic syndrome (MDS), hypoplastic bone marrow due to toxicity of prior therapy):
    a. Absolute neutrophil count ≥1.5 x 109/L
    b. Platelets ≥50 x 109/L and more than 7 days since last transfusion
    6. Creatinine clearance >60 ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured after 24 h urine collection
    7. Adequate liver function as indicated by a total bilirubin, AST, and ALT ≤2 the institutional ULN value, unless directly attributable to the patient’s CLL
    8. Negative serological Hepatitis B test (i.e. HBsAg negative and anti-HBc negative, patients positive for anti-HBc may be included if PCR for HBV DNA is negative); negative testing of Hepatitis C RNA; negative HIV test within 6 weeks prior to registration
    9. 18 years of age or older
    10. Life expectancy >6 months
    11. Able and willing to provide written informed consent and to comply with the study protocol procedures
    1. Diagnose einer behandlungsbedürftigen CLL gemäß den aktualisierten iwCLL Richtlinien 8
    2. Patienten mit rezidivierter oder refraktärer CLL nach mindestens einer und maximal drei vorangegangenen Therapien
    3. Medizinisch fitte Patienten ohne relevante Komorbidität, definiert als CIRS ≤6 (<4 Punkte insgesamt für eine Organkategorie)
    4. ECOG Leistungsstatus von 0 - 2
    5. Hämatologische Parameter innerhalb folgender Grenzwerte, außer die Zytopenie ist bedingt durch die Grunderkrankung, d.h. es gibt keinen Hinweis auf eine zusätzliche Knochenmarksdysfunktion (z.B. myelodysplastisches Syndrom (MDS), hypoplastisches Knochenmark aufgrund von Toxizität der vorangegangenen Therapie):
    a. Absolute Neutrophilenzahl (ANC) ≥1.5 x 109/l
    b. Thrombozytenzahl ≥50 x 109/l mindestens 7 Tage nach der letzten Transfusion
    6. Kreatinin-Clearance >60 ml/min, berechnet nach der modifizierten Formel von Cockcroft und Gault oder direkt im 24h- Sammelurin gemessen
    7. Adäquate Leberfunktion: Gesamt-Bilirubin, ALT und AST ≤ des 2-Fachen des oberen Normwertes, falls nicht direkt auf die CLL des Patienten zurückführbar
    8. Negative Hepatitis B Serologie (d.h. HBsAg negativ und anti-HBc negativ; Patienten, die anti-HBc-positiv sind, dürfen in die Studie eingeschlossen werden, wenn die PCR für die HBV-DNA negativ ausfällt); negativer Test auf Hepatitis C - RNA; negativer HIV-Test innerhalb der letzten 6 Wochen vor Studieneinschluss
    9. 18 Jahre alt oder älter
    10. Lebenserwartung >6 Monate
    11. Der Patient muss fähig und willens sein, die schriftliche Einverständniserklärung zu unterzeichnen und den im Studienprotokoll beschriebenen Prozeduren nachzukommen
    E.4Principal exclusion criteria
    1. Detected del817p) or TP53 mutation
    2. Refractoriness to FCR/BR
    3. Transformation of CLL to aggressive NHL (Richter’s transformation)
    4. Known central nervous system (CNS) involvement
    5. Evidence of significant uncontrolled concomitant disease
    6. Major surgery < 30 days before screening
    7. Decompensated hemolytic anemia 28 days before screening
    8. Hemolytic cystitis 28 days before screening
    9. Patients with a history of confirmed PML
    10. Prior treatment with GA101
    11. History of prior malignancy, except for conditions as listed below (a-d) and if patients have recovered from the acute side effects incurred as a result of previous therapy:
    a. Malignancies treated with curative intent and with no known active disease present for ≥ 2 years before randomization
    b. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease at screening
    c. Adequately treated cervical carcinoma in situ without evidence of disease at screening
    d. Surgically adequately treated low grade, early stage localized prostate cancer without evidence of disease at screening
    12. Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks before registration
    13. Patients with active infection requiring systemic treatment
    14. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies and/ or known sensitivity or allergy to murine products
    15. Hypersensitivity to fludarabine, cyclophosphamide, bendamustine, GA101 and/ or to any of the excipients for example mannitol
    16. An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive an intensive therapy for CLL
    17. Legal incapacity
    18. Women who are pregnant or lactating
    19. Fertile men or women of childbearing potential unless:
    a. surgically sterile or ≥2 years after the onset of menopause
    b. willing to use a highly effective contraceptive method (Pearl Index <1) during study treatment and for 12 months after end of study treatment
    20. Vaccination with a live vaccine within a minimum of 28 days before screening
    21. Participation in any other clinical trial which would interfere with study drug
    22. Prisoners or subjects who are institutionalized by regulatory or court order
    23. Persons who are in dependence to the sponsor or an investigator
    1. Erkannte del(17p) oder TP53 Mutation
    2. FCR/BR refraktär
    3. Transformation der CLL in ein aggressives NHL (Richter Transformation)
    4. Befall des zentralen Nervensystems (ZNS)
    5. Beweis einer signifikanten unkontrollierten Begleiterkrankung
    6. Schwerwiegende Operation < 30 Tage vor Start der Therapie
    7. Dekompensierte hämolytische Anämie 28 Tage vor Screening
    8. Hämorrhagische Cystitis 28 Tage vor Screening
    9. Patienten mit einer bestätigten PML in der Vorgeschichte
    10. Vorherige Therapie mit GA101
    11. Aktive, behandlungsbedürftige, maligne Zweiterkrankung mit Ausnahme von unten gelisteten Punkten (a-d) und wenn der Patient sich von den akuten Nebenwirkungen als Folge der deswegen vorangegangenen Therapie erholt hat:
    a. Malignome, welche mit kurativer Intention behandelt wurden und die seit ≥2 Jahren vor Randomisierung keine Krankheitsaktivität mehr gezeigt haben.
    b. Adäquat therapierter Hautkrebs mit Ausnahme von Melanomen oder Lentigo Maligna ohne Zeichen von Krankheitsaktivität zum Zeitpunkt des Screenings.
    c. Adäquat therapiertes Cervixkarzinom in situ ohne Zeichen von Krankheitsaktivität zum Zeitpunkt des Screenings.
    d. Chirurgisch adäquat therapiertes, hochdifferenziertes und im Frühstadium lokalisiertes Prostatakarzinom ohne Zeichen von Krankheitsaktivität zum Zeitpunkt des Screenings.
    12. Behandlung mit den Prüfpräparaten oder einer entsprechenden Krebstherapie innerhalb der letzten 4 Wochen vor Registrierung.
    13. Aktive Infektionen, die einer systemischen Behandlung bedürfen
    14. Schwere allergische oder anaphylaktische Reaktionen auf humanisierte oder murine monoklonale Antikörper in der Vorgeschichte und/ oder bekannte Sensibilität oder Allergie auf murine Produkte.
    15. Überempfindlichkeit gegen Fludarabin, Cyclophosphamid, Bendamustin, GA101 und/ oder gegen andere Bestandteile wie z.B. Mannitol.
    16. Vorliegen einer individuellen Organ-/ Systemschädigung von 4 gemessen mit dem CIRS-Score, welche die Möglichkeit limitiert, eine intensive CLL-Behandlung zu erhalten
    17. Geschäftsunfähigkeit
    18. Schwangere oder stillende Frauen
    19. Zeugungsfähige Männer oder gebärfähige Frauen, außer:
    a. Im Falle einer chirurgischen Sterilisation oder ≥2 Jahre nach Eintreten der Menopause
    b. Bereitschaft zur Anwendung einer sicheren Methode der Empfängnisverhütung (Pearl Index <1), während der Studienbehandlung und 12 Monate nach Beendigung der Studienbehandlung
    20. Impfung mit einem Lebendimpfstoff bis zu 28 Tage vor Screening
    21. Teilnahme an anderen klinischen Studien welche die Studienmedikation beeinträchtigen würde
    22. Gefängnisinsassen oder Personen, die auf behördliche oder richterliche Anweisung institutionalisiert sind
    23. Personen, die vom Sponsor oder Prüfer in irgendeiner Form abhängig sind
    E.5 End points
    E.5.1Primary end point(s)
    Best overall response rate (ORR) defined as best response assessed until and including response assessment at follow up 2 (6 months after final restaging/ induction), defined by the proportion of patients having achieved a CR/ CRi, clinical CR/ CRi or nPR/ PR as best response based on the respective population (= number of patients with best response CR/ CRi, clinical CR/ CRi or nPR/ PR divided by the number of the respective population)
    Gesamtansprechrate (Overall Response Rate, ORR) definiert als bestes Therapieansprechen bis einschließlich der Follow-up 2- Untersuchung (6 Monate nach dem Final Restaging), definiert als der prozentualer Anteil an Patienten, die eine CR/ CRi, clinical CR/ CRi oder eine nPR/ PR als bestes Ansprechen erreichen, bezüglich der entsprechenden Population (= Anzahl an Patienten mit dem besten Gesamtansprechen CR/ CRi, clinical CR/ CRi, nPR/ PR geteilt durch die Anzahl der entsprechenden Patientenpopulation)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The analysis of the primary endpoint will be performed 60 months after the last patient was randomized.
    Die Analyse des primären Endpunktes wird 60 Monate nachdem der letzte Patient randomisiert wurde, durchgeführt.
    E.5.2Secondary end point(s)
    • MRD levels during treatment and maintenance
    • Progression free survival (PFS)
    • Event-free survival (EFS)
    • Overall survival (OS)
    • Overall response to maintenance treatment
    • Duration of response in patients with CR/ CRi, clinical CR / clinical CRi or nPR/ PR
    • Time to next anti-leukemia treatment
    • Overall response rate in biological defined risk groups
    • Complete response rate
    • Safety parameters during induction and maintenance phase [type, frequency, and severity of adverse events (AEs), AESI (AEs of special interest) and relationship of AEs to study treatment]
    • Evaluation of relationship between various baseline markers and clinical outcome parameters
    • Level der minimalen Resterkrankung (MRD) während der Induktions- und Erhaltungstherapie
    • Progressionsfreies Überleben (Progression free survival, PFS)
    • Ereignisfreies Überleben (Event-free survival, EFS)
    • Gesamtüberleben (Overall survival, OS)
    • Gesamtansprechen aufdie Erhaltungstherapie
    • Dauer des Ansprechens bei Patienten mit CR/ CRi, clinical CR/ CRi oder nPR/ PR
    • Zeit bis zur nächsten antileukämischen Therapie
    • Gesamtansprechrate in den biologisch definierten Risikogruppen
    • Komplette Ansprechrate (Complete response rate)
    • Sicherheitsparameter während der Induktions- und Erhaltungstherapie [Art, Häufigkeit und Schweregrad von u unerwünschten Ereignissen (Adverse Events, AEs), unerwünschte Eregnisse von besonderem Interesse (AESI), sowie Zusammenhang der AEs mit der Studientherapie]
    • Beurteilung des Zusammenhangs zwischen verschiedenen Ausgangsmarkern und klinischen Ergebnisparametern
    E.5.2.1Timepoint(s) of evaluation of this end point
    The analysis of the primary endpoint will be performed 60 months after the last patient was randomized.
    Die Analyse des primären Endpunktes wird 60 Monate nachdem der letzte Patient randomisiert wurde, durchgeführt.
    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 No
    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.8.2.3.1Comparator description
    Fludarabin + GA101 versus Bendamustin + Cyclophosphamid + GA101
    Fludarabine + GA101 versus Bendamustine + Cyclophosphamide + GA101
    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 concerned35
    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 No
    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
    The end of the clinical trial is defined as 60 months after the last patient was randomized.
    Das Ende der klinischen Studie ist definiert als 60 Monate nachdem der letzte Patient randomisiert wurde.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 state58
    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)
    After participation in the trial has ended no special treatment or care is needed.
    Nach Beendigung der Studienteilnahme ist keine besondere Behandlung oder Versorgung mehr erfohrderlich.
    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 Decision2014-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-23
    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
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