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    Summary
    EudraCT Number:2006-006520-19
    Sponsor's Protocol Code Number:MT103-202
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-06-19
    Trial results View 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 number2006-006520-19
    A.3Full title of the trial
    An open-label, multicenter phase II study to investigate the efficacy, safety, and tolerability of the bi-specific T-cell engager (BITE) MT103 in patients with minimal residual disease (MRD) of positive B-precursor acute lymphoblastic leukemia (ALL)
    Offene, multizentrische Phase II Studie zur Untersuchung der Wirksamkeit, Sicherheit und Verträglichkeit des bispezifischen T-Zell-Aktivators (BiTE) MT103 bei Patienten mit minimaler Resterkrankung (MRD) bei positiver B-Zellen-Vorläufer akuter lymphoblastischer Leukämie (ALL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to treat adult patients who suffer from a low amount of remaining blood cancer cells after chemotherapy
    Eine klinische Studie bei erwachsenen Patienten, die nach einer Chemotherapie unter einer geringen Menge an verbleibenden Blutkrebszellen leiden
    A.3.2Name or abbreviated title of the trial where available
    MT103-202
    A.4.1Sponsor's protocol code numberMT103-202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00560794
    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 SponsorAmgen Research (Munich) GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen Research (Munich) GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstr. 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@amgen.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/650
    D.3 Description of the IMP
    D.3.1Product nameBlinatumomab
    D.3.2Product code MT103, AMG103
    D.3.4Pharmaceutical form Powder 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 INNBlinatumomab
    D.3.9.1CAS number 853426-35-4
    D.3.9.2Current sponsor codeMT103
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33 (process 4) to 30.3 (process 5)
    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
    Patients with minimal residual disease (MRD) of positive B-precursor acute lymphoblastic leukemia (ALL)
    Patienten mit minimaler Resterkrankung (MRD) mit positiver B-Zell-Vorläufer akuter lymphatischer Leukämie (ALL)
    E.1.1.1Medical condition in easily understood language
    Treatment of patients with acute lymphoblastic leukemia with remaining blood cancer cells in the bone marrow after chemotherapy
    Behandlung von erwachsenen Patienten mit akuter lymphoblastischer Leukämie mit noch vorhandenen Krebszellen im Knochenmark nach Chemotherapie
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of blinatumomab as defined by the effect on minimal residual disease (MRD)

    Untersuchung der Wirksamkeit von Blinatumomab, definiert als der Effekt von Blinatumomab auf die verbleibende Resterkrankung (MRD)
    E.2.2Secondary objectives of the trial
    - To assess the effect of blinatumomab on duration of complete hematological remission
    - To assess the impact of blinatumomab on the level of MRD
    - To assess the effect of blinatumomab on duration of MRD negativity
    - To evaluate the safety and tolerability of blinatumomab
    - To evaluate the pharmacodynamics of blinatumomab
    - To evaluate the pharmacokinetics of blinatumomab
    - Untersuchung des Effektes von Blinatumomab
    auf die Dauer der kompletten hämatologischen Remission
    - Untersuchung des Einflusses von Blinatumomab
    auf den MRD-Level
    - Untersuchung des Effektes von Blinatumomab
    auf die Dauer der MRD-Negativität
    - Beurteilung der Sicherheit und Verträglichkeit von Blinatumomab
    - Beurteilung der Pharmakodynamik von Blinatumomab
    - Beurteilung der Pharmakokinetik von Blinatumomab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. B–precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within GMALL standards or at any time outside GMALL standards.
    2. Patients must have a molecular marker for evaluation of minimal residual disease which is either:
    - Bcr/abl at any detection level and/or t (4;11) translocation at any detection level messured by reverse transcription - polymerase chain reaction (RT-PCR)
    - Individual rearrangements of immunoglobulin or TCR-genes measured by an assay with a sensitivity of minimum 10-4: At least one individual marker at a quantitative level equal or greater than 10-4.
    3. ECOG Performance Status equal or smaller than 1.
    4. Age equal or older than 18 years
    5. Ability to understand and willingness to sign a written informed consent
    6. Signed and dated written informed consent is available
    1. B–Zell-Vorläufer-ALL-Patienten in kompletter hämatologischer Remission mit molekularem Defekt oder molekularem Rezidiv zu jedem Zeitpunkt nach Konsolidierung I der “Front-line”-Therapie innerhalb des GMALL Standards oder zu jedem Zeitpunkt nach Therapie außerhalb des GMALL Standards.
    2. Patienten müssen entweder/oder einen der folgenden molekularen Marker zur Bewertung der minimalen Resterkrankung aufweisen:
    - Bcr/abl und/oder t(4;11) Translokation nachweisbar auf irgendeinem Level, gemessen durch RT/PCR.
    - Individuelle Rearrangements von Immunglobulin oder TCR-Genen gemessen mit einem Assay mit einer minimalen Sensitivität von 10-4 = Mindestens ein individueller Marker auf einem quantitativen Level von größer/gleich10-4.
    3. ECOG Performance Status kleiner/gleich 1
    4. Alter ≥18 Jahre
    5. In der Lage und willens, eine schriftliche Einwilligungserklärung abzugeben
    6. Vorhandensein einer unterzeichneten und datierten Patienteninformation/Einwilligungserklärung
    E.4Principal exclusion criteria
    1. Current extra medullar involvement
    2. History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebro-spinal fluid (CSF) by ALL, age-related findings such as arteriosclerosis or findings induced by radiation or chemotherapy)
    3. Current infiltration of cerebro-spinal fluid by ALL
    4. History of or current autoimmune disease
    5. Autologous stem cell transplantation within 6 weeks prior to study entry
    6. Any prior allogeneic stem cell transplantation
    7. Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)
    8. Radiotherapy within 4 weeks prior to study treatment
    9. Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment
    10. Any investigational product within 4 weeks prior to study entry
    11. Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
    12. Presence of human anti-murine antibodies (HAMA)
    13. Abnormal bone marrow function as defined below:
    - WBC < 3 000/mL
    - Platelets < 50 000/mL
    14. Abnormal renal or hepatic function as defined below:
    - AST (SGOT) and/or ALT (SGPT) and/or AP equal or greater than 2 x upper limit of normal (ULN)
    - GGT > 5 x ULN
    - Total bilirubin equal or greater than 1.5 x ULN
    - Creatinine clearance < 50 mL/min determined by the Cockroft-Gould formula.
    15. Indication for a hypercoagulative state as defined below:
    - D-Dimer equal or greater than 2,5 x ULN
    - Antithrombin activity < 70%
    16. Presenc of malignancy other than ALL
    17. Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
    18. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive)
    19. Pregnant or nursing women
    20. Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception dur-ing participation in the study and at least three months thereafter
    1. Bestehendes extramedulläres Involvment
    2. Vorgeschichte einer oder bestehende relevante ZNS-Pathologie (außer Migräne/Kopfschmerz und/oder frühere Liquorinfiltration durch ALL, altersabhängige Veränderungen wie Arteriosklerose oder durch Strahlen- oder Chemotherapie induzierte Veränderungen)
    3. Bestehende Liquorinfiltration durch ALL
    4. Vorgeschichte einer oder bestehende Autoimmunerkrankung
    5. Autologe Stammzellentransplantation innerhalb von 6 Wochen vor Studieneinschluss
    6. Jegliche frühere allogene Stammzellentransplantation
    7. Chemotherapie gegen Krebs innerhalb von 4 Wochen vor Studieneinschluss (außer für intrathekale Prophylaxe und/oder niedrig dosierte Erhaltungstherapie wie Vincalkalaoide, Mercaptourin, Methotrxat, Steroide)
    8. Radiotherapie innerhalb von 4 Wochen vor Behandlung in der Studie.
    9. Therapie mit monoklonalen Antikörpern (Rituximab, MabCampath) innerhalb von 6 Wochen vor Behandlung in der Studie
    10. Anwendung eines Studienpräparates innerhalb von 4 Wochen vor Studieneinschluss
    11. Bekannte Hypersensitivität auf Immunglobuline oder auf eine andere Komponente der Studienmedikationsformulierung
    12. Präsenz von menschlichen Anti-Maus-Antikörpern (HAMA)
    13. Abnorme Knochenmarksfunktion wie nachfolgend definiert:
    - WBC <3 000/µL
    - Thrombocyten <50 000/µL
    14. Abnorme renale oder hepatische Funktion wie nachfolgend definiert:
    - AST (SGOT) und/oder ALT (SGPT) und/oder AP größer/gleich 2 x oberer Normalwert (ULN)
    - GGT > 5 x ULN
    - Bilirubin gesamt größer/gleich 1.5 x ULN
    - Kreatinin Clearance <50 ml bestimmt durch die Cockroft-Gold Formel
    15. Anzeichen eines hyperkoagulativen Zustandes wie nachfolgend definiert:
    - D-Dimer größer/gleich 2,5 x ULN
    - Antithrombin Aktivität < 70
    16. Bestehende maligne Erkrankung außer ALL
    17. Aktive schwere Infektion, eine andere bestehende Erkrankung oder ein medizinischer Zustand, die nach Ansicht des Prüfarztes eine störende Auswirkung auf die Studiendurchführung haben könnten
    18. Bekannte Infektion mit dem “Human Immunodeficiency Virus” (HIV) oder chronische Infektion mit dem Hepatitis-B-Virus (HbsAg positiv) oder Hepatitis C Virus (anti-HCV positiv)
    19. Schwangere oder stillende Frauen
    20. Frauen im gebärfähigen Alter, nicht gewillt, eine effektive Verhütungsmethode während der Studiendauer und mindestens 3 Monate danach, anzuwenden oder männliche Patienten, nicht gewillt, eine effektive Verhütung während der Studie und mindestens 3 Monate danach sicherzustellen
    E.5 End points
    E.5.1Primary end point(s)
    MRD response rate defined by the incidence of MRD negativity within four cycles of treatment with MT103. MRD negativity is defined as bcr/abl below detection limit and/or by individual rearrangements of immunoglobulin or TCR-genes below 10-4.
    MRD-Ansprechrate, definiert als die Häufigkeit des Eintretens von MRD-Negativität innerhalb von vier Zyklen mit MT103. MRD-Negativität ist definiert als bcr/abl und/oder t(4;11) Translokation unterhalb der Nachweisgrenze und/oder individuelle Rearrangements von Immunglobulin oder TCR-Genen unter 10-4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Incidence of MRD-negativity within 4 cycle´s of blinatumomab treatment
    MRD-Ansprechrate innerhalb von 4 Behandlungszyklen mit Blinatumomab
    E.5.2Secondary end point(s)
    - MRD response rate defined by the incidence of MRD negativity after any treatment cycle
    -Time to hematological relapse
    - Change in MRD level. MRD progression is defined as the increase in the number of MRD positive cells by one
    log level as compared to the baseline level, which is equal to a 10-fold increase in the number of MRD positive
    cells. Progression has to be confirmed within six weeks. The time point of progression is the date of the first
    measurement.
    - Time to molecular relapse as defined by the period from the first detection of MRD negativity until the first detection
    of relapse. Molecular relapse is defined by the detection of bcr/abl, and/or t(4;11) translocation at any
    level, and/or by the detection of individual rearrangements of immunoglobulin or TCR-genes in ≥10-4 cells
    measured by an assay with a sensitivity of minimum 10-4. Molecular relapse has to be confirmed within six
    weeks.
    - Overall incidence and severity of adverse events
    - Quantification and characterization of peripheral blood lymphocytes
    - Cytokine serum concentrations
    - Pharmacokinetic parameters: serum half-life, maximum concentration, area under the curve, volume of distribution
    and clearance of blinatumomab
    - MRD-Ansprechrate, definiert als die Häufigkeit des Eintretens von MRD nach jedem beliebigen Zyklus
    - Zeit zum hämatologischen Rezidiv
    - Wechsel im MRD-Level. MRD-Progression ist definiert als die Erhöhung der Anzahl von MRD-positiven Zellen um einen Log-Level, verglichen zum Baseline-Level, gleichzusetzen mit einer 10-fachen Erhöhung der Anzahl von MRD-positiven Zellen. Die Progression muss innerhalb von 6 Wochen bestätigt werden. Zeitpunkt der Progression ist das Datum der ersten Messung
    - Zeit zum molekularen Rezidiv, definiert als die Periode des ersten Nachweises von MRD-Negativität bis zum ersten Nachweis des Rezidivs. Molekulares Rezidiv ist definiert als der Nachweis von bcr/abl und/oder t(4;11) Translokation auf jedem Nachweislevel und/oder als der Nachweis von individuellen Rearrangements von Immunglobulin oder TCR-Genen in ≥ 10-4 Zellen gemessen mit einem Assay mit einer Sensitivität von Minimum 10-4. Ein molekulares Rezidiv muss innerhalb von 6 Wochen bestätigt werden
    - Allgemeine Häufigkeit und Schwierigkeitsgrade von unerwünschten Ereignissen
    - Quantifizierung und Charakterisierung von Lymphozyten im peripheren Blut
    - Zytokin-Serumkonzentration
    - Pharmakokinetische Parameter: Serum-Halbzeit, maximale Konzentration, Bereich unter der Kurve, Volumen der Verteilung und Clearance von Blinatumomab
    E.5.2.1Timepoint(s) of evaluation of this end point
    - MRD response after any treatment cycle
    -Time to hematological relapse: First infusion until hematological relapse
    - Change in MRD level: At the time point of progression
    - Time to molecular relapse: Period of first detection of MRD-negativity until first detection of MRD-relapse
    Other endpoints: Evaluation on an ongoing base during the course of the study
    - MRD Reaktion nach jedem Behandlungszyklus
    - Zeit zum hämatologischen Rezidiv: erste Infusion bis zum hämatologischen Rezidiv
    - Wechsel im MRD-Level: zum Zeitpunkt der Progression
    - Zeit zum molekularen Rückfall: Periode vom ersten Nachweis von MRD-Negativität bis zum ersten Nachweis eines MRD-Rezidivs. Weitere Endpunkte: Untersuchungen in regelmäßigen Abständen während der Studie
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    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 patient out
    Datum der letzten Nachbeobachtungs-Visite des letzten Patienten
    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
    E.8.9.2In all countries concerned by the trial years0
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state21
    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 Decision2007-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-26
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