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    Summary
    EudraCT Number:2009-015989-62
    Sponsor's Protocol Code Number:MT103-206
    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:2010-04-29
    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 number2009-015989-62
    A.3Full title of the trial
    An Open Label, Multicenter, Exploratory Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of the BiTE Antibody Blinatumomab in Adult Patients with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)
    Offene, multizentrische, exploratorische Phase II Studie zur Untersuchung der Wirksamkeit, Sicherheit und Verträglichkeit des bispezifischen T-Zell-Aktivators (BiTE) Blinatumomab bei erwachsenen Patienten mit rezidivierter oder refraktärer B-Vorläufer akuter lymphoblastischer Leukämie (ALL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to treat adult patients with a medicine who suffer from acute relapse of their blood cancer after chemotherapy
    Eine klinische Studie zur Behandlung von erwachsenen Patienten mit Akuter Lymphoblastischer Leukämie die auf die bisherige Therapie nicht angesprochen haben oder unter einem Rückfall leiden.
    A.3.2Name or abbreviated title of the trial where available
    MT103-206
    A.4.1Sponsor's protocol code numberMT103-206
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01209286
    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 Relapsed/Refractory B-Precursor acute lymphoblastic leukemia (ALL)
    Patienten mit rezidivierter oder refraktärer B-Vorläufer akuter lymphoblastischer Leukämie (ALL)
    E.1.1.1Medical condition in easily understood language
    patients with relapse of their blood cancer
    Patienten die einen Rückfall Ihrer Blutkrebserkrankung akute lymphoblastische Leukämie (ALL) erlitten haben
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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 evaluate efficacy of blinatumomab in patients with relapsed/refractory B-precursor ALL
    Bewertung der Wirksamkeit von Blinatumomab bei Patienten mit rezidivierter oder refraktärer B-Vorläufer akuter lymphoblastischer Leukämie (ALL)
    E.2.2Secondary objectives of the trial
    To evaluate safety and tolerability of blinatumomab in patients with relapsed/refractory B-precursor ALL.

    To evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of blinatumomab.
    Bewertung der Sicherheit und Verträglichkeit von Blinatumomab bei Patienten mit rezidivierter oder refraktärer B-Vorläufer akuter lymphoblastischer Leukämie (ALL)

    Bewertung der Pharmakokinetik und Pharmakodynamik von Blinatumomab bei Patienten mit rezidivierter oder refraktärer B-Vorläufer akuter lymphoblastischer Leukämie (ALL)

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with B-precursor ALL relapsed after at least induction and consolidation or having refractory disease
    a. Relapse is defined as reappearance of disease after CR having at least lasted for 28 days
    b. Refractory disease is defined as not having achieved CR after induction and/or consolidation I
    2. More than 5% blasts in bone marrow
    3. ECOG performance status ≤ 2
    4. Age ≥ 18 years
    5. Life expectancy of ≥ 12 weeks
    6. Ability to understand and willingness to sign a written informed consent
    7. Signed and dated written informed consent is available
    1. Patienten mit B-Vorläufer ALL mit Rezidiv nach mindestens Induktion- und Konsolidierungstherapie oder mit refraktärer Erkrankung
    a. Rezidiv ist definiert als Wiederauftreten der Erkrankung nach Erreichen einer CR über mindestens 28 Tage
    b. Refraktäre Erkrankung ist definiert als Nicht-Erreichen einer CR nach Induktion und /oder Konsolidierung I.
    2. Mehr als 5% Blasten im Knochenmark
    3. ECOG Performance Status <2
    4. Alter ≥18 Jahre
    5. Lebenserwartung von ≥12 Wochen
    6. In der Lage und willens, eine schriftliche Einwilligungserklärung abzugeben
    7. Vorhandensein einer unterzeichneten und datierten Patienteninformation/Einwilligungserklärung
    E.4Principal exclusion criteria
    1. History or presence of clinically relevant CNS pathology as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis
    2. Infiltration of cerebrospinal fluid (CSF) and/or testis by ALL
    3. History of autoimmune disease with potential CNS involvement or current autoimmune disease
    4. Autologous hematopoietic stem cell transplantation (HSCT) within six weeks prior to start of blinatumomab treatment
    5. Allogeneic HSCT within three months prior to start of blinatumomab treatment
    6. Eligibility for allogeneic HSCT at the time of enrollment (as defined by disease status, performance status and availability of donor)
    7. Active Graft-versus-Host Disease (GvHD)
    8. Immunosuppressive therapy against GvHD within one week prior to start of blinatumomab treatment
    9. Patients with Ph+ ALL eligible for treatment with dasatinib or imatinib
    10. Cancer chemotherapy within two weeks prior to start of blinatumomab treatment and TKIs within 72 hours prior to start of blinatumomab treatment (intrathecal prophylaxis and/or steroids (≤24 mg/d) are allowed until start of blinatumomab treatment.)
    11. Radiotherapy within four weeks prior to start of blinatumomab treatment
    12. Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treatment
    13. Any investigational anti-leukemic product within four weeks prior to start of blinatumomab treatment
    14. Treatment with any other investigational product after signature of informed consent
    15. Known hypersensitivity to immunoglobulin’s or to any other component of the study drug formulation
    16. Presence of human anti-murine antibodies (HAMA)
    17. Abnormal laboratory values as defined below:
    a. AST (SGOT) and/or ALT (SGPT) and/or AP ≥ 5 x upper limit of normal (ULN)
    b. Total bilirubin ≥ 1,5 x ULN
    c. Creatinine clearance < 50 ml/min (calculated)
    d. Hb ≤ 9 g/dl (transfusion allowed)
    e. Pathological findings of INR or PTT > 1,5 ULN
    18. Symptoms or signs of disseminated intravascular coagulation (DIC)
    19. History of malignancy other than ALL within five years prior to start of blinatumomab treatment with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix
    20. Active infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
    21. Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBsAg positive) or hepatitis C virus (anti-HCV positive)
    22. Pregnant or nursing women
    23. Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least three months thereafter. Male patients not willing to ensure not to beget a child during participation in the study and at least three months thereafter
    24. Previous treatment with blinatumomab
    1.Vorgeschichte einer oder bestehende klinisch relevante ZNS-Pathologie wie Epilepsie, Anfälle, Parese, Aphasie, Schlaganfall, ernsthafte Hirnverletzungen, Demenz, Parkinson, Erkrankung des Kleinhirns, Organisches Hirnsyndrom, Psychose)
    2. Liquor- und/oder Hodenbefall infiltration durch ALL
    3. Vorgeschichte einer Autoimmunerkrankung mit möglicher ZNS Beteiligung oder bestehende Autoimmun¬erkrankung
    4. Autologe Stammzellentransplantation innerhalb von 6 Wochen vor Blinatumomab-Gabe
    5. Allogene Stammzellentransplantation innerhalb von 3 Monaten vor Blinatumomab-Gabe
    6. Eignung zur allogenen Stammzelltransplantation zum Zeitpunkt des Studieneinschlusses (definiert nach dem Erkrankungszustand, dem Allgemeinzustand und der Verfügbarkeit eines Spenders)
    7. Aktive Graft-versus-Host Disease (GvHD)
    8. Immunsuppressive Therapie gegen GvHD innerhalb von 1 Woche vor Blinatumomab-Gabe
    9. Patienten mit Ph+ ALL, die für eine Behandlung mit Dasatinib oder Imatinib geeignet sind
    10. Chemotherapie gegen Krebs innerhalb von 2 Wochen Blinatumomab-Gabe und Behandlung mit TKIs innerhalb von 72h vor Blinatumomab-Gabe (intrathekale Prophylaxe und/oder Steroide (≤24mg/d) sind erlaubt bis zum Beginn der Blinatumomabgabe)
    11. Radiotherapie innerhalb von 4 Wochen vor Blinatumomab-Gabe
    12. Immuntherapie (z.B. mit Rituximab) innerhalb von 4 Wochen vor Blinatumomab-Gabe
    13. Anwendung eines Studienpräparates gegen Leukämie innerhalb von 4 Wochen vor Blinatumomab-Gabe
    14. Behandlung mit irgendeinem anderen Studienpräparat nach Unterzeichnung der Einwilligungserklärung für diese Studie
    15. Bekannte Hypersensitivität auf Immunglobuline oder auf eine andere Komponente der Studienmedikations¬formulierung
    16. Humane-Anti-Maus-Antikörpern (HAMA)
    17. Abnorme Laborwerte wie nachfolgend definiert:
    a. AST (SGOT), und/oder ALT (SGPT), und/oder AP ≥ 5 x oberer Normalwert (ULN)
    b. Bilirubin gesamt ≥ 1,5 x ULN
    c. Kreatinin Clearance <50 ml/min (berechnet)
    d. Hb ≤ 9g/dl (Transfusion erlaubt)
    e. Pathologische Auffälligkeiten bei INR oder PTT > 1,5 x ULN
    18. Anzeichen von DIC (disseminierte intravasale Gerinnung)
    19. Vorgeschichte einer malignen Erkrankung außer ALL innerhalb von fünf Jahren vor Blinatumomab-Gabe mit Ausnahme von Basalzell-oder Plattenepithelzellkarzinom der Haut oder „in situ“ Zervixkarzinom
    20. Aktive Infektion, oder eine andere bestehende Erkrankung oder ein medizinischer Zustand, die nach Ansicht des Prüfarztes eine negative Auswirkung auf die Studiendurchführung haben könnten
    21.Infektion mit dem “Human Immunodeficiency Virus” (HIV) oder chronische Infektion mit dem Hepatitis-B-Virus (HbsAg positiv) oder Hepatitis C Virus (anti-HCV positiv)
    22.Schwangere oder stillende Frauen
    23. 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
    24. Frühere Behandlung mit Blinatumomab
    E.5 End points
    E.5.1Primary end point(s)
    CR and CRh* rate within two cycles of treatment with blinatumomab.
    Rate der kompletten Remissionen mit kompletter (CR) oder partieller (CRh*) hämatologischer Erholung innerhalb der ersten beiden Behandlungszyklen mit Blinatumomab
    E.5.1.1Timepoint(s) of evaluation of this end point
    the primary endpoint will be analyzed at the completion of the second cycle of the treatment
    Der primäre Endpunkt wird nach Beendigung des zweiten Zyklus untersucht
    E.5.2Secondary end point(s)
    - CR rate.
    - CRh* rate.
    - PR rate.
    - Rate of MRD response (defined as MRD < 10-4)
    Proportion of patients who undergo allogeneic hematopoietic stem cell transplantation (HSCT) after treatment with blinatumomab.
    - Time to hematological relapse.
    - Relapse-free survival.
    - Overall survival (OS).
    - Overall incidence and severity of adverse events.
    - Pharmacokinetic parameters: serum half-life, maximum concentration, area under the curve, volume of distribution and clearance of blinatumomab.
    - Quantification and characterization of peripheral blood leukocyte subsets and serum cytokine concentrations.
    - CR-Rate
    - CRh*-Rate
    - PR-Rate
    - MRD Ansprechrate (definiert als MRD<10-4)
    - Anteil der Patienten, die sich nach der Behandlung mit Blinatumomab einer allogenen Stammzelltransplan¬tation unterziehen
    - Zeit bis zum hämatologischen Rezidiv
    - Länge des rezidivfreien Überlebens
    - Länge des Gesamtüberlebens
    - Allgemeine Häufigkeit und Schwierigkeitsgrade von unerwünschten Ereignissen
    - Pharmakokinetische Parameter: Serum-Halbwertzeit, maximale Konzentration, Fläche unter der Kurve, Volumen der Verteilung und Clearance von Blinatumomab
    - Quantifizierung und Charakterisierung der Leukozyten Subpopulationen im peripheren Blut und Zytokin-konzentration im Serum
    E.5.2.1Timepoint(s) of evaluation of this end point
    the secundary endpoints will bee assessed at the latest five years following initiation of blinatumomab infusion
    Die sekundären Endpunkte werden spätestens nach 5 Jahren nach Beginn der ersten Infusionslösung untersucht
    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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned8
    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
    the study will end when the last patient had the last protocol mandated visit
    Die Studie wird beendet sein, wenn der letzte Patient die letzte laut Protokoll vorgesehene Studienvisite abgeschlossen hat.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    n.a.
    n.a.
    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 Decision2010-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
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