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    Summary
    EudraCT Number:2010-018314-75
    Sponsor's Protocol Code Number:MT103-203
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-018314-75
    A.3Full title of the trial
    Estudio multicéntrico confirmatorio de brazo único para evaluar la eficacia, seguridad y tolerabilidad del anticuerpo BiTE® conocido como blinatumomab en pacientes adultos con enfermedad mínima residual (EMR) de leucemia linfoblástica aguda de precursores B
    (A confirmatory multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE® antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia)
    A.3.2Name or abbreviated title of the trial where available
    MT103-203
    A.4.1Sponsor's protocol code numberMT103-203
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMicromet AG
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 typerange
    D.3.10.3Concentration number10 to 12.4
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Enfermedad mínima residual (EMR) de leucemia linfoblástica aguda de precursores B
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia de blinatumomab para inducir una respuesta completa de la EMR
    E.2.2Secondary objectives of the trial
    Objetivo secundario para pacientes con LLA que no presenten cromosomas Filadelfia (Ph) y no trasplantados en un plazo de 18 meses después del inicio del tratamiento del estudio
    -Evaluar el efecto de blinatumomab en la recaída hematológica

    Otros objetivos secundarios:
    -Evaluar la supervivencia general en pacientes con LLA tratados con blinatumomab
    -Evaluar el efecto de blinatumomab en la tasa de mortalidad a 100 días asociada con el TCMH alogénico
    -Evaluar la seguridad y la tolerabilidad de blinatumomab
    -Evaluar el efecto de blinatumomab en la duración de la ausencia de EMR
    -Evaluar el efecto de blinatumomab en la cinética de la EMR
    -Evaluar la calidad de vida del paciente durante el tratamiento y después del mismo
    -Evaluar la utilización de recursos
    Objetivos exploratorios
    -Evaluar los posibles predictores biológicos de respuesta para el blinatumomab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Los pacientes con LLA de precursores B en remisión hematológica completa definida como menos del 5% de blastos en la médula ósea después de al menos tres bloques de quimioterapia intensa (por ejemplo, inducción GMALL I-II/consolidación I, inducción/intensificación/consolidación de tres bloques de Hiper CVAD)
    2. Presencia de enfermedad mínima residual en un nivel de &#8805;10-3 (fallo molecular o recaída molecular) en un ensayo con una sensibilidad y un nivel más bajo de cuantificación de 10-4 documentado después de un intervalo de un mínimo de 2 semanas a partir de la última quimioterapia sistémica
    3. Para la evaluación de la enfermedad mínima residual, los pacientes deben tener al menos un marcador molecular basado en las reorganizaciones individuales de inmunoglobulina o genes de RCT o un perfil marcador de citometría de flujo, evaluado por un laboratorio de referencia nacional o local aprobado por el promotor
    9. Estado de rendimiento ECOG de 0 ó 1
    10. Edad >=18 años
    E.4Principal exclusion criteria
    1. Presencia de blastos circulantes o implicación extramedular en curso por parte de la LLA
    2. Historial de patología del SNC relevante o patología del SNC relevante en curso (por ejemplo, apoplejia, paresia, afasia, isquemia/hemorragia cerebrovascular, lesiones cerebrales graves, demencia, enfermedad de Parkinson, enfermedad cerebelosa, síndrome cerebral orgánico, psicosis, trastorno de coordinación o movimiento)
    3. Infiltración en curso de líquido cefalorraquídeo por parte de la LLA
    4. Enfermedad autoinmune relevante en historial o en curso
    5. TCMH alogénico previo
    6. Elegibilidad para el tratamiento con inhibidores de tirosina kinasa (ITK) (por ejemplo, pacientes que dan positivo en la prueba de cromosomas Filadelfia (Ph) sin fracaso de tratamiento documentado ni intolerancia/contraindicación para al menos 2 ITK)
    7. Quimioterapia sistémica contra el cáncer en el plazo de las 2 semanas anteriores al tratamiento del estudio (salvo para profilaxis intratecal)
    8. Radioterapia en el plazo de las 4 semanas anteriores al tratamiento del estudio
    9. Trasplante de células madre hematopoyéticas (TCMH) autólogo en el plazo de las seis semanas anteriores al tratamiento del estudio
    10. Tratamiento con anticuerpos monoclonales (rituximab, alemtuzumab) en el plazo de las 4 semanas anteriores al tratamiento del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Proporción de pacientes que logra una respuesta completa de la EMR definida por la ausencia de EMR después de un ciclo de tratamiento con blinatumomab
    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 Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 130
    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)
    expected normal treatment of that condition at the discretion of the treating physician
    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 Decision2010-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-07
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