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    Summary
    EudraCT Number:2011-002257-61
    Sponsor's Protocol Code Number:MT103-211
    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:2011-10-03
    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 number2011-002257-61
    A.3Full title of the trial
    An open label, multicenter, phase II study to evaluate efficacy and safety of the BiTE antibody blinatumomab in adult patients with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL)
    Estudio abierto, multicéntrico, de fase II para evaluar la eficacia y seguridad del anticuerpo blinatumomab BiTE en pacientes adultos con leucemia linfoblástica aguda (ALL) de precursores de células B con recidiva / que no responde al tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical phase II study to evaluate the efficacy and safety of the bispecific antibody blinatumomab (MT103) in adult patients with acute lymphoblastic leukemia (ALL) that did not respond to previous therapy or that relapsed after initially successful previous therapy
    Estudio Clínico de Fase II para evaluar la eficacia y la seguridad del anticuerpo biespecifico blinatumomab (MT103) en pacientes adultos con leucemia aguda linfoblástica (LLA) que no respondieron a terapia previa o que recayeron despues del éxito de la terapia previa
    A.4.1Sponsor's protocol code numberMT103-211
    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 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 supportMicromet AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMicromet AG
    B.5.2Functional name of contact pointClinical Development Department
    B.5.3 Address:
    B.5.3.1Street AddressStaffelseestrasse 2
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81477
    B.5.3.4CountryGermany
    B.5.4Telephone number+49(0)898952770
    B.5.6E-mailclinicaltrials@micromet.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
    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 microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33
    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
    Adult patients with relapsed / refractory B-precursor ALL.
    Pacientes adultos con LLA de precursores B en recaída o que no responden al tratamiento.
    E.1.1.1Medical condition in easily understood language
    Acute lymphoblastic leukemia--a cancer of the blood and marrow.
    Leucemia linfoblástica aguda-- cáncer de sangre y médula
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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.
    Evaluar la eficacia de blinatumomab en pacientes con ALL de precursores de células B con recidiva / que no responde al tratamiento
    E.2.2Secondary objectives of the trial
    - To evaluate safety of blinatumomab in patients with relapsed/refractory B-precursor ALL
    - To evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of blinatumomab
    - Evaluar la seguridad de blinatumomab en pacientes con ALL de precursores de células B con recidiva / que no responde al tratamiento
    - Evaluar PK y PD de blinatumomab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with Ph-negative B-precursor ALL, with any of the following:
    - relapsed or refractory with first remission duration less than or equal to 12 months in first salvage or
    - relapsed or refractory after first salvage therapy or
    - relapsed or refractory within 12 months of allogeneic HSCT or
    - if age 60 years or older: relapsed or refractory disease in first or later salvage independent of first remission duration
    2. 10% or more blasts in bone marrow
    3. In case of clinical signs of additional extramedullary disease: measurable disease (at least one lesion major or equal to 1.5 cm)
    4. Eastern Cooperative Oncology Group (ECOG) performance status minor or equal to 2
    5. Age major or equal to 18 years
    6. Ability to understand and willingness to sign a written informed consent
    7. Signed and dated written informed consent is available
    1. Pacientes con ALL de precursores de células B negativa para Ph, con cualquiera de lo siguiente:
    ­ recidiva o no responde al tratamiento con una duración de primera remisión inferior o igual a 12 meses en el primer rescate o
    ­ recidiva o no responde al tratamiento tras la primera terapia de rescate o
    ­ recidiva o no responde al tratamiento en el plazo de 12 meses tras el HSCT alogénico o
    ­ si tiene 60 años de edad o mayor: enfermedad con recidiva o que no responde al tratamiento en el primer rescate o posterior independientemente de la duración de la primera remisión
    2. 10% o más blastocitos en médula ósea
    3. En caso de signos clínicos de enfermedad extramedular adicional: enfermedad medible (al menos una lesión mayor o igual a 1,5 cm)
    4. Estado general de ECOG menor o igual a 2
    5. Edad mayor o igual a 18 años
    6. Capacidad para entender y deseo de firmar un consentimiento informado por escrito
    7. Consentimiento informado por escrito firmado y fechado esté disponible
    E.4Principal exclusion criteria
    1. Patients with Ph-positive ALL
    2. History or presence of clinically relevant CNS pathology as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson disease, cerebellar disease, organic brain syndrome, psychosis
    3. Active ALL in the CNS or testes
    4. Current autoimmune disease or history of autoimmune disease with potential CNS involvement
    5. Autologous HSCT within six weeks prior to start of blinatumomab treatment
    6. Allogeneic HSCT within three months prior to start of blinatumomab treatment
    7. Any active acute Graft-versus-Host Disease (GvHD), or active chronic GvHD Grade 2 to 4
    8. Immunosuppressive therapy against GvHD within two weeks prior to start of blinatumomab treatment
    9. Cancer chemotherapy within two weeks prior to start of blinatumomab treatment (intrathecal prophylaxis and pre-phase with dexamethasone are allowed until start of blinatumomab treatment)
    10. Radiotherapy within four weeks prior to start of blinatumomab treatment
    11. Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treatment
    12. Any investigational anti-leukemic product within four weeks prior to start of blinatumomab treatment
    13. Treatment with any other investigational medicinal product (IMP) after signature of informed consent
    14. Known hypersensitivity to immunoglobulins or to any other component of the IMP formulation
    15. Abnormal laboratory values as defined below:
    a. AST (SGOT) and/or ALT (SGPT) and/or AP major or equal to 5 x upper limit of normal (ULN)
    b. Total bilirubin major or equal to 1.5 x ULN (unless related to Gilbert´s or Meulengracht disease)
    c. Creatinine major or equal to 1.5 ULN or Creatinine clearance < 50 ml/min (calculated)
    d. Hemoglobin (Hb) minor or equal to 9 g/dl (transfusion allowed)
    16. Active malignancy requiring treatment other than ALL within two 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
    17. Active uncontrolled infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
    18. 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 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
    21. Previous treatment with blinatumomab
    1. Pacientes con ALL positiva para Ph
    2. Historia o presencia de patología de SNC clínicamente relevante tal como epilepsia, convulsión, paresia, afasia, accidente cerebrovascular, lesiones cerebrales graves, demencia, enfermedad de Parkinson, enfermedad cerebelar, síndrome orgánico cerebral, psicosis
    3. ALL activa en el SNC o los testículos
    4. Enfermedad autoinmune actual o historia de enfermedad autoinmune con posible implicación del SNC
    5. HSCT autólogo en el plazo de seis semanas antes de iniciar el tratamiento con blinatumomab
    6. HSCT alogénico en el plazo de tres meses antes de iniciar el tratamiento con blinatumomab
    7. Cualquier EICH aguda activa, o EICH crónica activa de grado 2 a 4
    8. Terapia inmunosupresora frente a EICH en el plazo de dos semanas antes de iniciar el tratamiento con blinatumomab
    9. Quimioterapia para el cáncer en el plazo de dos semanas antes de iniciar el tratamiento con blinatumomab (se permiten profilaxis intratecal y fase previa con dexametasona hasta el inicio del tratamiento con blinatumomab)
    10. Radioterapia en el plazo de cuatro semanas antes de iniciar el tratamiento con blinatumomab
    11. Inmunoterapia (por ejemplo, rituximab) en el plazo de cuatro semanas antes de iniciar el tratamiento con blinatumomab
    12. Cualquier producto antileucémico en investigación en el plazo de cuatro semanas antes de iniciar el tratamiento con blinatumomab
    13. Tratamiento con cualquier otro IMP tras la firma de consentimiento informado
    14. Hipersensibilidad conocida a inmunoglobulinas o a cualquier otro componente de la formulación de IMP
    15. Valores de laboratorio anómalos definidos a continuación:
    a. AST (SGOT) y/o ALT (SGPT)
    y/o AP mayor o igual a 5 x ULN
    b. Bilirrubina total mayor o igual a 1,5 x ULN (a menos que esté relacionado con enfermedad de Gilbert o de Meulengracht)
    c. Creatinina mayor o igual a 1,5 ULN o
    Aclaramiento de creatinina < 50 ml/min (calculado)
    d. Hb menor o igual a 9 g/dl (transfusión permitida)
    16. Cáncer maligno activo que requiere tratamiento distinto de ALL en el plazo de dos años antes de iniciar el tratamiento con blinatumomab con la excepción de carcinoma de piel de células basales o células escamosas, o carcinoma in situ de cuello uterino
    17. Infección activa no controlada, cualquier otra enfermedad concomitante o estado médico que se considere que interfiere con la realización del estudio según criterio del investigador
    18. Infección con VIH o infección crónica con virus de la hepatitis B (positivo para HBsAg) o virus de la hepatitis C virus (positivo para anti-VHC)
    19. Mujer embarazada o en periodo de lactancia
    20. Mujeres con capacidad de procrear que no estén dispuestas a usar un medio anticonceptivo eficaz durante su participación en el estudio y al menos tres meses después de ello. Pacientes varones que no estén dispuestos a garantizar que no tendrán un hijo durante su participación en el estudio y al menos tres meses después de ello
    21. Tratamiento previo con blinatumomab
    E.5 End points
    E.5.1Primary end point(s)
    CR (Complete response/remission) + CRh* (Complete response/remission with partial recovery of peripheral blood counts) rate within two cycles of treatment with blinatumomab.
    Tasa de RC (remisión/respuesta completa) + RCh* (Respuesta/remisión completa con recuperación parcial de los valores de sangre periférica) en el plazo de dos ciclos de tratamiento con blinatumomab
    E.5.1.1Timepoint(s) of evaluation of this end point
    At screening and at the end of each treatment cycle a bone marrow aspiration/biopsy will be performed to evaluate the efficacy of blinatumomab.
    Following the last treatment cycle, there will be efficacy follow-up visits at three, six, nine, 12, 18 and 24 months after treatment start for patients who did not undergo allogeneic HSCT
    Durante el screening y al final de cada ciclo de tratamiento se realizarán aspirados/bioposias de médula ósea para evaluar la eficacia de blinatumomab. Después del último ciclo, habrá un periodo de seguimiento de la eficacia con visitas en el tercer, sexo, noveno mes, así como en el mes 12, 18 y 24 después del inicio del tratamineto para los pacientes que no se sometieron a un trasplante alogénico de medula ósea.
    E.5.2Secondary end point(s)
    1. Duration of CR and CRh*
    2. Proportion of patients eligible for allogeneic HSCT who undergo the procedure after treatment with blinatumomab
    3. CR rate within two cycles of treatment with blinatumomab
    4. CRh* rate within two cycles of treatment with blinatumomab
    5. PR rate within two cycles of treatment with blinatumomab
    6. Relapse-free survival
    7. Overall survival
    8. Overall incidence and severity of AEs
    9. 100-day mortality after allogeneic HSCT
    10. Pharmacokinetic parameters: steady state concentration of blinatumomab
    11. Serum cytokine concentrations

    Exploratory endpoints
    1. Rate of MRD response within two cycles of treatment with blinatumomab
    2. Rate of MRD complete response within two cycles of treatment with blinatumomab
    3. Quantification and characterization of peripheral blood lymphocyte subsets
    1.Duración de RC y RCh*
    2.Proporción de pacientes elegibles para HSCT alogénico que se someten al procedimiento tras el tratamiento con blinatumomab
    3.Tasa de RC en el plazo de dos ciclos de tratamiento con blinatumomab
    4.Tasa de RCh* en el plazo de dos ciclos de tratamiento con blinatumomab
    5.Tasa de RP en el plazo de dos ciclos de tratamiento con blinatumomab
    6.Supervivencia libre de recidiva
    7.Supervivencia global
    8.Incidencia global y gravedad de los AAs
    9.Mortalidad a los 100 días tras HSCT alogénico
    10.Parámetros farmacocinéticos: concentración de blinatumomab en estado estacionario
    11. Concentraciones de citocina en suero

    Criterios de valoración exploratorios
    1.Tasa de respuesta de MRD en el plazo de dos ciclos de tratamiento con blinatumomab
    2.Tasa de respuesta completa de MRD en el plazo de dos ciclos de tratamiento con blinatumomab
    3.Cuantificación y caracterización de subconjuntos de linfocitos en sangre periférica
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Assessment at the end of each treatment cycle (and optionally at day 15 of the first cycle) and during efficacy follow up (until 24 months after treatment start at most)
    2. Until patient´s last follow up (until 3 years after treatment start at most)
    3.-5. At the end of the first and second treatment cycle and optionally at day 15 of the first cycle
    6.-8. Throughout entire study, until three years after treatment start at most
    9. 100 days after HSCT, if applicable
    10.-11. At baseline and during the first two treatment cycles

    Exploratory endpoints
    1.-2. At the end of each treatment cycle (and optionally at day 15 of the first cycle)
    3. At baseline, during the first two treatment cycles, and during efficacy follow-up (2 years after treatment start at most)
    1. Evaluación al final de cada ciclo de tratamiento (y opcionalmente en el día 15 del primer ciclo) y durante el seguimiento de la eficacia ( hasta 24 meses como máximo después del inicio del tratamiento)
    2. Hasta el último seguimiento del paciente (hasta 3 años después del inicio del tratamiento como mucho)
    3.-5. Al final del primer y el Segundo ciclo de tratamiento y opcionalmente en el día 15 del primer ciclo.
    6.-8. A lo largo de todo el estudio, hasta 3 años después del inicio del tratamiento como mucho
    9. 100 días después del trasplante alogénico HSCT, si aplica
    10.-11. Al inicio del estudio y durante los dos primeros ciclos de tratamiento
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    Spain
    Switzerland
    United Kingdom
    United States
    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 end of trial is defined as the time point of the last visit (including phone/mail follow-up with the patient´s physician in the follow-up period) of the last patient in the study.
    El final del ensayo se define como el momento de la última visita (incluyendo seguimiento por teléfono/correo con el médico del paciente en el periodo de seguimiento) del último paciente en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 61
    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)
    No specific treatment is planned after trial participation.
    No están planeados tratamientos específicos después de la participación en el ensayo
    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 Decision2011-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-03
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