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    Summary
    EudraCT Number:2016-002077-35
    Sponsor's Protocol Code Number:EC-HEM-HGUGM-2016-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-002077-35
    A.3Full title of the trial
    CLINICAL TRIAL PHASE I / II, SINGLE-CENTER, HISTORICAL CONTROL, TO EVALUATE THE EFFECTIVENESS OF DONOR IL-15-STIMULATED NK CELLS POST TRANSPLANT INFUSION, IN ACUTE LEUKEMIA PATIENTS WITH POOR PROGNOSIS AND HAPLOIDENTICAL UNMANIPULATED TRANSPLANT
    ENSAYO CLÍNICO FASE I/II, UNICÉNTRICO, CON CONTROL HISTÓRICO, PARA EVALUAR LA EFICACIA DE LA INFUSIÓN POST TRASPLANTE DE CÉLULAS NK DEL DONANTE ESTIMULADAS CON IL-15, EN PACIENTES CON LEUCEMIA AGUDA DE MAL PRONÓSTICO SOMETIDOS A TRASPLANTE HAPLOIDÉNTICO NO MANIPULADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECTIVENESS OF DONOR IL-15-STIMULATED NK CELLS POST TRANSPLANT INFUSION, IN ACUTE LEUKEMIA PATIENTS WITH POOR PROGNOSIS AND HAPLOIDENTICAL UNMANIPULATED TRANSPLANT
    EFICACIA DE LA INFUSIÓN POST TRASPLANTE DE CÉLULAS NK DEL DONANTE ESTIMULADAS CON IL-15, EN PACIENTES CON LEUCEMIA AGUDA DE MAL PRONÓSTICO SOMETIDOS A TRASPLANTE HAPLOIDÉNTICO NO MANIPULADO
    A.4.1Sponsor's protocol code numberEC-HEM-HGUGM-2016-01
    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 SponsorJosé Luís Díez Martín
    B.1.3.4CountrySpain
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJosé Luís Diéz Martín
    B.5.2Functional name of contact pointJosé Luís Diéz Martín
    B.5.3 Address:
    B.5.3.1Street AddressDr Esquerdo
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28007
    B.5.3.4CountrySpain
    B.5.4Telephone number0034915838443
    B.5.5Fax number0034915838394
    B.5.6E-mailjdiezm@salud.madrid.org
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCélulas NK , diferenciadas, alogénicas, de sangre periférica, estimuladas con IL-15
    D.3.4Pharmaceutical form 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 INNCélulas NK , diferenciadas, alogénicas, de sangre periférica estimuladas con IL-15
    D.3.9.2Current sponsor codeCélulas NK , diferenciadas, alogénicas, de sangre periférica estimuladas con IL-15
    D.3.9.3Other descriptive nameCélulas NK , diferenciadas, alogénicas, de sangre periférica estimuladas con IL-15
    D.3.10 Strength
    D.3.10.1Concentration unit U/g unit(s)/gram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number500 to 100000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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 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.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
    High risk acute myeloid leukemia
    Leucemia aguda mieloide de alto riesgo
    E.1.1.1Medical condition in easily understood language
    High risk acute myeloid leukemia
    Leucemia aguda mieloide de alto riesgo
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate safety and efectiveness of the NK cells exvivo incubated with IL-15 infusion in patients with high risk acute myeloid leukemia undergoing allogeneic transplant of an haploidentical donor with post-transplant cyclophosphamide administration.
    Evaluar la seguridad y eficacia de la infusión de células NK (CD56+, CD3-) incubadas exvivo con IL-15 en pacientes con leucemia aguda mieloide de alto riesgo sometidos a trasplante alogénico de donante haploidéntico con administración de ciclofosfamida post-trasplante.
    E.2.2Secondary objectives of the trial
    1. To establish the procedure safety.
    2. To evaluate the inmunological reconstitution of the NK population, particularly the phenotype, genotype and functionality of the donor NK cells.
    3. To compare the clinical evolution (overall survival, event-free survival) of the patients who receive NK IL-15 from the haploidentical donor with a historical control group of patients who have been undergone this kind of transplant in our site.
    4. To evaluate the chimerism in lineage of NK cells to know exactly their kinetics.
    5. To evaluate the dose-response in patients who receive NK IL-15.
    6. To evaluate the inmunological reconstitution of the different lymphocyte population in patients who receive NK IL-15 infusion.
    7. To evaluate the citotoxicity in Vitro of this cells facing a cell line (K562) or patient blasts if it were available.
    1. Determinar la seguridad del procedimiento.
    2. Evaluar la reconstitución inmunológica de las poblaciones NK, específicamente el fenotipo, genotipo y funcionalidad de las células NK del donante infundidas al paciente.
    3. Comparar la evolución clínica (supervivencia global, supervivencia libre de evento) de los pacientes que reciben NK IL-15 de su donante haploidéntico con un grupo control histórico de nuestro centro de pacientes con leucemia aguda mieloide de alto riesgo que hayan sido sometidos a esta modalidad de trasplante.
    4. Evaluar el quimerismo en linaje de células NK para conocer con exactitud la cinética de las mismas.
    5. Evaluar dosis-respuesta en los pacientes que reciben NK IL-15.
    6. Evaluar la reconstitución inmune de las diferentes poblaciones linfocitarias en los pacientes que reciben infusión de NK IL-15.
    7. Evaluar la citotoxicidad in Vitro de dichas células enfrentadas a línea celular (K562) ó a blastos del enfermo si estuvieran disponibles.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. More than 18 years old, with acute myeloid leukemia who goes to undergo haploidentical
    2. Assesable disease by analitic, molecular or image techniques.
    3.Comorbility Sorror Index less than 6.
    4.Give informed consent according to the legal requirements.
    5. Dispose of a donor without exclusion criteria.
    1. Paciente mayores de 18 años de edad, con diagnóstico de leucemia aguda mieloide que vayan a ser sometidos a trasplante haploidéntico no manipulado con PtCy.
    2. Presencia de enfermedad medible por técnicas analíticas, moleculares o de imagen.
    3. Índice de comorbilidad de Sorror menor de 6.
    4. Otorgar consentimiento informado de acuerdo con la normativa legal vigente.
    5. Disponer de un donante sin criterios de exclusión.
    E.4Principal exclusion criteria
    1. Possitive HIV serology.
    2. Patients with an active infection or other underlying serious medical statement.
    3. Any medical process, analytical abnormality or important psychiatric disorder, according to the investigator's opinion, that prevent the participation of the patient in the study.
    4. Participation of any other interventional clíncal trial within 30 days of planned
    enrollment into this study.
    5.Women who are pregnant or breastfeeding
    1. Serología HIV positiva.
    2. Pacientes con proceso infeccioso activo u otro estado médico subyacente grave.
    3. Cualquier proceso médico, anomalía analítica o enfermedad psiquiátrica importante,que a juicio del investigador, impida al sujeto participar en el estudio.
    4.Pacientes que hayan participado en otros estudios de intervención en el último mes.
    5.Mujeres gestantes o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    The main objective is to study the safety and efficacy of NK cells incubated infusion (CD56 +, CD3) ex vivo with IL-15 in patients with acute myeloid leukemia undergoing high-risk allogeneic haploidentical Pt-C donor
    El objetivo principal es estudiar la seguridad y eficacia de la infusión de células NK (CD56+, CD3-) incubadas exvivo con IL-15 en pacientes con leucemia aguda mieloide de alto riesgo sometidos a trasplante alogénico de donante haploidéntico con Pt-Cy
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety: all visits on the occurrence of possible adverse effects. events of relapse, death or EICR also recorded.
    Effectiveness: to evaluate the evolution of the underlying disease, following the usual protocol for the Department:
    SP chimerism in every 15 days of infusion of TPH, to complete chimerism
    SP molecular monitoring in those patients to be performed.
    Reassessment of disease with bone marrow study, cytological, residual disease by flow cytometry, and molecular genetic month, at 3 months (+100) and a year.
    Seguridad: en todas las visitas sobre la aparición de posibles efectos adversos. También se registraran los eventos de recaída, muerte o EICR.
    Eficacia: evaluar la evolución de su enfermedad de base, siguiendo el protocolo habitual del servicio:
    Quimerismo en SP cada 15 días desde la infusión del TPH, hasta quimerismo completo
    Seguimiento molecular en SP en aquellos pacientes en los que deba realizarse.
    Reevaluación de enfermedad con estudio de médula ósea, citológico, enfermedad residual por citometría de flujo, genético y molecular al mes, a los 3 meses (+100) y al año.
    E.5.2Secondary end point(s)
    •To compare the clinical outcome (overall survival, event-free survival) of patients receiving NK IL15 from his haploidentical donor, with a historical control group of our hospital patients with acute myeloid leukemia at high risk who have undergone this type of transplant.
    •Evaluate chimerism in NK cell lineage to know exactly kinetics of them.
    •Evaluate dose response in patients receiving IL NK 15.
    •Assess immune reconstitution of different lymphocyte populations in patients receiving infusion of NK IL15.
    •To evaluate the in vitro cytotoxicity of these cells facing a cell line (K562) or to blasts the patient if available.
    •Determinar la seguridad del procedimiento

    •Evaluar la reconstitución inmunológica de las poblaciones NK, específicamente el fenotipo, genotipo y funcionalidad de las células NK del donante infundidas al paciente.

    •Comparar la evolución clínica (supervivencia global, supervivencia libre de evento) de los pacientes que reciben NK IL15 de su donante haploidéntico, con un grupo control histórico de nuestro centro de pacientes con leucemia aguda mieloide de alto riesgo que hayan sido sometidos a esta modalidad de trasplante.
    •Evaluar el quimerismo en linaje de células NK para conocer con exactitud la cinética de las mismas.
    •Evaluar dosis-respuesta en los pacientes que reciben NK IL15.
    •Evaluar la reconstitución inmune de las diferentes poblaciones linfocitarias en los pacientes que reciben infusión de NK IL15.
    •Evaluar la citotoxicidad in Vitro de dichas células enfrentadas a línea celular (K562) ó a blastos del enfermo si estuvieran disponibles.

    .
    E.5.2.1Timepoint(s) of evaluation of this end point
    Security: all visits on the occurrence of possible adverse effects. events of relapse, death or EICR also recorded.
    Effectiveness: to evaluate the evolution of the underlying disease, following the usual protocol for the Department:
    SP chimerism in every 15 days of infusion of TPH, to complete chimerism
    SP molecular monitoring in those patients to be performed.
    Reassessment of disease with bone marrow study, cytological, residual disease by flow cytometry, and molecular genetic month, at 3 months (+100) and a year.
    Seguridad: en todas las visitas sobre la aparición de posibles efectos adversos. También se registraran los eventos de recaída, muerte o EICR.
    Eficacia: evaluar la evolución de su enfermedad de base, siguiendo el protocolo habitual del servicio:
    Quimerismo en SP cada 15 días desde la infusión del TPH, hasta quimerismo completo
    Seguimiento molecular en SP en aquellos pacientes en los que deba realizarse.
    Reevaluación de enfermedad con estudio de médula ósea, citológico, enfermedad residual por citometría de flujo, genético y molecular al mes, a los 3 meses (+100) y al año.
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    PHASE I/II
    FASEI/II
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    El ensayo clínico se considerará finalizado cuando se realice la última visita del último paciente incluido.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months48
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state20
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 20
    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)
    None
    Ninguno
    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 Decision2017-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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