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    Summary
    EudraCT Number:2012-000054-63
    Sponsor's Protocol Code Number:HNJ-NKAES-2012
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-01-27
    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 number2012-000054-63
    A.3Full title of the trial
    Salvage therapy with chemotherapy and Natural Killer cells in relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.
    INFUSIÓN DE CÉLULAS NATURAL KILLER EN COMBINACIÓN CON QUIMIOTERAPIA EN PACIENTES PEDIÁTRICOS CON LEUCEMIA/LINFOMA T REFRACTARIA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Salvage therapy with chemotherapy and Natural Killer cells in relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.
    INFUSIÓN DE CÉLULAS NATURAL KILLER EN COMBINACIÓN CON QUIMIOTERAPIA EN PACIENTES PEDIÁTRICOS CON LEUCEMIA/LINFOMA T REFRACTARIA.
    A.3.2Name or abbreviated title of the trial where available
    NK cells in leukemia / lymphoma
    Células NK en leucemia / linfoma
    A.4.1Sponsor's protocol code numberHNJ-NKAES-2012
    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 SponsorFUNDACION INVESTIGACION BIOMEDICA HOSPITAL NINO JESUS
    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 supportMINISTERIO DE SANIDAD
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL UNIVERSITARIO NINO JESUS
    B.5.2Functional name of contact pointSERVICIO ONCOHEMATOLOGIA
    B.5.3 Address:
    B.5.3.1Street AddressMenendez Pelayo 65
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28009
    B.5.3.4CountrySpain
    B.5.4Telephone number34915035900
    B.5.5Fax number34915744669
    B.5.6E-mailaperezm.hnjs@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 nameNK cells
    D.3.4Pharmaceutical form Injection
    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 INNNK cells
    D.3.9.3Other descriptive nameNatural killer cells
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number50000000
    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) 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) No
    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 Yes
    D.3.11.13.1Other medicinal product typeNK cells from haploidentical donor
    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
    Relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.
    LEUCEMIA/LINFOMA T REFRACTARIA en ninos
    E.1.1.1Medical condition in easily understood language
    Relapsed/refractory paediatric T cell lymphoblastic leukaemia and lymphoma.
    LEUCEMIA/LINFOMA T REFRACTARIA en ninos
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    The objective of this clinical trial is to assess the toxicity of activated and expanded NK cell immunotherapy after salvage chemotherapy in patients with relapsed or refractary acute lymphoblast leukemia/lymphoblast lymphoma (LLT).
    El objetivo de este estudio es determinar la seguridad de la inmunoterapia con células Natural Killer expandidas y activadas (NKAESs) tras quimioterapia de rescate en pacientes con leucemia aguda linfoblástica/linfoma linfoblástico (LLT) en recaída o refractariedad
    E.2.2Secondary objectives of the trial
    . Analyze incidence of episodes of febrile neutropenia, bacteremia, infections (viral and fungal), days of isolation, hematological recovery and days of hospitalization.
    . Assess rate of complete remission (cytomorphological and by criteria of "minimal residual disease")
    . Assess immune reconstitution of lymphocytes and cytotoxic activity of NK cells pre and post NKAES infusion
    Analizar la incidencia de episodios de neutropenia febril, bacteriemias, infecciones (víricas, fúngicas), días de aislamiento, recuperación hematológica e ingreso hospitalario.
    Evaluar la tasa de remisión completa (citomorfológica y por criterios de ?enfermedad mínima residual?)
    Evaluar la reconstitución inmune de poblaciones linfocitarias y la actividad citotóxica de las células NK pre y post infusión de NKAES.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients betweem 0 and 21 years of age with diagnosis of acute lymphoblastic T leukemia or lymphoma, relapsed or refractary.
    2. Lansky index > 60%
    3. Left ventricular ejection fraction > 39%
    4. Negative HIV serology
    1. Pacientes de edad comprendida entre 0 y 21 años diagnosticados de leucemia aguda linfoblástica de estirpe T o linfoma linfoblástico T en cualquier recaída o en situación de refractariedad terapéutica.
    2. Índice de Lansky > 60%.
    3. Fracción de eyección del ventriculo izquierdo >39%.
    4. Serología HIV negativa
    E.4Principal exclusion criteria
    1. Patients with history of bad therapeutical compliance
    2. Patients not valid after psycho-social evaluation
    3. Severe (4) functional organ disorders (hepatic, renal, respiratory) according to NCI CTCAE v4 criteria
    4. Should be considered the contraindications, drug interactions, precautions for use and dose reductions indicated in the corresponding Summary of Product Characteristics (SmPC) (read the SmPC)
    1. Pacientes con antecedentes de mal cumplimiento terapéutico.
    2. Pacientes que tras una evaluación psico-social se censuran como no aptos para el procedimiento.
    3. Alteración funcional de órganos (hepática, renal, respiratoria) grave (4) según los criterios del National Cancer Institute (NCI CTCAE v4).
    4. Se deben considerar las contraindicaciones, interacciones, precauciones de uso y reducciones de dosis indicadas en las fichas técnicas correspondientes (léase ficha técnica medicamentos).
    E.5 End points
    E.5.1Primary end point(s)
    Safety of NK cells infusion after chemotherapy
    Seguridad de la infusión de NKAEs tras quimioterapia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 months after end infusion
    2 meses tras la infusión
    E.5.2Secondary end point(s)
    Incidence of episodes of febrile neutropenia, bacteriemia or viral or fungal infections
    Days of isolation, hematological recovery (neutrophils >500/?l, lymphocytes >250/ ?l and platelets >50.000/?l), days of hospitalization in each cycle
    Immune reconstitution
    In vitro NK cells cytotoxic activity
    Objective response rate according to cytomorphic and by "minimal residual disease" criteria (cytometry and/or real time PCR) at the end of the treatment
    Incidencia de episodios de neutropenia febril, bacteriemia o infecciones víricas o fúngicas.
    Días de aislamiento, recuperación hematológica (neutrófilos >500/?l, linfocitos >250/ ?l y plaquetas >50.000/?l, días de ingreso hospitalario, en cada ciclo.
    Reconstitucion inmune
    Actividad citotóxica in vitro de las células NK.
    Tasa de respuesta objetiva según los criterios citomorfológicos y por de ?enfermedad mínima residual? (citometría y/o PCR tiempo real) al final del tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of infusion and follow-up (2 months and 1 year)
    Final de la infusión y seguimiento (2 meses y 1 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 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 No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immune reconstitution
    Reconstitución inmune
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Quimioterapia vs quimioterapia con células NK expandidas y activadas
    Chemotherapy vs chemotherapy with expanded and activated NK cells
    E.8.2.4Number of treatment arms in the trial2
    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
    End of follow-up
    Final de seguimiento
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 6
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 1
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 2
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    F.1.3Elderly (>=65 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children under 12
    Niños menores de 12 años
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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 the disease
    Tratamiento normal esperado de esta enfermedad
    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 Decision2012-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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