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    Summary
    EudraCT Number:2019-002311-26
    Sponsor's Protocol Code Number:INMUNOCELL
    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:2020-01-14
    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 number2019-002311-26
    A.3Full title of the trial
    PROPHYLAXIS OF CYTOMEGALOVIRUS INFECTION IN haploidentical PROGENITORS HEMATOPOIETIC TRANSPLANTATIONWITH ADOPTIVE CELL IMMUNOTHERAPY.
    PROFILAXIS DE LA INFECCIÓN POR CITOMEGALOVIRUS EN EL TRASPLANTE HAPLOIDÉNTICO DE PROGENITORES HEMATOPOYÉTICOS CON INMUNOTERAPIA CELULAR ADOPTIVA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CELL THERAPY FOR BONE MARROW TRANSPLANT PATIENTS
    TERAPIA CELULAR PARA PACIENTES CON TRASPLANTES DE MEDULA OSEA
    A.3.2Name or abbreviated title of the trial where available
    INMUNOCELL
    INMUNOCELL
    A.4.1Sponsor's protocol code numberINMUNOCELL
    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 SponsorIDIVAL
    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 supportIDIVAL
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIDIVAL
    B.5.2Functional name of contact pointLucía Lavín/María del Mar García
    B.5.3 Address:
    B.5.3.1Street AddressAvda.Valdecilla s/n
    B.5.3.2Town/ citySantander
    B.5.3.3Post code39008
    B.5.3.4CountrySpain
    B.5.4Telephone number+34942203373
    B.5.6E-maileclinicos5@idival.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 nameCytolityc T Lymphocytes
    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 INNCYTOMEGALOVIRUS-SPECIFIC T-CELLS
    D.3.9.2Current sponsor codeDonor-specific anti-CMV CTLs
    D.3.9.3Other descriptive nameCYTOMEGALOVIRUS-SPECIFIC T-CELLS
    D.3.9.4EV Substance CodeSUB194710
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100000
    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) Yes
    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 Yes
    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 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
    Primary prophylaxis of CMV infection in haploidentical transplantation of hematopoietic progenitors.
    Profilaxis primaria de la infección por CMV en el trasplante haploidéntico de progenitores hematopoyéticos.
    E.1.1.1Medical condition in easily understood language
    Prevention for CMV Infection in Bone Marrow Transplant Patients
    Prevención de la infeccion por CMV en pacientes con transplante de médula ósea
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10025309
    E.1.2Term Haematological and lymphoid tissue therapeutic procedures
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063581
    E.1.2Term Stem cell transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10067859
    E.1.2Term Allogenic stem cell transplantation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10011827
    E.1.2Term Cytomegaloviral infections
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025263
    E.1.2Term Lymphocytes
    E.1.2System Organ Class 100000004848
    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 the efficacy of antiviral prophylaxis with specific CTLs against CMV in reducing the incidence of CMV infection at 100 days post-transplant HAPLO, according to historical controls of the haematology service of the Hospital Universitario Marqués de Valdecilla.
    Evaluar la eficacia de la profilaxis antiviral con CTLs específicas frente a CMV en la reducción de la incidencia de infección por CMV al día 100 postrasplante HAPLO, con respecto a controles históricos del servicio de hematología del Hospital Universitario Marqués de Valdecilla.
    E.2.2Secondary objectives of the trial
    1. To evaluate the need for treatment for CMV
    a. Need for anti-CMV treatment
    b. Time to next anti-CMV treatment
    c. Duration of anti-CMV treatment
    2. To Evaluate the incidence of CMV disease
    a.Incidence of CMV disease
    b. Direct mortality per CMV
    3. SECURITY
    a. To evaluate the appearance of immediate (<24h) or late infusional reactions.
    b. Incidence and severity of adverse events (AE) and serious adverse events (SAEs)
    4. EXPLORATION
    a.To evaluate the persistence of CMV-specific CTLs
    b.Evaluating post-HAPLO immune reconstitution
    1. Evaluar la necesidad de tratamiento para CMV
    a.Necesidad de tratamiento anti-CMV
    b.Tiempo hasta siguiente tratamiento anti-CMV
    c. Duración del tratamiento anti-CMV
    2. Evaluar la incidencia de la enfermedad por CMV
    a.Incidencia de enfermedad por CMV
    b.Mortalidad directa por CMV
    3. SEGURIDAD
    a. Evaluar la aparición de reacciones infusionales inmediatas (<24h) o tardías.
    b. Incidencia y gravedad de eventos adversos (EA) y eventos adversos graves (EAG)
    4. EXPLORATORIOS
    a. Evaluar la persistencia de CTLs CMV-específicas
    b. Evaluar la reconstitución inmune post-HAPLO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    PRE-inclusion criteria
    Patients must meet all of the criteria below to participate in the study:
    Adult patients (over 18 years of age), whether or not diagnosed with haematological malignancy, who have received an allogeneic haematopoietic progenitor transplant from haploidentical family donors (HAPLO).
    2. Any source of hematopoietic progenitors for transplantation.
    3. Patients whose original haploidenetic donor is seropositive CMV (IgG positive antibodies and IgM negative in CMV serology).
    4. Negative pregnancy test in women.
    5. Informed consent in writing signed by the patient or legal representative.
    DONORS:
    a. Donors will be selected if they meet haploidentical HLA criteria with the patient and are CMV seropositive (Ig G positive antibodies and Ig M negative in CMV serology).
    b. The donor will be screened to determine if it is SUITABLE according to the evaluation criteria of hematopoietic progenitor donors.
    c. The donor must sign the informed written consent prior to inclusion.
    d. The donor must NOT have evidence of active infection at the time of lymphocyte apheresis.

    CRITERIA OF INCLUSION/INFUSION (the inclusion is made prior to the day of infusion, which will take place on the 21st post-HAPLO day +-7 days)

    Recovery of the post-HAPLO hematopoietic implant at least partially:
    i. Partial recovery: Absolute count of neutrophils > 0.5x10^9 cells/L for at least 3 consecutive post-HAPLO determinations.
    ii. Complete recovery: In addition to neutrophil count, platelet count > 20 x 10^9/L independent of transfusions at least 7 days.
    Criterios PRE-inclusión
    Los pacientes deberán cumplir todos los criterios que se detallan a continuación para participar en el estudio:
    1. Pacientes adultos (mayores de 18 años), con diagnóstico o no de enfermedad hematológica maligna, que hayan recibido un trasplante alogénico de progenitores hematopoyéticos de donantes familiares haploidénticos (HAPLO).
    2. Cualquier fuente de progenitores hematopoyéticos para el trasplante.
    3. Pacientes cuyo donante haploidéntico original sea CMV seropositivo (anticuerpos IgG positivos e IgM negativos en la serología de CMV).
    4. Test de embarazo negativo en mujeres.
    5. Consentimiento informado por escrito firmado por el paciente o representante legal.
    DONANTES:
    a. Los donantes serán seleccionados si cumplen criterios de HLA haploidéntico con el paciente y son CMV seropositivos (anticuerpos Ig G positivos e Ig M negativos en la serología de CMV).
    b. Se realizará un cribado del donante para determinar si es APTO según los criterios de valoración de donantes de progenitores hematopoyéticos.
    c. El donante deberá firmar el consentimiento informado por escrito previo a la inclusión.
    d. El donante NO debe tener evidencia de infección activa en el momento de la aféresis de linfocitos.

    CRITERIOS DE INCLUSIÓN/INFUSIÓN (la inclusión se realiza previa al día de infusión, que se realizará en el día 21 post-HAPLO +-7días)
    Recuperación del implante hematopoyético post-HAPLO al menos parcial:
    i. Recuperación parcial: Recuento absoluto de neutrófilos > 0.5x10^9 células/L durante al menos 3 determinaciones consecutivas post-HAPLO.
    ii. Recuperación completa: Además del recuento de neutrófilos, recuento de plaquetas > 20 x 10^9/L independiente de transfusiones al menos 7 días.
    E.4Principal exclusion criteria
    Patients must NOT meet any of the criteria below to participate in the study:
    1. Patients who do not have a CMV-positive haploidenetic donor.
    2. Patients who are unable to perform the follow-up or visits described for the trial.
    Infusion will NOT be performed if the patient meets any of the following criteria:
    i. Patients in treatment, at the time of infusion with doses of corticosteroids greater than 0.5mg/kg/day of prednisone or equivalent.
    ii. ECOG > or = 3.
    iii. Organic toxicity higher than grade 3 according to CTCAE Version 5.0.
    iv. Patients who have received anti-thymocyte globulin (ATG), donor lymphocyte infusion (ILD) or alemtuzumab within 28 days prior to infusion.
    v. Patients with uncontrolled infection defined by fever and/or hemodynamic instability and/or unresolved infectious focus.
    vi. Fever persistent in the 3 days prior to infusion.
    vii. Patients with acute graft-versus-receptor disease (GVHD), grade II-IV.
    viii. Active and uncontrolled relapse or progression of malignant disease.
    ix. A viral reactivation of CMV prior to the day of infusion (21 post-HAPLO) requiring anti-viral treatment (more than 200 copies of CMV per PCR).

    Patients who do not meet the infusion criteria after the 28th post-HAPLO day will be removed from the trial.
    Los pacientes NO deberán cumplir ninguno de los criterios que se detallan a continuación para participar en el estudio:
    1. Pacientes que no dispongan de donante haploidéntico con serología positiva para CMV.
    2. Pacientes que no puedan realizar el seguimiento o las visitas descritas para el ensayo.
    La infusión NO se realizará si el paciente cumple alguno de los siguientes criterios:
    i. Pacientes en tratamiento, al momento de la infusión con dosis de corticoides mayores a 0.5mg/kg/día de prednisona o equivalentes.
    ii. ECOG > o = 3.
    iii. Toxicidad orgánica superior a grado 3 según CTCAE Versión 5.0.
    iv. Pacientes que hayan recibido globulina anti-timocítica (ATG), infusión de linfocitos de donante (ILD) o alemtuzumab, en los 28 días previos a la infusión.
    v. Pacientes con infección no controlada definida por fiebre y/o inestabilidad hemodinámica y/o foco infeccioso no resuelto.
    vi. Fiebre persistente en los 3 días previos a la infusión
    vii. Pacientes con enfermedad injerto contra receptor (EICR) aguda, grado II-IV.
    viii. Recaída o progresión activa y no controlada de la enfermedad maligna.
    ix. Que se produzca una reactivación viral de CMV previo al día de infusión (21 post-HAPLO) que requiera tratamiento anti-viral (más de 200 copias de CMV por PCR).

    Los pacientes que no cumplan los criterios de infusión, pasados el día 28 post-HAPLO serán retirados del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy evaluations
    The primary endpoint (primary objective measure) of efficacy is the incidence of CMV infection AT DAY 100 POST-HAPLO (measured as viral load >200 copies in 1 determination (PCRq)).
    Evaluaciones de eficacia
    La variable principal (medición objetivo principal) de eficacia es la incidencia de infección por CMV AL DÍA 100 POST-HAPLO (medida como carga viral >200 copias en 1 determinación (PCRq))
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoint is 12 months for the recruitment and 12 months for Follow up
    12 meses de reclutamiento y 12 meses de seguimiento
    E.5.2Secondary end point(s)
    Secondary variables of efficacy are:
    1. Assessing the need for treatment for CMV
    a. Need for anti-CMV treatment: If viral load>200 copies in 2 determinations or more than 1000 copies in 1 determination, treatment with valganciclovir will be initiated.
    b. Time to next anti-CMV treatment from the day of transplant.
    c. Duration of anti-CMV treatment (days).
    2. Assess the incidence of CMV disease
    a. Incidence of CMV disease: criteria for CMV disease (P.Ljungman et al, Lancet Infect Dis 2019).
    b. Direct CMV mortality: primary cause of CMV death.
    Las variables secundarias de eficacia son:
    1. Evaluar la necesidad de tratamiento para CMV
    a. Necesidad de tratamiento anti-CMV: Si carga viral>200 copias en 2 determinaciones o mayor de 1000 copias en 1 determinación se iniciará tratamiento con valganciclovir.
    b. Tiempo hasta siguiente tratamiento anti-CMV desde el día del trasplante.
    c. Duración del tratamiento anti-CMV (días).
    2. Evaluar la incidencia de la enfermedad por CMV
    a. Incidencia de enfermedad por CMV: criterios de enfermedad por CMV (P.Ljungman et al, Lancet Infect Dis 2019).
    b. Mortalidad directa por CMV: causa primaria de muerte el CMV.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety evaluations (variables and parameters)
    To assess the occurrence of immediate (<24h) or delayed infusional reactions using the infusion adverse reaction questionnaire.
    Evaluaciones (variables y parámetros) de seguridad
    Evaluar la aparición de reacciones infusionales inmediatas (<24h) o tardías, mediante el cuestionario para reacciones adversas de la infusión
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    unirama
    single-arm trials
    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 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 last visit will be 12 months after HAPLO transplant
    La visita final será 12 MESES despúes el trasplante HAPLO
    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 months
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    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)
    According to rotiune clinical practice.
    De acuerdo a la práctica clínica habitual
    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 Decision2021-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-09
    P. End of Trial
    P.End of Trial StatusOngoing
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