Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   38185   clinical trials with a EudraCT protocol, of which   6272   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-002503-26
    Sponsor's Protocol Code Number:X16082
    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:2017-01-04
    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 number2016-002503-26
    A.3Full title of the trial
    Phase Ib/II trial to evaluate safety and efficacy of oral ixazomib in combination with sirolimus and tacrolimus in the prophylaxis of chronic graft-versus-host disease
    Ensayo de fase Ib/II para evaluar la eficacia y seguridad de ixazomib oral en combinación con sirolimus y tacrolimus como profilaxis de la enfermedad injerto contra huésped crónica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to evaluate the safety and efficacy of a new drug in combination with the standard therapy to prevent the rejection which could occur after a transplantation.
    Ensayo para evaluar la seguridad y eficacia de un fármaco en investigación en combinación con el tratamiento habitual para prevenir el rechazo que puede ocurrir tras un trasplante.
    A.4.1Sponsor's protocol code numberX16082
    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 SponsorFundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)
    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 supportOwn funding
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Investigación Clínica y ensayos Clínicos
    B.5.2Functional name of contact pointUICEC-HUVR
    B.5.3 Address:
    B.5.3.1Street AddressAVENIDA MANUEL SIUROT S/N
    B.5.3.2Town/ citySEVILLA
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034955013414
    B.5.5Fax number0034954232992
    B.5.6E-mailclaram.rosso.sspa@juntadeandalucia.es
    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 Yes
    D.2.1.1.1Trade name Ninlaro
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberNinlaro
    D.3 Description of the IMP
    D.3.1Product nameIxazomib
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIXAZOMIB
    D.3.9.1CAS number 1072833-77-2
    D.3.9.3Other descriptive nameIXAZOMIB
    D.3.9.4EV Substance CodeSUB121332
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3 to 4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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) 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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name RAPAMUNE
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameRAPAMUNE
    D.3.2Product code 724534
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSIROLIMUS
    D.3.9.1CAS number 53123-88-9
    D.3.9.3Other descriptive nameRAPAMICINE
    D.3.9.4EV Substance CodeSUB10537MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4 to 6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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) 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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name PROGRAF
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namePROGRAF
    D.3.2Product code 680678
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.9.4EV Substance CodeSUB10797MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.02 to 0.12
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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) 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
    Adult patiens after allogeneic stem cell transplantation
    Pacientes adultos tras traplante alogénico de médula osea
    E.1.1.1Medical condition in easily understood language
    Adult patients who receive bone marrow transplantation from a donor
    Pacientes adultos que reciben trasplante de médula ósea de un donante
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10018653
    E.1.2Term Graft-versus-host disease <GVHD>
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10067859
    E.1.2Term Allogenic stem cell transplantation
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I:
    To identify the optimal dose and to evaluate the safety profile of ixazomib in combination with sirolimus and tacrolimus in patients undergoing allogeneic stem cell transplantation.
    Phase II:
    To evaluate the efficacy of ixazomib in combination with sirolimus and tacrolimus to reduce the risk of moderate or severe chronic graft-versus-host disease (cGVHD) after 1 year postransplant.
    Fase I:
    Identificar la dosis óptima y evaluar el perfil de seguridad de ixazomib en combinación con sirolimus y tacrolimus en pacientes sometidos a trasplante alogénico de médula ósea.
    Fase II:
    Evaluar la eficacia de ixazomib en combinación con sirolimus y tacrolimus de reducir el riesgo de la enfermedad injerto contra huésped (EICH) crónica moderada o severa a un año postrasplante.
    E.2.2Secondary objectives of the trial
    Phase I:
    -To evaluate the efficacy of ixazomib in combination with sirolimus and tacrolimus in terms of incidence of moderate or severe chronic GVHD according to NIH scale after 9 months postransplant.
    -To evaluate the effect of ixazomib on immune response as compared to a control group of patients receiving sirolimus and tacrolimus.
    Phase II:
    -To evaluate the effect of ixazomib in combination with sirolimus and tacrolimus on the incidence of moderate or severe GVHD after 2 years postransplant.
    -To evaluate the effect of ixazomib in combination with sirolimus and tacrolimus on GVHD free survival and relapse-free GVHD-free survival as compared to a control group after 1 and 2 years postransplant.
    -To evaluate the effect of ixazomib in combination with sirolimus and tacrolimus on the immune response after transplantation
    -To describe the exposure to immunosuppressive treatment at 1 and 2 years postransplant.
    -Overall and disease free survival at 2 years postransplant.
    Fase I
    -Evaluar la eficacia de ixazomib en combinación con sirolimus y tacrolimus, en términos de incidencia de EICH crónica moderada o severa de acuerdo a la escala NIH a los 9 meses postrasplante.
    -Evaluar el efecto de ixazomib en la respuesta inmune comparado con un grupo control de pacientes que reciben sirolimus y tacrolimus.
    Fase II:
    -Evaluar el efecto de ixazomib en combinación con sirolimus y tacrolimus en la incidencia de EICH crónica moderada o severa a los 2 años postrasplante.
    -Evaluar el efecto de ixazomib en combinación con sirolimus y tacrolimus en la supervivencia libre de EICH crónica y supervivencia libre de recidiva de EICH crónica en comparación con un grupo control (1 y 2 años postrasplante)
    -Evaluar el efecto de ixazomib en combinación con sirolimus y tacrolimus en la respuesta inmune tras el trasplante.
    -Describir la exposición al tratamiento inmunosupresor (1 o 2 años postrasplante).
    -Supervivencia global y libre de enfermedad a los 2 años postrasplante.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients 18 years or older.
    2. Patients having received reduced intensity conditioning (RIC) peripheral blood allogeneic stem cell transplantation.
    3. Patients undergoing hematopoietic stem cell transplant from a matched or a single mismatched related or unrelated donor as definition accepted by protocol.
    4. Patients receiving GVHD prophylaxis with sirolimus and tacrolimus and on stable levels during the last 2 weeks before inclusion.
    5. Voluntary written consent must be given before performance of any study related procedure.
    6. Female patients who accomplish with requisitions for not possibility of pregnancy (menopausia, effective methods of contraception), as detailed by protocol.
    7. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
    8. Patients must meet the following clinical laboratory criteria:
    • Absolute neutrophil count (ANC) 1,000/mm3 and platelet count 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
    • Total bilirubin 1.5 the upper limit of the normal range (ULN).
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3 ULN.
    • Calculated creatinine clearance 30 mL/min (see Section 11.2).
    9. Ability to swallow and tolerate oral medication.
    10. Absence of gastrointestinal symptoms that precludes oral intake and absorption.
    11. Off antibiotics and amphotericin B formulations, voriconazole or other anti-fungal therapy for the treatment of active proven, probable or possible infections.
    1. Paciente hombre o mujer ≥ 18 años .
    2. Pacientes que hayan recibido un trasplante alogénico con acondicionamiento de intensidad reducida (AIR).
    3. Pacientes que hayan recibido un trasplante hematopoyético de médula ósea compatible o no, de donante emparentado o no, de acuerdo a requisitos detallados en el protocolo.
    4. Pacientes que estén recibiendo profilaxis para EICH con sirolimus y tacrolimus con niveles estables en las 2 semanas previas a la inclusión.
    5. Consentimiento voluntario por escrito y firmado antes de realizar ningún procedimiento relacionado con el estudio.
    6. Pacientes mujeres que cumplan requisitos detallados para que no sea posible el embarazo (menoapusia, métodos anticonceptivos aceptados)
    7. ECOG (Eastern Cooperative Oncology Group) y/o otros performance status debe ser 0, 1, o 2.
    8. Los pacientes deben cumplir los siguientes criterios de laboratorio:
    • Recuento absoluto de neutrófilos (RAN) 1,000/mm3 y recuento de plaquetas 75,000/mm3. No se permiten las transfusiones de plaquetas para ayudar a que los pacientes cumplan criterios de inclusión en los 3 días previos a la inclusión en el estudio.
    • Bilirrubina total 1.5 límite superior de la normalidad (LSN).
    • Alanino aminotransferasa (ALT) y aspartato aminotransferasa (AST) 3 LSN.
    a. Aclaramiento de creatinina calculado 30 mL/min (ver Sección 11.2).
    9. Capacidad para ingerir y tolerar medicación por vía oral.
    10. Ausencia de síntomas gastrointestinales que impidan la absorción e ingesta oral.
    11. Pacientes que no estén recibiendo antibióticos ni formulaciones de anfotericina B, voriconazol u otra terapia antifúngica para el tratamiento de infecciones probadas, probables o posibles.
    Durante el período de tratamiento del estudio se requiere profilaxis antiviral (desde el inicio hasta la discontinuidad de la terapia, ver Sección 6.5).
    E.4Principal exclusion criteria
    1. Female patients who are lactating or have a positive serum pregnancy test during the screening period.
    2. Major surgery within 14 days before enrollment.
    3. Central nervous system involvement with malignant cells.
    4. Uncontrolled infection within 14 days before study enrollment.
    5. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
    6. Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John’s wort.
    7. Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
    8. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
    9. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
    10. Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
    11. Patient has Grade 1 peripheral neuropathy.
    12. Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
    13. Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.
    14. Active Graft versus host disease at the time of inclusion: patients are allowed to be included if acute GVHD is in complete remission and are receiving systemic steroids at < 0.25 mg / kg.
    15. Active hematologic malignancy at the time of inclusion.
    16. Active microangiopathy at the time of inclusion (according to IWG criteria)
    17. Gastrointestinal disease or procedure than can interfere with oral absortion , intolerance to the ixazomib or difficulty to swallow.
    1. Mujeres en período de lactancia o test de embarazo positivo durante el período de screening.
    2. Cirugía mayor realizada en los 14 días previos a la inclusión en el estudio.
    3. Afectación de sistema nervioso central con células neoplásicas.
    4. Infección no controlada en los 14 días previos a la inclusión en el estudio.
    5. Evidencia de problemas cardiovasculares no controlados, incluyendo hipertensión, arritmias cardíacas, insuficiencia cardíaca congestiva sintomática, angina inestable o infarto miocárdico en de los 6 últimos meses.
    6. Tratamiento sistémico, en los 14 días antes de la primera dosis de ixazomib, con inductores potentes del CYP3A (rifampicina, rifapentina, rifabutina, carbamazepina, fenitoína, fenobarbital), o uso de Ginkgo biloba o Hierba de San Juan.
    7. Infección sistémica activa o persistente, infección por virus B o C activa, o presencia de Virus de la Inmunodeficiencia Humana (VIH).
    8. Cualquier enfermedad grave médica o psiquiátrica que pudiera, en la opinión del investigador, interferir potencialmente en el cumplimiento del tratamiento de acuerdo al protocolo.
    9. Alergia conocida a cualquiera de los medicamentos del estudio, sus análogos, o excipientes en las formulaciones de cualquiera de los agentes.
    10. Que el paciente haya sido diagnosticado o tratado de otra neoplasia en los dos años antes de la inclusión en el estudio o previamente diagnosticado de otra neoplasia y que aún presente evidencia de enfermedad residual. Los pacientes con enfermedad de piel no melanoma o carcinoma in situ de cualquier tipo no se excluyen del estudio si han recibido tratamiento con resección completa.
    11. Paciente con neuropatía periférica Grado 1.
    12. Participación en otros ensayos clínicos, incluyendo aquellos con otros agentes en investigación no incluidos en este ensayo, en los 30 días previos al inicio y durante todo el periodo de duración del mismo.
    13. Pacientes que hayan sido tratados previamente con ixazomib, o participado en estudios con ixazomib aún habiendo sido tratados con o sin ixazomib.
    14. Enfermedad injerto contra huésped activa en el momento de la inclusión: sólo se permite la inclusión de pacientes si la EICH aguda se encuentra en remisión completa y está recibiendo una dosis de esteroides inferior a 0.25 mg/kg.
    15. Enfermedad hematológica activa en el momento de la inclusión.
    16. Microangiopatía activa en el momento de la inclusión (de acuerdo a los criterios IWG o International Working Group).
    17. Enfermedad GI conocida o procedimiento GI que pueda interferir con la absorción oral o tolerancia del ixazomib, incluyendo dificultad para tragar.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I:
    -To identify the optimal dose and evaluate the safety of ixazomib used after transplantation.
    -To evaluate the efficacy of ixazomib used after transplantation, measured in terms of risk of moderate or severe GVHD according to NIH scale.
    -To evaluate the immune recovery of the 12 patients included in the safety expansion cohort and compare it with a cohort of 12 patients receiving sirolimus and tacrolimus out of the trial.
    Phase II.
    -To evaluate the reduction of risk of moderate or severe GVHD according to NIH scale
    Fase I:
    -Identificar la dosis óptima y evaluar la seguridad de ixazomib utilizado tras el trasplante.
    -Evaluar la eficacia de ixazomib utilizado después del trasplante , y medido en términos de riesgo de EICH crónica moderada o severa de acuerdo a la escala NIH.
    -Evaluar la recuperación inmune en los 12 pacientes incluidos en la cohorte de seguridad y compararlo con una cohorte de 12 pacientes que reciban sirólimus y tacrólimus fuera del ensayo.
    Fase II:
    Evaluar la reducción del riesgo de EICH crónica moderada o severa de acuerdo a la escala NIH.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Nine months after transplantation.
    Nueve meses post transplante
    E.5.2Secondary end point(s)
    Phase I study:
    -To evaluate the risk of moderate or revere cGVHD according to NIH scale at 2 years postrasplantation,this is, 6 months after ixazomib discontinuation.
    -To evaluate the effect of ixazomib on cGVHD free survival
    -To evaluate the immune recovery after transplantation among patients exposed or not to ixazomib.
    -To describe exposure to immunosuppressive treatment at 1 and 2 years postransplant.
    -To describe the overall and disease free survival at 2 years postransplant among patients exposed or not to ixazomib.
    Fase I:
    -Evaluar el riesgo de EICHc moderada o severa de acuerdo a la escala NIH
    -Evaluar el efecto de ixazomib en la supervivencia libre de EICHc.
    -Evaluar la recuperación inmune tras el trasplante en pacientes expuestos y no expuestos a ixazomib.
    -Describir la exposición al tratamiento inmunosupresor a 1 y 2 años postrasplante.
    -Describir la supervivencia global y libre de enfermedad entre pacientes expuestos y no expuestos a ixazomib.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 2 years postransplant.
    1 y 2 años postrasplante.
    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 Yes
    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
    Searching for optimized dosage.
    Búsqueda de dosis optima.
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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
    tratamiento recomendado
    recommended treatment
    E.8.2.4Number of treatment arms in the trial2
    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 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
    Final visit of the last patient included.
    El día de la visita final del último paciente incluido.
    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 months8
    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: 124
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state152
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 152
    F.4.2.2In the whole clinical trial 152
    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)
    Treatment after study as per investigators juice according to GCP
    A juicio del investigador de acuerdo a BPCs
    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 Decision2017-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-07
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA