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    Summary
    EudraCT Number:2017-002139-41
    Sponsor's Protocol Code Number:R1979-ONC-1625
    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:2019-07-26
    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 number2017-002139-41
    A.3Full title of the trial
    An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an anti CD20 x anti-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory Follicular Lymphoma
    Estudio abierto para evaluar la actividad antitumoral y la seguridad de REGN1979, un anticuerpo biespecífico anti-CD20 y anti-CD3 en pacientes con linfoma folicular recidivante o resistente al tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Anti-Tumor Activity and Safety of REGN1979 in patients with Follicular Lymphoma that has been previously treated
    Estudio para evaluar la actividad antitumoral y la seguridad de REGN1979 en pacientes con linfoma folicular que se ha tratado previamente
    A.4.1Sponsor's protocol code numberR1979-ONC-1625
    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 SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown, NY
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code REGN1979
    D.3.4Pharmaceutical form Concentrate 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 INNREGN1979
    D.3.9.2Current sponsor codeREGN1979
    D.3.9.3Other descriptive nameREGN1979
    D.3.9.4EV Substance CodeSUB179367
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Follicular lymphoma
    Linfoma folicular
    E.1.1.1Medical condition in easily understood language
    Cancer (Follicular lymphoma)
    Cáncer (Linfoma folicular)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's lymphoma
    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
    The primary objective of this study is to assess the anti-tumor activity of single agent REGN1979, as measured by objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma by independent central review, in patients with relapsed or refractory follicular lymphoma (FL) previously treated with at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.
    El objetivo principal de este estudio es evaluar la actividad antitumoral del agente único REGN1979, medida por la tasa de respuesta objetiva (TRO) de acuerdo con la Clasificación de Lugano de la respuesta en el linfoma maligno por una revisión central independiente, en pacientes con linfoma folicular (LF) recidivante o resistente al tratamiento tratados previamente con al menos 2 líneas anteriores de tratamiento sistémico, incluidos un anticuerpo anti-CD20 y un agente alquilante.
    E.2.2Secondary objectives of the trial
    The secondary objectives include:
    •To assess the anti-tumor activity of single agent REGN1979 in patients with relapsed or refractory FL, as measured by:
    o ORR according to the Lugano Classification (Cheson, 2014) as assessed by local investigator evaluation
    o CR rate according to the Lugano Classification as assessed by:
    Independent central review, and Local investigator evaluation
    o PFS according to Lugano Classification as assessed by:
    Independent central review, and Local investigator evaluation
    o OS

    Refer to protocol for the full list of Secondary objectives of the trial
    Los objetivos secundarios del estudio son:
    •Evaluar la actividad antitumoral del agente único REGN1979 en pacientes con LF recidivante o resistente al tratamiento, medida por:
    o TRO de acuerdo con la Clasificación de Lugano (Cheson, 2014) según la evaluación del investigador local
    o Tasa de respuesta completa (RC) de acuerdo con la Clasificación de Lugano, evaluada mediante:
    Revisión central independiente y Evaluación del investigador local
    o Supervivencia sin progresión (SSP) de acuerdo con la Clasificación de Lugano evaluada mediante:
    Revisión central independiente y Evaluación del investigador local
    o Supervivencia general (SG)
    Refiéranse a la lista completa de objetivos secundarios del estudio incluida en el protocolo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is an optional Genomics sub-study. The purpose of the genomic analyses is to identify genomic associations with clinical or biomarker response, other clinical outcome measures, and possible AEs. In addition, associations between genomic variants and prognosis or progression of FL as well as other related diseases may also be studied.
    Hay un sub-estudio opcional de genómica. El propósito de los análisis genómicos es identificar asociaciones genómicas con respuesta clínica o de biomarcadores, otras medidas de resultados clínicos y posibles EA. Además, también se pueden estudiar las asociaciones entre las variantes genómicas y el pronóstico o la progresión de FL, así como otras enfermedades relacionadas.
    E.3Principal inclusion criteria
    Principal inclusion in the study are:
    1. Age 18 years or greater
    2. Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).
    3. Must have received at least 2 prior lines of therapy, including an anti-CD20 antibody and an alkylating agent.
    4. Measurable disease on cross sectional imaging (defined as at least 1 bi dimensionally measurable nodal lesion of ≥1.5 cm in the greatest transverse diameter (GTD) regardless of the short axis diameter) documented by diagnostic imaging (computed tomography [CT], or magnetic resonance imaging [MRI]).
    5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or1.
    6. Adequate bone marrow function as documented by:
    a. Platelet count ≥50 x 109/L. A patient may not have received platelet transfusion within 7 days prior to first dose of REGN1979 in order to meet the platelet eligibility criterion.
    b. Hemoglobin ≥9.0 g/dL
    c. Absolute neutrophil count (ANC) ≥1.0 x 109/L. A patient may not have received granulocyte colony stimulating factor within 2 days prior to first dose of REGN1979 in order to meet the ANC eligibility criterion.
    7. Adequate hepatic function

    Refer to protocol for the full list of inclusion criteria of the trial
    Los principales criterios de inclusion son:
    1. 18 o más años de edad.
    2. Confirmación por el laboratorio central de histopatología deldiagnóstico de LF de grado 1 a 3a antes de la inclusión en el estudio. Los pacientes con LF de grado 3b no son aptos. La caracterización del linfoma folicular en subtipos se basa en la clasificación de la Organización Mundial de la Salud (OMS) (Swerdlow, 2017).
    3. Haber recibido al menos 2 líneas previas de tratamiento, incluidos un anticuerpo anti-CD20 y un agente alquilante.
    4. Enfermedad medible en imagen axial (definida como la presencia de al menos 1 lesión ganglionar medible en dos dimensiones con un diámetro transverso máximo [DTM] ≥1,5 cm, independientemente del diámetro del eje corto) documentada por técnicas de diagnóstico por la imagen (tomografía axial computarizada [TAC] o resonancia magnética [RM]).
    5. Estado funcional según el Grupo Oncológico Cooperativo de la Costa Este (Eastern Cooperative Oncology Group, ECOG) de 0 o 1.
    6. Función de médula ósea adecuada documentada por los siguientes
    parámetros:
    a. Recuento de plaquetas ≥50 × 109/l. Para cumplir el criterio de aptitud relativo a las plaquetas, los pacientes no pueden haber recibido una transfusión plaquetaria en los 7 días anteriores a la primera dosis de REGN1979.
    b. Hemoglobina ≥9,0 g/dl.
    c. Recuento absoluto de neutrófilos (RAN) ≥1,0 × 109/l. Para cumplir el criterio de aptitud relativo al RAN, los pacientes no pueden haber recibido factor estimulante de colonias de granulocitos en los 2 días anteriores a la primera dosis de REGN1979.
    7. Función hepática adecuada:

    Refiéranse a la lista completa de criterios de inclusion incluida en el
    protocolo
    E.4Principal exclusion criteria
    Principal exclusion criteria are:
    1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
    2. Treatment with any systemic anti lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter.
    3. History of allogeneic stem cell transplantation
    4. Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy
    5. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
    6. History of neurodegenerative condition or CNS movement disorder
    7. Vaccination within 28 days prior to first study drug administration with a vector that has replicative potential

    Refer to protocol for the full list of exclusion criteria of the trial
    Los principales criterios de exclusión son:
    1. Linfoma primario del sistema nervioso central (SNC) o afectación
    conocida por LNH no primario del SNC (la sospecha de linfoma del SNC
    se debe evaluar mediante punción lumbar, según corresponda, además
    de la TAC o RM obligatoria de cabeza).
    2. Tratamiento sistémico contra el linfoma en las 5 semividas o los 28
    días anteriores a la primera administración del fármaco del estudio, lo
    que suponga menos tiempo.
    3. Antecedentes de alotrasplante de células madre.
    4. Tratamiento previo de linfocitos T con receptores de antígenos
    quiméricos (CAR-T).
    5. Tratamiento continuo con corticoesteroides sistémicos a una dosis
    superior a 10 mg/día de prednisona o antiinflamatorio equivalente en las
    72 horas antes del inicio del fármaco del estudio.
    6. Antecedentes de trastorno neurodegenerativo o trastorno motor del
    SNC.
    7. Vacunación en los 28 días anteriores a la primera administración del
    fármaco del estudio con un vector que tenga potencial de replicación.

    Refiéranse a la lista completa de criterios de exclusión incluida en el
    protocolo
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is ORR from first dose until 194 weeks following the first dose, as measured by the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and according to independent central review, in patients with relapsed or refractory FL previously treated with at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.
    El criterio de valoración principal de este estudio es la TRO desde la primera dosis hasta 194 semanas después de la primera dos, medida de acuerdo con la Clasificación de Lugano de la respuesta en el linfoma maligno (Cheson, 2014) y de acuerdo con una revisión central independiente, en pacientes con LF recidivante o resistente al tratamiento tratados previamente con al menos 2 líneas anteriores de tratamiento sistémico, incluidos un anticuerpo anti-CD20 y un agente alquilante.
    E.5.1.1Timepoint(s) of evaluation of this end point
    194 weeks
    194 Semanas
    E.5.2Secondary end point(s)
    Secondary endpoints include:
    • ORR according to the Lugano Classification, as assessed by local investigator evaluation, from first dose until 194 weeks following the first dose
    • CR rate from first dose until 194 weeks following the first dose, according to the Lugano Classification, as assessed by:
    o Independent central review, and
    o Local investigator evaluation
    • PFS from first dose until 194 weeks following the first dose, according to the Lugano Classification, as assessed by:
    o Independent central review, and
    o Local investigator evaluation
    • OS from first dose until 194 weeks following the first dose
    • DOR from first dose until 194 weeks following the first dose, according to the Lugano Classification, as assessed by:
    o Independent central review, and
    o Local investigator evaluation
    • DCR from first dose until 194 weeks following the first dose, according to the Lugano Classification, as assessed by:
    o Independent central review, and
    o Local investigator evaluation
    • DDC from first dose until 194 weeks following the first dose, according to the Lugano Classification, as assessed by:
    o Independent central review, and
    o Local investigator evaluation
    • Incidence and severity of TEAEs from first dose until 194 weeks following the first dose
    • Changes in scores of patient-reported outcomes from first dose until 194 weeks following the first dose, as measured by the validated instruments EORTC QLQ C30 and EQ-5D-3L
    Los criterios de valoración secundarios son:
    • TRO de acuerdo con la Clasificación de Lugano, evaluada por el investigador local, desde la primera dosis hasta 194 semanas después de la primera dosis.
    • Tasa de RC desde la primera dosis hasta 194 semanas después de la primera dosis, de acuerdo con la Clasificación de Lugano, evaluada mediante:
    o Revisión central independiente y
    o Evaluación del investigador local
    • SSP desde la primera dosis hasta 194 semanas después de la primera dosis, de acuerdo con la Clasificación de Lugano, evaluada mediante:
    o Revisión central independiente y
    o Evaluación del investigador local
    • SG desde la primera dosis hasta un máximo de 194 semanas después de la primera dosis.
    • DR desde la primera dosis hasta 194 semanas después de la primera dosis, de acuerdo con la Clasificación de Lugano, evaluada mediante:
    o Revisión central independiente y
    o Evaluación del investigador local
    • DCR desde la primera dosis hasta 194 semanas después de la primera dosis, de acuerdo con la Clasificación de Lugano, evaluada mediante:
    o Revisión central independiente y
    o Evaluación del investigador local
    • DCE desde la primera dosis hasta 194 semanas después de la primera dosis, de acuerdo con la Clasificación de Lugano, evaluada mediante:
    o Revisión central independiente y
    o Evaluación del investigador local
    • Incidencia e intensidad de los acontecimientos adversos surgidos durante el tratamiento (AAST) desde la primera dosis hasta 194 semanas después de la primera dosis.
    • Cambios en las puntuaciones de los resultados notificados por el paciente desde la primera dosis hasta 194 semanas después de la primera dosis medidos por los instrumentos validados QLQ-C30 de la EORTC y el cuestionario EQ-5D-3L.
    E.5.2.1Timepoint(s) of evaluation of this end point
    194 weeks
    194 Semanas
    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) 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 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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Australia
    Canada
    France
    Germany
    Italy
    Korea, Democratic People's Republic of
    Poland
    Singapore
    Spain
    Taiwan
    United Kingdom
    United States
    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
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days19
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 112
    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 Decision2019-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
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