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    Summary
    EudraCT Number:2021-001037-39
    Sponsor's Protocol Code Number:M20-356
    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:2021-12-02
    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 number2021-001037-39
    A.3Full title of the trial
    A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients with Recurring Chronic Lymphocytic Leukemia
    Estudio multicéntrico, abierto, de fase 2 para evaluar la eficacia y seguridad del retratamiento con venetoclax-obinituzumab en pacientes con leucemia linfocítica crónica recurrente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Chronic Lymphocytic Leukemia: Venetoclax-Obinutuzumab Retreatment in Patients with Recurring Disease
    Leucemia linfocítica crónica: retratamiento con venetoclax-obinutuzumab en pacientes con enfermedad recurrente
    A.4.1Sponsor's protocol code numberM20-356
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie.Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointGlobal Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road,
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34901200103
    B.5.6E-mailabbvie_reec@abbvie.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.3.1Product nameVenetoclax
    D.3.2Product code ABT-199 (GDC-0199)
    D.3.4Pharmaceutical form Film-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 INNVENETOCLAX
    D.3.9.1CAS number 1257044-40-8
    D.3.9.2Current sponsor codeABT-199 (GDC-0199)
    D.3.9.4EV Substance CodeSUB176260
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 nameVenetoclax
    D.3.2Product code ABT-199 (GDC-0199)
    D.3.4Pharmaceutical form Film-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 INNVENETOCLAX
    D.3.9.1CAS number 1257044-40-8
    D.3.9.2Current sponsor codeABT-199 (GDC-0199)
    D.3.9.4EV Substance CodeSUB176260
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 nameVenetoclax
    D.3.2Product code ABT-199 (GDC-0199)
    D.3.4Pharmaceutical form Film-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 INNVENETOCLAX
    D.3.9.1CAS number 1257044-40-8
    D.3.9.2Current sponsor codeABT-199 (GDC-0199)
    D.3.9.4EV Substance CodeSUB176260
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 4
    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 Gazyvaro 1,000 mg concentrate for solution for infusion.
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameObinutuzumab
    D.3.2Product code RO5072759/F06-01
    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 INNOBINUTUZUMAB
    D.3.9.1CAS number 949142-50-1
    D.3.9.2Current sponsor codeRO5072759
    D.3.9.4EV Substance CodeSUB32751
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Yes
    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
    Chronic lymphocytic leukemia (CLL)
    Leucemia linfocítica crónica (LLC)
    E.1.1.1Medical condition in easily understood language
    Cancer of the blood and bone marrow
    Cáncer de sangre y médula ósea
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008977
    E.1.2Term Chronic lymphocytic leukemia recurrent
    E.1.2System Organ Class 100000004864
    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 the study is to assess the efficacy of venetoclax (Ven) in combination with obinutuzumab (G), (VenG), in subjects with CLL who previously received the same combination as a fixed duration therapy, achieved a response, and subsequently progressed no sooner than 24 months after completing 1L treatment (Cohort 1), based on overall response rate (ORR) after completion of the combination phase of the study.
    El objetivo principal del estudio es evaluar la eficacia de venetoclax (Ven) en combinación con obinutuzumab (O), (VenO), en pacientes con LLC que recibieron previamente la misma combinación como una terapia de duración fija, lograron una respuesta y posteriormente progresaron no antes de los 24 meses después de completar el tratamiento de 1ª línea (cohorte 1), según la tasa de respuesta global (TRG) después de completar la fase de combinación del estudio.
    E.2.2Secondary objectives of the trial
    The secondary efficacy objective is to evaluate the efficacy of treatment with VenG in Cohort 1 with respect to specified secondary endpoints.
    El objetivo de eficacia secundario es evaluar la eficacia del tratamiento con VenO en la cohorte 1 con respecto a los criterios de valoración secundarios especificados.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Adult male or female, at least 18 years old.
    •Subjects or their legally authorized representative must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
    •Adequate marrow function independent of growth factor or transfusion support within 2 weeks of Screening as follows, unless cytopenia is due to marrow involvement of CLLPreviously completed venetoclax + obinutuzumab (VenG) regimen as first line fixed duration therapy and achieved documented response, defined as CR, CRi, PR, or nPR.
    •Patients who will not receive approved second-line therapies as assessed by the investigator and patient preference may be eligible for the study.
    •For Cohort 1: More than 24 months between the last dose of venetoclax and progression re-quiring treatment after completion of 1L VenG treatment; b) for Cohort 2: 12- 24 months be-tween the last dose of venetoclax and progression requiring treatment after completion of 1L VenG treatment.
    •For all females of child-bearing potential; a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug; more frequent testing is acceptable if required per local regulation.
    •Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of venetoclax and at least 18 months after the last dose of obinutuzumab. Female subjects of non-childbearing potential do not need to use birth control.
    •If male, and subject is sexually active with female partner(s) of childbearing potential, he must agree, from Study Day 1 for at least 3 months after the last dose of obinutuzumab and/or ve-netoclax, to practice the protocol-specified contraception. In addition, his female partner(s) of childbearing potential must use at least one of the contraceptive measures as defined.
    • Hombre o mujer adulto, mayor de 18 años.
    • Los pacientes o su representante legalmente autorizado deben firmar y fechar voluntariamente un consentimiento informado, aprobado por un comité de ética independiente / junta de revisión institucional, antes del inicio de cualquier procedimiento de selección o de estudio específico.
    • Función adecuada de la médula ósea independiente del factor de crecimiento o del soporte de transfusión dentro de las 2 semanas posteriores al cribado, como se indica a continuación, a menos que la citopenia se deba a la afectación de la médula ósea por LLC. Régimen de venetoclax + obinutuzumab (VenO) previamente completado como terapia de duración fija de primera línea y se logró una respuesta documentada, definida como RC, RCi, RP o nRP.
    • Los pacientes que no recibirán terapias de segunda línea aprobadas según la evaluación del investigador y la preferencia del paciente pueden ser elegibles para el estudio.
    • Para la cohorte 1: más de 24 meses entre la última dosis de venetoclax y la progresión que requirió tratamiento después de completar el tratamiento con 1L de VenO;
    b) para la cohorte 2: 12-24 meses entre la última dosis de venetoclax y la progresión que requiere tratamiento después de completar el tratamiento con 1L de VenO.
    • Para todas las mujeres en edad fértil; una prueba de embarazo en suero negativa en la visita de selección y una prueba de embarazo en orina negativa en el día 1 del ciclo 1 antes de la primera dosis del fármaco del estudio. Se aceptan pruebas más frecuentes si así lo exige la normativa local.
    • Las mujeres en edad fértil deben practicar al menos 1 método anticonceptivo especificado por el protocolo, que sea eficaz desde el día 1 del estudio hasta al menos 30 días después de la última dosis de venetoclax y al menos 18 meses después de la última dosis de obinutuzumab. Las mujeres en edad fértil no necesitan utilizar métodos anticonceptivos.
    • Si el hombre, y el paciente es sexualmente activo con su pareja (s) en edad fértil, debe estar de acuerdo, desde el Día 1 del Estudio durante al menos 3 meses después de la última dosis de obinutuzumab y / o venetoclax, para practicar la anticoncepción especificada en el protocolo. Además, su pareja femenina en edad fértil debe utilizar al menos una de las medidas anticonceptivas definidas.
    E.4Principal exclusion criteria
    •Subject has not received an intervening treatment for CLL after completing previous treatment with VenG.
    •Subject has no contraindication for all available uric acid reducing agents.
    •Subject has not discontinued prior VenG treatment due to progressive disease (PD) during treatment.
    •No active or uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytope-nic purpura (ITP).
    •No history of clinically significant medical conditions or any other reason that the investigator determines would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug.
    •No history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
    •No positive test results for, or suspicion of, hepatitis B virus infection (HBV) infection (defined as positive hepatitis B surface antibody [HBsAg] serology), based on site standard practices prior to anti-CD20 antibody infusion and obinutuzumab prescribing information.3 Testing should be conducted prior to initiation of obinutuzumab per site standard of care and obinutuzumab prescribing information.
    •For subjects who show evidence of hepatitis B infection (HBsAg positive [regardless of anti-body status] or HBsAg negative but anti-HBc positive), consult physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy.
    •Subjects may be included if HBV DNA is undetectable, provided that they are willing to under-go monthly DNA testing, during and for several months following treatment with obinutuzumab. Subjects who have protective titers of hepatitis B surface antibody (HBsAb) af-ter vaccination or prior but cured hepatitis B are eligible.
    •No positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing), based on site standard practices prior to anti-CD20 antibody infusion and obinutuzumab prescribing information.3
    •No known active SARS-CoV-2 infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test result. In addition, if the site considers the subject currently at risk for developing SARS-CoV-2 infection, then the subject should either be tested or advised to come back for study screening after 14 days.
    •Subject must not have used known strong cytochrome P450 (CYP)3A inhibitors or strong CYP3A inducers from 7 days prior to venetoclax initiation through dose ramp-up, nor other prohibited drugs and food products within 3 days prior to first dose of study drug (see Section 5.3).
    •Subject must not have received any live vaccine within 4 weeks prior to the first dose of study drug or be expected need of live vaccination during study participation including at least 4 weeks after the last dose of venetoclax and/or after B cell recovery for obinutuzumab.
    • El paciente no ha recibido un tratamiento intermedio para la LLC después de completar el tratamiento anterior con VenO.
    • El paciente no tiene contraindicaciones para todos los agentes reductores de ácido úrico disponibles.
    • El paciente no ha interrumpido el tratamiento anterior con VenO debido a una enfermedad progresiva (EP) durante el tratamiento.
    • Sin anemia hemolítica autoinmune activa o incontrolada (AIHA) o púrpura trombocitopénica inmune (ITP).
    • Sin antecedentes de afecciones médicas clínicamente significativas o cualquier otra razón que el investigador determine que interferiría con la participación del paciente en este estudio o haría que el paciente no fuera un candidato apto para recibir el fármaco del estudio.
    • Sin antecedentes de una reacción alérgica o sensibilidad significativa a los componentes del fármaco del estudio (y sus excipientes) y / u otros productos de la misma clase.
    • Sin resultados positivos o sospecha de infección por el virus de la hepatitis B (VHB) (definida como serología positiva de anticuerpos de superficie de hepatitis B [HBsAg]), según las prácticas estándar del sitio antes de la infusión de anticuerpos anti-CD20 y la información de prescripción de obinutuzumab. Se deben realizar pruebas antes de iniciar el tratamiento con obinutuzumab según el estándar de atención del centro y la información de prescripción de obinutuzumab.
    • Para los pacientes que muestren evidencia de infección por hepatitis B (HBsAg positivo [independientemente del estado de anticuerpos] o HBsAg negativo pero anti-HBc positivo), consulte a médicos con experiencia en el manejo de la hepatitis B con respecto a la monitorización y consideración de la terapia antiviral contra el VHB.
    • Se pueden incluir pacientes si el ADN del VHB es indetectable, siempre que estén dispuestos a someterse a pruebas de ADN mensuales, durante el tratamiento y durante varios meses después del tratamiento con obinutuzumab. Son elegibles los pacientes que tienen títulos protectores de anticuerpos de superficie de la hepatitis B (HBsAb) después de la vacunación o de la hepatitis B previa pero curada.
    • Ningún resultado positivo de la prueba para la hepatitis C (prueba serológica de anticuerpos contra el virus de la hepatitis C [VHC]), según las prácticas estándar del sitio antes de la infusión de anticuerpos anti-CD20 y la información de prescripción de obinutuzumab.
    • No se conoce ninguna infección activa por SARS-CoV-2. Si un paciente tiene signos / síntomas que sugieren una infección por SARS-CoV-2, el paciente debe tener un resultado de prueba molecular negativo (p. Ej., PCR). Además, si el sitio considera que el paciente está actualmente en riesgo de desarrollar una infección por SARS-CoV-2, entonces el paciente debe ser evaluado o aconsejado que regrese para la selección del estudio después de 14 días.
    • El paciente no debe haber usado inhibidores potentes conocidos del citocromo P450 (CYP) 3A o inductores potentes del CYP3A desde 7 días antes del inicio de venetoclax hasta el aumento de la dosis, ni otros medicamentos y productos alimenticios prohibidos dentro de los 3 días anteriores a la primera dosis del medicamento del estudio ( consulte la Sección 5.3).
    • El paciente no debe haber recibido ninguna vacuna viva dentro de las 4 semanas anteriores a la primera dosis del fármaco del estudio o se espera que necesite una vacuna viva durante la participación en el estudio, incluidas al menos 4 semanas después de la última dosis de venetoclax y / o después de la recuperación de las células B para obinutuzumab .
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is ORR in Cohort 1 as assessed by the Investigator. Overall response rate is defined as the proportion of subjects achieving a best response of partial remission (PR), nodular partial remission (nPR), complete remission with incomplete marrow recovery (CRi), or complete remission (CR) by EOCT, evaluated 3 months after the EOCT with VenG (EOCT + 3, i.e., Cycle 9). Disease assessments will be based on the 2018 International Workshop for Chronic Lymphocytic Leukemia (iwCLL) criteria for tumor response.
    El criterio principal de valoración de la eficacia es la TRG (Tasa Respuesta Global) en la cohorte 1 según la evaluación del investigador. La tasa de respuesta global se define como la proporción de pacientes que logran una mejor respuesta de remisión parcial (PR), remisión parcial nodular (nPR), remisión completa con recuperación incompleta de la médula (CRi) o remisión completa (CR) por EOCT (Fin del ciclo de tratamiento) , evaluado 3 meses después de la EOCT con VenG (EOCT + 3, es decir, ciclo 9). Las evaluaciones de la enfermedad se basarán en los criterios del Taller internacional para la leucemia linfocítica crónica (iwCLL) de 2018 para la respuesta tumoral.
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 Months
    9 meses
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints, all based on Cohort 1, are:
    •CR rate (defined as the proportion of subjects achieving a best response of CR or CRi) at EOCT+ 3
    •CR rate at end of treatment assessment (EOT + 3);
    •ORR at EOT + 3;
    •Time to response (TTR);
    •Duration of response (DOR);
    •Time to next treatment (TTNT) for CLL;
    •Progression-free survival (PFS);
    •Overall survival (OS);
    •Undetectable minimal residual disease (uMRD) rate (10-4) at EOCT + 3, measured in peripheral blood (PB);
    •uMRD rate at EOT + 3, measured in PB.
    Los criterios de valoración secundarios de eficacia, todos basados en la cohorte 1, son:
    • Tasa de RC (definida como la proporción de pacientes que lograron una mejor respuesta de RC o RCi) en EOCT (Fin de la terapia combinada) + 3
    • Tasa de RC al final de la evaluación del tratamiento (EOT + 3);
    • Tasa de respuesta global en EOT + 3;
    • Tiempo de respuesta (TTR);
    • Duración de la respuesta (DOR);
    • Tiempo hasta el próximo tratamiento (TTNT) para LLC;
    • Supervivencia libre de progresión (SLP);
    • Supervivencia global (SG);
    • Tasa de enfermedad residual mínima indetectable (uMRD) (10-4) en EOCT + 3, medida en sangre periférica (SP);
    • Tasa de uMRD en EOT + 3, medida en PB.
    E.5.2.1Timepoint(s) of evaluation of this end point
    15 months
    15 meses
    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 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.8.2.4Number 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 Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Austria
    Germany
    Italy
    New Zealand
    Spain
    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
    The end-of-study is defined as the date of the last subject's last visit or date of last follow-up contact, whichever is later.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 65
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 75
    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)
    Subjects will be followed for disease progression and survival. Post-treatment follow-up visits will be performed every 3 months until discontinuation from the study.
    Se hará un seguimiento de los pacientes para determinar la progresión de la enfermedad y la supervivencia. Las visitas de seguimiento posteriores al tratamiento se realizarán cada 3 meses hasta la interrupción del estudio.
    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 Decision2021-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-26
    P. End of Trial
    P.End of Trial StatusOngoing
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