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    Summary
    EudraCT Number:2019-002752-16
    Sponsor's Protocol Code Number:GCT3009-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-01-23
    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 number2019-002752-16
    A.3Full title of the trial
    Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma – A First-in-Human, Open-label, Phase I/IIa Dose Escalation Trial with Dose Expansion Cohorts
    Seguridad y eficacia de GEN3009 (DuoHexaBody®-CD37) en el linfoma no Hodgkin de células B recidivante o resistente: primer ensayo en humanos, abierto y de escalada de dosis Fase I / IIa con cohortes de aumento de dosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and efficacy study of GEN3009-01 (DuoHexaBody®-CD37) in patients with B-cell Non-Hodgkin Lymphoma
    Seguridad y eficacia de GEN3009 (DuoHexaBody®-CD37) en pacientes con linfoma no Hodgkin de células B
    A.4.1Sponsor's protocol code numberGCT3009-01
    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 SponsorGenmab Holding B.V.
    B.1.3.4CountryNetherlands
    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 supportGenmab Holding B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenmab Holding B.V.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressUppsalalaan 15
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+34932607750
    B.5.6E-mailclinicaltrials@genmab.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 nameDuoHexaBody®-CD37
    D.3.2Product code GEN3009
    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 INNGEN3009
    D.3.9.1CAS number 2364496-42-2
    D.3.9.2Current sponsor codeDuoHexaBody®-CD37
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)
    Linfoma no Hodgkin de células B recidivante o resistente
    E.1.1.1Medical condition in easily understood language
    Non-Hodgkin Lymphoma (NHL)
    Linfoma no Hodgkin (LNH)
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Dose Escalation:
    - Determine the MTD with and/or determine the RP2D
    - Evaluate safety and tolerability of GEN3009

    Dose Expansion:
    -Evaluate (preliminary) anti-tumor efficacy
    Aumento gradual de la dosis:
    • Determinar la DMT y/o determinar la DRF2
    • Evaluar la seguridad y la tolerabilidad de GEN3009

    Ampliación de la dosis:
    • Evaluar (preliminarmente) la eficacia antitumoral
    E.2.2Secondary objectives of the trial
    Dose Escalation:
    - Establish PK profile
    - Evaluate immunogenicity
    - Evaluate preliminary anti-tumor efficacy
    - Evaluate preliminary clinical efficacy

    Dose Expansion:
    -Establish PK profile
    - Evaluate safety and tolerability of GEN3009
    - Evaluate clinical efficacy
    - Evaluate immunogenicity
    Aumento gradual de la dosis:
    • Establecer el perfil farmacocinético (FC)
    • Evaluar la inmunogenia
    • Evaluar la eficacia antitumoral preliminar
    • Evaluar la eficacia clínica preliminar

    Ampliación de la dosis:
    • Establecer el perfil farmacocinético (FC)
    • Evaluar la seguridad y la tolerabilidad de GEN3009
    •Evaluar la eficacia clínica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each potential subject must fulfill all of the following criteria to be enrolled in the trial.
    - Be at least 18 years of age.
    - Must sign an informed consent form (ICF) prior to any screening procedures.
    - Has histologically or cytologically confirmed relapsed and/or refractory B-cell NHL with no available standard therapy or is not a candidate for available standard therapy.
    - Has 1 of the following B-cell NHL subtypes for the Dose Escalation:
    o DLBCL, de novo or histologically transformed
    o HGBCL
    o PMBCL
    o FL, with advanced symptomatic disease and with a need for treatment
    o MCL, without leukemic manifestation
    o MZL, either nodal, extranodal or mucosa associated, with a need for treatment initiation based on symptoms and/or disease burden
    o SLL, with a need for treatment based on symptoms and/or disease burden
    o CLL, with B-cell count < 20x109/L (20,000/µL) in the peripheral blood and presence of measurable lymphadenopathy and/or organomegaly.
    -Has 1 of the following B-cell NHL subtypes for the Dose Expansion:
    o DLBCL, de novo or histologically transformed
    o FL, with advanced symptomatic disease and with a need for treatment initiation
    o CLL, with B-cell count < 20x109/L (20,000/µL) in the peripheral blood and presence of measurable lymphadenopathy and/or organomegaly.
    - Has measurable disease for B-cell NHL, or has active disease for CLL (refer to Protocol Section 5.1 for details).
    - Has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
    - Has acceptable laboratory parameters (refer to protocol for details).
    - Before the first dose of GEN3009, during the trial, and for 12 months after the last dose of GEN3009, a woman must be either not of childbearing potential or of childbearing potential and practicing a highly effective method of birth control, and must have a negative serum beta-human chorionic gonadotropin (beta-hCG) and urine pregnancy test at screening.
    - A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control.
    Cada sujeto potencial debe cumplir todos los criterios siguientes para ser inscrito en el ensayo.
    • Tiene al menos 18 años de edad.
    • Debe firmar un formulario de consentimiento informado (FCI) antes de someterse a cualquier procedimiento de selección.
    • Presenta LNH de células B recidivante y/o resistente confirmado citológica o histológicamente con ningún tratamiento estándar disponible o no es candidato para el tratamiento estándar disponible.
    • Tiene 1 de los siguientes subtipos de LNH de células B para el aumento gradual de la dosis:
    o LDLBG, de novo o histológicamente transformado
    o LLBGM
    o LLBMP
    o LF, con enfermedad sintomática avanzada y con necesidad de tratamiento
    o LCM, sin manifestaciones leucémicas
    o LZM, ya sea ganglionar, extraganglionar o asociado a la mucosa, con necesidad de iniciar el tratamiento en base a los síntomas y/o la carga de la enfermedad
    o LLCP, con necesidad de tratamiento de acuerdo con los síntomas y/o la carga de la enfermedad
    o LLC, con recuento de células B < 20x109 /l (20 000/µl) en sangre periférica y presencia de linfadenopatía medible y/o organomegalia.
    • Tiene 1 de los siguientes subtipos de LNH de células B para la ampliación de la dosis:
    o LDLBG, de novo o histológicamente transformado
    o LF, con enfermedad sintomática avanzada y con necesidad de iniciar el tratamiento
    o LLC, con recuento de células B < 20x109 /l (20 000/µl) en sangre periférica y presencia de linfadenopatía medible y/o organomegalia.
    • Tiene enfermedad medible para el LNH de células B, o tiene enfermedad activa para el LLC (consulte la sección 5.1 para obtener más información).
    • Estado general de 0-1 según la escala del Grupo Oncológico Cooperativo del Este (Eastern Cooperative Oncology Group, ECOG).
    • Presenta parámetros analíticos aceptables (consulte la sección 5.1 para obtener más información).
    • Antes de la primera dosis de GEN3009, durante el ensayo y durante los 12 meses posteriores a la última dosis de GEN3009, las mujeres no deben tener capacidad de concebir o si tienen capacidad de concebir, deben utilizar un método anticonceptivo altamente eficaz, y deben tener un resultado negativo en la prueba de gonadotropina coriónica humana en suero (beta-hCG) y en la prueba de embarazo en orina en la selección.
    • Un hombre sexualmente activo con una mujer capacidad de concebir que no se ha sometido a una vasectomía debe aceptar el uso de un método anticonceptivo de barrera.
    E.4Principal exclusion criteria
    Any potential subject who meets any of the following criteria will be excluded from participating in the trial.
    - Prior treatment with a CD37-targeting agent.
    - Prior allogeneic hematopoietic stem cell transplantation (HSCT).
    - Autologous HSCT within 3 months before the first dose of GEN3009.
    - Treatment with an anti-cancer biologic including anti-CD20 therapy, radio-conjugated or toxin-conjugated antibody or chimeric antigen receptor-T (CAR-T) cell therapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose of GEN3009.
    - Chemotherapy or radiation therapy within 2 weeks of the first dose of GEN3009.
    - Treatment with an investigational drug or an invasive investigational medical device within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of GEN3009. Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy.
    - Received a cumulative dose of corticosteroids more than the equivalent of 250 mg of prednisone within the 2–week period before the first dose of GEN3009.
    - Has uncontrolled intercurrent illness (refer to Protocol Section 5.2 for details).
    - Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy.
    - Primary central nervous system (CNS) lymphoma or known CNS involvement at screening.
    - Has known past or current malignancy other than inclusion diagnosis (refer to Section 5.2 for details).
    - Has had major surgery within 3 weeks before screening or will not have fully recovered from surgery, or has major surgery planned during the time the subject is expected to participate in the trial (or within 4 weeks after the last dose of GEN3009).
    - Has known history/positive serology for hepatitis B.
    - Known medical history or ongoing hepatitis C infection that has not been cured.
    - HIV tested positive at screening.
    - Is a woman who is pregnant or breast-feeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of GEN3009.
    - Is a man who plans to father a child while enrolled in this trial or within 12 months after the last dose of GEN3009.
    Se excluirá de la participación en este ensayo a los sujetos potenciales que cumplan alguno de los siguientes criterios:
    • Tratamiento previo con un agente anti-CD37.
    • Alotrasplante de células madre hematopoyéticas (TCMH) previo.
    • TCMH autólogo en el plazo de 3 meses antes de la primera dosis de GEN3009.
    • Tratamiento con un producto biológico antineoplásico, incluido el tratamiento con anti-CD20, anticuerpos radioconjugados o conjugados con toxinas o receptores de antígeno quimérico de linfocitos T (CAR-T) durante las 4 semanas o 5 semividas, lo que sea más corto, antes de la primera dosis de GEN3009.
    • Quimioterapia o radioterapia en las 2 semanas antes de la primera dosis de GEN3009.
    • El tratamiento con un fármaco en investigación o un dispositivo invasivo en investigación en las 4 semanas o 5 semividas, lo que sea más corto, antes de la primera dosis de GEN3009.
    • Enfermedad autoinmunitaria u otras enfermedades que requieran tratamiento inmunodepresor permanente o en dosis elevadas.
    • Haber recibido una dosis acumulada de corticoesteroides superior al equivalente de 250 mg de prednisona en el periodo de 2 semanas antes de la primera dosis de GEN3009.
    • Presentar una enfermedad intercurrente no controlada, (consulte la sección 5.2 para obtener más información).
    • Las toxicidades de los tratamientos antineoplásicos previos no se han resuelto a los niveles de iniciales o a Grado 1 o inferior, excepto la alopecia y la neuropatía periférica.
    • Linfoma primario del sistema nervioso central (SNC) o afectación conocida del SNC en la selección.
    • Presentar antecedentes de o neoplasia actual distinta del diagnóstico de inclusión (consulte la sección 5.2 para obtener más información).
    • Haber tenido una cirugía mayor en las 3 semanas antes de la selección o no haberse recuperado totalmente de la cirugía, o tener programada una cirugía mayor durante el periodo que el sujeto está previsto que participe en el ensayo (o en el plazo de 4 semanas después de la última dosis de GEN3009).
    • Tener antecedentes conocidos/serología positiva para hepatitis B.
    • Antecedentes médicos conocidos o infección en curso por hepatitis C que no se ha curado.
    • VIH positivo en la selección.
    • Ser una mujer embarazada o en periodo de lactancia, o que tiene previsto quedarse embarazada mientras esté inscrita en este ensayo o en un plazo de 12 meses después de la última dosis de GEN3009.
    • Ser un hombre que tiene previsto tener hijos mientras esté inscrito en este ensayo o en un plazo de 12 meses después de la última dosis de GEN3009.
    E.5 End points
    E.5.1Primary end point(s)
    Dose Escalation:
    • Rate of DLTs
    • Frequency and severity of AEs/SAEs
    • Changes in laboratory parameters
    • Changes in vital signs

    Dose Expansion:
    • ORR
    Aumento gradual de la dosis:
    • Incidencia de toxicidades limitantes de la dosis (TLD)
    • Frecuencia y gravedad de los acontecimientos adversos (AA)/acontecimientos adversos graves (AAG)
    • Cambios en los parámetros analíticos
    • Cambios en las constantes vitales

    Ampliación de la dosis:
    • TRO
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the trial, see protocol
    Durante el ensayo, ver protocolo
    E.5.2Secondary end point(s)
    Dose Escalation:
    • PK parameters: clearance, volume of distribution and area under the curve (AUC) at different time points (AUC7days, AUClast and AUCinf), maximum concentration (Cmax), time to Cmax (Tmax), predose trough concentrations (Ctrough), and half-life (T1/2)
    • Incidence of neutralizing anti-GEN3009 antibodies (ie, anti-drug antibodies [ADAs])
    • Objective response rate (ORR)
    • Complete response rate (CR)
    • Duration of response (DoR)
    • Time to response (TTR)
    • Progression-free survival (PFS)
    • Overall survival (OS)

    Dose Expansion:
    - PK parameters: clearance, volume of distribution and AUC at different time points (AUC7days, AUClast and AUCinf), Cmax, Tmax, Ctrough, and half-life (T1/2)
    • Frequency and severity of AEs
    • Changes in laboratory parameters
    • Changes in vital signs
    • CR
    • DoR
    • TTR
    • PFS
    • OS
    Incidence of neutralizing anti-GEN3009 antibodies (ie, ADAs)
    Aumento gradual de la dosis:
    • Parámetros FC
    • Incidencia de anticuerpos neutralizantes anti-GEN3009
    • Tasa de respuesta objetiva (TRO)
    • Tasa de respuesta completa (RC)
    • Duración de la respuesta (DR)
    • Tiempo hasta la respuesta (THR)
    • Supervivencia sin progresión (SSP)
    • Supervivencia general (SG)

    Ampliación de la dosis:
    • Parámetros FC
    • Frecuencia y gravedad de los AA
    • Cambios en los parámetros analíticos
    • Cambios en las constantes vitales
    • RC
    • DR
    • THR
    • SSP
    • SG
    • Incidencia de anticuerpos neutralizantes anti-GEN3009
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the trial, see protocol
    Durante el ensayo, ver protocolo
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Inmunogenia
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Diferentes dosis de GEN3009
    Different doses of GEN3009
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Denmark
    Netherlands
    Spain
    United States
    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 trial is considered completed when the last subject dies or withdraws from the trial. However, the maximum trial duration is 5 years after the last subject’s first treatment in the trial.
    El ensayo se considerará completado cuando el último sujeto muera o se retire del ensayo. Sin embargo, la duración máxima del ensayo es de 5 años después del primer tratamiento del último sujeto en el ensayo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 72
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    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 70
    F.4.2.2In the whole clinical trial 120
    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)
    Post trial treatment is at the discretion of the patient's doctor per standard of care per country. Sponsor will ensure provisioning of post-trial treatment for ongoing trial participants with a potential treatment benefit.
    El tratamiento posterior al ensayo queda a criterio del médico del paciente según la práctica clínica de cada país. El promotor garantizará el suministro de tratamiento posterior al ensayo para los participantes del ensayo en curso con un beneficio potencial de tratamiento.
    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 Decision2020-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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