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    Summary
    EudraCT Number:2018-002556-32
    Sponsor's Protocol Code Number:ADCT-301-201
    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:2019-10-29
    Trial results View 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 number2018-002556-32
    A.3Full title of the trial
    A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients with Relapsed or Refractory Hodgkin Lymphoma
    Estudio de fase II, abierto, de un solo grupo para evaluar la eficacia y la seguridad de Camidanlumab Tesirina (ADCT-301) en pacientes con linfoma de Hodgkin recidivante o resistente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Study to Evaluate the Effectiveness and Safety of ADCT-301 in Patients with Relapsed or Refractory Hodgkin Lymphoma
    Estudio de fase II para evaluar la eficacia y la seguridad de ADCT-301 en pacientes con linfoma de Hodgkin recidivante o resistente
    A.4.1Sponsor's protocol code numberADCT-301-201
    A.5.4Other Identifiers
    Name:IND numberNumber:121912
    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 SponsorADC Therapeutics SA
    B.1.3.4CountrySwitzerland
    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 supportADC Therapeutics SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationADC Therapeutics SA
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressRoute de la Corniche, 3B
    B.5.3.2Town/ cityEpalinges
    B.5.3.3Post code1066
    B.5.3.4CountrySwitzerland
    B.5.6E-mailclinicaltrials@adctherapeutics.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 nameCamidanlumab tesirine
    D.3.2Product code ADCT-301
    D.3.4Pharmaceutical form Lyophilisate 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 INNCamidanlumab Tesirine
    D.3.9.2Current sponsor codeADCT-301
    D.3.9.3Other descriptive nameADCT-301
    D.3.9.4EV Substance CodeSUB181444
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Hodgkin Lymphoma
    Linfoma de Hodgkin recidivante o resistente
    E.1.1.1Medical condition in easily understood language
    Lymphoma
    Linfoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080208
    E.1.2Term Classical Hodgkin lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020267
    E.1.2Term Hodgkin's disease refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10020234
    E.1.2Term Hodgkin's disease mixed cellularity refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10020233
    E.1.2Term Hodgkin's disease mixed cellularity recurrent
    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
    Evaluate the efficacy of single agent camidanlumab tesirine in patients with relapsed or refractory Hodgkin Lymphoma
    Evaluar la eficacia de camidanlumab tesirina en monoterapia en pacientes con Linfoma de Hodgkin recidivante o resistente
    E.2.2Secondary objectives of the trial
    Secondary objectives
    Characterize additional efficacy endpoints of camidanlumab tesirine
    Characterize the safety profile of camidanlumab tesirine
    Characterize the PK profile of camidanlumab tesirine
    Evaluate the immunogenicity of camidanlumab tesirine
    Evaluate the impact of camidanlumab tesirine treatment on health-related quality of life (HRQoL)
    Objetivos Secundarios
    Describir criterios de valoración adicionales de camidanlumab tesirina
    Describir el perfil de seguridad de camidanlumab tesirina
    Describir el perfil farmacocinético (FC) de camidanlumab tesirina
    Evaluar la inmunogenicidad de camidanlumab tesirina
    Evaluar el efecto del tratamiento con camidanlumab tesirina en la calidad de vida relacionada con la salud (CdVRS)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained prior to any procedures.
    2. Male or female patients aged 18 years or older.
    For US sites only: Male or female patients aged 16 years or older.
    3. Pathologic diagnosis of cHL.
    4. Patients with relapsed or refractory cHL, who have received at least 3 prior lines of systemic therapy (or at least 2 prior lines in HSCT ineligible patients) including brentuximab vedotin and a checkpoint inhibitor approved for cHL (e.g., nivolumab or pembrolizumab).
    Note 1: Receipt of HSCT to be included in the number of prior therapies needed to meet eligibility.
    Note 2: The reason(s) for HSCT ineligibility must be documented in the patient medical records/source documents and eCRF.
    5. Measurable disease as defined by the 2014 Lugano Classification.
    6. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available).
    Note: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred.
    7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
    8. Adequate organ function as defined by screening laboratory values within the following parameters:
    a. Absolute neutrophil count (ANC) ≥ 1.0 × 10^3/μL (off growth factors at least 72 h).
    b. Platelet count ≥ 75 × 10^3/μL without transfusion in the past 2 weeks.
    c. ALT, AST, or GGT ≤ 2.5 × the upper limit of normal (ULN) if there is no liver involvement; ALT or AST ≤ 5 × ULN if there is liver involvement.
    d. Total bilirubin ≤ 1.5 × ULN (patients with known Gilbert’s syndrome may have a total bilirubin up to ≤ 3 × ULN with direct bilirubin ≤ 1.5 × ULN).
    e. Blood creatinine ≤ 3.0 × ULN or calculated creatinine clearance ≥ 30 mL/min by the Cockcroft-Gault equation.
    Note: A laboratory assessment may be repeated a maximum of two times during the Screening period to confirm eligibility.
    9. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential.
    10. Women of childbearing potential (WOCBP)* must agree to use a highly effective** method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of camidanlumab tesirine. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of giving informed consent until at least 16 weeks after the patient receives his last dose of camidanlumab tesirine.
    * Women of childbearing potential are defined as sexually mature women who have not undergone bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or who have not been postmenopausal (i.e., who have not menstruated at all) for at least 1 year.
    ** Highly effective forms of birth control are methods that achieve a failure rate of less than 1% per year when used consistently and correctly. Highly effective forms of birth control include: hormonal contraceptives (oral, injectable, patch, intrauterine devices), male partner sterilization, or total abstinence from heterosexual intercourse, when this is the preferred and usual lifestyle of the patient.
    Note: The double-barrier method (e.g., synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), periodic abstinence (such as calendar, symptothermal, post-ovulation), withdrawal (coitus interruptus), lactational amenorrhea method, and spermicide-only are not acceptable as highly effective methods of contraception.
    1. Se debe obtener el consentimiento informado por escrito antes de ningún procedimiento.
    2. Pacientes hombres o mujeres de 18 años en adelante.
    Solo en centros de EE. UU.: pacientes hombres o mujeres de 16 años en adelante.
    3. Diagnóstico anatomopatológico de LHc
    4. Pacientes con LHc recidivante o resistente que hayan recibido al menos 3 líneas previas de tratamiento sistémico (o al menos 2 líneas previas en pacientes no aptos para TCMH) que incluyan brentuximab vedotina y un inhibidor del punto de control aprobado para el LHc (p. ej., nivolumab o pembrolizumab).
    Nota 1: se debe incluir la recepción de un TCMH en el número de tratamientos previos necesarios para cumplir los criterios de aptitud.
    Nota 2: las razones de la falta de aptitud para el TCMH se deben documentar en la historia clínica/los documentos originales y en el CRDe del paciente
    5. Enfermedad medible, tal como se define en la clasificación de Lugano de 2014.
    6. Disponibilidad de bloque de tejido tumoral fijado en formol e incluido en parafina (FFIP) (o un mínimo de 10 portaobjetos recién cortados sin tinción si el bloque no está disponible).
    Nota: cualquier biopsia desde el diagnóstico inicial es aceptable, pero si hay varias muestras disponibles, se prefiere la muestra más reciente.
    7. Estado funcional ECOG 0-2.
    8. Función orgánica adecuada, tal como se define mediante valores analíticos dentro de los siguientes parámetros:
    a. Recuento absoluto de neutrófilos (RAN) ≥1.0 × 10^3/μL (sin factores de crecimiento durante al menos 72 horas).
    b. Recuento de plaquetas ≥75 × 10^3/μL sin transfusión en las últimas 2 semanas.
    c. ALT, AST y GGT ≤2.5 × el límite superior de la normalidad (LSN) si no hay afectación hepática; ALT o AST ≤ 5 × LSN si hay afectación hepática.
    d. Bilirrubina total ≤1.5 × LSN (los pacientes con síndrome de Gilbert conocido pueden tener un valor de bilirrubina total hasta ≤3 × LSN con bilirrubina directa ≤ 1.5 × LSN).
    e. Creatinina sérica ≤3.0 × LSN o aclaramiento de creatinina calculado ≥30 ml/min mediante la ecuación de Cockcroft-Gault.
    Nota: Una evaluación de laboratorio puede repetirse un máximo de dos veces durante la fase de selección para confirmar la idoneidad.
    9. Resultado negativo en la prueba de gonadotropina coriónica beta humana (β-HCG) en la prueba de embarazo en el plazo de 7 días anteriores al inicio de la administración del fármaco del ensayo para las mujeres en edad fértil.
    10. Las mujeres en edad fértil (MEEF)* deben aceptar usar un método anticonceptivo muy eficaz** desde el momento en el que dan el consentimiento informado hasta al menos 16 semanas después de la última dosis de camidanlumab tesirina. Los hombres con parejas mujeres en edad fértil deben aceptar usar un preservativo durante las relaciones sexuales o practicar la abstinencia sexual total desde el momento en el que dan el consentimiento informado hasta al menos 16 semanas después de que el paciente reciba la última dosis de camidanlumab tesirina
    *Mujeres en edad fértil se definen como mujeres sexualmente maduras que no se han sometido a ligadura de trompas bilateral, ooforectomía bilateral o histerectomía; o que no han sido posmenopáusicas (es decir, que no han menstruado en absoluto) durante al menos 1 año.
    **Las formas altamente efectivas de control de la natalidad son métodos que logran una tasa de fracaso de menos del 1% por año cuando se usan de manera consistente y correcta. Los métodos anticonceptivos altamente efectivos incluyen: anticonceptivos hormonales (orales, inyectables, parches, dispositivos intrauterinos), esterilización de pareja masculina o abstinencia total de relaciones sexuales heterosexuales, cuando este es el estilo de vida preferido y habitual del paciente.
    Nota: El método de doble barrera (p. Ej., Condones sintéticos, diafragma o capuchón cervical con espuma espermicida, crema o gel), abstinencia periódica (como calendario, sintomotérmica, post-ovulación), abstinencia (coitus interruptus), método de la amenorrea de la lactancia y el espermicida solo, no son aceptables como métodos anticonceptivos altamente efectivos.
    E.4Principal exclusion criteria
    1. Previous treatment with camidanlumab tesirine.
    2. Participation in another investigational interventional study. Being in follow-up of another investigational study is allowed.
    3. Known history of hypersensitivity to or positive serum human anti-drug antibody (ADA) to a CD25 antibody.
    4. Allogenic or autologous HSCT within 60 days prior to start of study drug.
    5. Active graft-versus-host disease (GVHD), except for non-neurologic symptoms as a manifestation of mild (≤ Grade 1) chronic GVHD.
    6. Post-HSCT lymphoproliferative disorders.
    7. Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor’s medical monitor and Investigator agree and document should not be exclusionary.
    8. History of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, Sjögren's syndrome, autoimmune vasculitis [e.g., Wegener's granulomatosis]) (subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism, hypophysitis due to autoimmune condition only requiring hormone replacement may be enrolled).
    9. History of neuropathy considered of autoimmune origin (e.g., polyradiculopathy including Guillain-Barré syndrome and myasthenia gravis) or other central nervous system autoimmune disease (e.g., poliomyelitis, multiple sclerosis).
    10. History of recent infection (within 4 weeks of C1D1) considered to be caused by one of the following pathogens: HSV1, HSV2, VZV, EBV, CMV, measles, Influenza A, Zika virus, Chikungunya virus, mycoplasma pneumonia, Campylobacter jejuni, or enterovirus D68.
    11. Patients who are carriers of human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV), and require antiviral therapy or prophylaxis.
    Note: Serology testing is mandatory for patients with unknown status.
    12. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
    13. Failure to recover ≤ Grade 1 (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0]) from acute non-hematologic toxicity (except ≤ Grade 2 neuropathy or alopecia), due to previous therapy, prior to screening.
    14. HL with central nervous system involvement, including leptomeningeal disease.
    15. Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).
    16. Breastfeeding or pregnant.
    17. Significant medical comorbidities, including uncontrolled hypertension (blood pressure [BP] ≥ 160/100 mmHg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 3 months prior to screening, severe uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, or severe chronic pulmonary disease.
    18. Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug, except shorter if approved by the Sponsor.
    19. Use of any other experimental medication within 14 days prior to start of study drug.
    20. Planned live vaccine administration after starting study drug.
    21. Congenital long QT syndrome, or a corrected QTc interval of ≥ 480 ms, at screening (unless secondary to pacemaker or bundle branch block).
    22. Any other significant medical illness, abnormality, or condition that would, in the Investigator’s judgment, make the patient inappropriate for study participation or put the patient at risk.
    1. Tratamiento previo con camidanlumab tesirina.
    2. Participación en otro ensayo de investigación intervencionista. Se permite participar en el seguimiento de otro ensayo de investigación intervencionista.
    3. Antecedentes conocidos de hipersensibilidad a un anticuerpo contra CD25.
    4. TCMH alógeno o autólogo en los 60 días anteriores al inicio del fármaco del ensayo.
    5. Enfermedad de injerto contra huésped (EICH) activa, salvo los síntomas no neurológicos como manifestación de EICH crónica leve (≤Grado 1).
    6. Trastornos linfoproliferativos posteriores al TCMH.
    7. Una segunda neoplasia maligna primaria activa distinta del cáncer de piel no melanoma, cáncer de próstata no metastásico, cáncer de cuello uterino in situ, carcinoma ductal o lobular in situ de mama, u otra neoplasia maligna que el monitor médico y el investigador del promotor acuerden y documenten no debe ser excluyente.
    8. Antecedentes de enfermedad autoinmunitaria sintomática (por ejemplo, artritis reumatoide, esclerosis progresiva sistémica [esclerodermia], lupus eritematoso sistémico, síndrome de Sjögren, vasculitis autoinmunitaria [p. ej., granulomatosis de Wegener]) (pueden inscribirse sujetos con vitíligo, diabetes mellitus tipo I, hipotiroidismo residual, hipofisitis debida a una enfermedad autoinmunitaria que solo requiere reemplazo hormonal).
    9. Antecedentes de neuropatía considerada de origen autoinmunitario (p. ej., polirradiculopatía, como el síndrome de Guillain-Barré y la miastenia gravis) u otra enfermedad autoinmunitaria del sistema nervioso central (p. ej., poliomielitis, esclerosis múltiple).
    10. Antecedentes de infección reciente (en las 4 semanas anteriores al día 1 del ciclo 1) considerada como causada por uno de los siguientes patógenos: HSV1, HSV2, VZV, EBV, CMV, sarampión, gripe A, virus de Zika, virus de Chikungunya, neumonía por micoplasma, Campylobacter jejuni, o enterovirus D68.
    11. Pacientes que se sabe que están o han estado infectados por el virus de la inmunodeficiencia humana (VIH), el virus de la hepatitis B (VHB) o el virus de la hepatitis C (VHC), y requieren tratamiento antivírico o profilaxis.
    Nota: las pruebas serológicas son obligatorias para los pacientes con un estado desconocido
    12. Antecedentes de síndrome de Stevens-Johnson o necrólisis epidérmica tóxica.
    13. Incapacidad para recuperarse hasta grado ≤ 1 (según la versión 4.0 de los Criterios Terminológicos Comunes para Acontecimientos Adversos [CTCAE v4.0]) de una toxicidad no hemática aguda (salvo neuropatía o alopecia de grado ≤ 2) debido a un tratamiento anterior antes de la selección.
    14. LH con afectación del sistema nervioso central, incluyendo enfermedad leptomeníngea.
    15. Acumulación de líquidos en el tercer espacio clínicamente significativa (es decir, ascitis que requiera drenaje o derrame pleural que requiera drenaje o se asocie con disnea).
    16. Embarazo o lactancia.
    17. Comorbilidades médicas significativas como hipertensión no controlada (presión arterial [PA] ≥ 160/100 mmHg repetidamente), angina de pecho inestable, insuficiencia cardíaca congestiva (superior a la clase II de la Asociación del Corazón de Nueva York [New York Heart Association]), indicios electrocardiográficos de isquemia aguda, angioplastia coronaria o infarto de miocardio en los 3 meses anteriores a la selección, arritmia cardíaca auricular o ventricular no controlada grave, diabetes mal controlada o neumopatía crónica grave.
    18. Cirugía mayor, radioterapia, quimioterapia u otro tratamiento antineoplásico en los 14 días anteriores al inicio del fármaco del estudio, excepto más breve si lo aprueba el promotor.
    19. Uso de algún otro medicamento experimental dentro de los 14 días anteriores al inicio del fármaco del estudio
    20. Administración programada de alguna vacuna de virus vivos después del inicio del fármaco del estudio.
    21. Síndrome de QT largo congénito o intervalo QTc corregido ≥ 480 ms en el momento de la selección (a menos que sea secundario a un marcapasos o bloqueo de rama).
    22. Cualquier otra enfermedad, anomalía o afección médica importante que, en la opinión del investigador, podría volver inadecuado al paciente para su participación en el estudio o poner en riesgo al paciente.
    E.5 End points
    E.5.1Primary end point(s)
    ORR according to the 2014 Lugano classification as determined by central review in all-treated patients
    TRG de acuerdo con la clasificación de Lugano de 2014 según lo determinado por la revisión central de todos los pacientes tratados.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline (screening), 6 weeks post-dose, 12 weeks post-dose, then every 9 weeks until EOT. If no progression at EOT, then every 12 weeks for 1 year post-EOT, then every 6 months until disease progression.
    Desde el inicio (selección), 6 semanas después de la dosis, 12 semanas después de la dosis, luego cada 9 semanas hasta FdT. Si no hay progresion al FdT, entonces cada 12 semanas por 1 año despues de FdT, luego cada 6 meses hasta la progresión de la enfermedad.
    E.5.2Secondary end point(s)
    - DOR defined as the time from the first documentation of tumor response to disease progression or death
    - CR rate defined as the percentage of treated patients with a best overall response (BOR) of CR
    - Relapse-free survival (RFS) defined as the time from the documentation of CR to disease progression or death
    - Progression-free survival (PFS) defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause
    - Overall survival (OS) defined as the time from first dose of study drug until death due to any cause
    - Fraction of patients receiving hematopoietic stem cell transplant (HSCT).
    - Frequency and severity of AEs and SAEs
    - Changes from Baseline of safety laboratory values, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, and 12-lead electrocardiograms (ECGs)
    - Concentrations and PK parameters of camidanlumab tesirine total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199
    - Frequency of confirmed positive anti-drug antibody (ADA) responses, their associated ADA titers and, if applicable, neutralizing activity to camidanlumab tesirine after treatment with camidanlumab tesirine
    - Change from Baseline in HRQoL as measured by EuroQoL–5 Dimensions–5 Levels (EQ-5D-5L) and Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
    - Duración de la respuesta (DR) definida como el tiempo desde la primera documentación de respuesta de la respuesta tumoral a la progresión de la enfermedad o la muerte.
    - Tasa de RC definida como el porcentaje de pacientes tratados con una mejor respuesta global (BOR) de RC.
    - Supervivencia libre de recidiva (SLR) definida como el tiempo de documentacion de RC a la progresión de la enfermedad o la muerte.
    - Supervivencia libre de progresión (SLP) definida como el tiempo desde la primera dosis del fármaco del estudio hasta la primera fecha de progresión de la enfermedad o muerte por cualquier causa.
    - Supervivencia global (SG) definida como el tiempo desde la primera dosis del fármaco del estudio hasta la muerte por cualquier causa.
    - Fracción de pacientes que reciben trasplante de células madre hematopoyéticas (TCMH)
    - Frecuencia y gravedad de los acontecimientos adversos (AA) y acontecimientos adversos graves (AAG).
    - Cambios desde el inicio en los valores analíticos de seguridad, las constantes vitales, el estado general según ECOG (Eastern Cooperative Oncology Group) y los electrocardiogramas (ECG) de 12 derivaciones
    - Las concentraciones y los parámetros de FC de anticuerpos totales, anticuerpos conjugados con PBD y ojiva no conjugada SG3199 de camidanlumab tesirina
    - Frecuencia de respuestas positivas confirmadas de anticuerpos antifármaco (AAF), sus títulos asociados (AAF) y, si procede, actividad neutralizante de camidanlumab tesirina después del tratamiento con camidanlumab tesirina
    - Cambio desde el inicio en la CdVRS medido por el cuestionario EuroQoL de 5 dimensiones y 5 niveles (EQ-5D-5L) y la evaluación funcional del tratamiento del cáncer en el linfoma (Functional Assessment of Cancer Therapy - Lymphoma, FACT Lym)
    E.5.2.1Timepoint(s) of evaluation of this end point
    DOR, CR rate, RFS, PFS: From baseline (screening), 6 weeks post-dose, 12 weeks post-dose, then every 9 weeks until EOT. If no progression at EOT, then every 12 weeks for 1 year post-EOT, then every 6 months until disease progression.
    Fraction of patients receiving HSCT, OS: from baseline (screening) until End of study.
    AE/SAE: From informed consent signature until EOT or maximum of 30 days after last dose, thereafter only SAEs when related to study medication.
    ECOG, ECGs, PK, ADA, EQ-5D-5L, FACT-Lym: From Day one assessment/sample collection through multiple days across cycles until EOT.
    DR, Tasa de RC, SLR, SLP: Desde el inicio (selección), 6 semanas después de la dosis, 12 semanas después de la dosis, luego cada 9 semanas hasta FdT. Si no hay progresion al FdT, entonces cada 12 semanas por 1 año despues de FdT, luego cada 6 meses hasta la progresión de la enfermedad.
    Fracción de pacientes que reciben TCMH, SG: desde el inicio (selección) hasta fin del estudio.
    AA/AAG: Desde la firma del consentimiento informado hasta FdT o máximo de 30 días desde la última dosis, después de eso, solo AAG cuando está relacionado con la medicación del estudio.
    ECOG, ECG, FC, ADA, EQ-5D-5L, FACT-Lym: Desde el día uno de evaluación/ recolección de muestras a través de varios días a través de ciclos hasta FdT.
    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 No
    E.6.10Pharmacogenetic Yes
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA66
    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
    Belgium
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Poland
    Spain
    United Kingdom
    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
    LVLS
    UVUP
    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 months0
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 5
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 100
    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 remain in treatment until discontinuation.
    After subjects have ended participation on the study, standard of care treatment by their physician is expected.
    Los pacientes permanecerán en tratamiento hasta la interrupción.
    Después de que los pacientes hayan finalizado su participación en el estudio, se espera el tratamiento estándar de atención por parte de su médico.
    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 Decision2019-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-27
    P. End of Trial
    P.End of Trial StatusOngoing
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