Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-005122-28
    Sponsor's Protocol Code Number:AB18001
    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:2021-08-25
    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 number2020-005122-28
    A.3Full title of the trial
    A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous of AB8939 in patients with Relapsed/Refractory Acute Myeloid Leukemia
    Estudio de fase I/II para evaluar la seguridad, la farmacocinética y la eficacia de la administración intravenosa diaria de AB8939 en pacientes con leucemia mieloide aguda recidivante/refractaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Assess the Safety, Pharmacokinetics, and Efficacy of AB8939 in patients with Relapsed/Refractory Acute Myeloid Leukemia
    Estudio para evaluar la seguridad, la farmacocinética y la eficacia de AB8939 en pacientes con leucemia mieloide aguda en recaída o refractaria
    A.4.1Sponsor's protocol code numberAB18001
    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 SponsorAB Science
    B.1.3.4CountryFrance
    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 supportAB Science
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB Science
    B.5.2Functional name of contact pointMr. Alain Moussy, CEO
    B.5.3 Address:
    B.5.3.1Street Address3 Avenue George V
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number33147201261
    B.5.6E-mailDL_MEDICALWRITERS@ab-science.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 name1-{4-[2-(5-ethoxymethyl-2-methyl-phenylamino)-oxazol-5-yl]-phenyl}-imidazolidin-2-one
    D.3.2Product code AB8939
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    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 INNABSABULIN
    D.3.9.2Current sponsor codeAB8939
    D.3.9.3Other descriptive name1-{4-[2-(5-ethoxymethyl-2-methyl-phenylamino)-oxazol-5-yl]-phenyl}-imidazolidin-2-one
    D.3.9.4EV Substance CodeSUB197706
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vidaza
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAzacitidine
    D.3.9.1CAS number 320-67-2
    D.3.9.3Other descriptive nameVidaza
    D.3.9.4EV Substance CodeSUB05624MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed/Refractory Acute Myeloid Leukemia
    Leucemia mieloide aguda recidivante/refractaria
    E.1.1.1Medical condition in easily understood language
    Refractory Acute Myeloid Leukemia
    Leucemia mieloide aguda refractaria
    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 PT
    E.1.2Classification code 10081513
    E.1.2Term Acute myeloid leukaemia refractory
    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
    To define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose (MTD) and the recommended dose for dose expansion study.
    Definir la seguridad y tolerabilidad de AB8939 en pacientes con LMA mediante la determinación de las toxicidades limitantes de la dosis, la dosis máxima tolerada (DMT) y la dosis recomendada para el estudio de expansión de dosis.
    E.2.2Secondary objectives of the trial
    To determine the pharmacokinetic profile in the function of dose.
    To assess early efficacy.
    Determinar el perfil farmacocinético en función de la dosis.
    Evaluar la eficacia temprana.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    EXPANSION COHORT STUDY
    Primary objective: To define the safety and tolerability of AB8939 in patients with refractory or relapsed AML by determining the dose-limiting toxicities, the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D).

    Secondary objectives:
    To determine the early efficacy of AB8939
    To determine the best regimen for AB8939
    To determine the pharmacokinetic profile in AML patients
    ESTUDIO DE COHORTE DE EXPANSIÓN
    Objetivo primario: Definir la seguridad y tolerabilidad de AB8939 en pacientes con LMA refractaria o en recaída, determinando las toxicidades limitantes de la dosis, la dosis máxima tolerada (DMT) y la dosis recomendada de fase 2 (DPR).

    Objetivos secundarios:
    Determinar la eficacia temprana de AB8939
    Determinar el mejor régimen para AB8939
    Determinar el perfil farmacocinético en pacientes con LMA
    E.3Principal inclusion criteria
    [Dose Escalation Study]
    1. Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification.
    2. If AML patients were eligible in first line to high dose chemotherapy, then patients should be in second or third line of treatment. If patients were not eligible in first line to high dose chemotherapy, then patient should be in second line of treatment. A line of treatment is defined as a combination of treatments that ends by a progression of the disease or toxicity related to this treatment
    3. Patients with refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognostic based on the IPSS-R scoring system. A line of treatment is defined as a combination of treatments that ends by a progression of the disease or toxicity related to this treatment
    4. Patients not eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
    5. Patients must be expected to complete the treatment period, in the opinion of the investigator.
    6. Male or non-pregnant female ≥ 18 years old at the time of signing the informed consent.
    7. ECOG performance status ≤ 1
    8. Patients must have adequate organ function without severe heart, lung, liver, kidney or nervous system dysfunction or immune deficiency
    9. In the absence of rapidly progressing disease, the interval from prior treatment to time of AB8939 administration should be at least 14 days.
    10. Adequate recovery, to a maximum of Grade 1 (CTCAE version5.0) from toxicity of prior therapy.
    11. Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
    12. Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies

    [Expansion Cohort Study]
    1. Patients with a documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification.
    2. If AML patients were eligible in first line to high dose chemotherapy, then patients should be in second or third line of treatment. If patients were not eligible in first line to high dose chemotherapy, then patients should be in second line of treatment. A line of treatment is defined as a combination of treatments that ends by a progression of the disease or toxicity related to this treatment
    3. Patients not eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
    4. Patients must be expected to complete the treatment period, in the opinion of the investigator.
    5. Male or non-pregnant female ≥ 18 years old at the time of signing the informed consent.
    6. ECOG performance status ≤ 2
    7. Patients must have adequate organ function without severe heart, lung, liver, kidney or nervous system dysfunction or immune deficiency
    8. In the absence of rapidly progressing disease, the interval from prior treatment to time of AB8939 administration should be at least 14 days.
    9. Adequate recovery, to a maximum of Grade 1 (CTCAE version5.0) from toxicity of prior therapy.
    10. Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
    11. Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies
    [Estudio de escalada de dosis]
    1. Pacientes con diagnóstico documentado de leucemia mieloide aguda (LMA) según la última versión de la clasificación de la Organización Mundial de la Salud.
    2. Si los pacientes con LMA eran elegibles en primera línea para la quimioterapia de alta dosis, entonces los pacientes deben estar en segunda o tercera línea de tratamiento. Si los pacientes no eran elegibles en primera línea de quimioterapia de alta dosis, entonces el paciente debe estar en segunda línea de tratamiento. Una línea de tratamiento se define como una combinación de tratamientos que termina por una progresión de la enfermedad o toxicidad relacionada con este tratamiento
    3. Pacientes con síndrome melyodisplásico refractario en segunda o tercera línea de tratamiento, y con alto riesgo pronóstico basado en el sistema de puntuación IPSS-R. Una línea de tratamiento se define como una combinación de tratamientos que termina por una progresión de la enfermedad o toxicidad relacionada con este tratamiento
    4. Pacientes no elegibles para trasplante de células madre hematopoyéticas (HSCT) en el momento de la inclusión
    5. Se debe esperar que los pacientes completen el período de tratamiento, a juicio del investigador.
    6. Hombre o mujer no embarazada ≥ 18 años en el momento de firmar el consentimiento informado.
    7. Estado de rendimiento ECOG ≤ 1
    8. Los pacientes deben tener una función orgánica adecuada sin disfunción grave del corazón, los pulmones, el hígado, los riñones o el sistema nervioso ni inmunodeficiencia
    9. En ausencia de una enfermedad de rápida progresión, el intervalo desde el tratamiento previo hasta el momento de la administración de AB8939 debe ser de al menos 14 días.
    10. Recuperación adecuada, hasta un máximo de grado 1 (CTCAE versión 5.0) de la toxicidad del tratamiento anterior.
    11. Los pacientes son capaces de entender, firmar y fechar el formulario de consentimiento informado por escrito en la visita de selección antes de cualquier procedimiento específico del protocolo.
    12. Los pacientes pueden y están dispuestos a cumplir con los procedimientos del estudio según el protocolo, incluyendo las biopsias de médula ósea.

    [Estudio de cohorte de expansión]
    1. Pacientes con un diagnóstico documentado de leucemia mieloide aguda (LMA) basado en la última versión de la clasificación de la Organización Mundial de la Salud.
    2. Si los pacientes con LMA eran elegibles en primera línea de quimioterapia de alta dosis, entonces los pacientes deben estar en segunda o tercera línea de tratamiento. Si los pacientes no eran elegibles en primera línea de quimioterapia de alta dosis, entonces los pacientes deben estar en segunda línea de tratamiento. Una línea de tratamiento se define como una combinación de tratamientos que termina por una progresión de la enfermedad o toxicidad relacionada con este tratamiento
    3. Pacientes no elegibles para trasplante de células madre hematopoyéticas (HSCT) en el momento de la inclusión
    4. Se debe esperar que los pacientes completen el período de tratamiento, en opinión del investigador.
    5. Hombre o mujer no embarazada ≥ 18 años en el momento de firmar el consentimiento informado.
    6. Estado de rendimiento ECOG ≤ 2
    7. Los pacientes deben tener una función orgánica adecuada sin disfunción grave del corazón, los pulmones, el hígado, los riñones o el sistema nervioso ni inmunodeficiencia
    8. En ausencia de una enfermedad de rápida progresión, el intervalo desde el tratamiento previo hasta el momento de la administración de AB8939 debe ser de al menos 14 días.
    9. Recuperación adecuada, hasta un máximo de grado 1 (CTCAE versión 5.0) de la toxicidad del tratamiento anterior.
    10. Los pacientes son capaces de entender, firmar y fechar el formulario de consentimiento informado por escrito en la visita de selección antes de cualquier procedimiento específico del protocolo.
    11. Los pacientes pueden y están dispuestos a cumplir con los procedimientos del estudio según el protocolo, incluidas las biopsias de médula ósea.
    E.4Principal exclusion criteria
    [Dose Escalation Study]
    1. Patients eligible to a standard of care
    2. Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
    3. Patients diagnosed with acute promyelocytic leukemia (M3)
    4. Patients with clinically active CNS leukemia
    5. Patients with other active malignancies are ineligible unless they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence or progression of that malignancy
    6. Patients with major surgery within 28 days prior to the first administration of AB8939
    7. Patients with radiation therapy within 28 days prior to the first administration of AB8939
    8. Patients with HSCT within 100 days prior to the first administration of AB8939
    9. Patients who have received prior standard treatment within 2 weeks or those who have not recovered from adverse events due to treatment administered more than 2 weeks earlier.
    10. Patients who are receiving any other investigational administered with the intention to treat their malignancy within 2 weeks from the last dose prior to entering the study, with the exception of hydroxyurea.
    11. Patients with history or evidence of cardiovascular, renal, neuromuscular or CNS disease.
    12. Patients with diabetes, vitamin B12 deficiency, or alcohol addiction
    13. Patients with known positive test for HIV, Hepatitis B, C
    14. Patients with white blood cells count or circulating blasts ≥ 20,000 cells/μL with hydroxyurea at screening
    15. Patients with
    • AST and or ALT ≥ 2.5 ULN,Total bilirubin level > 1.5 ULN (except in case of Gilbert’s syndrome but within the limit of 3 x ULN)
    • Serum creatinine ≥ 1.5 ULN
    • Albumin <30g/l
    16. Women who are lactating/breastfeeding or who plan to breastfeed while on sudy
    17. Women with a positive pregnancy test
    18. Men and women of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 6months + 5 times plasma half-life of AB8939 for women and 3 months for men after receiving the last dose of study drug
    19. Women planning to become pregnant while on study through 6months + 5 times plasma half-life of AB8939 after receiving the last dose of study drug
    20. Patients likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge
    21. Patients under psychiatric or, protected by law under guardianship or curatorship, or in emergency situations or, prisoners or, without National Health Insurance

    [Expansion Cohort Study]
    1. Patients eligible to a standard of care
    2. Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion
    3. Patients diagnosed with acute promyelocytic leukemia (M3)
    4. Patients with clinically active CNS leukemia
    5. Patients with other active malignancies are ineligible unless they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence or progression of that malignancy
    6. Patients with major surgery within 28 days prior to the first administration of AB8939
    7. Patients with radiation therapy within 28 days prior to the first administration of AB8939
    8. Patients with HSCT within 100 days prior to the first administration of AB8939
    9. Patients who have received prior standard treatment within 2 weeks or those who have not recovered from adverse events due to treatment administered more than 2 weeks earlier.
    10. Patients who are receiving any other investigational administered with the intention to treat their malignancy within 2 weeks from the last dose prior to entering the study, with the exception of hydroxyurea.
    11. Patients with history or evidence of cardiovascular, renal, neuromuscular or CNS disease.
    12. Patients with diabetes, vitamin B12 deficiency, or alcohol addiction
    13. Patients with known positive test for HIV, Hepatitis B, C
    14. Patients with white blood cells count or circulating blasts ≥ 20,000 cells/μL with hydroxyurea at screening
    15. Patients with
    • AST and or ALT ≥ 2.5 ULN,Total bilirubin level > 1.5 ULN (except in case of Gilbert’s syndrome but within the limit of 3 x ULN)
    • Serum creatinine ≥ 1.5 ULN
    • Albumin <30g/l (as AB8939 has a strong plasma protein binding)
    16. Women who are lactating/breastfeeding or who plan to breastfeed while on sudy
    17. Women with a positive pregnancy test
    18. Men and women of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through through 6months + 5 times plasma half-life of AB8939 for women and 3 months for men after receiving the last dose of study drug
    19. Women planning to become pregnant while on study through 6months + 5 times plasma half-life of AB8939 after receiving the last dose of study drug [Not complete due to characters maximum - please check protocol]
    [Estudio de escalada de dosis]
    1. Pacientes elegibles a un estándar de cuidado
    2. Pacientes elegibles para un trasplante de células madre hematopoyéticas (HSCT) en el momento de la inclusión
    3. Pacientes diagnosticados de leucemia promielocítica aguda (M3)
    4. Pacientes con leucemia del SNC clínicamente activa
    5. Los pacientes con otras neoplasias activas no son elegibles a menos que hayan estado libres de enfermedad durante al menos 3 años o que el investigador considere que tienen un bajo riesgo de recurrencia o progresión de esa neoplasia
    6. Pacientes con cirugía mayor dentro de los 28 días anteriores a la primera administración de AB8939
    7. Pacientes con radioterapia dentro de los 28 días anteriores a la primera administración de AB8939
    8. Pacientes con HSCT dentro de los 100 días anteriores a la primera administración de AB8939
    9. Pacientes que hayan recibido un tratamiento estándar previo en un plazo de 2 semanas o aquellos que no se hayan recuperado de acontecimientos adversos debidos a un tratamiento administrado más de 2 semanas antes.
    10. Pacientes que estén recibiendo cualquier otro tratamiento en investigación administrado con la intención de tratar su neoplasia en las 2 semanas siguientes a la última dosis antes de entrar en el estudio, con la excepción de la hidroxiurea.
    11. Pacientes con historia o evidencia de enfermedad cardiovascular, renal, neuromuscular o del SNC.
    12. Pacientes con diabetes, deficiencia de vitamina B12 o adicción al alcohol.
    13. Pacientes con pruebas positivas conocidas de VIH, Hepatitis B, C
    14. Pacientes con recuento de glóbulos blancos o blastos circulantes ≥ 20.000 células/μL con hidroxiurea en el momento del cribado
    15. Pacientes con
    - AST y o ALT ≥ 2,5 ULN,Nivel de bilirrubina total > 1,5 ULN (excepto en caso de síndrome de Gilbert pero dentro del límite de 3 x ULN)
    - Creatinina sérica ≥ 1,5 ULN
    - Albúmina <30g/l
    16. Mujeres que estén amamantando/amamantando o que planeen amamantar mientras estén en el estudio
    17. Mujeres con una prueba de embarazo positiva
    18. Hombres y mujeres con potencial reproductivo que no estén dispuestos a practicar un método(s) anticonceptivo(s) altamente efectivo(s) mientras estén en el estudio hasta 6 meses + 5 veces la vida media plasmática de AB8939 para las mujeres y 3 meses para los hombres después de recibir la última dosis del medicamento del estudio
    19. Las mujeres que planean quedarse embarazadas durante el estudio hasta 6 meses + 5 veces la vida media plasmática de AB8939 después de recibir la última dosis del fármaco del estudio
    20. Pacientes que probablemente no estén disponibles para completar todas las visitas o procedimientos del estudio requeridos por el protocolo, y/o para cumplir con todos los procedimientos del estudio requeridos según el mejor conocimiento del sujeto y del investigador
    21. 21. Pacientes con problemas psiquiátricos, protegidos por la ley bajo tutela o curatela, o en situaciones de emergencia, o presos, o sin Seguro Nacional de Salud.

    [Estudio de cohorte de expansión]
    1. Pacientes elegibles a un estándar de atención
    2. Pacientes elegibles para un trasplante de células madre hematopoyéticas (HSCT) en el momento de la inclusión
    3. Pacientes diagnosticados de leucemia promielocítica aguda (M3)
    4. Pacientes con leucemia del SNC clínicamente activa
    5. Los pacientes con otras neoplasias activas no son elegibles a menos que hayan estado libres de enfermedad durante al menos 3 años o que el investigador considere que tienen un bajo riesgo de recurrencia o progresión de esa neoplasia
    6. Pacientes con cirugía mayor dentro de los 28 días anteriores a la primera administración de AB8939
    7. Pacientes con radioterapia dentro de los 28 días anteriores a la primera administración de AB8939
    8. Pacientes con HSCT dentro de los 100 días anteriores a la primera administración de AB8939
    9. Pacientes que hayan recibido un tratamiento estándar previo en un plazo de 2 semanas o aquellos que no se hayan recuperado de acontecimientos adversos debidos a un tratamiento administrado más de 2 semanas antes.
    10. Pacientes que estén recibiendo cualquier otro tratamiento en investigación administrado con la intención de tratar su neoplasia en las 2 semanas siguientes a la última dosis antes de entrar en el estudio, con la excepción de la hidroxiurea.
    11. Pacientes con historia o evidencia de enfermedad cardiovascular, renal, neuromuscular o del SNC.
    12. Pacientes con diabetes, deficiencia de vitamina B12 o adicción al alcohol.
    13. Pacientes con pruebas positivas conocidas de VIH, Hepatitis B, C
    14. Pacientes con recuento de glóbulos blancos o blastos circulantes ≥ 20.000 células/μL con hidroxiurea en el momento del cribado
    15. Pacientes con
    - AST y o ALT ≥ 2,5 ULN,Nivel de bilirrubina total > 1,5 ULN (excepto en caso de síndrome de Gilbert pero dentro del límite de 3 x ULN)
    ...

    [No está completo debido a los caracteres máximos - por favor, compruebe el protocolo].
    E.5 End points
    E.5.1Primary end point(s)
    Rate of dose-limiting toxicity (DLT)
    Tasa de toxicidad limitante de la dosis (DLT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    Día 28
    E.5.2Secondary end point(s)
    PK parameters: Tmax, Cmax, AUC0-t, AUC0-inf, t1/2, Cl, Vd after the first administration for all patients.
    Rate of ORR
    Rate and durability of CR, CRi, CRMRD-, PR, HI, and MLFS
    Response rate based on the subtype of leukemia, risk-status, and genetic abnormalities.
    Parámetros PK: Tmáx, Cmáx, AUC0-t, AUC0-inf, t1/2, Cl, Vd después de la primera administración para todos los pacientes.
    Tasa de ORR
    Tasa y durabilidad de RC, RCi, RCMRD-, PR, HI y SLM
    Tasa de respuesta en función del subtipo de leucemia, el estado de riesgo y las anomalías genéticas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 28
    Día 28
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans 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 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 Yes
    E.8.1.7.1Other trial design description
    Diseño clínico 3+3 para el escalado de dosis con la secuencia 0,9; 1,8; 3,6; 9,0; 12,0; 16,0mg/m².
    Clinical 3+3 design for the dose escalation with the sequence 0.9; 1.8; 3.6; 9.0; 12.0; 16.0mg/m²
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Canada
    United States
    Belgium
    Spain
    Greece
    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 years1
    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 years1
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 48
    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 Decision2021-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-01
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA