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    Summary
    EudraCT Number:2017-004232-11
    Sponsor's Protocol Code Number:M16-085
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-10
    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 number2017-004232-11
    A.3Full title of the trial
    A Phase 2, Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in combination with Pomalidomide and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma
    Estudio en fase 2, multicéntrico, abierto y de incremento escalonado y ampliación de la dosis de venetoclax en combinación con pomalidomida y dexametasona en pacientes con mieloma múltiple recidivante o resistente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-Label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in Combination with Pomalidomide and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma
    Estudio de fase 2, en distintos centros, abierto, de escalado y expansión de dosis de venetoclax en compbinación con pomalidomida y dexametasona en pacientes con mieloma múltiple resistente o en recaída
    A.4.1Sponsor's protocol code numberM16-085
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34901200103
    B.5.6E-mailabbvie_reec@abbvie.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Venclyxto
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1767
    D.3 Description of the IMP
    D.3.1Product nameVenetoclax
    D.3.2Product code ABT-199 (GDC-0199)
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVenetoclax
    D.3.9.2Current sponsor codeABT-199 (GDC-0199)
    D.3.9.4EV Substance CodeSUB176260
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Imnovid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/672
    D.3 Description of the IMP
    D.3.1Product nameImnovid
    D.3.2Product code pomalidomide
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpomalidomide
    D.3.9.1CAS number 19171-19-8
    D.3.9.3Other descriptive namePOMALIDOMIDE
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Imnovid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/672
    D.3 Description of the IMP
    D.3.1Product nameImnovid
    D.3.2Product code pomalidomide
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpomalidomide
    D.3.9.1CAS number 19171-19-8
    D.3.9.3Other descriptive namePOMALIDOMIDE
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Imnovid
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/672
    D.3 Description of the IMP
    D.3.1Product nameImnovid
    D.3.2Product code pomalidomide
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpomalidomide
    D.3.9.1CAS number 19171-19-8
    D.3.9.3Other descriptive namePOMALIDOMIDE
    D.3.9.4EV Substance CodeSUB33379
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    R/R Multiple Myeloma
    Mieloma múltiple recidivante o resistente
    E.1.1.1Medical condition in easily understood language
    Subjects with a type of blood cancer (multiple myeloma) that is either relapsed (comes back) or refractory (did not get better) after prior treatment.
    Sujetos con un tipo de cáncer de sangre (mieloma múltiple) que es en recaída (la enfermedad ha vuelto) o resistente (que no tiene mejoras) después del primer tratamiento
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the safety and tolerability profiles of venetoclax combined with pomalidomide and dexamethasone when co-administered in subjects with R/R MM
    Para caracterizar los perfiles de seguridad y tolerabilidad de venetoclax en combinación con pomalidomida y dexametasona suministrados conjuntamente en sujetos con mieloma múltiple recidivante o resistente
    E.2.2Secondary objectives of the trial
    -To evaluate the anti-MM activity of co-administered venetoclax combined with pomalidomide and dexamethasone when co-administered in subjects with R/R MM

    -To characterize the plasma pharmaacokinetics (PK) of venetoclax and pomalidomide when co-administered in subjects with R/R MM
    - Evaluar la activad anti mieloma múltiple de venetoclax en combinación con pomalidomida y dexametasona cuando suministrados conjuntamente en sujetos con mieloma múltiple recidivante o resistente
    - Caracterizar la farmacocinética en plasma del venetoclax y pomalidomida cuando suministrados conjuntamente en sujetos con mieloma múltiple recidivante o resistente
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male of female, at least 18 years old
    • R/R MM with documented evidence of progression during or after the subject's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) criteria
    • Measurable disease, defined by at least 1 of the following disease activity criteria:
    - serum M-protein ≥ 1.0 g/dL (≥ 10 g/L) for immunoglobulin (Ig)G MM
    - serum M-protein ≥ 0.5 g/dL (≥ 5 g/L) for IgA, IgD, IgE, and IgM MM
    - urine M-protein ≥ 200 mg/24 hours
    - serum-free light chain (FLC) ≥ 10 mg/dL provided serum FLC ratio is abnormal
    • Has received at least 1 prior line of therapy
    • Must meet all of the following prior antimyeloma treatment parameters:
    - subject must have received at least 2 consecutive cycles of lenalidomide or a lenalidomide-containing regimen
    - subject must be refractory to lenalidomide
    - subject must have been exposed to a proteasome inhibitor alone or in combination with another agent
    - subject must have had a response of PR or better to prior therapy based on the investigator's determination of response as defined by IMWG criteria
    • Has t(11;14) status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per central laboratory testing of a bone marrow aspirate sample and meets the following criteria:
    - For Part 1: MM subjects independent of cytogenetic profile
    - For Part 2, Arm A: subject must be t(11;14) positive
    - For Part 2, Arm B: subject must be t(11;14) negative
    • (ECOG) performance status ≤ 2
    - Hombre o mujer, de al menos 18 años
    - Mieloma múltiple recidivante o resistente con signos documentados de progresión durante o después de la última pauta de tratamiento del paciente según la determinación del investigador de los criterios del International Myeloma Working Group (IMWG).
    - Enfermedad mensurable, definida por al menos 1 de los siguientes criterios de actividad de la enfermedad:
    • Proteína M sérica ≥ 1,0 g/dl (≥ 10 g/l) para MM de inmunoglobulina (Ig)G.
    • Proteína M sérica ≥ 0,5 g/dl (≥ 5 g/l) para MM IgA, IgD, IgE e IgM.
    • Proteína M en orina ≥ 200 mg/24 horas.
    • Cadenas ligeras libres (CLL) en suero ≥ 10 mg/dl (100 mg/l) siempre que el cociente de CLL en suero sea anómalo.
    - Han recibido previamente al menos 1 línea de tratamiento.
    - Deben cumplir todos los siguientes parámetros del tratamiento previo contra el mieloma:
    • El paciente debe haber recibido al menos 2 ciclos consecutivos de lenalidomida o una pauta con lenalidomida.
    • El paciente debe ser resistente a lenalidomida.
    • El paciente debe haber estado expuesto a un inhibidor del proteasoma solo o en combinación con otro fármaco.
    • El paciente debe haber tenido una respuesta de RP o mejor al tratamiento previo basándose en la determinación de la respuesta por el investigador según lo definido por los criterios del IMWG.
    - El paciente tiene un estado t(11;14) determinado mediante un análisis de hibridación in situ con fluorescencia (FISH) validado analíticamente según el laboratorio central de una muestra de aspirado de médula ósea y cumple los criterios siguientes:
    • En la parte 1: Pacientes con MM independientes del perfil citogenético.
    • En la parte 2, grupo A: el paciente debe presentar positividad de t(11;14).
    • En la parte 2, grupo B: el paciente debe presentar negatividad de t(11;14).
    • Estado funcional del Eastern Cooperative Oncology Group (ECOG) ≤ 2.
    E.4Principal exclusion criteria
    • previous treatment with venetoclax or other BCL-2 inhibitors, or previous treatment with pomalidomide
    • known sensitivity to any IMiDs
    • allogenic or syngeneic stem cell transplant within 6 months before the first dose of study drug or active ongoing graft versus host disease
    • autologous stem cell transplant within 12 weeks before the first dose of study drug
    • known meningeal involvement of MM
    - tratamiento previo con venetoclax u otros inhibidores de BCL-2, o tratamientos previos con pomalidomida
    - sensibilidad conocida a cualquier fármaco inmunomodulador
    - transplante de células madre allogénico o singénico en los 6 meses antes de la primera dosis del medicamento del estudio o enfermedad activa de injerto en huesped
    - transplante de células madre autólogo en las 12 semanas antes de la primera dosis del fármaco en estudio
    - afectación meníngea conocida de mieloma múltiple
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate
    Ratio de respuesta global
    E.5.1.1Timepoint(s) of evaluation of this end point
    Dependent on individual subjects response to therapy. All subjects with be treated until progressive disease, unacceptable toxicity, or other reason for discontinuation
    Dependiendo de la respuesta individual de cada sujeto a la terapia. Cada sujeto se tratará hasta la progresión de la enfermedad, toxicidad inaceptable, o cualquier otra razón para la discontinuación
    E.5.2Secondary end point(s)
    - Secondary Endpoints are:
    • Progression-free survival (PFS)
    • Duration of response (DOR)
    • Time-to-progression (TTP
    Objetivos secundarios
    - Supervivencia libre de progresión
    - Duración de la respuesta
    - Tiempo hasta la progresión
    E.5.2.1Timepoint(s) of evaluation of this end point
    Will be monitored throughout the subject's participation in the study.
    Se monitorizará a lo largo de la participación del sujeto en el estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 concerned5
    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
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end-of-study is defined as the last subject’s last visit, or date of the last follow-up contact, whichever is later.
    El final del estudio está definido como la última visita del último sujeto o la fecha del último contacto de seguimiento, la que más tarde sea.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 60
    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)
    For subjects that continue to derive benefit after 2 years of treatment following the date of the last subject enrolled, AbbVie will work with the investigator to evaluate options for continuation of venetoclax therapy.
    Para los sujetos que continúan obteniendo beneficio 2 años después de tratamiento contando a partir de la fecha del último sujeto incluido, Abbvie trabajará con el Investigador para evaluar las opciones disponibles para continuar la terapia con Venetoclax.
    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 Decision2018-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-18
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