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    EudraCT Number:2020-005461-14
    Sponsor's Protocol Code Number:LD-VenEx
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-12
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNorway - NOMA
    A.2EudraCT number2020-005461-14
    A.3Full title of the trial
    The Nordic AML Group – LD-VenEx:
    Fase II studie av Akutt Myelogen Leukemi behandling med Azacitidine i kombinasjon med lavdose Venetoclax inkludert Ex Vivo Vurdering av sensitivtet og resistence utvikling mot medikamenter
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Acute myelogenic Leukemia (AML) treatment for patients who can not recieve intensiv chemotherapy combining standard treatment (Azacitidin ) with study medicine(low dose Venetoclax) for better responce and we will look at effect of medicines on leukemic cells and possible resistence developement to help find new ways for treatment
    Studie om behandling av Akutt Myelogen Leukemi(AML) med kombinasjon av Standard behandling (Azacytidine) med studiemedisin(Lavdose Venetoclax )hos pasienter som ikke kan få kraftig cellgiftbehandling
    A.3.2Name or abbreviated title of the trial where available
    NAMLG-001 LD-VenX
    A.4.1Sponsor's protocol code numberLD-VenEx
    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 SponsorRighospitalet
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRigshospitalet
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointPeter Brown
    B.5.3 Address:
    B.5.3.1Street AddressRigshospitalet, Dept. of Hematology Address: Blegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    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. name Venclyxto
    D. of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    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.3.1Product nameVENETOCLAX
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive nameVenetoclax
    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 number400
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Acute Myelogenic Leukemia is aggressiv leukemia and treatment i challenging specialy in patients not eligible for intensiv chemotherapy or relapsed after intensiv chemotherapy.In this study we will use study medicine (low dose Venetoclax)in combination with standard treatment (Azacitidine) for better responce and survival and examine mechanism for drug sensitivity and resistence
    Akutt Myelogen Leukemi (AML) er agressiv type leukemia og behandlingen er ufordrende hos pasienter som ikke kan få intensiv cellgift behandling eller fått tilbakefall etter intensiv cellgift kuren
    I denne studien vil vi kombinere studiemedisin (lav dose Venetoclax )med Standard behandling(Azacitidin)for bedre responce og overlevelse
    Vi vil også undersøkre mekanismer for medikament responce og resistence utvikling
    E.1.1.1Medical condition in easily understood language
    AML is agressiv type blood cancer which is common in elderly and is challenging to treat specialy i patient who can not recieve intensiv chemotherapy or get relapsed disease after such therapy ,
    AML er aggressiv type blodkreft vanligvis rammer eldre det er utfordrende å behandle spesielt hos pasienter som ikke kan få intensiv cellegift behandling eller fått tilbakefall etter slik behandling
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of azacitidine in combination with low dose venetoclax in patients with AML

    (ORR=CR/CRi/MLFS rate, composite CR/CRh rate, PR rate).

    Vurdere effekt av kombinasjon Azacitidine med lav dose Venetoclax i AML behandling

    ORR= CR/CRi/MLFS rate, composite CR/CRh rate, PR rate).
    E.2.2Secondary objectives of the trial
    To assess overall survival (OS), duration of response (DOR), event free survival (EFS) in patients with AML.

    To assess the safety of azacitidine in combination with low dose venetoclax in patients with AML.

    Vurdere overlevelse med OS,Varighet av responce ,EFS

    Vurdere safety av kombinasjon Azacitidine med lav dose Venetoclax
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent.
    2. Patients who present with one of the following (except acute promyelocytic leukemia).
    a. De novo or secondary AML unfit for standard induction therapy (see inclusion criterion 8).
    b. Relapsed/refractory AML after at least 1 line of prior therapies (see inclusion criterion 9).
    3. Written informed consent to participate in an exploratory research protocol including biobanking, comprehensive AML profiling (genomics, transcriptomics, proteomics, etc.) and ex vivo drug sensitivity testing to assess venetoclax and other drug sensitivities.
    a. All patients are treated with azacitidine+venetoclax irrespective of the ex vivo screening results.
    4. ECOG Performance status ≤ 2 for patients ≥ 75 years of age OR ≤ 3 for patients ≥ 18 to 74 years of age.
    5. Leukocyte count < 25 x10E9/l. Hydroxyurea use is permitted to meet this criterion.
    6. Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 30 mL/min; determined by the Cockcroft Gault formula.
    7. Adequate liver function as demonstrated by
    a. alanine aminotransferase (ALT) ≤ 4.0 × ULN.
    b. bilirubin ≤ 1.5 × ULN.

    8. Specific inclusion criteria for elderly/unfit AML patients:
    a. ≥ 70 years of age
    b. ≥ 18 to 69 years of age and ineligible for intensive chemotherapy meeting at least one of the following criteria:
    • Clinically significant comorbidities, as reflected by at least 1 of the following criteria:
    o Left ventricular ejection fraction (LVEF) < 50%.
    o Lung diffusion capacity for carbon monoxide (DLCO) ≤ 65% of expected.
    o Forced expiratory volume in 1 second (FEV1) ≤ 65% of expected.
    o Chronic stable angina or congestive heart failure controlled with medication.
    o Alanine aminotransferase (ALT) 3.0-4.0 × ULN.
    • Other contraindication(s) to anthracycline therapy (must be documented).
    • Adverse risk genetics (ELN criteria) associated with poor outcome with standard chemotherapy.
    • Patient declines intensive chemotherapy.
    • Secondary AML after previous disease modifying treatment (i.e. HMA/induction chemotherapy and/or allogeneic stem cell transplantation) of clonal myeloid diseases such as MDS, MDS/MPN, or MPN.

    9. Specific inclusion criteria for relapsed AML patients:
    a. ≥ 55 years of age with non-CBF AML relapse
    b. ≥ 18 of age and meeting at least one of the following criteria:
    • Not candidate for intensive chemotherapy (see criterion 8).

    • Relapse after chemotherapy, or monotherapy with HMA, or allogeneic stem cell transplantation. (note: patients with 4th or higher relapse are excluded).
    • Patient declines intensive chemotherapy.

    10. Specific inclusion criteria for refractory AML patients: Patients who fail to achieve a complete or partial remission after previous monotherapy with HMA or induction chemotherapy (at least 1 cycle of chemotherapy containing cytarabine or clofarabine, in combination with a topoisomerase II inhibitor (e.g. anthracycline or mitoxantrone).

    E.4Principal exclusion criteria
    1. Acute promyelocytic leukemia (APL).
    2. Patients with 4th or higher AML relapse.
    3. Leukemic cell content (blast percentage) in bone marrow/peripheral blood < 10 %.
    4. ECOG >3 (see also inclusion criteria 4).
    5. Prior venetoclax treatment for myeloid malignancy.
    6. AML patients with CNS involvement (note: cerebrospinal fluid or radiological investigations are not required without clinical suspicion).
    7. HIV infection or active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection that is not controlled with antiviral medication with the definition hereof at the discretion of the investigator.
    8. Cardiovascular disability status of New York Heart Association Class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in palpitations, fatigue, dyspnea, or anginal pain.
    9. Evidence of clinically significant condition(s), which at the investigator's discretion would adversely affect the patient's participation in this study (including but not limited to):
    a. Chronic respiratory disease that requires continuous oxygen use.
    b. Systemic uncontrolled infection requiring therapy (viral, bacterial or fungal).
    c. Malabsorption syndrome or other condition that precludes enteral route of administration.
    d. Uncontrolled GVHD.
    10. Previous malignancies with the exception of previous malignancy treated successfully with curative intent and indolent/smoldering malignancies (defined at the investigator's discretion).

    11. Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment).
    12. Fertile men or women of childbearing potential unless:
    a. Surgically sterile or ≥ 2 years after the onset of menopause.
    b. Willing to use two methods of reliable contraception including one highly effective contraceptive method (Pearl Index <1) and one additional effective (barrier) method during study treatment and for 3 months after the end of study treatment.
    13. Known hypersensitivity to venetoclax or azacitidine or excipients of any of the drugs.
    E.5 End points
    E.5.1Primary end point(s)
    Complete Remission CR
    Complete Remission with Incomplete Hematologic Recovery (CRi)
    Morphologic Leukemia-Free State MLFS

    Komplett Remisjon
    Komplett remisjon med inkomplett hematologisk remisjon
    Morfologisk leukemifri status
    E.5.1.1Timepoint(s) of evaluation of this end point
    When relevant data of all patients are available and validated
    Når relevente data fra alle inkluderte pasienter er tilgjengelig og validert
    E.5.2Secondary end point(s)
    • Overall survival (OS), duration of response (DOR), event free survival (EFS)
    • The correlation of ex vivo sensitivity and specific clinical responses (OS, DOR, EFS, MRD status)
    • The correlation of venetoclax blood concentrations and specific responses (OS, DOR, EFS, MRD status)
    • Frequency and severity of adverse events (AEs)
    Total overlevelse,Hendelse fri overlevelse
    Relasjon mellom ex vivo medikament test med klinisk effekt
    Relasjon mellom medikament speil i serum ift responce
    E.5.2.1Timepoint(s) of evaluation of this end point
    When relevant data of all patients are available and validated
    Når alle relevente data er tilgjengelig og validert
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 the study is defined as the date when the last patient has
    received 2 years of treatment or been followed-up for at least 2 years
    after inclusion in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months12
    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: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 53
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 117
    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)
    Patients who responding properly to the treatment will continue with treatment with Azacitidine and Low dose Venetoclax until disease progression or developed uacceptable side effects
    responding patient to treatment will be followed regularily for responce evaluation with bone marrow examination every 3 mounths
    Patients with progressed disease will recieve alternativ treatment for AML which is standard care
    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 Decision2022-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-11
    P. End of Trial
    P.End of Trial StatusOngoing
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