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    Summary
    EudraCT Number:2021-000722-96
    Sponsor's Protocol Code Number:PS-CLL-005
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-000722-96
    A.3Full title of the trial
    Lymph Node Microenvironment Modifications in Patients with CLL Treated with Venetoclax-based regimens
    Modificazioni del microambiente linfonodali in pazienti con leucemia linfatica cronica CLL in trattamento con regimi contenenti venetoclax
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    changes in lymph nodes in patients with CLL treated with venetoclax-containing regimens
    Modificazioni del microambiente linfonodali in pazienti con leucemia linfatica cronica CLL in trattamento con regimi contenenti venetoclax
    A.3.2Name or abbreviated title of the trial where available
    LymBIO
    LymBIO
    A.4.1Sponsor's protocol code numberPS-CLL-005
    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 SponsorOSPEDALE SAN RAFFAELE
    B.1.3.4CountryItaly
    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 supportAbbVie
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointUfficio Data Management PS-CLL
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number0226433919
    B.5.5Fax number0226432611
    B.5.6E-mailghia.paolo@hsr.it
    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.2.1.1.2Name 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 nameVenclyxto
    D.3.2Product code [Venclyxto]
    D.3.4Pharmaceutical form 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.3.9.1CAS number 1257044-40-8
    D.3.9.2Current sponsor codevenetoclax
    D.3.9.4EV Substance CodeSUB176260
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Chronic Lymphocytic Leukemia
    Leucemia Linfatica Cronica
    E.1.1.1Medical condition in easily understood language
    Chronic Lymphocytic Leukemia
    Leucemia Linfatica Cronica
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10009310
    E.1.2Term CLL
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate changes in lymph nodes in patients with CLL treated with venetoclax-containing regimens at both the molecular and ultrasound level
    Valutare i cambiamenti nei linfonodi in pazienti con CLL trattati con regimi contenenti venetoclax sia a livello molecolare che ecografico
    E.2.2Secondary objectives of the trial
    ¿ To evaluate CLL cell changes in PB in CLL patients treated with venetoclax-based regimens
    ¿ Correlate changes in the lymph node microenvironment and CLL cells from LN and PB with response to treatment and clinical course
    ¿ Evaluate lymph node characteristics in patients with CLL treated with venetoclax-based regimens who achieve undetectable (<10-4) vs detectable (=10-4) MRD status,
    ¿ To evaluate lymph node characteristics in patients with CLL treated with venetoclax-based regimens that achieve complete (CR) or partial (PR) response
    ¿ Valutare i cambiamenti delle cellule CLL nel PB nei pazienti con CLL trattati con regimi a base di venetoclax
    ¿ Correlare i cambiamenti nel microambiente linfonodale e nelle cellule CLL da LN e PB con la risposta al trattamento ed il decorso clinico
    ¿ Valutare le caratteristiche dei linfonodi nei pazienti con CLL trattati con regimi a base di venetoclax che raggiungono uno stato di MRD non rilevabile (<10-4) vs rilevabile (=10-4),
    ¿ Valutare le caratteristiche dei linfonodi nei pazienti con CLL trattati con regimi a base di venetoclax che raggiungono una risposta completa (CR) o parziale (PR)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of CLL
    2. Candidate patients for treatment with venetoclax-based regimens
    3. Basal value of platelets> 100x109 / l
    4. PT INR and aPTT within the limits
    1. Diagnosi di CLL
    2. Pazienti candidate a trattamento con regimi a base di venetoclax
    3. Valore basale di piastrine >100x109/l
    4. PT INR e aPTT nei limiti
    E.4Principal exclusion criteria
    1. Patients receiving antiplatelet and / or anticoagulant therapy that cannot be safely stopped prior to biopsy
    1. Pazienti che ricevono terapia antiaggregante e/o anticoagulante che non può essere interrotta in sicurezza prima della biopsia
    E.5 End points
    E.5.1Primary end point(s)
    - Characterization by immunohistochemistry, gene expression profile, protein expression and proliferative activity of CLL lymphocytes and LN-derived accessory cells of CLL patients treated with venetoclax-based regimens 12 months after completion of the venetoclax ramp-up phase
    - Definition of ultrasound characteristics of LNs in CLL patients treated with venetoclax-based regimens 12 months after completion of the venetoclax acceleration phase
    -Caratterizzazione mediante immunoistochimica, profilo di espressione genica, espressione proteica e attività proliferativa dei linfociti CLL e delle cellule accessorie derivate da LN di pazienti con CLL trattati con regimi a base di venetoclax 12 mesi dopo il completamento della fase di ramp-up di venetoclax
    - Definizione delle caratteristiche ecografiche dei LN in pazienti con CLL trattati con regimi a base di venetoclax 12 mesi dopo il completamento della fase di accelerazione di venetoclax
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after completion of venetoclax acceleration phase
    12 mesi dopo il completamento della fase di ramp-up di venetoclax
    E.5.2Secondary end point(s)
    Immuhistochemical characterization, gene expression profile, protein expression and proliferative activity of CLL lymphocytes and PB-derived accessory cells of CLL patients treated with venetoclax-based regimens 12 months after completion of the ramp-up phase up by venetoclax
    Caratterizzazione immuistochimica, del profilo di espressione genica, dell'espressione proteica e dell'attività proliferativa dei linfociti CLL e delle cellule accessorie derivate da PB di pazienti con CLL trattati con regimi a base di venetoclax 12 mesi dopo il completamento della fase di ramp-up di venetoclax
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months after completion of venetoclax acceleration phase
    12 mesi dopo il completamento della fase di ramp-up di venetoclax
    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 No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 Information not present in EudraCT
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    not applicable
    non applicabile
    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 Decision2021-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-09
    P. End of Trial
    P.End of Trial StatusOngoing
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