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    Summary
    EudraCT Number:2021-000602-17
    Sponsor's Protocol Code Number:CABL001A2001B
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-10-17
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2021-000602-17
    A.3Full title of the trial
    An open label, multi-center asciminib roll-over study to assess long-term safety in patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess long-term safety in patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
    A.4.1Sponsor's protocol code numberCABL001A2001B
    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 SponsorNovartis Pharma AG
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma Services Romania S.R.L.
    B.5.2Functional name of contact pointRadu Boroghina - TMO Head Romania
    B.5.3 Address:
    B.5.3.1Street Address2 Gara Herastrau St., Equilibrium Complex, Buliding 1, Floor 10, Section E10.02, District 2
    B.5.3.2Town/ cityBucharest
    B.5.3.3Post code020334
    B.5.3.4CountryRomania
    B.5.4Telephone number+4021 3129901
    B.5.5Fax number+4021 3129907
    B.5.6E-mailradu_dan.boroghina@novartis.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/20/2261
    D.3 Description of the IMP
    D.3.1Product nameAsciminib
    D.3.2Product code ABL001
    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 INNASCIMINIB
    D.3.9.2Current sponsor codeABL001
    D.3.9.4EV Substance CodeSUB188597
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 No
    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/3/20/2261
    D.3 Description of the IMP
    D.3.1Product nameAsciminib
    D.3.2Product code ABL001
    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 INNASCIMINIB
    D.3.9.2Current sponsor codeABL001
    D.3.9.4EV Substance CodeSUB188597
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Male and female adult participants (= 18 years) with Ph+ CML or Ph+ ALL at the end of parent study, who are currently participating in an asciminib Novartis sponsored parent study
    E.1.1.1Medical condition in easily understood language
    cancer of the blood cells: CML and Ph+ ALL
    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 10009012
    E.1.2Term Chronic myelogenous leukemia
    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 10034877
    E.1.2Term Philadelphia chromosome positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess long term safety data and provide continued access to study treatment received in the parent protocol.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate clinical benefit as assessed by the Investigator.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent must be obtained prior to participation in the study.
    2. Participant with Ph+ CML or Ph+ ALL, currently enrolled in a Novartis
    sponsored study, that has completed treatment phase and has fulfilled
    the requirements for the primary objective, receiving:
    -asciminib
    -asciminib in combination with imatinib or nilotinib or dasatinib
    -imatinib
    -nilotinib
    -bosutinib
    and, in the opinion of the Investigator, would benefit from continued treatment.
    3. Participant has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.
    4. Other protocol-defined inclusion criteria may apply
    E.4Principal exclusion criteria
    1. Participant has been discontinued from parent study treatment due to any reason.
    2. Participant currently has unresolved toxicities of grade 3 or 4 reported as possibly related to study treatment in the parent study, which have:
    - not resolved to Grade 2 or lower within 42 days and /or require dose interruption for longer than 42 days for hematological toxicities,
    - not resolved to Grade 2 or lower within 28 days and /or require dose interruption for longer than 28 days in case of non-hematological toxicities.
    3. Participant’s ongoing treatment is currently approved and reimbursed at country level.
    4. Pregnant or nursing (lactating) women.
    5b. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 3 days after stopping asciminib. If local regulations or locally
    approved prescribing information are more stringent than the protocol
    required duration of contraception (Section 8.4.3), local regulations or
    locally approved prescribing information apply and will be described in
    the ICF. Participants receiving imatinib, nilotinib, bosutinib or dasatinib should be willing to follow the relevant contraception requirements as in the local prescribing information.
    6a. Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib should be willing to follow the relevant contraception requirements as in the local prescribing information.
    7. Applicable only for participants on bosutinib treatment at the end of the ABL001A2301 study that switch to asciminib treatment at enrollment:
    -Any Grade 3 or 4 toxicity which has not resolved to Grade 2 or lower within 28 days before starting asciminib treatment.
    -Asymptomatic (grade 2) pancreatitis if not resolved within 28 days.
    -QTcF > 480 msec or inability to determine QTc interval
    8. Other protocol-defined exclusion criteria may apply
    E.5 End points
    E.5.1Primary end point(s)
    The frequency and severity of AEs/SAEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Study of 5 years
    E.5.2Secondary end point(s)
    Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Study of 5 years
    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 No
    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) Yes
    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
    Roll-over study, Bosutinib patients have the option to switch to asciminib during the study
    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 trial8
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    Argentina
    Singapore
    Taiwan
    Brazil
    Canada
    China
    Japan
    Korea, Republic of
    Lebanon
    Mexico
    Russian Federation
    Saudi Arabia
    United Kingdom
    United States
    Austria
    Bulgaria
    Czechia
    Denmark
    France
    Germany
    Italy
    Netherlands
    Poland
    Portugal
    Romania
    Spain
    Türkiye
    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
    Study is expected to remain open for 5 years or until one of the below scenario occurs for all participants, whichever comes first:
    •ongoing treatment becomes available following product launch and/or subsequent reimbursement (where applicable)
    •benefit-risk profile of ongoing treatment for participant is no longer positive
    •participant meets treatment discontinuation criteria
    •other access program becomes available or is identified (i.e. compassionate use, MAP, etc.) for ongoing treatment
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 260
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 660
    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 remain on the study as long as they benefit from the study treatment until the IMP gets available outside of the study. Patients that discontinue the study will be treated with local available standard of 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 Decision2022-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-25
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    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
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