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    Summary
    EudraCT Number:2016-004106-34
    Sponsor's Protocol Code Number:Dastop2October17th2016
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-01-25
    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 ConcernedFinland - Fimea
    A.2EudraCT number2016-004106-34
    A.3Full title of the trial
    PERSISTENCE OF MAJOR MOLECULAR REMISSION IN CHRONIC MYELOID LEUKEMIA AFTER a second stop of TKI TREATMENT in patients who failed an initial stop attempt: A prospective multicenter study .
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter trial where patients with CML stop medication a second time.
    Etenevä monikeskustutkimus, jossa tutkitaan tyrosiinikinaasiestäjä (TKE) lääkityksen lopettamismahdollisuutta kroonista myelooista leukemiaa (KML) sairastavilla potilailla, joilla ensimmäinen TKE-lääkityksen lopettamisyritys ei ole onnistunut
    A.3.2Name or abbreviated title of the trial where available
    DASTOP2
    A.4.1Sponsor's protocol code numberDastop2October17th2016
    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 SponsorUppsala University Hospital
    B.1.3.4CountrySweden
    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 supportBMS
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUppsala University Hospital
    B.5.2Functional name of contact pointUlla Olsson-Strömberg
    B.5.3 Address:
    B.5.3.1Street AddressVO Hematologi, Avd 50C, Akademiska Sjukhuset
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75185
    B.5.3.4CountrySweden
    B.5.4Telephone number+46186113738
    B.5.6E-mailulla.stromberg@talk21.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 SPRYCEL (Dasatinib)
    D.2.1.1.2Name of the Marketing Authorisation holderBMS
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameSprycel
    D.3.2Product code L01XE06
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    D.3.11.13.1Other medicinal product typeMyelosuppressive
    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 Myeloid Leukemia
    E.1.1.1Medical condition in easily understood language
    A type of chronic blood cancer
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main objective:
    Assessment of treatment-free remission (persistence of MMR) after sec-ond attempt of TKI discontinuation in patients who failed a relapsed in the EURO-SKI study or under EURO-SKI like conditions Patients must have received least three years of further TKI treatment of which the two last years should be dasatinib. The patients must have been in MR4 for at least one year.

    E.2.2Secondary objectives of the trial
    Secondary objectives:
    1.Identification of clinical and biological factors correlating with the persistence of MMR or better after stopping TKI a second time.
    2.Estimation of overall and progression free survival
    3.Evaluation of medico-economic impact of stopping TKI a second time.
    4.Time to re-achievement of MR4 after restart of therapy following a second molecular relapse
    5.Assessment of incidence of any AEs (e.g. from treatment related musculoskeletal AE ) that arise after stopping TKI treatment a sec-ond time.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Immunophenotyping of lymphocyte subsets.
    2. Assessment of antileukemic cytotoxic T-cell responses.
    3. Plasma cytokine profiling.
    4. Functional assessments of NK and T cells.
    5. Immunological monitoring-plasmacytoid DCs.
    6. Evaluation of soluble CD62L levels and TACE.
    activity as relapse risk sensing tools.
    7. TCR repertoire analysis by deep sequencing.
    8. Kir genotyping.
    9. Cytof-based Immune-phospho-flow cytometry
    E.3Principal inclusion criteria
    1.CML in CP under TKI treatment after failing a prior attempt to stop treatment within EURO-SKI or outside the study but according to EURO-SKI trial procedures. For the latter group this requires at least 3 years of TKI treatment (first line or second line due to intolerance to first line) before first stop, and MR4 for at least one year before stopping,
    2.Treated with TKI for at least one year after having failed a prior at-tempt to stop TKI. Previous TKI can be any.
    3.Typical BCR/ABL1 transcript (b3a2 and/or b2a2) must have been confirmed at diagnosis or later during the disease course.

    4.18 years or older
    E.4Principal exclusion criteria
    1.Previous hematological relapse after first stop of TKI.
    2.Previous AP/BC at any time in the history of the disease.
    3.Restart of TKI without loss of MMR after first stop
    4.Current participation in another clinical study.
    5.Previous or planned allogeneic stem cell transplantation.
    6.Patients with contra-indications to dasatinib therapy due to comor-bidities.
    7.Subjects with acute hepatitis B virus (HBV) infections.
    8.Uncontrolled or significant cardiovascular disease.
    9. Pulmonary arterial hypertension
    9.Pleural or pericardial effusions of any grade at study entry
    11. History of significant bleeding disorder unrelated to CML
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients maintaining MMR at 6 and 12 months after discontinuing TKI a second time (survival without loss of major molecular response, MMR, defined as BCR-ABL1 > 0.1% on IS at one time point).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 and 12 months after discontinuing TKI a second time.
    E.5.2Secondary end point(s)
    Assessment of:
    1.Number of patients who re-achieved stable MR4, and were offered study participation; proportion of patients who accept/refuse study participation.
    2.Clinical and biological factors correlating with persistence of MMR or better after second TKI stop (BCR-ABL level before 2nd stop, Sokal score, gender, duration and type of TKI-treatment, duration of first TKI-stop, immunological biomarkers)
    3.Overall and progression-free survival and the occurrence of a restart of TKI without prior molecular relapse.
    4.Net treatment cost savings from the time off TKI therapy a second time considering also the more frequent PCR monitoring.
    5.Time to reachievement of MR4 after second loss of MMR.
    6.Adverse events related to second TKI stop, clinical and biological factors correlated to development of these AE’s.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years after stop of TKI therapy
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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) 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 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 EEA19
    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 Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 134
    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)
    The treatment will be the physicians choice.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Nordic CML study group
    G.4.3.4Network Country Norway
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-01
    P. End of Trial
    P.End of Trial StatusOngoing
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