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    Summary
    EudraCT Number:2011-000440-22
    Sponsor's Protocol Code Number:Euro-SKI
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-01-14
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-000440-22
    A.3Full title of the trial
    Multicenter prospective trial estimating the persistence of molecular remission in chronic myeloid leukemia after stopping TKI
    Multizentrische Studie zur Abschätzung der Fortdauer der molekularen Remission bei
    Chronischer Myeloischer Leukämie (CML) nach dem Absetzen von
    Tyrosinkinaseinhibitoren (TKI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stopping TKI in patients with CML in complete molecular remission
    Absetzen von TKI bei CML-Patienten in kompletter molekularer Remission (MR4)
    A.3.2Name or abbreviated title of the trial where available
    EUROpe Stop TKI
    A.4.1Sponsor's protocol code numberEuro-SKI
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01596114
    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 SponsorEuropean LeukemiaNet, Ruprecht-Karls-Universität Heidelberg
    B.1.3.4CountryGermany
    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 supportEuropean LeukemiaNet
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProf. François-Xavier Mahon
    B.5.2Functional name of contact pointMain Investigator
    B.5.3 Address:
    B.5.3.1Street AddressCHU de Bordeaux 33
    B.5.3.2Town/ cityPessac
    B.5.3.3Post code604
    B.5.3.4CountryFrance
    B.5.6E-mailfrancoisxavier.mahon@umr5540.ubordeaux2.fr
    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 Glivec 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.4Pharmaceutical 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 INNImatinib
    D.3.9.1CAS number 152459-95-5
    D.3.9.4EV Substance CodeSUB25387
    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 Tasigna 200mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm
    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.3.4Pharmaceutical 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 INNNILOTINIB
    D.3.9.1CAS number 641571-10-0
    D.3.9.4EV Substance CodeSUB25225
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Sprycel 140mg
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB
    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.3.4Pharmaceutical 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 INNDASATINIB
    D.3.9.1CAS number 302962-49-8
    D.3.9.4EV Substance CodeSUB23322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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
    chronic myeloid leukemia
    Chronische Myeloische Leukämie (CML)
    E.1.1.1Medical condition in easily understood language
    chronic myeloid leukemia
    Chronische Myeloische Leukämie (CML)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Evaluation of molecular relapse-free survival after stopping TKI (survival without molecular relapse defined by BCR-ABL1 > 0.1% on the IS at one time point (loss of major molecular response, MMR))
    E.2.2Secondary objectives of the trial
    • Overall and progression-free survival and the probabilities of a restart of TKI without prior molecular relapse
    • Clinical and biological profile of complete and major molecular remission persistence
    • Saved treatment costs / country from the time off TKI therapy considering also the more frequent PCR monitoring
    • Patient reported QoL and symptom burden over time
    • Registering patients in confirmed CMR4 and CMR4.5
    • Analysing the time to recovery of CMR4 after loss of MMR
    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: immunological monitoring
    • The study will assess here, whether stopping imatinib boosts PR3-specific CTL frequencies as a principal mechanism contributing to the maintenance of remissions
    2: more sensitive methods for MRD monitoring
    • Detection and quantitation of very low levels of minimal residual disease (MRD) till 10-6 could probably help to follow the course of the disease more precisely and thereby to more accurately tailor personalized therapeutic choices
    3: Assessment of the expression level of ICSBP (IRF-8) and IRF-4: role in predicting durability of CMR after TKI discontinuation
    • It is postulated that the expression level of IRF-4 and ICSBP genes predict, which patients can successfully maintain their remission after terminating of imatinib or a second generation TKI.
    E.3Principal inclusion criteria
    • CML in CP under treatment with TKI in first line or in second line because of toxicity to first line TKI or with TKI in combination
    • Duration of TKI treatment before enrolment at least 3 years
    • At least complete molecular remission CMR4 (either (i) detectable disease ≤0.01% BCR-ABL IS or (ii) undetectable disease in cDNA with ≥10,000 ABL or ≥24,000 GUS transcripts) for at least one year; at least three PCR-results with CMR4 within the last year (± 2 months) before study entry and no PCR-results > 0.01% during the same period
    • Before inclusion confirmation of CMR4 through a EUTOS-CMR laboratory
    • Baseline data and documentation on treatment before study entry available
    • Both sexes but fertile women only if using effective contraceptive
    • Health insurance coverage
    • 18 years or older
    • Known baseline data at diagnosis, EURO-Score
    CML in CP in TKI-Erstlinientherapie bzw. Zweitlinientherapie aufgrund von
    Unverträglichkeiten oder TKI-Kombinationsbehandlung
    -
    - Mindestens 3 Jahre TKI-Behandlung vor Studieneinschluss
    Vor Studieneinschluss eine molekulare Resterkrankung von MR4 (entweder (i)
    nachweisbare Resterkrankung von <=0.01% BCR-ABL IS oder (ii) nicht
    nachweisbare Resterkrankung in cDNA mit >=10,000 ABL oder >=24,000 GUS
    Transkripte) seit mindestens 1 Jahr; mindestens 3 PCR-Resultate mit MR4 innerhalb
    des letzten Jahres (+- 2 Monate) und keine PCR-Resultate > 0.01% während des
    gleichen Zeitraums
    -
    Vor Studieneinschluss Bestätigung der MR4 durch ein ausgewiesenes EUTOS-CMR
    Labor
    -
    - Baseline Daten and Therapie vor Studieneintritt können dokumentiert werden
    - Frauen nur, wenn eine effektive Empfängnisverhütung angewandt wird
    - Vorhandene Krankenversicherung
    - Volljährigkeit (18 Jahre oder älter)
    - Baseline Daten zum Diagnosezeitpunkt und EURO-Score bekannt
    E.4Principal exclusion criteria
    • Under 18 years old
    • Hospitalized patients without ability to give informed consent
    • Adults under law protection or without ability to consent
    • Previous or planned allogeneic stem cell transplantation
    - Nicht einwilligungsfähige Patienten
    - Adults under law protection or without ability to consent
    - Vorangegangene oder geplante allogene Stammzelltransplantation
    - Alter >= 18 Jahre
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of the duration of MMR or better after stopping of TKI therapy
    E.5.1.1Timepoint(s) of evaluation of this end point
    An interim analysis will be performed as soon as 200 patients have been observed for at least six months without a restart of TKI treatment prior to molecular relapse.
    E.5.2Secondary end point(s)
    1- Identification of clinical and biological factors affecting the persistence of complete molecular remission and MMR after stopping TKI (e.g. level of CMR before treatment stop, risk score, duration of TKI treatment, type of TKI pretreatment)
    2- Estimation of overall and progression free survival, and probabilities of a restart of TKI treatment without prior molecular relapse
    3- Patient reported QoL and symptom burden over time
    4- Evaluation of medico-economic impact of stopping TKI
    5- Estimating the number of patients in CMR (CMR4 and CMR4.5) who would be eligible for stopping TKI therapy
    6- Time to recovery of CMR4 after restart of therapy following molecular relapse
    E.5.2.1Timepoint(s) of evaluation of this end point
    An interim analysis will be performed as soon as 200 patients have been observed for at least six months without a restart of TKI treatment prior to molecular relapse. With two year recruitment and three years follow-up, for all projected patients, the six-month and the three-year molecular relapse-free survival statuses will be available. Thus, above hypothesis can be examined at the final analysis, too.
    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 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) 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA94
    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
    the last visit of the last subject
    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: 500
    F.1.3Elderly (>=65 years) No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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)
    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 Decision2013-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-01-08
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