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    Summary
    EudraCT Number:2017-000899-28
    Sponsor's Protocol Code Number:CAMN107CNL08T
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-15
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-000899-28
    A.3Full title of the trial
    Dipeptidylpeptidase IV (CD26) on Philadelphia-positive leukemic stem cells (LSC) as marker and novel therapeutic target in chronic myeloid leukemia (CML).
    Dipeptidylpeptidase IV (CD26) op Philadelphia-chromosoom positieve leukemie stamcellen (LSC) als marker en nieuwe therapeutische target in chronische myeloïde leukemie (CML).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial evaluating vildagliptin and nilotinib as a combination treatment to achieve and succesfully maintain treatment free remission in patients with chronic myeloid leukemia.
    Een klinisch onderzoek naar vildagliptine en nilotinib als combinatiebehandeling voor het bereiken en handhaven van behandelingsvrije remissie bij patiënten met chronische myeloïde leukemie.
    A.3.2Name or abbreviated title of the trial where available
    Dolphin-STAR
    Dolphin-STAR
    A.4.1Sponsor's protocol code numberCAMN107CNL08T
    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 SponsorAlbert Schweitzer Hospital
    B.1.3.4CountryNetherlands
    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 supportAlbert Schweitzer Hospital
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlbert Schweitzer Hospital
    B.5.2Functional name of contact pointPrinicpal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressAlbert Schweitzer Hospital
    B.5.3.2Town/ cityDordrecht
    B.5.3.3Post code3318 AT
    B.5.3.4CountryNetherlands
    B.5.4Telephone number003107846432
    B.5.5Fax number003107846426
    B.5.6E-mailp.e.westerweel@asz.nl
    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 Tasigna
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameNilotinib
    D.3.2Product code AMN107
    D.3.4Pharmaceutical form Capsule
    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 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 Galvus
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameVildaglipitin
    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 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 myeloïde leukemie
    E.1.1.1Medical condition in easily understood language
    Chronic myeloid leukemia is a disease of the stem cells in the bone marrow. The abnormal stem cell multiplies and mature and develop into near-normal white cells .
    Chronische myeloïde leukemie is een ziekte van stamcellen in het beenmerg. De kern van een stamcel is beschadigd geraakt en dat zorgt ervoor dat witte bloedcellen in het beenmerg zich te snel delen.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10009015
    E.1.2Term Chronic myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10009016
    E.1.2Term Chronic myeloid leukemia in remission
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10009700
    E.1.2Term CML
    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
    Achieving succesful Treatment Free Remission (TFR) in patients with Chronic Myeloid Leukemia (CML) who have previously failed a TFR attempt
    Het bereiken van succesvolle behandelingsvrije remissie (TFR) bij patiënten met chronische myeloïde leukemie (CML) bij wie een eerdere poging tot TFR mislukte.
    E.2.2Secondary objectives of the trial
    Not applicable
    Niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients ≥18 years of age.
    2. At diagnosis chronic myeloid leukemia in chronic phase.
    3. Previous relapse during attempt at TFR (Treatment Free Remission)
    4. Documented regain of deep molecular remission at the level of at least MR4.0, defined as a measurable BCR-ABL level ≤0.01% IS or an undetectable BCR-ABL with a minimal total control gene copy number of ABL1 ⩾10 000 or GUSB ⩾24 000 in two replicates. A sample showing MR4.0 or better needs to have been taken within 31 days of study inclusion.
    5. Continuous treatment with any TKI for a minimum of 12 months prior to entering the study
    6. No other current or planned anti-leukemia therapy.
    7. ECOG Performance status 0,1, or 2.
    8. Adequate organ function as defined by:
    a) Total bilirubin <1.5 x ULN (ULN = local lab upper limit of normal). Does not apply to patients with isolated hyperbilirubinemia (e.g. Gilbert’s disease) grade <3.
    b) ASAT and ALAT <2.5 x ULN.
    c) Serum amylase and lipase ≤1.5 x ULN.
    d) Alkaline phosphatase ≤2.5 x ULN.
    e) Creatinine clearance >30 ml/min.
    f) Mg++, K+ ≥LLN.
    9. Life expectancy of more than 12 months in the absence of any intervention
    10. Written informed consent to participate in the study
    1. Patienten ≥18 jaar.
    2. Gediagnostiseerd met chronische myeloide leukemie in de chronische fase.
    3. Eerdere terugval na een poging tot een behandelingsvrije remissie (Treatment Free Remission)
    4. Gedocumenteerd herstel van een diepe moleculaire remissie van minimaal MR4.0, gedefinieerd als een meetbaar BCR-ABL level ≤0.01% IS of een niet bepaalbare BCR-ABL met een minimale totale control gen kopienummer van BL1 ⩾10 000 of GUSB ⩾24 000 in twee kopieën. Een sample welke een MR4.0 of meer aantoont moet afgenomen zijn binnen 31 dagen vanaf inclusie in het onderzoek.
    5. Behandeling met een TKI voor minimaal 12 maanden voor deelname aan het onderzoek
    6. Geen andere (huidig of geplande) anti-leukemische behandeling.
    7. ECOG Performance status 0,1, of 2.
    8. Adequate orgaan fucntie gedefinieerd als:
    a) Total bilirubin <1.5 x ULN (ULN = local lab upper limit of normal). Geldt niet voor patienten met geisoleerde hyperbilirubinemia (e.g. Gilbert’s disease) graad <3.
    b) ASAT en ALAT <2.5 x ULN.
    c) Serum amylase en lipase ≤1.5 x ULN.
    d) Alkaline phosphatase ≤2.5 x ULN.
    e) Creatinine clearance >30 ml/min.
    f) Mg++, K+ ≥LLN.
    9. Levensverwachting van meer dan 12 maanden zonder behandeling.
    10. Schriftelijke toestemming voor deelname aan het onderzoek.
    E.4Principal exclusion criteria
    1. Prior accelerated phase or blast crisis.
    2. Patient has received another investigational agent within last 6 months.
    3. Prior stem cell transplantation.
    4. History of occlusive cardiovascular disease, including peripheral occlusive arterial disease, cerebrovascular disease and coronary artery disease.
    5. Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension)
    6. Increased risk of cardiac arrhythmia, defined as:
    a) Inability to monitor the QT/QTc interval on ECG.
    b) Long QT syndrome or a known family history of long QT syndrome.
    c) Clinically significant resting brachycardia (<50 beats per minute).
    d) QTc >450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc.
    e) History of or presence of clinically significant ventricular or atrial tachyarrhythmias
    6. Known atypical BCR-ABL transcript not quantifiable by standard RQ-PCR
    7. History of active malignancy during the past 2 years with the exception of basal carcinoma of the skin or carcinoma in situ of cervix uteri or breast.
    8. Acute liver disease or cirrhosis.
    9. Previous or active acute or chronic pancreatic disease.
    10. Another severe and/or life-threatening medical disease.
    11. History of significant congenital or acquired bleeding disorder unrelated to cancer.
    12. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
    13. Patients actively receiving therapy with strong CYP3A4 inhibitors where the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
    14. Patients who are currently receiving treatment with any medication that has the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
    15. Patients who are:
    a) pregnant.
    b) breast feeding.
    c) of childbearing potential without a negative pregnancy test prior to baseline.
    d) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
    16. Interruption of TKI therapy for a cumulative period in excess of 21 days in the preceding 3 months.
    17. Known intolerance to nilotinib
    18. Known intolerance to vildagliptin
    19. History of non-compliance, or other inability to grant informed consent.
    20. Past or present history of alcohol abuse, use of illicit drugs, or severe psychiatric disorders, including depression.
    21. Autoimmune hepatitis or a history of autoimmune disease.
    22. Pre-existing thyroid disease unless it can be controlled with conventional treatment.
    23. Epilepsy and/or compromised central nervous system (CNS) function.
    24. HCV/HIV patients.
    25. Poorly controlled diabetes mellitus(i.e. HbA1c >9.0) or
    clinically relevant diabetic complications such as neuropathy, retinopathy, nephropathy, coronary or peripheral vascular disease.
    1. Eerdere accelerated fase of een blast crisis.
    2. Patient iheeft een behandeling in onderzoeksverband gehad in de afgelopen 6 maanden.
    3. Stamceltransplantatie.
    4. Geschiedenis van een occlusieve cardiovasculaire aandoening, inclusief een perifeer occlusieve arteriele aandoening, cerebrovasculaire aandoening en een coronaire aandoening.
    5. Andere klinische significate ongecontroleerde hartaandoeningen (bijv. instabiele angina pectoris, congestief hart falen of ongecontroleerde hypertensie.
    6. Verhoogd risico op cardiale arrhytmie, gedefnieerd als:
    a) Onvermogen om het QT/QTc interval van het ECG te monitoren.
    b) Lang QT syndroom of een familiegeschiedenis van lang QT syndroom.
    c) Klinisch significante brachycardia in rust (<50 slagen per minuut).
    d) QTc >450 msec op een baseline ECG (gebruikmakende van de QTcF formule). Wanneer QTcF >450 msec en electrolyten zijn niet binnen de normaalwaarde, dan dient er voor electrolyten te worden gecorrigeerd dient de patient te worden gere-screened voor QTc.
    e) Geschiedenis of aanwezigheid van klinisch significante ventriculair of atriaal tachyarrhythmias
    6. Bekend met een atypische BCR-ABL transcript, niet kwantificeerbaar met een standaard RQ-PCR
    7. Geschiedenis of aanwezigheid van kanker in de afgelopen 2 jaar met uitzondering van basaal cell carcinomen van de huid of carcinoom in situ van de cervix uteri of borst.
    8. Acute lever aandoening of cirrose .
    9. Geschiedenis of aanwezigheid van chronische alvleesklier aandoening.
    10. Een andere ernstige en/of levensbedreigende medische aandoening.
    11. Geschienis van significante congenital or acquired bleeding aandoening, niet gerelateerd aan kanker.
    12. Vermindering van gastro-intestinale (GI) functie of GI aandoening die de absorptie van het onderzoeksgeneesmiddel zou kunnen veranderen.
    13. Patiënten die actief een behandeling ontvangen met een CYP3A4 remmer, waarbij de behandeling niet kan worden gestopt of kan worden geswitched naar een andere behandeling voor de start van het onderzoek.
    14. Patiënten die actief een behandeling ontvangen met een medicijn dat van invloed kan zijn op het verlegen van de QT interval en waarbij de behandeling niet kan worden gestopt of kan worden geswitched naar een andere behandeling voor de start van het onderzoek.
    15. Patiënten wie:
    a) zwanger zijn.
    b) borstvoeding geven.
    c) vruchtbaar zijn, zonder negatieve zwangerschapstest voorafgaand aan de start van het onderzoek.
    d) vruchtbaar zijn (mannen en vrouwen) en geen anticonceptie willen toepassen gedurende het onderzoek (post-menopausale vrouwen dienen meer dan 12 maanden geen menstruatie te hebben gehad alvorens zij gedefinieerd mogen worden als onvruchtbaar).
    16. Onderbreking van TKI therapie gedurende een cumulatieve periode van meer dan 21 dagen in de voorgaande 3 maanden
    17. Bekend met intolerantie voor nilotinib
    18. Bekend met intolerantie voor vildagliptine
    19. Geschiedenis van niet-naleving, of andere onvermogen om toestemming voor deelname aan het onderzoek te verlenen
    20. Geschiedenis van of bekend met alcohol en/of drugs misbruik of ernstige psychiatrische stoornissen, waaronder depressie.
    21. Auto-immuun hepatitis of een geschiedenis van een auto-immuun aandoening.
    22. Reeds bestaande schildklieraandoening tenzij deze aandoening kan worden behandeld met een conventionele behandeling
    23. Epilepsie en / of stoornissen van het centraal zenuwstelsel (CZS).
    24. HCV/HIV patienten.
    25. Slecht gecontroleerde diabetes mellitus (i.e. HbA1c >9.0) of klinisch relevante diabetisch complicaties zoals neuropathie, retinopathie, nephropathie, coronaire of perifere vasculaire aandoeningen.
    E.5 End points
    E.5.1Primary end point(s)
    For phase 1 part of the study:
    Occurrence of drug-related adverse events causing dose limiting toxicity for vildagliptin when added to nilotinib treatment in CML patients

    For phase 2 part of the study:
    Reduction of Ph+CD34+CD38-CD26+ cell frequency in bone marrow in CML patients before and after addition of vildagliptin to nilotinib in CML patients
    Voor het Fase 1 gedeelte van de studie:
    Aanwezigheid van onderzoekmedicatie gerelateerde ongewenst voorvallen resulterend in dosis gelimiteerde toxiciteit voor vildagliptine wanneer gecombineerd met nilotinib in de behandeling van CML patiënten.

    Voor het Fase 2 gedeelte van de studie:
    Vermindering van Ph+CD34+CD38-CD26+ cel frequentie in het beenmerg bij CML patiënten voor en na toevoeging van vildaglitpine aan nilitonib in de behandeling van CML patiënten.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1:
    4 week monitoring interval

    Phase 2:
    At baseline, after 3 and 6 months of vildagliptin-co-treatment
    At 3,6,12 and 18 monts after nilotinib (TKI) discontinuation
    Fase 1:
    4 weekse monitoring interval

    Fase 2:
    Bij baseline, na 3 en 6 maanden van nilotinib-vildagliptine combinatie behandeling
    3,6,12,18 maanden na het stoppen van nilotinib (TKI)
    E.5.2Secondary end point(s)
    For phase 1 part of the study:
    AE rate for the combination of vildagliptin and nilotinib treatment in CML patients

    For phase 2 part of the study:
    1. The percentage of patients showing a reduction of at least one log of BCR-ABL levels in bone marrow or peripheral blood by nilotinib-vildagliptin co-treatment
    2. the percentage of patients with undetectable Ph+CD34+CD38-CD26+ cells in the bone marrow after TKI discontinuation and after vildagliptin discontinuation
    3. the percentage of patients in treatment-free remission 6 months after TKI discontinuation while still treated with vildagliptin
    4. the percentage of patients in treatment-free remission 12 months after TKI discontinuation (6 months after vildagliptin discontinuation)
    5. the incidence of infectious adverse effects during nilotinib/vildagliptin co-treatment
    Voor het Fase 1 gedeelte van de studie:
    Aantal ongewenste voorvallen voor de combinatiebehandeling van vildagliptine en nilotinib bij CML patiënten.

    Voor het Fase 2 gedeelte van de studie:
    1. Het percentage patiënten dat een vermindering van tenminste 1 log BCR-ABL niveau in het beenmerg of perifeer bloed tijdens de combinatiebehandeling van nilotinib en vildagliptine
    2. Het percentage patiënten met niet nader te bepalen Ph+CD34+CD38-CD26+ cellen in het beenmerg na het stoppen van nilotinib (TKI) en na het stoppen van vildagliptine.
    3. Het percentage patiënten wie in een behandelingsvrije remissie zijn, 6 maanden na het stoppen van nilotinib (TKI), maar nog steeds behandeld worden met vildagliptine.
    4. Het percentage patiënten wie in behandelingsvrije remissie zijn, 12 maanden na het stoppen van nilotinib (TKI) en 6 maanden na het stoppen van de behandeling met vildagliptine.
    5. De incidentie van infectieve ongewenste voorvallen tijdens de combinatiebehandeling van nilotinib en vildagliptine.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase 1:
    4 week monitoring interval

    Phase 2:
    At baseline, after 3 and 6 months of vildagliptin-co-treatment
    At 3,6,12 and 18 monts after nilotinib (TKI) discontinuation
    Fase 1:
    4 weekse monitoring interval

    Fase 2:
    Bij baseline, na 3 en 6 maanden van nilotinib-vildagliptine combinatie behandeling
    3,6,12,18 maanden na het stoppen van nilotinib (TKI)
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Prospectief
    Prospective
    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.8.3 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 concerned1
    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 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 sponsor can stop the study for well explained reasons. If the investigator considers stopping the study or wants to retract from the study, the sponsor will immediately be notified explaining reasons.
    In case of hematological relapse or progression to accelerated or blastic phase of CML without previous molecular relapse, the data safety monitoring board will be contacted. Inclusion of patients in the trial will then be stopped until the decision of the committee.
    De verrichter kan het onderzoek voortijdige beëindigen om meerdere redenen. Als de onderzoeker het onderzoek wil beëindigen of zich distantieert van het onderzoek, dient te verrichter direct te worden geïnformeerd. In het geval van hematologische terugval of progressie naar blastische fase van CML zonder voorafgaande moleculaire terugval, dient de data safety monitoring board te worden geïnformeerd. Inclusie van patiënten in het onderzoek wordt dan tot nader oordeel van de DSMB gestopt.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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.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)
    None
    Geen
    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 Decision2017-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-04
    P. End of Trial
    P.End of Trial StatusOngoing
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