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    Summary
    EudraCT Number:2011-002749-37
    Sponsor's Protocol Code Number:ISAV
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-19
    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 number2011-002749-37
    A.3Full title of the trial
    Validation of digital-PCR analysis through programmed imatinib interruption in PCR negative chronic myeloid leukemia patients.
    Validazione dell'analisi digital PCR (dPCR) mediante interruzione programmata di imatinib in pazienti affetti da leucemia mieloide cronica con PCR negativa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Validation of a new analytical method in asymptomatic chronic myeloid leukemia patients for whom the treatment with imatinib is suspended.
    Validazione di un nuovo metodo di analisi in pazienti con leucemia mieloide cronica senza sintomi per i quali si interrompe il trattamento con imatinib.
    A.4.1Sponsor's protocol code numberISAV
    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 SponsorUNIVERSITA' DEGLI STUDI DI MILANO - BICOCCA
    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 supportRegione Lombardia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversita' degli Studi Milano Bicocca
    B.5.2Functional name of contact pointDip. Medicina Clinica e Prevenzione
    B.5.3 Address:
    B.5.3.1Street AddressVia Cadore 48
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20052
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 039 2339277
    B.5.5Fax number+39 039 2333539
    B.5.6E-mailsilvia.mori@unimib.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 GLIVEC*30CPS 50MG
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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/3/01/021
    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 MESILATE
    D.3.9.1CAS number 220127-57-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 GLIVEC*120CPS 100MG
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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/3/01/021
    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 MESILATE
    D.3.9.1CAS number 220127-57-1
    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.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 (CML) with substained Complete Molecular Response (CMR).
    Leucemia Mieloide Cronica (LMC) con Risposta Molecolare Completa (CMR) consolidata.
    E.1.1.1Medical condition in easily understood language
    Chronic Myeloid Leukemia (CML) asymptomatic and with no sign of disease by the most sensitive conventional hospital investigations.
    Leucemia Mieloide Cronica (LMC) asintomatica e senza segni di malattia all'analisi di laboratorio più sensibile.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10052065
    E.1.2Term Chronic phase chronic myeloid leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.
    Valutare la capacità della tecnica dPCR di predire l'assenza di ricaduta della LMC dopo la sospensione di imatinib in pazienti con Q-RT-PCR con esito negativo da più di 18 mesi.
    E.2.2Secondary objectives of the trial
    1. To estimate relapse rate after imatinib discontinuation. 2. To characterize the performances of the dPCR technique. 3. To quantify the maintenance of the molecular remission, after imatinib discontinuation, in CML patients with negative Q-RT-PCR for longer than 18 months. 4. To evaluate the impact of imatinib treatment (discontinuation and resumption) on quality of life. 5. To assess the timing of recurrence. 6. To quantify the occurrence of progression/resistance in patients who relapse after imatinib resumption. 7. To evaluate whether survival of patients dPCR negative and relapse free at 36 months is comparable to the one of normal population. 8. To evaluate whether survival of relapsing patients is comparable to the survival of the non relapsing ones.
    1. Valutare il tasso di ricaduta dopo la sospensione di imatinib. 2. Analizzare le caratteristiche tecniche della dPCR. 3. Quantificare la durata della RMC dopo la sospensione di imatinib nei pazienti di LMC con Q-RT-PCR a esito negativo da più di 18 mesi. 4. Valutare l'impatto del trattamento con imatinib (sospensione e riassunzione) sulla qualità della vita. 5. Determinare il momento della ricaduta della malattia. 6. Quantificare gli eventi di progressione/resistenza dopo riassunzione di imatinib nei pazienti ricaduti. 7. Valutare se la sopravvivenza dei pazienti con dPCR con esito negativo, che non sono ricaduti dopo 36 mesi, e' comparabile con quella della popolazione normale. 8. Valutare se la sopravvivenza dei pazienti che sono ricaduti è comparabile con quella dei pazienti che non sono ricaduti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated IRB/IEC-approved Informed Consent. 2. Age >/= 18 years. 3. Male or female patients with CML diagnosed in chronic phase and who have been treated for more than 2 consecutive years with imatinib therapy. 4. Sustained CMR (as defined by the treating center) for at least 18 months with imatinib treatment. 5. A minimum of 3 CMR determined by Q-RT-PCR analysis to support disease status, with the least one performed within 3 calendar months prior to enrollment date. 6. Willingness and ability to comply with scheduled visits, laboratory tests and other study procedures.
    1. Consenso informato approvato dal Comitato Etico firmato e datato. 2. Età &gt;/= 18 anni. 3. Pazienti di sesso maschile o femminile con diagnosi di LMC in fase cronica e che sono stati trattati per più di 18 mesi consecutivi con imatinib. 4. Il raggiungimento della CMR (come definito dal proprio centro) per almeno 18 mesi di trattamento con imatinib. 5. Un minimo di 3 CMR determinate mediante l'analisi Q-RT-PCR che dimostrano lo stato della malattia, l'ultima delle quali effettuata entro 3 mesi dalla data di arruolamento. 6. Volontà e capacità di rispettare le visite programmate, gli esami di laboratorio e le procedure di studio.
    E.4Principal exclusion criteria
    1. Allogenic hematopoietic stem cell transplantation. 2. Known active infections, including human immunodeficiency virus (HIV) positivity. 3. Current enrollment in another clinical trial. 4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results.
    1. Trapianto allogenico di cellule staminali. 2. Infezioni in corso compresa positività verso l'immunodeficienza acquisita (HIV). 3. Concomitante partecipazione in un altro studio clinico. 4. Altri tipi di patologie con carattere acuto, severo o cronico o condizioni psichiatriche o di laboratorio che potrebbero aumentare i rischi associati alla partecipazione allo studio, o alla somministrazione del farmaco o che potrebbero interferire con l'interpretazione dei risultati dello studio, e che comunque a giudizio del medico rendono il paziente inappropriato per lo studio.
    E.5 End points
    E.5.1Primary end point(s)
    The Negative Predicted Value Ratio (rNPV) of dPCR over Q-RT-PCR, i.e. the capability of the dPCR method to predict relapse-free patients relative to the standard method. NPV of each method will be computed as the number of patients who are negative according to either method at the time of imatinib discontinuation and remain relapse-free 36 months later over the total of negative patients according to either method, respectively.
    Rapporto tra Valore Predittivo Negativo (VPN) della dPCR e della Q-RT-PCR, ovvero la capacità della dPCR di predire i pazienti che non ricadono rispetto al metodo standard. Il VPN per ciascun metodo sarà calcolato come numero di pazienti per i quali il metodo da' esito negativo al momento della sospensione di imatinib e non ricadono nei successivi 36 mesi sul totale dei pazienti per i quali il metodo da' esito negativo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 36 months.
    A 36 mesi.
    E.5.2Secondary end point(s)
    1. Rate of molecular and cytogenetic relapse after discontinuation of imatinib treatment out of total number of patients enrolled. 2. Rate of patients who are dPCR positive before discontinuation of imatinib and who do not relapse within the following 36 months (false positive) out of the total number of relapse-free patients at month 36. 3. Rate of patients who are dPCR negative before discontinuation of imatinib and who relapse (false negative) out of the total number of patients relapsing within the following 36 months. 4. Rate of patients maintaining dPCR negativity for 36 months over the patients who are Q-RT-PCR negative at the end of the interval. 5. Time to molecular relapse, both from the first PCR negative and from the discontinuation of imatinib to the time of loss of molecular response, respectively. 6. Overall survival. 7. Quality of Life, as measured by the Global Health Status/QOL and other subscales scores of EORTC-QLQ-C30 questionnaire. 8. Rate of patients progressing or developing resistance after imatinib resumption out of total number of patients enrolled.
    1. Tasso di pazienti con ricaduta della malattia a livello molecolare e citogenetico dopo la sospensione del trattamento con imatinib rispetto al totale di pazienti arruolati. 2. Tasso di pazienti con dPCR a esito positivo prima della sospensione di imatinib che non ricadono nei successivi 36 mesi (falsi positivi) rispetto al totale di pazienti che non sono ricaduti al mese 36. 3. Tasso di pazienti con dPCR a esito negativo prima della sospensione di imatinib che ricadono (falsi negativi) rispetto al totale di pazienti che ricadono nei successivi 36 mesi. 4. Tasso di pazienti che mantengono la dPCR con esito negativo per 36 mesi rispetto ai pazienti con Q-RT-PCR a esito negativo al termine dell'intervallo. 5. Durata della RMC, dalla data della prima Q-RT-PCR a esito negativo e da quella di sospensione dell'imatinib fino alla data della perdita della RMC. 6. Sopravvivenza totale. 7. Qualita' della vita, misurata secondo il Global Health Status/QoL e i punteggi di altre sottoscale del questionario EORTC QLQ-C30. 8. Tasso di pazienti che progrediscono o sviluppano resistenza dopo la riassunzione di imatinib rispetto al totale dei pazienti arruolati.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All at 36 months, except for the overall survival (point 6) that will be evaluated at the end of the study.
    Tutti a 36, mesi tranne la sopravvivenza totale (punto 6) che verrà valutata a fine sperimentazione.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Validation of a new analytical method, quality of life.
    Validazione di un nuovo metodo analitico, qualita' della vita.
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.2.4Number 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Canada
    Israel
    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, including follow-up.
    LVLS, follow-up incluso.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months84
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months84
    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.1.1Number of subjects for this age range: 0
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-12-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 100
    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 medical care for that condition.
    Terapie per la patologia secondo la pratica clinica.
    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 Decision2011-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
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