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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42752   clinical trials with a EudraCT protocol, of which   7042   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2012-005702-22
    Sponsor's Protocol Code Number:IELSG39
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-02-06
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-005702-22
    A.3Full title of the trial
    International prospective Phase 2 trial addressing the efficacy of first-line
    Chlamydophila psittaci-eradicating therapy with protracted administration of
    doxycycline followed by eradication monitoring and antibiotic re-treatment at
    infection re-occurrence in patients with newly diagnosed Ocular Adnexal Margina Zone Lymphoma (OAMZL).
    Studio Internazionale Prospettico di fase 2 per valutare il ruolo di una terapia
    prolungata di prima linea eradicante l’infezione da CHLAMYDOPHILA PSITTACI,
    seguita da monitoraggio dell’eradicazione e ripetizione della terapia antibiotica
    nei pazienti con re-infezione, in pazienti affetti da linfoma degli annessi orbitari
    di nuova diagnosi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    International prospective Phase 2 trial addressing the efficacy of first-line
    Chlamydophila psittaci-eradicating therapy with protracted administration of
    doxycycline followed by eradication monitoring and antibiotic re-treatment at
    infection re-occurrence in patients with newly diagnosed Ocular Adnexal Margina Zone Lymphoma (OAMZL).
    Studio Internazionale Prospettico di fase 2 per valutare il ruolo di una terapia
    prolungata di prima linea eradicante l’infezione da CHLAMYDOPHILA PSITTACI,
    seguita da monitoraggio dell’eradicazione e ripetizione della terapia antibiotica
    nei pazienti con re-infezione, in pazienti affetti da linfoma degli annessi orbitari
    di nuova diagnosi.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberIELSG39
    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.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 supportINTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP
    B.4.1Name of organisation providing supportFONDAZIONE ITALIANA LINFOMI ONLUS
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.2Functional name of contact pointFIL SECRETARY
    B.5.3 Address:
    B.5.3.1Street AddressVia Venezia, 16
    B.5.3.2Town/ cityAlessandria
    B.5.3.3Post code15121
    B.5.4Telephone number00390131206132
    B.5.5Fax number00390131206132
    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. of the Marketing Authorisation holderPHARMACIA Italia S.p.A.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDOXYCYCLINE
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Patients with newly diagnosed Ocular Adnexal Marginal Zone Lymphoma (OAMZL)
    Pazienti affetti da linfoma degli annessi orbitari di nuova diagnosi
    E.1.1.1Medical condition in easily understood language
    Patients with newly diagnosed Ocular Adnexal Marginal Zone Lymphoma (OAMZL)
    Pazienti affetti da linfoma degli annessi orbitari di nuova
    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
    To establish in a prospective, multicentre phase 2 trial, the efficacy of an upfront targeted therapy consisting of Chlamydophila psittaci (Cp)-eradicating therapy with prolonged administration of doxycycline followed by eradication monitoring and antibiotic re-treatment at infection re-occurrence in patients with newly diagnosed OAMZL.
    Stabilire in uno studio prospettico, multicentrico, di fase 2 l’efficacia di una terapia di prima linea eradicante l’infezione da Chlamydophila psittaci (Cp), con una somministrazione prolungata di doxiciclina seguita da monitoraggio dell’avvenuta eradicazione e ri-trattamento antibiotico in caso di reinfezione.
    E.2.2Secondary objectives of the trial
    Not applicable.
    Non applicabile.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histological diagnosis of OAMZL
    2. Single or bilateral lesion (stage IE) localized to the ocular adnexae (conjunctiva, lachrymal gland or sac, orbit soft tissue)
    3. Absence of B symptoms
    4. Previously untreated patients
    5. No systemic antibiotic therapy in the last 3 months
    6. Age >18 years
    7. ECOG PS 0-2
    8. Negative HIV, HBV and HCV serology
    9. Adequate bone marrow, renal, and hepatic function
    10. No previous or concurrent malignancies with the exception of surgically cured carcinoma in situ of the cervix, carcinoma of the skin, prostatic cancer, or other cancers without evidence of disease at least from 5 years
    11. Absence of any familial, sociological or geographical condition potentially hampering compliance with study & follow-up schedule
    12. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation
    13. No concurrent treatment with other experimental drugs
    14. Patient-signed informed consent obtained before registration
    1. Diagnosi istologica di OAMZL
    2. Lesione singola o bilaterale (stadio IE) localizzata agli annessi oculari
    (congiuntiva, ghiandola lacrimale o sacco lacrimale, tessuti molli dell’orbita)
    3. Assenza di sintomi B
    4. Pazienti non pretrattati
    5. Non assunzione di terapia antibiotica nei 3 mesi precedenti l’arruolamento
    6. Età >18 anni
    7. ECOG PS 0-2
    8. Sierologia negativa per infezione da HIV, HBV e HCV.
    9. Adeguata funzionalità midollare, renale, epatica
    10. Assenza di neoplasie pregresse o concomitanti con l’eccezione di carcinoma in situ della cervice, carcinoma della cute, cancro della prostata
    chirurgicamente asportati, o altre neoplasie in assenza di malattia nei 5 anni precedenti
    11. Assenza di qualsiasi condizione familiare, sociologica, geografica che possa condizionare la compliance con lo studio e il follow-up
    12. I pazienti in età fertile devono utilizzare adeguate misure contraccettive
    13. Non trattamenti concomitanti con farmaci sperimentali
    14. Firma del consenso informato
    E.4Principal exclusion criteria
    1. Pregnant or lactating women
    2. Known allergy to tetracycline
    3. Patients unwilling to comply with the requirements of follow-up
    4. Myasthenia gravis (tetracycline can exacerbate muscle weakness)
    5. Systemic lupus erythematous (tetracycline can exacerbate this condition)
    6. Patients with large or rapidly enlarging tumours requiring immediate
    1. Donne in gravidanza o allattamento
    2. Allergia nota a tetracicline
    3. Pazienti non disponibili ad effettuare le visite di follow-up
    4. Miastenia grave (le tetracicline possono esacerbare la debolezza muscolare)
    5. Lupus eritematoso sistemico (le tetracycline possono esacerbare questa
    6. Pazienti con malattia rapidamente ingravescente che richieda radioterapia
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the 2-year progression-free survival (PFS) of patients with newly diagnosed stage-IE OAMZL treated with the experimental strategy.
    L’endpoint primario è la sopravvivenza libera da progressione (PFS) a 2 anni nei pazienti con OAMZL stadio IEA di nuova diagnosi che ricevono il trattamento sperimentale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 anni
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    1. Feasibility
    2. Tolerability of prolonged administration of doxycycline
    3. Activity (overall response rate)
    4. Overall survival
    5. Cp eradication rate
    6. Infection re-occurrence rate
    7. Assessment of prevalence of IRTA1 marker in OAMZL
    8. Assessment of genetic lesions and gene expression changes in OAMZL and their possible relationship with Cp infection and response to treatment
    9. Identification of possible SNPs associated with Cp infection in OAMZL patients
    10. Identification of possible bacterial polymorphisms responsible for antibiotic resistance, infection recurrence or persistence.
    Gli endpoint secondari sono:
    1. Fattibilità
    2. Tollerabilità di somministrazione prolungata di doxiciclina
    3. Attività (overall response rate)
    4. Sopravvivenza globale
    5. Tasso di eradicazione di Cp
    6. Tasso di re-infezione
    7. Valutazione della prevalenza del marker IRTA1 nei OAMZL
    8. Valutazione di lesioni genetiche e modificazioni di espressione genica nei
    OAMZL e loro possibile relazione con l’infezione da Cp e la risposta al
    9. Identificazione di possibili SNPs associate con l’infezione da Cp nei pazienti con OAMZL
    10. Identificazione dei possibili polimorfismi batterici responsabili della
    resistenza agli antibiotici e della ricorrenza o persistenza dell’infezione
    E.5.2.1Timepoint(s) of evaluation of this end point
    Infection re-occurrence rate at 3 years.
    Overall Survival at 5 years.
    Tasso di re-infezione a 3 anni.
    Sopravvivenza Globale a 5 anni.
    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 No
    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. 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.8.3 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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    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
    Ultima visita ultimo paziente in studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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 years8
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 34
    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)
    All patients will be followed up for 10 years.
    Up to the 5th year of FU: MRI and ophthalmologist evaluation will be performed at 3, 12, 18, 24, 30, 36, 42, 48, 54 and 60 months from upfront doxycycline. Chlamydial infection will be monitored at baseline and at 3, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months from upfront doxycycline. From the 5th year of FU and up to the 10th year of FU only PFS and OS data will be collected but in case of relapse, Chlamydial inf. should be investigated.
    Tutti i pazienti saranno seguiti per 10 anni. Fino al 5° anno di FU: RMN delle orbite e una visita oftalmologica verranno eseguite a 3, 12, 18, 24, 30, 36, 42, 48, 54 e 60 mesi dal trattamento con doxiciclina. L’infezione da Chlamydia verrà monitorata al basale e a 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 mesi dalla doxiciclina.
    Dal 5° anno FU sarnnoraccolti dati di OS e PFS. In caso di ricaduta andrà ricercata l'eventuale associazione con infezione da Chlamydia.
    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 Decision2013-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-07
    P. End of Trial
    P.End of Trial StatusOngoing
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