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    Summary
    EudraCT Number:2011-004808-37
    Sponsor's Protocol Code Number:HD-K
    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:2011-12-16
    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 number2011-004808-37
    A.3Full title of the trial
    Phase II clinical study on the activity of salvage therapy with high doses of oral clarithromycin in patients with extranodal marginal zone relapsed or refractory lymphoma
    Studio clinico di fase II sull'attivita' della terapia di salvataggio con claritromicina orale ad alte dosi in pazienti con linfoma della zona marginale extranodale recidivato o refrattario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the activity of oral clarithromycin in patients with extranodal marginal zone relapsed or refractory lymphoma.
    Studio sulla attivita' di claritromicina orale in pazienti affetti da linfoma della zona marginale extranodale recidivato o refrattario.
    A.4.1Sponsor's protocol code numberHD-K
    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 SponsorFONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
    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 supportnessun finanziamento a supporto
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione San Raffaele del Monte Tabor
    B.5.2Functional name of contact pointUnita' Operativa Linfomi
    B.5.3 Address:
    B.5.3.1Street Addressvia Olgettina, 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number02-26437649
    B.5.5Fax number02-26437603
    B.5.6E-mailferreri.andres@hsr.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 KLACID*14CPR RIV 500MG
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT Srl
    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.3.4Pharmaceutical form Film-coated 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 INNclaritromicina
    D.3.9.1CAS number 81103-11-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 typenatura chimica
    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 extranodal marginal zone relapsed or refractory lymphoma
    pazienti affetti da linfoma della zona marginale extranodale recidivato o refrattario
    E.1.1.1Medical condition in easily understood language
    lymphoma
    linfoma
    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 PT
    E.1.2Classification code 10015823
    E.1.2Term Extranodal marginal zone B-cell lymphoma (MALT type) recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10015824
    E.1.2Term Extranodal marginal zone B-cell lymphoma (MALT type) refractory
    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 evaluate the activity of oral clarithromycin high-dose (2 g/day) in patients with extranodal marginal zone relapsed / refractory lymphoma.
    valutare l’attività della claritromicina orale ad alte dosi (2 g/die) in pazienti affetti da linfoma della zona marginale extranodale recidivato/refrattario.
    E.2.2Secondary objectives of the trial
    to assess the feasibility and tolerability of oral clarithromycin at high doses (2 g / day) in the treatment of extranodal marginal zone relapsed / refractory lymphoma.
    valutare la fattibilità e tollerabilita' della claritromicina orale ad alte dosi (2 g/die) nel trattamento del linfoma della zona marginale extranodale recidivato/refrattario.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Histological diagnosis of B-cell lymphoma of extranodal marginal zone extragastric or gastric Helicobacter pylori-positive refractory to conventional antibiotic therapy or H. pylori negative -least one measurable/ configurable lesion -lymphoma relapsed or refractory to systemic therapies (chemotherapy, immunotherapy, antibiotic therapy) or local (surgery or radiotherapy)-age > or equal 18 years -ECOG-PS < 3 -no antibiotics in the three months prior to enrollment -in women of childbearing potential, appropriate contraceptive cover intake during treatment -signed written informed consent
    -diagnosi istologica di linfoma a cellule B della zona marginale extranodale extragastrico o gastrico Helicobacter pylori-positivo refrattario a terapia antibiotica convenzionale o H. pylori-negativo -almeno una lesione misurabile/parametrabile -linfoma recidivato o refrattario a terapie sistemiche (chemioterapie, immunoterapie, antibiotico terapie) o locali (chirurgia o radioterapia) -età &gt; o uguale a 18 anni -ECOG-PS &lt; 3 -nessuna terapia antibiotica nei tre mesi precedenti l’arruolamento -in donne potenzialmente fertili, assunzione di adeguata copertura contraccettiva durante il trattamento -consenso informato scritto firmato
    E.4Principal exclusion criteria
    -HIV 1-2 infections -conventional cancer treatments (chemotherapy, radiotherapy, immunotherapy, corticosteroids) or experimental concomitant severe hepatic impairment (AST < = 3 UNL, ALT < = 3 UNL, bilirubin < = 3 UNL) and renal (creatinine ≤ 1 , 5 UNL) that is not due to lymphoma -allergy to macrolides
    -ongoing pregnancy and nursing
    -presence of other malignancies in the past 5 years (except basal cell skin squamous cell carcinomas in situ of the skin or cervical)-presence of any physical or mental condition that prevents the intake of antibiotic therapy
    -inf
    E.5 End points
    E.5.1Primary end point(s)
    activity of clarithromycin oral high-dose (2 g / day) in terms of overall response, complete response and duration of response. Based on previous clinical experience of the one part of the marginal zone lymphomas, we expect a higher overall response rate of 38%. Responses will be evaluated during treatment and for the duration of follow-up.
    attività della claritromicina orale ad alte dosi (2 g/die) in termini di risposte globali, risposte complete e durata della risposta. Sulla base dell’unica precedente esperienza clinica nell’ambito dei linfomi della zona marginale, ci si attende un tasso di risposte globali superiore al 38%. Le risposte verranno valutate in corso del trattamento e per tutta la durata del follow-up.
    E.5.1.1Timepoint(s) of evaluation of this end point
    during treatment and at follow up
    durante trattamento e a follw up
    E.5.2Secondary end point(s)
    security of oral clarithromycin at high doses , defined as adverse events of grade > or = 3 (NCI CTCAE v. 4.3) in patients enrolled in the protocol. The AE will be recorded during treatment and follow-up, until the end of the study. -Overall survival (OS), as months of survival from participation in the experimental protocol until death from any cause. The OS data will be collected for all patients enrolled even after exit from the study.
    -sicurezza di claritromicina orale ad alte dosi, definita come incidenza di eventi avversi di grado > o uguale 3 (NCI CTCAE v. 4.3) nei pazienti arruolati nel protocollo. Gli AE verranno registrati in corso di trattamento e nel follow-up, fino alla chiusura dello studio. -Sopravvivenza globale (OS), intesa come mesi di sopravvivenza dalla partecipazione al protocollo sperimentale fino al decesso per qualsiasi causa. Il dato di OS verrà raccolto per tutti i pazienti arruolati anche dopo uscita dallo studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    during treatment and at follow up
    durante trattamento e a follw up
    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 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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years0
    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.1.1Number 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 19
    F.4.2.2In the whole clinical trial 19
    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)
    periodic visits till death due to any type of cause
    controlli periodici fino a decesso dovuto a qualsiasi causa
    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 Decision2011-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
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