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    Summary
    EudraCT Number:2012-001768-31
    Sponsor's Protocol Code Number:ZENO-01
    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:2012-08-02
    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 number2012-001768-31
    A.3Full title of the trial
    ZENO-01 90Y ibritumomab tiuxetan in patients with extra-nodal marginal zone B-cell lymphoma of Mucosa associated lymphoid tissue (MALT Lymphoma)
    ZENO-01 90Y IBRITUMOMAB TIUXETANO IN PAZIENTI CON LINFOMA A CELLULE B DELLA ZONA MARGINALE EXTRANODALE DEL TESSUTO LINFOIDE ASSOCIATO ALLA MUCOSA (LINFOMA MALT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ZENO-01 90Y ibritumomab tiuxetan in patients with extra-nodal marginal zone B-cell lymphoma of Mucosa associated lymphoid tissue (MALT Lymphoma)
    ZENO-01 90Y IBRITUMOMAB TIUXETANO IN PAZIENTI CON LINFOMA A CELLULE B DELLA ZONA MARGINALE EXTRANODALE DEL TESSUTO LINFOIDE ASSOCIATO ALLA MUCOSA (LINFOMA MALT)
    A.3.2Name or abbreviated title of the trial where available
    ZENO-01
    ZENO-01
    A.4.1Sponsor's protocol code numberZENO-01
    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 SponsorAZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    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 supportSpectrum pharmaceuticals, Irvine , California
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU di Bologna, Policlinico S.Orsola-Malpighi
    B.5.2Functional name of contact pointU.O.Ematologia-PI Zinzani
    B.5.3 Address:
    B.5.3.1Street AddressVia Albertoni 15
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.4Telephone number051/6363680
    B.5.5Fax number051/6364037
    B.5.6E-mailpierluigi.zinzani@unibo.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 ZEVALIN*INFUS 1F 2ML 1,6MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNYTTRIUM (90Y) IBRITUMOMAB TIUXETAN
    D.3.9.4EV Substance CodeSUB30555
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.6
    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) Yes
    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 Yes
    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 Yes
    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
    MALT Lymphoma
    LINFOMA MALT
    E.1.1.1Medical condition in easily understood language
    extra-nodal marginal zone B-cell lymphoma of Mucosa associated lymphoid tissue (MALT Lymphoma)
    LINFOMA A CELLULE B DELLA ZONA MARGINALE EXTRANODALE DEL TESSUTO LINFOIDE ASSOCIATO ALLA MUCOSA (LINFOMA MALT)
    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 10060707
    E.1.2Term MALT lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Antitumor activity, in terms of overall response rate (ORR)
    Attività antitumorale in termini di tasso di risposta globale
    E.2.2Secondary objectives of the trial
    Safety, as acute and long-term toxicity; Progression-free survival (PFS); Histological response and molecular residual disease (MRD) for gastric MALT lymphoma
    Sicurezza del trattamento inteso come tossicità acuta e a lungo termine; Sopravvivenza libera da progressione; Risposta istologica e malattia molecolare residua per linfoma MALT gastrico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extra nodal site • Any stage (Ann Arbor I-IV) • Either de novo, or relapsed/refractory disease following local therapy (including surgery, radiotherapy, and antibiotics for Helicobacter pylori-positive gastric lymphoma) or prior chemotherapy regimen +/- anti-CD20 immunotherapy • No evidence of histologic transformation to a high grade lymphoma • Measurable or evaluable disease • For primary gastric localized Helicobacter pylori-positive disease at diagnosis: 1) persistent disease 1 year after documented Helicobacter pylori infection eradication and 2) clinical, endoscopic (or histologic) evidence of progression at any time after Helicobacter pylori infection eradication • Patient age ≥ 18 years • ECOG performance status ≤ 2 • Life expectancy of at least 6 months • Effective contraception in female pre-menopausal patients • No prior disease of neoplasm within 5 years, except cervical intra-epithelial neoplasia type-1(CIN1) or localized non melanomatous skin cancer • No prior chemotherapy, immunotherapy and radiotherapy in the last 6 weeks • No corticosteroids during the last 28 days unless prednisone chronically administered at a dose <20 mg/day for indications other than lymphoma or lymphoma-related symptoms • No evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry • No evidence of symptomatic central nervous system (CNS) disease • No impairment of bone marrow function (WBC >3,000/mm3, ANC >1,500/mm3, PLT >100,000/mm3) • No impairment of renal or liver function, unless due to lymphoma involvement • No known HIV infection, no active HBV and/or HCV infection and no evidence of active opportunistic infection • No pregnant or lactating status and appropriate contraceptive method in women of childbearing potential • Appropriate contraceptive method in men • No psychiatric illness precluding understanding concepts of the trial or signing informed consent • The patient has given written informed consent
    Diagnosi istologica di MALT CD20 positivo esordito in qualsiasi sito extranodale. • Qualsiasi stadio di malattia secondo classificazione di Ann Arbor (I-IV). • Pazienti mai trattati o ricaduti/refrattari alle precedenti terapie. • Assenza di trasformazione in linfoma ad alto grado. • Malattia misurabile e/o valutabile. • Per linfoma gastrico positivo alla diagnosi per Helicobacter pylori: 1) Malattia persistente 1 anno dopo la documentata eradicazione dell’infezione da Helicobacter pilori e 2) Evidenza clinica, endoscopica (o istologica) di progressione in qualsiasi momento dopo l’eradicazione dell’infezione da Helicobacter pilori. • Pazienti maggiorenni (≥18 anni). • ECOG performance status ≤ 2. • Aspettativa di vita di almeno 6 mesi. • Uso di metodi contraccettivi efficaci in entrambi I sessi. • No storia di neoplasie nei 5 anni precedenti l’inclusione nello studio ad eccezione neoplasia CIN1 o melanoma della pelle. • No precedente chemioterapia, immunoterapia o radioterapia nelle ultime 6 settimane precedenti l’inclusione nello studio. • No assunzione di corticosteroidi nei 28 giorni precedenti l’inclusione nello studio ad eccezione di assunzione cronica di prednisone a dosi &lt;20 mg/die per indicazioni diverse da linfoma o da sintomi linfoma-relati. • Nessuna evidenza di patologie cardiache clinicamente rilevanti nei 12 mesi precedenti l’inclusione nello studio. • Nessuna evidenza di patologie del sistema nervoso centrale. • Adeguata funzione midollare: WBC&gt;3,000/mm3, ANC&gt;1,500/mm3, PLT&gt;100,000/mm3. • Adeguate funzioni renale ed epatica (a meno di un coinvolgimento da parte del linfoma). • No infezioni attive da HIV, HBV o HCV. • Firma del consenso informato scritto
    E.4Principal exclusion criteria
    • Prior autologous or allogeneic SCT or previous organ transplantation • >25% bone marrow infiltration • Active auto-immune haemolytic anaemia • Participation in another clinical trial during the last 4 weeks • Renal insufficiency (creatinine > 2.0 mg/dl), not related to lymphoma • Hepatic insufficiency (transaminase >3-fold of upper normal limit or bilirubin > 2.0 mg/dl), not related to lymphoma • Active infection (e.g. HBV, HCV, HIV) • Concurrent disease which may hamper the per protocol therapy • Severe psychiatric disease or cerebral dysfunction
    • Precedente trapianto autologo e/o allogenico o precdente trapianto di organo. • Infiltrazione midollare &gt;25%. • Anemia emolitica autoimmune attiva. • Partecipazione ad un altro studio clinico nelle 4 settimane precedenti l’inclusione nel presente studio. • Insufficienza renale (creatinina &gt; 2.0 mg/dl), non correlata al linfoma. • Insufficienza epatica (transaminase &gt;3ULN o bilirubina&gt;2.0 mg/dl), non correlata al linfoma. • Saranno escluse pazienti in gravidanza e/o in periodo di allattamento. • Patologie psichiatriche severe o disfunzioni cerebrali
    E.5 End points
    E.5.1Primary end point(s)
    Antitumor activity, in terms of overall response rate (ORR)
    Tasso di risposta (Risposta Globale, Remissione Completa)
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 years
    3 anni
    E.5.2Secondary end point(s)
    Safety, as acute and long-term toxicity; Progression-free survival (PFS); Histological response and molecular residual disease (MRD) for gastric MALT lymphoma
    Sicurezza del trattamento inteso come tossicità acuta e a lungo termine; Sopravvivenza libera da progressione; Risposta istologica e malattia molecolare residua per linfoma MALT gastrico
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years
    3 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 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) 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 No
    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 years0
    E.8.9.1In the Member State concerned months54
    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.1.1Number 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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.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)
    NA
    NA
    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 Decision2012-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-17
    P. End of Trial
    P.End of Trial StatusOngoing
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