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    Summary
    EudraCT Number:2011-002565-38
    Sponsor's Protocol Code Number:CD-ON-MEDI-551-1088
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2012-08-07
    Trial results View 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 number2011-002565-38
    A.3Full title of the trial
    A Phase 2 Randomized Open-label Study of MEDI-551 in Adults
    With Relapsed or Refractory DLBCL
    Studio in aperto randomizzato di fase 2 su MEDI-551 in adulti con LDGCB recidivante o refrattario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2 Randomized Open-label Study of MEDI-551 in Adults
    With Relapsed or Refractory DLBCL
    Studio in aperto randomizzato di fase 2 su MEDI-551 in adulti con LDGCB recidivante o refrattario
    A.4.1Sponsor's protocol code numberCD-ON-MEDI-551-1088
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01453205
    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 SponsorMEDIMMUNE ONCOLOGY INC
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedImmune LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.4Telephone number301 398-4012
    B.5.5Fax number301 398-9012
    B.5.6E-mailclinicaltrialenquiries@medimmune.com
    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 No
    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 nameMEDI-551
    D.3.2Product code MEDI-551
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeMEDI-551
    D.3.9.3Other descriptive namea-fucosylated anti-CD19 antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 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 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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo Monoclonale
    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 No
    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 nameMEDI-551
    D.3.2Product code MEDI-551
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeMEDI-551
    D.3.9.3Other descriptive namea-fucosylated anti-CD19 antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 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 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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo Monoclonale
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 MabThera
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Concentrate 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    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 No
    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 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 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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo monoclonale
    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
    Relapsed or Refractory Diffuse Large B-cell Lymphoma .(DLBCL)
    Linfoma diffuso a grandi cellule B recidivante o refrattario.(DLBCL)
    E.1.1.1Medical condition in easily understood language
    Relapsed or Refractory Diffuse Large B-cell Lymphoma .(DLBCL)
    Linfoma diffuso a grandi cellule B recidivante o refrattario.(DLBCL)
    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 10012818
    E.1.2Term Diffuse large B-cell 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
    Determine if MEDI-551, when used in combination with salvage
    chemotherapy, Ifosafamide-carboplatin-etoposide (ICE) or
    Dexamethasone-cytarabine (DHAP) in patients with relapsed or
    refractory DLBCL who are eligible for Autologous Stem Cell Tansplant
    (ASCT), has superior efficacy compared to rituximab in the same
    population.
    Determinare se MEDI-551, se usato in combinazione con la chemioterapia di salvataggio, Ifosafamide-carboplatino-etoposide (ICE) o
    Desametasone-citarabina (DHAP) in pazienti con DLBCL recidiva o
    refrattaria che sono eligibili per trapianto autologo di cellule staminali (ASCT), ha efficacia superiore rispetto a rituximab nella stessa
    popolazione.
    E.2.2Secondary objectives of the trial
    Evaluate anti-tumor activities and overall survival (OS),to determine an
    acceptable dose for MEDI-551 when used in combination with ICE or
    DHAP, to describe the safety and tolerability, to determine the
    immunogenicity (IM), and to describe the pharmacokinetic (PK) profile.
    Valutare l'attività anti-tumorale e la sopravvivenza globale (OS),per determinare una
    dose accettabile di Medi-551 quando usato in combinazione con ICE o
    DHAP,per descriverne la sicurezza e tollerabilità,per determinarne l'
    immunogenicità (IM),e per descriverne il profilo farmacocinetico (PK).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed aggressive B-cell DLBCL, including FL
    transforming to DLBCL & Grade III FL
    • Relapsed from or refractory to at least one treatment containing
    rituximab or another anti-CD20 based immunotherapy combined with
    anthracycline- or anthracenedione-based chemotherapy
    • Eligible for ASCT
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0,
    1, or 2
    • Life expectancy of ≥ 12 weeks
    • Adequate hematological function
    • DLBCL confermato istologicamente , comprese trasformazioni FL di DLBCL & FL di Grado III
    • forma recidivante o refrattaria ad almeno un trattamento a base di
    rituximab o un altro anti-CD20 immunoterapia basata sulla combinazione con antracicline o chemioterapia a base di antracendione
    • eligibile per ASCT
    • Eastern Cooperative Oncology Group (ECOG) performance status pari a 0,
    1, o 2
    • L'aspettativa di vita di ≥ 12 settimane
    • Funzione ematologica adeguata
    E.4Principal exclusion criteria
    • Any chemotherapy, radiotherapy, immunotherapy, biologic,
    investigational or hormonal therapy for treatment of lymphoma within
    28 days prior to treatment
    • Previous cancer therapy for DLBCL other than anthracycline- or
    anthracenedione based chemoimmunotherapy, monotherapy rituximab
    prior to first line therapy and/or as a maintenance therapy, or limited
    field radiotherapy
    • Prior autologous or allogeneic SCT
    • New York Heart Association ≥ Class II congestive heart failure;
    • Clinically significant abnormality on ECG
    • History of other invasive malignancy within 5 years except for
    localized/in situ, carcinomas such as cervical carcinoma in situ.
    • Evidence of active infection
    • Documented current central nervous system involvement by leukemia
    or lymphoma
    • Qualsiasi chemioterapia, radioterapia, immunoterapia, biologica,
    ormonale o terapia sperimentale per il trattamento del linfoma effettuato entro 28 giorni prima del trattamento
    • terapia del cancro precedente per DLBCL diversa da antracicline o chemioimmunoterapia basata su
    antracenedione , precedente monoterapia
    di rituximab come terapia di prima linea e / o come terapia di mantenimento, o radioterapia a campo limitato.
    • Precedente STC autologo o allogenico
    • New York Heart Association ≥ insufficienza cardiaca congestizia di Classe II ;
    • anormalità ECG clinicamente significativa
    • Storia di altre neoplasie invasive entro 5 anni, salvo quelle
    localizzata / in situ, carcinomi come il carcinoma cervicale in situ.
    • Prove di infezione attiva
    • Coinvolgimento attuale e documentato del sistema nervoso centrale da leucemia o linfoma
    E.5 End points
    E.5.1Primary end point(s)
    The overall response rate (ORR), including Partial Response (PR) and
    Complete Response (CR), of subjects treated with MEDI-551 when used
    in combination with ICE or DHAP versus rituximab in combination with
    ICE or DHAP in subjects with relapsed or refractory DLBCL.
    Il tasso di risposta globale (ORR), compresa la risposta parziale (PR) e
    Risposta completa (CR), dei soggetti trattati con MEDI-551 quando viene utilizzato
    in combinazione con ICE o DHAP rispetto a rituximab in combinazione con
    ICE DHAP o in soggetti con DLBCL recidivato o refrattario.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1080
    1080 giorni
    E.5.2Secondary end point(s)
    Antitumor activity: Includes complete response rate, Minimal residual
    disease negative complete response rate, time to response (TTR), time
    to progression (TTP), progression-free survival (PFS), and overall
    survival (OS)
    Acceptable Dose: Benefit/Risk Analysis of Safety and Efficacy to be
    determined
    Safety and Tolerability: The safety endpoints include Adverse Events
    (AEs), Serious Adverse Events (SAEs) occurring during the protocolspecified
    reporting period and changes in clinical laboratory evaluations,
    Electrocardiogram (ECGs), vital signs, and weight from baseline.
    Immunogenicity (IM): Number and percentage of subjects who develop
    detectable anti-drug antibodies
    Pharmacokinetics (PK): Area Under Curve, CMAX, T1-half
    Attività antitumorale: Include tasso di risposta completa, tasso negativo di risposta completa alla malattia minima residua, il tempo di risposta (TTR), il tempo alla progressione (TTP), sopravvivenza libera da progressione (PFS), e in generale
    sopravvivenza (OS)
    Dose Accettabile :Analisi per determinare il rapporto rischi / benefici della sicurezza e dell'efficacia.
    Sicurezza e tollerabilità: Gli endpoint di sicurezza includono eventi avversi
    (EA), eventi avversi gravi (SAE) che si verificano durante il periodo di riferimento specificato dal protocollo e i cambiamenti rispetto al basale nei risultati di laboratorio clinico, negli elettrocardiogrammi (ECG) e nei segni vitali e nel peso. Immunogenicità (IM): Numero e percentuale di soggetti che sviluppano anticorpi anti-farmaco rilevabili. Farmacocinetica (PK): area sotto la curva, CMAX, T1-mezzo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Antitumor activity: Study Day 1080
    Acceptable dose: Study Day 42
    Safety and Tolerability: Study Day 1080
    IM: Up to Study Day 1080
    PK: Study Day 1; Study Day 8; Study Day 12; Study Day 19; Study Day
    26; Study Day 54; Study Day 110; Study Day 138; Study Day 166
    Attività antitumorale: giorno 1080
    Dose accettabile: giorno 42
    Sicurezza e Tollerabilità: 1080
    IM: fino al 1080
    PK: giorni 1,8,12,19,26, 54, 110, 138, 166
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    rituximab - Stesso farmaco ad altro dosaggio
    rituximab - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial3
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Japan
    Russian Federation
    United States
    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 end of the study (''study completion'') is defined as the date of the last protocol-specified visit/assessment (including telephone contact) for the last subject in the study. This date will be after a combined total of 82 deaths occur in the rituximab arm and the selected MEDI-551 arm, or 24 months from the date the last subject is randomized into the study, or the date the sponsor stops the study, whichever occurs first.
    La fine dello studio è definita come la data dell'ultima visita/valutazione specificata dal protocollo(compreso il contatto telefonico) per l'ultimo paziente.Questa data sarà dopo82decessi totali avvenuti in un braccio o 24 mesi dalla LPI.
    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 months48
    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 months58
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 127
    F.4.2.2In the whole clinical trial 170
    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 Decision2012-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-18
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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