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    Summary
    EudraCT Number:2016-003255-30
    Sponsor's Protocol Code Number:20150291
    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:2021-02-10
    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 number2016-003255-30
    A.3Full title of the trial
    A phase 2 open-label study to determine the effect of Blinatumomab on minimal residual disease in subjects with high-risk diffuse large B-cell lymphoma post-autologous hematopoietic stem-cell transplantation.
    Studio in aperto di fase 2 volto a stabilire l¿effetto di blinatumomab sulla malattia minima residua nei soggetti con linfoma diffuso a grandi cellule B ad alto rischio dopo trapianto autologo di cellule staminali ematopoietiche
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate the effect of blinatumomab in patients with remaining cells of lymph gland cancer after stem cell transplantation
    Studio clinico volto a valutare l'effetto di blinatumomab in pazienti con cellule rimanenti dal tumore della ghiandola linfatica dopo il trapianto di celllule staminali
    A.3.2Name or abbreviated title of the trial where available
    A clinical study to investigate the effect of blinatumomab in patients with remaining cells of lymph
    Studio clinico per valutare l'effetto di blinatumomab nei pazienti con residui di cellule tumorali d
    A.4.1Sponsor's protocol code number20150291
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03298412
    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 SponsorAMGEN INC.
    B.1.3.4CountryUnited States
    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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O. Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6301
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number004141690300
    B.5.5Fax number004141690200
    B.5.6E-mailMedinfoInternational@amgen.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 Yes
    D.2.1.1.1Trade name Blincyto
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBlinatumomab
    D.3.2Product code [AMG 103]
    D.3.4Pharmaceutical form Powder 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 INNBlinatumomab
    D.3.9.1CAS number 853426-35-4
    D.3.9.2Current sponsor codeAMG103
    D.3.9.4EV Substance CodeSUB35403
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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) Yes
    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
    High-risk diffuse large B-cell Lymphoma (DLBCL)
    Linfoma diffuso a grandi cellule B (DLBCL)
    E.1.1.1Medical condition in easily understood language
    A type of lymph gland cancer
    Una tipologia di tumore della ghiandola linfatica
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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
    To determine minimal residual disease (MRD) negative rate following blinatumomab treatment in high-risk diffuse large B-cell lymphoma (DLBCL) subjects who are MRD-positive post-autologous hematopoietic stem cell transplantation (aHSCT).
    Determinare il tasso di negativit¿ per la malattia minima residua (MRD) in seguito al trattamento con blinatumomab nei soggetti affetti da DLBCL ad alto rischio con positivit¿ per MRD dopo trapianto autologo di cellule staminali ematopoietiche (aHSCT).
    E.2.2Secondary objectives of the trial
    To describe the efficacy of blinatumomab in relation to progression-free survival (PFS), duration of MRD-negative status, and overall survival (OS).
    To evaluate the safety and tolerability of blinatumomab.
    Descrivere l'efficacia di blinatumomab in relazione a sopravvivenza libera da progressione (PFS), durata dello stato di negativit¿ per MRD e sopravvivenza globale (OS).
    Valutare la sicurezza e la tollerabilit¿ di blinatumomab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age = 18 at time of informed consent
    -Biopsy-proven DLBCL excluding DLBCL that represents transformation of indolent NHL (Lymphoblastic Lymphoma and Burkitt Lymphoma histology are not eligible)
    -Subject has = 1 characteristic feature of high-risk DLBCL:
    • High-risk first complete remission (defined as interim PET-CT positive or < complete remission to frontline chemotherapy AND achieved complete remission to platinum-containing salvage)
    •Relapse within 1 year of diagnosis
    •Secondary aaIPI > 1 (see Appendix D)
    •Partial response/partial metabolic response after minimum of 2 cycles of platinum-containing salvage chemotherapy
    • C-myc rearrangement
    -aHSCT with high-dose chemotherapy following first (or later) salvage treatment.
    -PET-CT negative (Deauville score = 3) 90 days (± 30 days) post aHSCT -Available relapsed and/or diagnostic pathology formalin-fixed paraffin-embedded (FFPE) tumor block or slide samples at the time of enrollment including the successful identification of malignant clone sequences by the central laboratory.
    -MRD plasma sample collected = 3 weeks after the post aHSCT PET-CT scan
    -MRD-positive assessment (by NGS analysis) at enrollment or at any time during the run-in 1 period
    -PET-CT negative (defined by Deauville criteria = 3) at run-in 2 performed = 3 weeks from MRD test result available to the site at run-in
    1.. Historical PET-CT are allowed if performed = 6 weeks from day 1 (first dose of blinatumomab) and subject has no clinical signs or symptoms suggestive of disease progression (eg, increase in lactate dehydrogenase [LDH] not otherwise explained)
    -Age = 18 al momento del consenso informato
    - DLBCL comprovato da bipoplasma escluso DLBCL che rappresenta la trasformazione dell'HLL indolente (linfoma linfoblastica e istologia del linfoma Burkitt non sono idonei)
    -Subject ha = 1 caratteristica di DLBCL ad alto rischio:
    • La prima remissione completa a rischio elevato (definita come rimedio intermedio PET-CT o <remissione completa alla chemioterapia frontale e ha ottenuto la remissione completa al recupero contenente platino)
    • Relapse entro un anno dalla diagnosi
    • AaIPI secondario> 1 (vedi appendice D)
    • risposta parziale / risposta metabolica parziale dopo un minimo di 2 cicli di chemioterapia di salvataggio contenente platino
    • Riorganizzazione C-myc
    -HSCT con chemioterapia ad alte dosi dopo il primo (o successivo) trattamento di salvataggio.
    -PET-CT negativo (punteggio Deauville = 3) 90 giorni (± 30 giorni) post aHSCT -Analisi di recupero e / o diagnosi patologica diagnostica o blocco dei tumori embedded (FFPE) o diapositiva in fase formalizzata a tempo di iscrizione incluso il successo identificazione delle sequenze di cloni maligne dal laboratorio centrale.
    -MRD campione di plasma raccolto = 3 settimane dopo la scansione post-aHSCT PET-CT
    -MRD-positive valutazione (tramite analisi NGS) all'iscrizione o in qualsiasi momento durante il periodo di esecuzione 1
    -PET-CT negativo (definito da = 3 criteri Deauville ) al run-in 2 eseguito = 3 settimane dalla valutazione MRD disponibile al centro al run-in 1. PET-CT storici sono ammessi se eseguiti = 6 settimane dal primo giorno (prima dose di blinatumomab) e soggetto non presenta sintomi o sintomi clinici che indicano la progressione della malattia (ad esempio, aumento della lattato deidrogenasi [LDH] non diversamente spiegato)
    E.4Principal exclusion criteria
    -Clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis
    -Evidence of CNS involvement with DLBCL at disease evaluation
    obtained prior to starting blinatumomab
    -Current autoimmune disease or history of autoimmune disease with potential of CNS involvement
    •Prior anti-CD19 directed therapies
    •Prior alloHSCT
    -Received radiation = 2 weeks prior to enrollment
    -Known infection with HIV or chronic infection with HBV or HCV
    -History of malignancy other than DLBCL within the past 3 years with the following exceptions:
    •Malignancy treated with curative intent and with no known active disease present for = 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
    •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    •Adequately treated cervical carcinoma in situ without evidence of disease
    •Adequately treated breast ductal carcinoma in situ without evidence of disease
    •Prostatic intraepithelial neoplasia without evidence of prostate cancer
    •Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
    -Subject has known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing.
    -History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
    •Women who are pregnant or breastfeeding or planning to become pregnant or breastfeed while receiving blinatumomab and for an additional 48 hours after the last treatment dose of blinatumomab. (Females of child bearing potential should only be included after a negative highly sensitive urine or serum pregnancy test.)
    •Women of childbearing potential unwilling to use an acceptable method of effective contraception while receiving blinatumomab and for an additional 48 hours after last dose of blinatumomab.
    -Currently receiving treatment in another investigational device or drug study or less than 30 days since ending treatment on another investigational device or drug study. Other investigational procedures while participating in this study are excluded.
    -Subject has active infection requiring systemic therapy
    -Any change in the part 1 eligibility criteria during the run-in period.
    - Patologie del CNS clinicamente rilevanti come epilessia, sequestro, paresi, afasia, ictus, gravi lesioni cerebrali, demenza, malattia di Parkinson, malattia cerebellare, sindrome del cervello organico e psicosi
    -Evidenza del coinvolgimento del CNS con DLBCL alla valutazione della malattia ottenuta prima di iniziare il trattamnto con blinatumomab
    -Current autoimmune malattia o storia di malattie autoimmuni con potenziale di coinvolgimento del CNS
    • Terapie anti-CD19 precedenti
    • Prima di HSCT
    -La radiazione ricevuta = 2 settimane prima dell'iscrizione
    - Infezione da HIV o infezione cronica con HBV o HCV
    -Storia della malignità diversa da DLBCL negli ultimi 3 anni con le seguenti eccezioni:
    • Malignità trattata con intento curativo e senza malattia attiva nota presente per = 3 anni prima dell'iscrizione e ritenuta a basso rischio di ricorrenza da parte del medico curante
    • Tumore cutaneo non melanoma adeguatamente trattato o maligna lentigo senza evidenze di malattia
    • Carcinoma cervicale adeguatamente trattato in situ senza prove di malattia
    • Carcinoma del seno del seno adeguatamente trattato in situ senza prove di malattia
    • Neoplasia intraepiteliale prostatica senza evidenze di cancro alla prostata
    • carcinoma o carcinoma noninvasivo papilare urothelial adeguatamente trattato in situ
    -Soggetto ha notato l'ipersensibilità alle immunoglobuline o ad uno qualsiasi dei prodotti o componenti da somministrare durante il dosaggio.
    - la storia o la prova di qualsiasi altro disturbo, condizione o malattia clinicamente significativa (ad eccezione di quelli sopra descritti) che, a giudizio del medico di ricerca o medico di Amgen, se consultati, costituirebbe un rischio per la sicurezza del soggetto o interferire con lo studio valutazione, procedure o completamento.
    • Le donne in gravidanza o in allattamento o che intendono diventare incinte o allattate durante la somministrazione di blinatumomab e per altre 48 ore dopo l'ultima dose di trattamento di blinatumomab. (Le femmine del potenziale di cotone dovrebbero essere incluse solo dopo una prova di gravidanza negativa negativa o urinaria).
    • Le donne in età fertile che non desiderano utilizzare un metodo accettabile di efficace contraccezione durante la somministrazione di blinatumomab e per altre 48 ore dopo l'ultima dose di blinatumomab.
    - effettivamente ricevere il trattamento in un altro dispositivo di ricerca o uno studio farmacologico o meno di 30 giorni dalla conclusione del trattamento su un altro dispositivo o uno studio farmacologico. Sono escluse altre procedure di ricerca durante la partecipazione a questo studio.
    -Subject ha un'infezione attiva che richiede una terapia sistemica
    - ogni modifica dei criteri di ammissibilità di parte 1 durante il periodo di esecuzione.
    E.5 End points
    E.5.1Primary end point(s)
    MRD negative rate at the end of cycle 1 of blinatumomab.
    MRD tasso negativo alla fine del ciclo 1 di blinatumomab.
    E.5.1.1Timepoint(s) of evaluation of this end point
    L'analisi primaria verrà attivata quando i primi 30 soggetti iscritti hanno avuto l'opportunità di completare il ciclo 1 del trattamento con blinatumomab.
    L'analisi finale (vedi sotto) includerà anche stime aggiornate per gli endpoint valutati nell'analisi primaria (tasso negativo MRD e MRD prima del trattamento con blinatumomab).
    The primary analysis will be triggered when the first 30 enrolled subjects have had the opportunity to complete cycle 1 of blinatumomab treatment.
    The final analysis (see below) will also include updated estimates for the endpoints assessed at the primary analysis (MRD-negative rate and MRD prior to blinatumomab treatment).
    E.5.2Secondary end point(s)
    -PFS
    -Duration of MRD negative status
    -OS
    -Incidence,grade and severity of treatment emergent adverse events
    -PFS
    -Durata dello stato negativo di MRD
    -OS
    -Incidenza, grado e gravit¿ degli eventi avversi emergenti
    E.5.2.1Timepoint(s) of evaluation of this end point
    The final analysis will be conducted when the subjects in the Primary Analysis set have had the opportunity to complete the long term follow up visit 1 year from the first dose of blinatumomab. The safety and tolerability of blinatumomab will be assessed at the time of the primary analysis (see above).
    L'analisi finale sar¿ condotta quando i soggetti dell'insieme di analisi primaria hanno avuto l'opportunit¿ di completare la visita a lungo termine dopo un anno dalla prima dose di blinatumomab. La sicurezza e la tollerabilit¿ del blinatumomab saranno valutate al momento dell'analisi primaria (vedi sopra).
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    United States
    Belgium
    Finland
    France
    Greece
    Italy
    Switzerland
    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
    Primary Completion: The primary completion date is defined as the date when the last subject is assessed or receives an intervention for the final collection of data for the primary endpoint.
    End of study: the end of study date is defined as the date when the last subject is assessed or receives an intervention for evaluation in the study (ie, last subject last visit).
    Completamento primario: la data di completamento primario ¿ definita come la data in cui viene valutato l'ultimo soggetto o riceve un intervento per la raccolta finale dei dati per l'endpoint primario.
    Fine dello studio: la data della fine dello studio ¿ definita come la data in cui viene valutato l'ultimo soggetto o riceve un intervento per la valutazione nello studio (ovvero l'ultima visita del soggetto ultimo).
    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 years3
    E.8.9.2In all countries concerned by the trial months1
    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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 57
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    This study will include study subjects who may require a legally acceptable representative to partecipate. Prerequisite: subjects fulfill the inclusion criteria and, in the opinion of the investigator, may benefit from partecipation in the study.
    Questo studio includer¿ soggetti che possono richiedere un rappresentante legalmente accettabile per partecipare. Prerequisito: i soggetti soddisfano i criteri di inclusione e, a giudizio del ricercatore, possono beneficiare della partecipazione nell
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 90
    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)
    None
    Nessuno
    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 Decision2017-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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