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    Summary
    EudraCT Number:2014-001673-14
    Sponsor's Protocol Code Number:CCTL019A2205B
    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:2021-06-17
    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 number2014-001673-14
    A.3Full title of the trial
    Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy
    Follow up a lungo termine di pazienti esposti a CAR terapia basata su lentivirus con cellule T
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long term follow-up study for patients who have been treated with lentivirus-based chimeric antigen receptor (CAR) T-Cell Therapy
    Studio di follow-up a lungo termine con CAR-T
    A.3.2Name or abbreviated title of the trial where available
    CD19 CART Long Term Follow Up (LTFU) study
    Studio di follow-up a lungo termine con CD19 CART
    A.4.1Sponsor's protocol code numberCCTL019A2205B
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02445222
    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 SponsorNOVARTIS PHARMA SERVICES AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNOVARTIS FARMA S.p.A.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityORIGGIO
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number00390296541
    B.5.5Fax number0039029659066
    B.5.6E-mailinfo.studiclinici@novartis.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 nameCTL019
    D.3.2Product code [CTL019]
    D.3.4Pharmaceutical form Suspension for injection
    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 INNtisagenlecleucel-T
    D.3.9.2Current sponsor codeCTL019
    D.3.9.4EV Substance CodeSUB176601
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100000000 to 500000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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) 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 Yes
    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 who have received CAR T-cell therapy in the context of a Novartis and/or Penn treatment trial.
    Pazienti che hanno ricevuto terapia con cellule CAR-T nel contesto di uno studio di trattamento Novartis e / o Penn.
    E.1.1.1Medical condition in easily understood language
    Patients who have been treated in a Novartis or Penn sponsored or supported study with chimeric antigen receptor (CAR) T-cell treatment
    Pazienti che sono stati trattati in uno studio sponsorizzato o supportato da Novartis o Penn con il trattamento con cellule T del recettore dell'antigene chimerico (CAR)
    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 10003917
    E.1.2Term B-cell type acute leukaemia
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10003899
    E.1.2Term 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to monitor all patients exposed to CAR T-cells (CAR-T) for 15 years following last CAR-T (e.g.CTL019) infusion to assess the risk of delayed adverse events (AEs) and assess long term efficacy, including vector persistence.
    Primary objective:
    Describe selected, delayed AEs that are suspected to be related to previous CAR T-cell therapy as outlined in current Health Authority guidelines
    Lo scopo di questo studio è di monitorare tutti i pazienti esposti alle cellule T CAR (CAR-T) per 15 anni dopo l'ultima infusione CAR-T (ad esempio CTL019) per valutare il rischio di eventi avversi ritardati (eventi avversi) e valutare l'efficacia a lungo termine , compresa la persistenza vettoriale.
    Obiettivo primario:
    Descrivere gli eventi avversi ritardati selezionati che si sospetta siano correlati alla precedente terapia con cellule T CAR come indicato nelle attuali linee guida delle autorità sanitarie
    E.2.2Secondary objectives of the trial
    1 • Monitor the persistence of modified T-cells in peripheral blood
    2 • Monitor for RCL (Replication Competent Lentivirus)
    3 • Assess the long-term efficacy of CAR-T
    4 • Monitor lymphocyte levels
    5 • Describe the growth, development, and female reproductive status for patients who were aged < 18 years at the time of the initial CAR-T infusion
    1 • Monitorare la persistenza delle cellule T modificate nel sangue periferico
    2 • Monitor per RCL (Replication Competent Lentivirus)
    3 • Valutare l'efficacia a lungo termine di CAR-T
    4 • Monitorare i livelli dei linfociti
    5 • Descrivere la crescita, lo sviluppo e lo stato riproduttivo femminile per i pazienti di età <18 anni al momento dell'infusione iniziale di CAR-T
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients must have received CAR-T therapy within one of the following:
    • Novartis or Penn sponsored CAR-T treatment trials where CAR-T was given as monotherapy or as combination therapy.
    • Novartis managed access programs outside of the commercial setting, i.e. where CAR-T therapy was intended to be given in the setting of a Novartis or Penn sponsored CAR-T treatment trial
    2. Patients must provide informed consent prior to their entry into this study.
    1. I pazienti devono aver ricevuto terapia con CAR-T all’interno di uno dei seguenti:
    - Studi di Novartis o Penn con il trattamento con CAR-T nei quali CAR-T è stato somministrato in monoterapia o in terapia d’associazione (vedi Tabella 14-1 per un elenco degli studi clinici).
    - Programmi gestiti di accesso al farmaco di Novartis (MAP) al di fuori del contesto commerciale, ossia, nei quali la terapia con CAR-T veniva somministrata nell’ambito di studi clinici sponsorizzati da Novartis o da Penn (vedi Tabella 14-1 per un elenco dei MAP).
    2. I pazienti devono fornire il proprio consenso informato prima del loro ingresso nello studio.
    E.4Principal exclusion criteria
    - There are no specific exclusion criteria for this study.
    - Non vi sono criteri di esclusione specifici per questo studio
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with events in each of the following categories:
    • New secondary malignancies
    • New serious infections,
    • New incidence of serious neurologic disorder,
    • New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder,
    • New incidence of a hematologic disorder
    • Other adverse events considered related to CAR T cell therapy
    Proporzione di pazienti con eventi in ciascuna delle seguenti categorie:
    • Nuove neoplasie secondarie
    • Nuove infezioni gravi,
    • Nuova incidenza di gravi disturbi neurologici,
    • Nuova incidenza o esacerbazione di un precedente disturbo reumatologico o di altri disturbi autoimmuni,
    • Nuova incidenza di un disturbo ematologico
    • Altri eventi avversi considerati correlati alla terapia con cellule CAR-T
    E.5.1.1Timepoint(s) of evaluation of this end point
    As defined per protocol
    Come definito per protocollo
    E.5.2Secondary end point(s)
    1- Proportion of patients with detectable CAR transgene levels in peripheral blood by q-PCR at pre-specified time points
    2- Proportion of patients with detectable RCL by VSV-G q-PCR in peripheral blood at pre-specified time points
    3- Proportion of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry and Incidence of death
    4- B and T lymphocyte count
    5-Height and weight, Tanner staging, menstruation status
    1- Proporzione di pazienti con livelli rilevabili di transgene CAR nel sangue periferico mediante q-PCR a time points predefiniti
    2- Proporzione di pazienti con RCL rilevabile mediante VSV-G q-PCR nel sangue periferico in corrispondenza di time points predefiniti
    3- Proporzione di pazienti che hanno avuto una ricaduta o progrediscono tra i pazienti che non avevano recidivato o progredito all'entrata / rientro nello studio e Incidenza della morte
    4- Conta dei linfociti B e T.
    5-Altezza e peso, messa in scena del conciatore, stato delle mestruazioni
    E.5.2.1Timepoint(s) of evaluation of this end point
    As defined per protocol
    Come definito per protocollo
    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 Yes
    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) Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Brazil
    Canada
    China
    Hong Kong
    Korea, Democratic People's Republic of
    Singapore
    Taiwan
    United States
    Austria
    Belgium
    France
    Germany
    Italy
    Netherlands
    Norway
    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
    The end of the LTFU study for each individual patient will be 15 years after the date of patients' last infusion of Novartis or Penn CAR-T therapy. The end of study as a whole is defined as the last patient's last visit (LPLV), which is the last patient's last evaluation (visit Year 15), or the time of premature withdrawal. All patients who complete the LTFU study will be followed for survival every 6 months until the end of the LTFU study.l.
    La fine dello studio LTFU per ogni singolo paziente sarà di 15 anni dopo la data dell'ultima infusione di Novartis o della terapia CAR-T di Penn da parte dei pazienti. La fine dello studio nel suo insieme è definita come l'ultima visita dell'ultimo paziente (LPLV), che è l'ultima valutazione dell'ultimo paziente (visita Anno 15) o il momento del ritiro prematuro. Tutti i pazienti che completano lo studio LTFU saranno seguiti per la sopravvivenza ogni 6 mesi fino alla fine dello studio LTFU..
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years20
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years20
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 115
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 140
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 700
    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 Decision2017-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-20
    P. End of Trial
    P.End of Trial StatusOngoing
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