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    EudraCT Number:2016-002739-14
    Sponsor's Protocol Code Number:ACT14596
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-27
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-002739-14
    A.3Full title of the trial
    Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients with Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL)
    Studio di Fase 2 sulla sicurezza ed efficacia di isatuximab, un anticorpo monoclonale anti-CD38, somministrato per infusione endovenosa (EV) in pazienti con leucemia linfoblastica acuta tipo T (T-LLA) o linfoma linfoblastico tipo T (T-LLB) recidivante o refrattario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia
    Sicurezza ed efficacia di Isatuximab nella leucemia linfoblastica
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberACT14596
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1179-5294
    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.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 supportSanofi-aventis recherche & d¿veloppement
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI S.P.A.
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street AddressViale Bodio 37 B
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20158
    B.5.4Telephone number800226343
    B.5.5Fax number00390239394168
    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 nameisatuximab
    D.3.2Product code SAR650984
    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 INNIsatuximab
    D.3.9.2Current sponsor codeSAR650984
    D.3.9.3Other descriptive nameSAR650984
    D.3.9.4EV Substance CodeSUB119676
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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) 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
    E.1.1.1Medical condition in easily understood language
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036543
    E.1.2Term Precursor T-lymphoblastic lymphoma/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 21.0
    E.1.2Level PT
    E.1.2Classification code 10042987
    E.1.2Term T-cell type acute leukaemia
    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 evaluate the efficacy of isatuximab
    Valutare l'efficacia di Isatuximab
    E.2.2Secondary objectives of the trial
    -To evaluate the safety profile of isatuximab
    -To evaluate the duration of response (DOR)
    -To evaluate progression free survival (PFS) and overall survival (OS)
    -To evaluate the pharmacokinetics (PK) of isatuximab in patients with T-ALL or T-LBL
    -To evaluate immunogenicity of isatuximab in patients with T-ALL or T-LBL
    -To assess minimal residual disease (MRD) and correlate it with clinical outcome
    -Valutare il profilo di sicurezza di Isatuximab
    -Valutare la durata della risposta (DOR)
    -Valutare la sopravvivenza libera da progressione (PFS) e la sopravvivenza globale (OS).
    -Valutare la farmacocinetica (PK) di Isatuximab in pazienti con T-LLA o T-LLB
    -Valutare l'immunogenicit¿ di Isatuximab in pazienti con T-LLA o T-LLB
    -Valutare la malattia minima residua (MRD) e la sua correlazione con l' esito clinico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients must have a known diagnosis of ALL of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy
    -Patients must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Patients in first relapse will be eligible regardless of the first remission duration
    -Patients must have been previously exposed to nelarabine in countries where this drug is available (unless due to a contraindication to its use or administrative issue)
    -No more than 3 prior salvage therapies.
    -I pazienti devono avere una diagnosi nota di LLA di tipo T, compresi T-LLB e T-LLA con coinvolgimento extramidollare isolato in recidiva, confermato mediante biopsia
    -I pazienti devono essere stati precedentemente trattati per T-LLA o T-LLB e aver sviluppato una recidiva o essere refrattari al trattamento più recente. I pazienti alla prima recidiva saranno
    considerati idonei a prescindere dalla durata della prima remissione
    -I pazienti devono essere stati precedentemente esposti a nelarabina nei Paesi in cui tale farmaco è disponibile (salvo in caso di controindicazioni all’utilizzo o di problemi amministrativi)
    -Non più di 3 precedenti terapie di salvataggio
    E.4Principal exclusion criteria
    - Prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy within 2 weeks of study treatment. Must have recovered from acute toxicity before first study treatment administration
    - Prior stem cell transplant within 4 months and/or evidence of active systemic Graft versus Host Disease and/or immunosuppressive therapy for Graft versus Host Disease within 1 week before the first study treatment administration
    - Clinical evidence of active central nervous system (CNS) leukemia
    - T-ALL with testicular involvement alone.
    -I pazienti devono aver concluso un eventuale trattamento precedente con agenti immunoterapici/sperimentali da >3 settimane e chemioterapia da >2 settimane e devono essersi ripresi da eventuali tossicità acute prima della prima somministrazione del trattamento in studio
    -Precedente trapianto di cellule staminali entro 4 mesi e/o evidenza di malattia del trapianto contro l’ospite sistemica attiva e/o terapia immunosoppressiva per malattia del trapianto contro l’ospite entro la settimana precedente la prima somministrazione del trattamento in studio
    -Evidenza clinica di leucemia attiva nel sistema nervoso centrale (SNC)
    - T-LLA con solo coinvolgimento del testicolo
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate
    Tasso di risposta globale
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1)
    6 mesi dopo la prima somministrazione (giorno 1) all'ultimo paziente, 12 mesi dopo la prima somministrazione (giorno 1) all'ultimo paziente
    E.5.2Secondary end point(s)
    - Duration of response - Time
    - Progression free survival - Time
    - Overall survival - Time

    - Durata della risposta - Tempo
    - Sopravvivenza libera da progressione - Tempo
    - Sopravvivenza globale - Tempo
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1)
    6 mesi dopo la prima somministrazione (giorno 1) all'ultimo paziente, 12 mesi dopo la prima somministrazione (giorno 1) all'ultimo paziente
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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. 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    Russian Federation
    United States
    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
    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 months5
    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 months7
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 7
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 31
    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 Yes
    F. of subjects incapable of giving consent
    Patients <18 years of age
    Pazienti con meno di 18 anni
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 43
    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)
    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 Decision2017-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-11-08
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