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    Summary
    EudraCT Number:2014-000584-41
    Sponsor's Protocol Code Number:BP-004
    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:2014-04-15
    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 number2014-000584-41
    A.3Full title of the trial
    Phase I/II study of CaspaCide T cells from an HLA-partially matched family donor after negative selection of TCR αβ+ T cells in pediatric patients affected by hematological disorders
    Studio di fase I/II sull’impiego di cellule T CaspaCide derivate da donatore familiare parzialmente compatibile sottoposto a procedura di T deplezione αβ, in pazienti pediatrici affetti da disordini ematologici dopo trapianto aploidentico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I/II study of CaspaCide T cells from an HLA-partially matched family donor after negative selection of TCR αβ+ T cells in pediatric patients affected by hematological disorders
    Studio di fase I/II volto alla valutazione della sicurezza e della efficacia della somministrazione di cellule T BPX-501 dopo trapianto aploidentico da donatore familiare parzialmente compatibile sottoposto a procedura di T deplezione αβ in pazienti pediatrici.
    A.3.2Name or abbreviated title of the trial where available
    CaspaCide TCR αβ haplo HSCT
    A.4.1Sponsor's protocol code numberBP-004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02065869
    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 SponsorBellicum Pharmaceuticals, 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 supportBellicum Pharmaceuticals
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBellicum Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointMartha French
    B.5.3 Address:
    B.5.3.1Street Address2130 W. Holcombe Blvd. Suite 850
    B.5.3.2Town/ cityHouston
    B.5.3.3Post codeTX 77030
    B.5.3.4CountryUnited States
    B.5.6E-mailmfrench@bellicum.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 nameBPX-501 cells
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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) No
    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.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 nameAP1903
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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) No
    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 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
    Hematological disorders (ALL;AML;Non-Hodgkin lymphoma;Myelodysplastic
    syndromes;Congenital immune deficiencies;Severe aplastic anemia;Fanconi anemia; Osteopetrosis;Selected cases of hemoglobinopathies)
    Patologie neoplastiche ematologiche
    E.1.1.1Medical condition in easily understood language
    Hematological disorders
    Patologie neoplastiche ematologiche
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level HLGT
    E.1.2Classification code 10018849
    E.1.2Term Haematological disorders NEC
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This is a Phase1 study evaluating the safety and feasibility of BPX-501 T cells infused after partially mismatched, related, T cell-depleted HSCT in pediatric patients. The purpose of this clinical trial is to determine whether BPX-501 infusion can enhance immune reconstitution and retain the graft-versus-leukemia (GvL) effect, with the potential for reducing the severity and duration of severe acute GvHD. The trial will evaluate the treatment of GvHD by the infusion of dimerizer drug (AP1903) in those subjects who present with Grade III-IV acute GVHD, as well as those subjects with Grade II gut/liver GvHD or with Grade I/II GvHD (skin only) who progress or do not respond within 7 days to standard of care treatment.
    Valutare la sicurezza dell’infusione di BPX-501 in 3 differenti escalating doses (2.5 x 10^5, 5 x 10^5, 1 x 10^6 cellule/kg di peso ideale del ricevente), somministrate in giornata + 10 dopo il trapianto aploidentico da donatore familiare parzialmente compatibile (HSCT);Valutare la sicurezza dell’infusione dell’agente dimerizzante, AP1903, nei soggetti che abbiano ricevuto BPX-501 e abbiano sviluppato GvHD acuta di grado III/IV o GvHD di grado II con interessamento intestinale/epatico o GvHD di grado I/II (ad esclusivo coinvolgimento cutaneo) che progrediscano o non rispondano entro 7 giorni al trattamento standard;Determinare gli effetti sulla ricostituzione immunologica post trapianto in ciascuna delle 3 coorti
    E.2.2Secondary objectives of the trial
    Disease-free survival rates after transplantation;Cumulative incidence of relapse;
    Cumulative incidence of neutrophil and platelet engraftment; Kinetics of donor cell engraftment; Cumulative incidence of both primary and secondary graft failure; Cumulative incidence and severity of acute and chronic GvHD;Time to resolution of acute GVHD after administration of AP1903; Rates of infectious complications, with particular regards to HCMV reactivation or other
    viral or invasive fungal infections. In detail, we will estimate the rate of patients
    experiencing any HCMV reactivation, as well as that of patients who will need antiviral treatment because of a viral load (measured as HCMV DNA in blood) greater than 5,000copies/mL;Duration of hospitalization;T-cell immune reconstitution (as measured by time to reach an alpha/beta positive CD3+
    cell count greater than 200/μl; CD8+ cell count greater than 200/μl;diversity of T cell receptor repertoire,and response to polyclonal activators.
    Incidenza cumulativa della mortalità non correlata alla recidiva della patologia di base (NRM) al giorno 180 e ad un anno; Probabilità di sopravvivenza libera da malattia post trapianto; Incidenza cumulativa di recidiva; Incidenza cumulativa dell’attecchimento di neutrofili e piastrine; Cinetica dell’attecchimento delle cellule del donatore; Incidenza cumulativa di graft failure primaria e secondaria; Incidenza cumulativa e severità della GvHD acuta e cronica;Numero di giorni necessari per la risoluzione della GvHD acuta dopo somministrazione di AP1903;Incidenza di complicanze infettive, in particolare verrà valutata la percentuale di pazienti che presenteranno riattivazione da HCMV, così come quelli che necessiteranno di trattamento farmacologico per la presenza di un viral load (HCMV DNA si sangue) superiore a 5000 copie/ml;
    Ricostituzione immunologica del comparto T- cellulare ...
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males or females;Age < 21 years and > 3 months; Life expectancy > 10 weeks;
    Deemed eligible for allogeneic stem cell transplantation; Children with life-threatening hematological malignancies (high-risk ALL in 1st CR,ALL in 2nd or subsequent CR, high-risk AML in 1st CR, AML in 2nd or subsequentCR,myelodysplastic syndromes, non-Hodgkin lymphomas in 2nd or subsequent CR);Non-malignant disorders amenable to be cured by an allograft:
    a. primary immune deficiencies,b. severe aplastic anemia not responding to immune suppressive therapy,c. osteopetrosis,d. selected cases of hemoglobinopathies ande. congenital/hereditary cytopenia, including Fanconi Anemia before any clonalmalignant evolution (MDS, AML);Lack of suitable conventional donor (HLA identical sibling or HLA phenotipically identical relative or 9-10/10 unrelated donor evaluated using high resolution molecular typing) or presence of rapidly progressive disease not permitting time to identify an unrelated donor; A minimum genotypic identical match of 5 / 1 0 is required.
    The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLADRB1;Lansky/Karnofsky score > 50, WHO > 4;Signed written informed consent
    Sesso maschile o femminile;Età compresa tra i 3 mesi e i 21 anni;Aspettativa di vita superiore a 10 settimane;Pazienti affetti da patologie ematologiche maligne a rischio di vita, eleggibili a trattamento mediante trapianto allogenico di cellule staminali emopoietiche; Pazienti affetti da patologie non maligne suscettibili di trattamento attraverso trapianto allogenico di cellule staminali (immunodeficienze primitive;anemia aplastica severa non responsive alla terapia immunosoppressiva;osteopetrosi;casi selezionati di emoglobinopatie e citopenie congenite/ereditarie, inclusa l’Anemia di Fanconi, prima di un’evoluzione clonale maligna (MDS, AML).);Indisponibilità di un donatore convenzionale (germano HLA identico o donatore familiare HLA fenotipicamente identico o donatore non familiare con compatibilità pari a 9-10/10 valutata mediante tipizzazione molecolare ad alta risoluzione) o condizioni di urgenza trapiantologica che non consentano l’identificazione di un donatore non familiare compatibile (È necessaria una compatibilità genotipica minima di 5/10; il donatore ed il ricevente devono risultare HLA identici, come determinato dalla tipizzazione ad alta risoluzione, almeno per un allele di ciascuno dei seguenti loci genici: HLA-A, HLA-B, HLA-Cw e HLA-DRB1);Lansky/Karnofsky score >50, WHO > 4;Acquisizione per iscritto del consenso informato.
    E.4Principal exclusion criteria
    Age < 3 months or >21 years;Greater than grade II acute GvHD or chronic extensive GvHD due to a previous allograft at the time of inclusion; Patient receiving an immunosuppressive treatment for GvHD treatment at the time of
    inclusion;Dysfunction of liver (ALT/AST > 5 times normal value, or bilirubin > 3 times normal value), or of renal function (creatinine clearance < 30 ml / min); Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction <40%); Current active infectious disease (including positive HIV serology or viral RNA);Serious concurrent uncontrolled medical disorder;Pregnant or breast feeding female patient; Lack of parents’ informed consent. Patients who have received more than 1 x 105 T cells/Kg with the graft infusion will be excluded.
    Età inferiore ai 3 mesi o superiore ai 21 anni;GvHD acuta di grado superiore al II o GVHD cronica estesa al momento dell’inclusione nello studio quali complicanze di un precedente trapianto allogenico; Pazienti in terapia immunosoppressiva per trattamento della GvHD quale complicanza di un precedente trapianto allogenico al momento dell’inclusione nello studio;Alterazione della funzionalità epatica (concentrazione plasmatica di ALT/AST > 5 volte i valori normali, o bilirubinemia > 3 volte i valori normali) o della funzionalità renale (clearance della creatinina < 30 ml/min);Patologie cardiovascolari di grado severo (aritmie che richiedano trattamento farmacologico cronico, insufficienza cardiaca congestizia o frazione di eiezione del ventricolo sinistro < 40%);Infezioni in fase attiva (inclusa positività alla sierologia per HIV o RNA virale);Gravi comorbidità concomitanti;Gravidanza o allattamento nelle pazienti di sesso femminile;Mancanza del consenso informato da parte dei genitori;Verranno inoltre esclusi dallo studio pazienti che abbiano ricevuto un numero di linfociti T αβ/Kg superiore a 1 x 10^5.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the safety of infusion of BPX-501 at 3 different escalating doses (2.5 x 105/kg, 5 x105 and 1 x 106cells/kg recipient ideal body weight) to be administered within 14 + 4days aftertransplantation of partially mismatched T cell depleted hematopoietic stem cell transplant(HSCT). To determine the pediatric maximum tolerated and/or recommended phase 2 dose of BPX-50. To evaluate the safety of the infusion of dimerizer drug, AP1903, to subjects who
    received BPX 501 and have developed Grade III-IV acute GVHD, as well as to those subjects with Grade II gut/liver acute GvHD or with Grade I/II GvHD (skin only) who progress or do not respond within 7 days to standard of care treatment.To determine the optimal dose resulting in improved immune reconstitution without a significant impact on incidence on GHVD.
    Valutare la sicurezza dell’infusione di BPX-501 in 3 differenti escalating doses (2.5 x 10^5, 5 x 10^5, 1 x 10^6 cellule/kg di peso ideale del ricevente), somministrate in giornata + 10 dopo il trapianto aploidentico da donatore familiare parzialmente compatibile (HSCT);Valutare la sicurezza dell’infusione dell’agente dimerizzante, AP1903, nei soggetti che abbiano ricevuto BPX-501 e abbiano sviluppato GvHD acuta di grado III/IV o GvHD di grado II con interessamento intestinale/epatico o GvHD di grado I/II (ad esclusivo coinvolgimento cutaneo) che progrediscano o non rispondano entro 7 giorni al trattamento standard;Determinare gli effetti sulla ricostituzione immunologica post trapianto in ciascuna delle 3 coorti
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 24 months post-transplant
    Fino a 24 mesi dopo il trapianto
    E.5.2Secondary end point(s)
    Disease-free survival rates after transplantation; Cumulative incidence of relapse;Cumulative incidence of neutrophil and platelet engraftment; Kinetics of donor cell engraftment; Cumulative incidence of both primary and secondary graft failure; Cumulative incidence and severity of acute and chronic GvHD;
    Time to resolution of acute GVHD after administration of AP1903; Rates of infectious complications, with particular regards to HCMV reactivation or other
    viral or invasive fungal infections. In detail, we will estimate the rate of patients
    experiencing any HCMV reactivation, as well as that of patients who will need antiviral treatment because of a viral load (measured as HCMV DNA in blood) greater than 5,000 copies/mL;Duration of hospitalization; T-cell immune reconstitution (as measured by time to reach an alpha/beta positive CD3+
    cell count greater than 500/l; CD4+ cell count greater than 200/μl; CD8+ cell countgreater than 200/μl;Research evaluations will include: diversity of T cell receptor repertoire, virus specific immunity, quantitation of sjTREC and KREC, and response to polyclonal activators or nominal antigens will be the objective of ancillary biological studies.
    Incidenza cumulativa della mortalità non correlata alla recidiva della patologia di base (NRM) al giorno 180 e ad un anno; Probabilità di sopravvivenza libera da malattia post trapianto; Incidenza cumulativa di recidiva; Incidenza cumulativa dell’attecchimento di neutrofili e piastrine; Cinetica dell’attecchimento delle cellule del donatore; Incidenza cumulativa di graft failure primaria e secondaria; Incidenza cumulativa e severità della GvHD acuta e cronica;
    Numero di giorni necessari per la risoluzione della GvHD acuta dopo somministrazione di AP1903;Incidenza di complicanze infettive, in particolare verrà valutata la percentuale di pazienti che presenteranno riattivazione da HCMV, così come quelli che necessiteranno di trattamento farmacologico per la presenza di un viral load (HCMV DNA si sangue) superiore a 5000 copie/ml;
    Ricostituzione immunologica del comparto T- cellulare valutata come giorni necessari per raggiungere una conta di CD3 αβ+ superiore a 500/ml; CD4+ superiore a 200/µl; CD8+ superiore a 200/ µl;Durata dell’ospedalizzazione; tasso di infezioni e di terapie antivirali;diversità del repertoire del T - cell receptor, immunità virus specifica, risposta ad antigeni attivatori policlonali o ad antigeni nominali.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For a period of 15 years.
    Per un periodo di 15 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I/II
    Fase I/II
    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.8.3 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.8.5The 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
    The study will be closed after evaluation of overall survival and disease free survival for all patients enrolled at 24 months after transplantation.
    Lo studio verrà chiuso dopo la valutazione della sopravvivenza globale e la sopravvivenza libera da malattia per tutti pazienti arruolati a 24 mesi dopo il trapianto.
    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 months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    Bambini
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    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
    Non previsto
    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 Decision2014-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
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