[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462332":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":61,"studyPopulation":53,"armGroups":62,"interventions":79,"overallOfficials":94,"centralContacts":99,"locations":108,"responsibleParty":485,"collaborators":487,"id":491,"slug":53,"hasResults":492,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":492,"sex":498,"minAge":499,"maxAge":500,"enrollmentInfo":501,"targetDuration":53,"studyType":504,"phases":505,"briefSummary":508,"conditions":509,"keywords":511,"overallStatus":111,"whyStopped":53,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":527},{"fullName":5,"class":6},"Fondazione Italiana Linfomi - ETS","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":53},[9,13],{"measure":10,"description":11,"timeFrame":12},"For Phase I part: evaluation of the maximum tolerated dose (MTD) of the atezolizumab.","The maximum tolerated dose (MTD) of the atezolizumab in combination with BEGEV will be established in the first cycle of therapy, in order to determine the recommended phase II dose (RP2D). Patients will be accrued in 3 patients cohorts at each dose level, starting from level 1. Dose de-escalation will be performed following the standard 3+3 rule, registering any Dose Limiting Toxicity (DLT).","During first cycle of treatment based on atezolizumab in combination with BEGEV in phase I study. Maximum time frame 17 months.",{"measure":14,"description":15,"timeFrame":16},"For Phase II part: evaluation of the Complete Response Rate (CRR) before ASCT.","The assessment of CRR before ASCT will be performed by an independent radiologic review committee (IRRC) according to the Lugano classification response criteria (2014) and the LYmphoma Response to Immunomodulatory Therapy Criteria (LYRIC 2016).\n\nCRR will be defined as the proportion of patients in CR after the first 4 cycles of induction treatment, according to Lugano classification response Criteria and LYRIC 2016 criteria. Patients without response assessment (due to whatever reason) will be considered as non-responders.","From initial treatment based on Atezolizumab and BEGEV to intensification treatment with ASCT. Time frame 4 months.",[18,22,26,30,34,38,42,46,50],{"measure":19,"description":20,"timeFrame":21},"For Phase II part: evaluation of the overall response rate (ORR), partial response (PR), stable disease (SD) and progression disease (PD) rates.","The assessment of the overall response rate (ORR), partial response (PR), stable disease (SD) and progression disease (PD) rates will be performed according to the Lugano 2014 criteria and LYRIC 2016 criteria.","The best response between the date of beginning of therapy and the last restaging. Time frame 14 months.",{"measure":23,"description":24,"timeFrame":25},"For Phase II part: evaluation of the rate of partial response (PR) converted to Complete Response (CR).","The rate of PR converted to CR will be assessed as the number of PR converted in CR at the end of consolidation treatment with atezolizumab in the experimental arm.","At the end of consolidation treatment with atezolizumab in the experimental arm. Time Frame 14 months.",{"measure":27,"description":28,"timeFrame":29},"For Phase II part: evaluation of the peripheral blood stem-cell mobilization","The peripheral blood stem-cell mobilization will be assessed in patients receiving atezolizumab combined to BEGEV schedule. Adequate stem cells mobilization will be defined by the target cell harvesting of 3 x 1.000.000 CD34+ cells\u002Fkg.","At the end of treatment based on atezolizumab and BEGEV. Time Frame 3 months.",{"measure":31,"description":32,"timeFrame":33},"For Phase II part: evaluation of engraftment after ASCT","Engraftment will be assessed in patients who received ASCT after salvage treatment with atezolizumab combined to BEGEV. Engraftment will be defined as the first of three consecutive days of achieving a sustained peripheral blood neutrophil count of \\>500 × 1.000.000\u002FL. Platelet engraftment is usually defined as independence from platelet transfusion for at least 7 days with a platelet count of more than \\>20 × 1.000.000.000\u002FL.","Between 30 and 60 days after ASCT: Time Frame 5 months.",{"measure":35,"description":36,"timeFrame":37},"For Phase II part: evaluation of duration of response (DoR).","The duration of response will be defined as the time from date of documented tumor response (CR) until lymphoma relapse or progression.","From the CR to the date of relapse or progression or last scheduled visit. Time frame 50 months.",{"measure":39,"description":40,"timeFrame":41},"For Phase II part: evaluation of Progression Free Survival (PFS) for all patients.","PFS will be assessed for all patients and it will be defined as the time from beginning of therapy until lymphoma relapse or progression or death as a result of any cause; responding patients and patients who are lost to follow up will be censored at their last assessment date. It will be measured also in long-tem follow up in order to better assess patients' prognosis.","From beginning therapy to progression or relapse disease or death. Time frame 50 months.",{"measure":43,"description":44,"timeFrame":45},"For Phase II part: evaluation of OS.","OS will be assessed for all patients and it will be defined as the time from beginning of therapy until death as a result of any cause; alive patients and those who are lost to follow up will be censored at their last assessment date. it will be measured also in long-tem follow up in order to better assess patients' prognosis.","From the beginning of therapy to death for any cause or last scheduled visit. Time frame 50 months.",{"measure":47,"description":48,"timeFrame":49},"For Phase II part: evaluation of safety and tolerability of atezolizumab and BEGEV.","The safety and the tolerability of a first salvage treatment based on the combination of intravenous (IV) atezolizumab and BEGEV regimen will be assessed throughout the study by the measurement of: patients' withdrawal rate, incidence, type and grade of any adverse event (AE) and serious adverse event (SAE) assessed by CTCAE v.4.0, hospitalization rate (except it for study therapy administration).","From the beginning of treatment to death or lost to follow-up or last scheduled visit. Time frame 50 months.",{"measure":51,"description":52,"timeFrame":49},"For Phase II part: evaluation of he correlation of quantitative baseline PET parameters","To evaluate the correlation of quantitative baseline PET parameters with progression\u002Ffailure free survival and overall survival.",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":57,"primaryPurpose":58,"observationalModel":53,"timePerspective":53,"maskingInfo":59},"RANDOMIZED","SEQUENTIAL","The phase I part is aimed at determining the MTD of atezolizumab when combined with BEGEV schedule. Atezolizumab dosing starts at 1200 mg and decreases in the successive cohort to the dose of 840 mg and 600 mg to reach MTD which will be used in the phase II part where patients will be randomized in 2 arms: arm A will receive the BEGEV regimen followed by ASCT for patients achieving CR and arm B will receive combination treatment with Atezolizumab and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks.","TREATMENT",{"masking":60,"maskingDescription":53,"whoMasked":53},"NONE","The phase I part (safety assessment of the combination treatment) is aimed at determining the MTD of atezolizumab when combined with BEGEV schedule.\n\n6-18 patients enrolled in this phase will be treated with atezolizumab in combination with BEGEV regimen every 3 weeks for 4 cycles.\n\nPatients without a DLT in the first cycle and without disease progression after cycle 2, will undergo stem cell mobilization with 3-4 cycle of A-BEGEV + granulocyte colony-stimulating factor (G-CSF) and subsequently receive a myeloablative therapy followed by ASCT.\n\nPatients with documented CR following ASCT will receive a consolidation therapy with atezolizumab as single agent every 4 weeks for 6 doses, starting preferably between 60 and 90 days, but ≥ 60 days and not \\> 120 days after autografting. In patients not previously radiotreated, adjuvant radiotherapy (RT) should be planned during consolidation treatment within the start of second consolidation dose, according to clinician's judgment and response assessment. RT will be administered at 30-36 Gy on sites of initial bulky disease or on single PET positive residual site.\n\nPatients reaching PR after four cycles of atezolizumab combined with BEGEV or with documented PR after ASCT may continue the study protocol according to the physician judgment.\n\nDosing starts at 1200 mg and decreases in the successive cohort to the dose of 840 mg and 600 mg, according to Flow chart A. in the section 6 of the protocol.\n\nIn the consolidation phase atezolizumab will be administered at dose of 1200 mg every 4 weeks for 6 doses without dose reduction, but only delay or discontinuation.\n\nPatients included in the cohort developing DLT, withdraw the protocol due to toxicity and continue the treatment according to good clinical practice.\n\nFor patients included in the cohort of MTD, monitoring and collection of AEs will be continuous during induction, consolidation treatment and follow-up.\n\nThe phase IIb part (expansion cohort) plans to randomize 122 patients in two arms (A and B, 61 per arm):\n\n1. arm A will receive the BEGEV regimen followed by ASCT for patients achieving CR.\n2. arm B will receive combination treatment with Atezolizumab and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks.\n\nIn patients not previously radiotreated, adjuvant RT should be planned for both patients in arm A and arm B according to clinician's judgment and response assessment. RT will be administered at 30-36 Gy on sites of initial bulky disease or on single PET positive residual site.\n\nPatients reaching PR after four induction cycles (atezolizumab combined with BEGEV or BEGEV alone) or with documented PR after ASCT may continue the study protocol according to the physician judgment.\n\nAfter the last treatment date of the last patient (LPLT), the phase IIb will be ended. A long term follow up will start, in order to better assess patients' prognosis. All evaluable patients from phase I and phase IIb study will enter in the long term follow up phase and will be followed for 18 months. Disease status, survival outcome, secondary primary malignancies and late toxicity will be collected every 6 months until patient withdrawal of consent, lost to follow up and patient's death. Long term follow-up phase will end 18 months after the end of phase IIb.",[63,70,75],{"label":64,"type":65,"description":66,"interventionNames":67},"phase I","EXPERIMENTAL","patients will receive the BEGEV regimen plus Atezolizumab in order to determine MTD of the last one drug.",[68,69],"Drug: Atezolizumab","Combination Product: BEGEV",{"label":71,"type":72,"description":73,"interventionNames":74},"phase IIb - arm A","ACTIVE_COMPARATOR","patients will receive the BEGEV regimen followed by ASCT for patients achieving CR.",[69],{"label":76,"type":65,"description":77,"interventionNames":78},"phase IIb - arm B","patients will receive combination treatment with Atezolizumab (at dose obtained from phase I) and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks.",[68,69],[80,85],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":53},"DRUG","Atezolizumab","In phase I study: Atezolizumab will be administered until the determination of its MTD when combined with BEGEV schedule.\n\nIn phase II b study - arm A (standard): Atezolizumab will not be administered. In phase II b study - arm B (experimental): Atezolizumab will be administered at MTD determined in phase I study plus BEGEV regimen (at dosages performed by local practice).",[64,76],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":90},"COMBINATION_PRODUCT","BEGEV","In phase I study: Atezolizumab will be administered until the determination of its MTD when combined with BEGEV schedule.\n\nIn phase II b study - arm A (standard): only BEGEV will be administered. In phase II b study - arm B (experimental): BEGEV regimen will be administered in combination with Atezolizumab at MTD determined in phase I.",[64,71,76],[91,92,93],"Bendamustine","Gemcitabine","Vinorelbine",[95],{"name":96,"affiliation":97,"role":98},"Armando Santoro, MD","U.O. Ematologia - Istituto Clinico Humanitas - Rozzano - ITALY","PRINCIPAL_INVESTIGATOR",[100,105],{"name":101,"role":102,"phone":103,"phoneExt":53,"email":104},"Uffici Studi FIL","CONTACT","0131033153","startup@filinf.it",{"name":106,"role":102,"phone":103,"phoneExt":53,"email":107},"Lorenza Randi, Dr.","lrandi@filinf.it",[109,126,139,151,163,175,188,200,212,224,236,248,260,269,281,293,305,317,329,341,353,365,377,389,398,407,416,428,440,452,461,473],{"facility":110,"status":111,"city":112,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo","RECRUITING","Alessandria","15121","Italy","IT",{"type":117,"coordinates":118},"Point",[119,120],8.61007,44.90924,{"lat":120,"lon":119},[123],{"name":124,"role":102,"phone":53,"phoneExt":53,"email":125},"Zanni Manuela, Dr.","manuela.zanni@ospedale.al.it",{"facility":127,"status":111,"city":128,"state":129,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Ematologia - Fondazione del Piemonte per l'Oncologia - IRCCS","Candiolo","Turin",{"type":117,"coordinates":131},[132,133],7.59812,44.95858,{"lat":133,"lon":132},[136],{"name":137,"role":102,"phone":53,"phoneExt":53,"email":138},"Delia Rota Scalabrini, Dr.","delia.rotascalabrini@ircc.it",{"facility":140,"status":111,"city":141,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"S.C. Ematologia e Trapianto emopoietico - Azienda Ospedaliera S.Giuseppe Moscati","Avellino",{"type":117,"coordinates":143},[144,145],14.79103,40.91494,{"lat":145,"lon":144},[148],{"name":149,"role":102,"phone":53,"phoneExt":53,"email":150},"Sonya De Lorenzo, Dr.","sonya.delorenzo@tin.it",{"facility":152,"status":111,"city":153,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Divisione di Oncologia e dei Tumori immuto-correlati - IRCCS Centro di Riferimento Oncologico di Aviano","Aviano",{"type":117,"coordinates":155},[156,157],12.59472,46.07056,{"lat":157,"lon":156},[160],{"name":161,"role":102,"phone":53,"phoneExt":53,"email":162},"Michele Spina, Dr.","mspina@cro.it",{"facility":164,"status":111,"city":165,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"U.O.C Ematologia - IRCCS Istituto Tumori Giovanni Paolo II","Bari",{"type":117,"coordinates":167},[168,169],16.86982,41.12066,{"lat":169,"lon":168},[172],{"name":173,"role":102,"phone":53,"phoneExt":53,"email":174},"Lorenzo Tonialini, Dr.","lorenzo.tonialini@hotmail.it",{"facility":176,"status":177,"city":178,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Ematologia - Ospedale \"Monsignor Raffaele Dimiccoli\"","NOT_YET_RECRUITING","Barletta",{"type":117,"coordinates":180},[181,182],16.28165,41.31429,{"lat":182,"lon":181},[185],{"name":186,"role":102,"phone":53,"phoneExt":53,"email":187},"Gaetano De Santis, dR.","desantis.emat@gmail.com",{"facility":189,"status":111,"city":190,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Ematologia - ASST Spedali Civili di Brescia","Brescia",{"type":117,"coordinates":192},[193,194],10.21472,45.53558,{"lat":194,"lon":193},[197],{"name":198,"role":102,"phone":53,"phoneExt":53,"email":199},"Alessandro Re, Dr.","alessandro.re@asst-spedalicivili.it",{"facility":201,"status":177,"city":202,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Ospedale S. Maria Goretti - UOC Ematologia con Trapianto","Latina",{"type":117,"coordinates":204},[205,206],12.9043,41.46614,{"lat":206,"lon":205},[209],{"name":210,"role":102,"phone":53,"phoneExt":53,"email":211},"Sergio Mecarocci, MD","s.mecarocci@ausl.latina.it",{"facility":213,"status":111,"city":214,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Ematologia - Ospedale Vito Fazzi","Lecce",{"type":117,"coordinates":216},[217,218],18.17244,40.35481,{"lat":218,"lon":217},[221],{"name":222,"role":102,"phone":53,"phoneExt":53,"email":223},"Nicola Di Renzo, Dr.","direnzo.ematolecce@gmail.com",{"facility":225,"status":177,"city":226,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"IRCCS Istituto Romagnolo per lo studio dei Tumori \"Dino Amadori\" - IRST S.R.L. - Ematologia","Meldola",{"type":117,"coordinates":228},[229,230],12.0626,44.12775,{"lat":230,"lon":229},[233],{"name":234,"role":102,"phone":53,"phoneExt":53,"email":235},"Gerardo Musuraca, MD","gerardo.musuraca@irst.emr.it",{"facility":237,"status":111,"city":238,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia","Messina",{"type":117,"coordinates":240},[241,242],15.55256,38.19394,{"lat":242,"lon":241},[245],{"name":246,"role":102,"phone":53,"phoneExt":53,"email":247},"Donato Mannina, MD","donamanni@gmail.com",{"facility":249,"status":111,"city":250,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Ematologia - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano","Milan",{"type":117,"coordinates":252},[253,254],9.18951,45.46427,{"lat":254,"lon":253},[257],{"name":258,"role":102,"phone":53,"phoneExt":53,"email":259},"Paolo Corradini, Prof.","paolo.corradini@unimi.it",{"facility":261,"status":111,"city":250,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":262,"geoPoint":264,"contacts":265},"SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda",{"type":117,"coordinates":263},[253,254],{"lat":254,"lon":253},[266],{"name":267,"role":102,"phone":53,"phoneExt":53,"email":268},"Vittorio Ruggero Zilioli, Dr.","vittorioruggero.zilioli@ospedaleniguarda.it",{"facility":270,"status":111,"city":271,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - UOC Ematologia Oncologica","Naples",{"type":117,"coordinates":273},[274,275],14.26811,40.85216,{"lat":275,"lon":274},[278],{"name":279,"role":102,"phone":53,"phoneExt":53,"email":280},"Emanuela Morelli, MD","e.morelli@istitutotumori.na.it",{"facility":282,"status":111,"city":283,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":284,"geoPoint":288,"contacts":289},"U.O. Onco-ematologia - Presidio ospedaliero \"A. TORTORA\"","Pagani",{"type":117,"coordinates":285},[286,287],14.61448,40.74199,{"lat":287,"lon":286},[290],{"name":291,"role":102,"phone":53,"phoneExt":53,"email":292},"Catello Califano, Dr.","c.califano@aslsalerno.it",{"facility":294,"status":111,"city":295,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":296,"geoPoint":300,"contacts":301},"Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello","Palermo",{"type":117,"coordinates":297},[298,299],13.3636,38.1166,{"lat":299,"lon":298},[302],{"name":303,"role":102,"phone":53,"phoneExt":53,"email":304},"Caterina Patti, Dr.","k.patti@villasofia.it",{"facility":306,"status":111,"city":307,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":308,"geoPoint":312,"contacts":313},"Div. di Ematologia - IRCCS Policlinico S. Matteo di Pavia","Pavia",{"type":117,"coordinates":309},[310,311],9.15917,45.19205,{"lat":311,"lon":310},[314],{"name":315,"role":102,"phone":53,"phoneExt":53,"email":316},"Manuel Gotti, Dr","manuel.gotti@hotmail.it",{"facility":318,"status":111,"city":319,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":320,"geoPoint":324,"contacts":325},"Ematologia - Ospedale S. Maria della Misericordia","Perugia",{"type":117,"coordinates":321},[322,323],12.38878,43.1122,{"lat":323,"lon":322},[326],{"name":327,"role":102,"phone":53,"phoneExt":53,"email":328},"Leonardo Flenghi, Dr","leonardo.flenghi@ospedale.perugia.it",{"facility":330,"status":111,"city":331,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":332,"geoPoint":336,"contacts":337},"Azienda USL Piacenza - UOC Ematologia e Centro Trapianti","Piacenza",{"type":117,"coordinates":333},[334,335],9.69342,45.05242,{"lat":335,"lon":334},[338],{"name":339,"role":102,"phone":53,"phoneExt":53,"email":340},"Annalisa Arcari, MD","a.arcari@ausl.pc.it",{"facility":342,"status":111,"city":343,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":344,"geoPoint":348,"contacts":349},"Ospedale delle Croci - Ematologia","Ravenna",{"type":117,"coordinates":345},[346,347],12.20121,44.41344,{"lat":347,"lon":346},[350],{"name":351,"role":102,"phone":53,"phoneExt":53,"email":352},"Monica Tani, MD","monica.tani@auslromagna.it",{"facility":354,"status":111,"city":355,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":356,"geoPoint":360,"contacts":361},"Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova","Reggio Emilia",{"type":117,"coordinates":357},[358,359],10.63125,44.69825,{"lat":359,"lon":358},[362],{"name":363,"role":102,"phone":53,"phoneExt":53,"email":364},"Stefano Luminari, Prof.","stefano.luminari@ausl.re.it",{"facility":366,"status":177,"city":367,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":368,"geoPoint":372,"contacts":373},"Ospedale degli Infermi di Rimini - U.O. di Ematologia","Rimini",{"type":117,"coordinates":369},[370,371],12.56528,44.05755,{"lat":371,"lon":370},[374],{"name":375,"role":102,"phone":53,"phoneExt":53,"email":376},"Melania Celli, MD","melania.celli@auslromagna.it",{"facility":378,"status":111,"city":379,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":380,"geoPoint":384,"contacts":385},"Ematologia - Ospedale S. Camillo","Roma",{"type":117,"coordinates":381},[382,383],11.10642,44.99364,{"lat":383,"lon":382},[386],{"name":387,"role":102,"phone":53,"phoneExt":53,"email":388},"Roberta Battistini, Dr.","rbattistini@scamilloforlanini.rm.it",{"facility":390,"status":111,"city":379,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":391,"geoPoint":393,"contacts":394},"Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università \"La Sapienza\"",{"type":117,"coordinates":392},[382,383],{"lat":383,"lon":382},[395],{"name":396,"role":102,"phone":53,"phoneExt":53,"email":397},"Ilaria Del Giudice, Prof.","ilaria.delgiudice@uniroma1.it",{"facility":399,"status":111,"city":379,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":400,"geoPoint":402,"contacts":403},"Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare",{"type":117,"coordinates":401},[382,383],{"lat":383,"lon":382},[404],{"name":405,"role":102,"phone":53,"phoneExt":53,"email":406},"Luigi Rigacci, Prof.","l.rigacci@policlinicocampus.it",{"facility":408,"status":177,"city":379,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":409,"geoPoint":411,"contacts":412},"Universitа Cattolica S. Cuore - Ematologia",{"type":117,"coordinates":410},[382,383],{"lat":383,"lon":382},[413],{"name":414,"role":102,"phone":53,"phoneExt":53,"email":415},"Stefan Hohaus, MD","stefan.hohaus@Unicatt.it",{"facility":417,"status":111,"city":418,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":419,"geoPoint":423,"contacts":424},"U.O. Ematologia - Istituto Clinico Humanitas","Rozzano",{"type":117,"coordinates":420},[421,422],9.1559,45.38193,{"lat":422,"lon":421},[425],{"name":426,"role":102,"phone":53,"phoneExt":53,"email":427},"Armando Santoro, Dr.","armando.santoro@cancercenter.humanitas.it",{"facility":429,"status":177,"city":430,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":431,"geoPoint":435,"contacts":436},"S.C. Oncoematologia - A.O. S. Maria di Terni","Terni",{"type":117,"coordinates":432},[433,434],12.64329,42.56335,{"lat":434,"lon":433},[437],{"name":438,"role":102,"phone":53,"phoneExt":53,"email":439},"Angelo Genua, Dr.","a.genua@aospterni.it",{"facility":441,"status":177,"city":442,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":443,"geoPoint":447,"contacts":448},"A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria","Torino",{"type":117,"coordinates":444},[445,446],11.99138,44.88856,{"lat":446,"lon":445},[449],{"name":450,"role":102,"phone":53,"phoneExt":53,"email":451},"Candida Vitale, MD","candida.vitale@unito.it",{"facility":453,"status":111,"city":442,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":454,"geoPoint":456,"contacts":457},"S.C.Ematologia - A.O.U. Città della Salute e della Scienza di Torino",{"type":117,"coordinates":455},[445,446],{"lat":446,"lon":445},[458],{"name":459,"role":102,"phone":53,"phoneExt":53,"email":460},"Barbara Botto, Dr.","bbotto@cittadellasalute.to.it",{"facility":462,"status":177,"city":463,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":464,"geoPoint":468,"contacts":469},"A.O. C. Panico - U.O.C Ematologia e Trapianto","Tricase",{"type":117,"coordinates":465},[466,467],18.35421,39.93018,{"lat":467,"lon":466},[470],{"name":471,"role":102,"phone":53,"phoneExt":53,"email":472},"Anna Mele, MD","a.mele@piafondazionepanico.it",{"facility":474,"status":111,"city":475,"state":53,"zip":53,"country":114,"countryCode":115,"cosmosGeoPoint":476,"geoPoint":480,"contacts":481},"Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia","Trieste",{"type":117,"coordinates":477},[478,479],13.77678,45.64953,{"lat":479,"lon":478},[482],{"name":483,"role":102,"phone":53,"phoneExt":53,"email":484},"Francesco Zaja, Dr.","francesco.zaja@asugi.sanita.fvg.it",{"type":486,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[488],{"name":489,"class":490},"Roche Pharma AG","INDUSTRY","100462332",false,"NCT05300282","Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients","A Phase I\u002FII b (Randomized Controlled) Study of Atezolizumab Combined to BEGEV Regimen as First Salvage Treatment in Patients With Relapsed or Refractory Hodgkin's Lymphoma Candidate to Autologous Stem-Cell Transplantation","FIL_A-BEGEV","Inclusion Criteria:\n\n* 18-60 years old (upper limit valid only for phase I).\n* Histologically confirmed cHL, at first disease relapse or refractory to a first-line treatment or with documented persistent disease at interim positron emission tomography (PET) performed after 2 cycles of first line (ABVD\u002FABVD like\u002FBEACOPP).\n* Only one prior systemic therapy for Hodgkin's lymphoma (HL).\n* First disease relapse or refractory to a first-line treatment.\n* Eligibility for ASCT.\n* Performance status (PS) ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.\n* Adequate haematological function, unless abnormalities due to underlying disease, at the moment of signing informed consent, defined as follows:\n\n  * neutrophils \\> or = 1.500\u002Fmmc and\n  * platelets \\> or = 75.000\u002Fmmc and\n  * haemoglobin \\> or = 8,0 g\u002FdL with transfusion independence\n* Capacity and willingness to adhere to study visit schedule and specific protocol procedures.\n* Compliance with effective contraception without interruption, according to physician's judgement, from 28 days before treatment start up to at least 6 months after treatment discontinuation, agreeing not to donate semen\u002Feggs during treatment and for at least 6 months after last treatment dose.\n\nExclusion Criteria:\n\n* More than one prior systemic therapy for HL.\n* Presence of autoimmune disease (based on medical history): systemic lupus erythematosus, autoimmune thyroid disease (Hashimoto's thyroiditis, Basedow's disease), Sjögren's syndrome, glomerulonephritis, multiple sclerosis, rheumatoid arthritis, vasculitis, idiopathic pulmonary fibrosis (includine bronchiolitis obliterans organizing pneumonia) and inflammatory bowel disease (Crohn's disease, ulcerative colitis).\n* Previous skin toxicity (i.e. Steven-Johnson Sdr, severe skin reactions.\n* Prior allogeneic stem cell transplantation or prior solid organ transplant.\n* History of active tubercolosis.\n* History of leptomeningeal disease.\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment.\n* Central nervous system (CNS) involvement by lymphoma.\n* Major surgery (excluding any lymph node biopsy) within 28 days prior to signing informed consent.\n* Seropositivity for HBV or evidence of active infection. The following categories may be considered for the study:\n\n  * HBsAg positive with HBV DNA \\\u003C 2000 UI\u002Fml (inactive carriers); HBV DNA \\> 2000 UI\u002Fml is criteria of exclusion\n  * HBsAg negative but HBsAb positive\n  * HBsAg negative but HBcAb positive HBsAg positive with HBV DNA \\\u003C 2000 UI\u002Fml and HBsAg negative but HBcAb positive will be eligible for the study only if they accept to receive antiviral prophylaxis for all the period of treatment and at least for 12 months after the end of therapy. Treatment should be stopped in case of hepatitis reactivation. - Seropositivity for HCV. Patients with presence of HCV antibody are eligible only if PCR result are negative for HCV RNA\n* Seropositivity for HIV.\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail bed) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics except if for tumor fever) within 2 weeks of the start of Cycle 1.\n* Life expectancy lower than 6 months.\n* Prior history of malignancies, other than HL, unless the patient has been free for at least 5 years (exceptions: localized non-melanoma skin cancer ad carcinoma in situ of the cervix).\n* Any of the following laboratory abnormalities: liver enzymes (AST\u002FSGOT and\u002For ALT\u002FSGPT) \\> 3 fold the upper limit of normal (except of liver involvement by lymphoma); total bilirubin \\> 1.5 mg\u002FdL (except for patients with known Gilbert's disease or biliary tree compression by lymphoma masses); creatinine clearance \\\u003C 30 mL\u002Fmin.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Pregnancy or breastfeeding, or unwillingness to comply with adequate contraception (one negative pregnancy test within 14 days prior to initiation of study treatment required).\n* Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or which may place the patient at unacceptable risk if participating in the study.\n\nException to Exclusion:\n\n* Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n* Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n* Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n  * Rash must cover \\\u003C 10% of body surface area\n  * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n  * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease (COPD) exacerbation) are eligible for the study.","ALL","18 Years","60 Years",{"count":502,"type":503},122,"ESTIMATED","INTERVENTIONAL",[506,507],"PHASE1","PHASE2","The phase I part (safety assessment of the combination treatment) is aimed at determining the MTD of atezolizumab when combined with BEGEV schedule.\n\n6-18 patients enrolled in this part will be treated with atezolizumab in combination with BEGEV regimen every 3 weeks for 4 cycles.\n\nPatients without a DLT in the first cycle and without disease progression after cycle 2, will undergo stem cell mobilization with 3-4 cycle of A-BEGEV + granulocyte colony-stimulating factor (G-CSF) and subsequently receive a myeloablative therapy followed by ASCT.\n\nThe phase IIb part (expansion cohort) plans to randomize 122 patients in two arms (A and B, 61 per arm):\n\n1. arm A will receive the BEGEV regimen followed by ASCT for patients achieving CR.\n2. arm B will receive combination treatment with Atezolizumab and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks.\n\nAfter the last treatment date of the last patient (LPLT), the phase IIb will be ended. A long term follow up will start, in order to better assess patients' prognosis. All evaluable patients from phase I and phase IIb study will enter in the long term follow up phase and will be followed for 18 months.",[510],"Relapsed or Refractory Hodgkin's Lymphoma",[512,513,87,514,515,516,517],"Hodgkin's lymphoma","atezolizumab","phase I\u002FII b study","relapsed","refractory","MTD","2026-01-26",{"date":520,"type":521},"2026-01-28","ACTUAL",{"date":523,"type":521},"2023-02-27",{"date":525,"type":503},"2030-04-27",{"name":5,"class":6},32]