[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458464":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":337,"collaborators":21,"id":339,"slug":340,"hasResults":341,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":341,"sex":347,"minAge":348,"maxAge":349,"enrollmentInfo":350,"targetDuration":21,"studyType":353,"phases":354,"briefSummary":356,"conditions":357,"keywords":360,"overallStatus":44,"whyStopped":21,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":374},{"fullName":5,"class":6},"Fondazione Italiana Linfomi - ETS","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Consolidation with ADCT-402 (loncastuximab tesirine) after a short course of immunochemotherapy","EXPERIMENTAL","R\u002FR MCL after one, two, three or four lines of treatment including BTKi treatment (or BTKi intolerant), with complete response (CR) or partial response (PR) or with stable disease (SD) after salvage immunochemotherapy (R-BAC, Rituximab - Bendamustine, Ara-C x 2 cycles) will undergo consolidation with loncastuximab tesirine. A patient with CR, PR or SD after one R-BAC course, which is unable to undergo a second course due to toxicity to chemotherapy, can be considered to proceed for consolidation.",[13,14],"Drug: Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at standard dose (R-BAC, Rituximab - Bendamustine, Ara-C))","Drug: Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at reduced dose (R-BAC, Rituximab - Bendamustine, Ara-C)",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at standard dose (R-BAC, Rituximab - Bendamustine, Ara-C))","Standard Induction phase (cycle 1-2 of R-BAC every 28 days according to the following schedule):\n\n* Rituximab 375 mg\u002Fm2 i.v. Day 1\n* Bendamustine 70 mg\u002Fm2, Days 2 and 3\n* Cytarabine 500 mg\u002Fm2, Day 2-4\n\nAfter restaging at the End of Induction (EOI) patients with CR (complete response), PR (partial response) or SD (stable disease) will receive:\n\nCONSOLIDATION PHASE:\n\n* 2 infusions of loncastuximab tesirine at a dose of 150 microgram\u002Fkg every three weeks followed by\n* 2 infusions of loncastuximab tesirine at a dose of 75 microgram\u002Fkg every three weeks",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at reduced dose (R-BAC, Rituximab - Bendamustine, Ara-C)","Reduced Induction phase (cycle 1-2 with two different schedules for patients deemed FRAIL or UNFIT for standard induction therapy,based on protocol dose and as per medical judgment are allowed).\n\n* Rituximab 375 mg\u002Fm2 i.v. Day 1\n* Bendamustine 70 mg\u002Fm2, Days 2 and 3\n* Cytarabine 500 mg\u002Fm2, Day 2 and 3\n\nor\n\n* Rituximab 375 mg\u002Fm2 i.v. Day 1\n* Bendamustine 100 mg, Days 2 and 3\n* Cytarabine 500 mg, Day 2 and 3\n\nAfter restaging at the End of Induction (EOI) patients with CR (complete response), PR (partial response) or SD (stable disease) will receive:\n\nCONSOLIDATION PHASE:\n\n* 2 infusions of loncastuximab tesirine at a dose of 150 microgram\u002Fkg every three weeks followed by\n* 2 infusions of loncastuximab tesirine at a dose of 75 microgram\u002Fkg every three weeks",[9],[27],{"name":28,"affiliation":29,"role":30},"Marco Ladetto","S.C. Ematologia - A.S.O. \"SS Antonio e Biagio e Cesare Arrigo\" di Alessandria","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Stefania Badiali","CONTACT","+39.059.9769912","sbadiali@filinf.it",{"name":38,"role":34,"phone":39,"phoneExt":21,"email":40},"Giorgio Priolo","+39.0131.033175","gpriolo@filinf.it",[42,60,74,88,102,116,130,141,155,169,183,197,211,225,239,253,267,281,295,309,323],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":46,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"ASST Spedali Civili di Brescia","RECRUITING","Brescia","Italy","25123","IT",{"type":50,"coordinates":51},"Point",[52,53],10.21472,45.53558,{"lat":53,"lon":52},[56,59],{"name":57,"role":34,"phone":21,"phoneExt":21,"email":58},"Alessandro Re","alessandro.re@asst-spedalicivili.it",{"name":57,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":61,"status":44,"city":62,"state":21,"zip":21,"country":46,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"S.C. Ematologia - A.S.O. \"SS Antonio e Biagio e Cesare Arrigo\"","Alessandria",{"type":50,"coordinates":64},[65,66],8.61007,44.90924,{"lat":66,"lon":65},[69,73],{"name":70,"role":34,"phone":71,"phoneExt":21,"email":72},"Marco Ladetto, MD","+39 0131 206262","marco.ladetto@ospedale.al.it",{"name":70,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":75,"status":44,"city":76,"state":21,"zip":77,"country":46,"countryCode":48,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"S.C. di Ematologia - A.O. S. Croce e Carle","Cuneo","12100",{"type":50,"coordinates":79},[80,81],7.54828,44.39071,{"lat":81,"lon":80},[84,87],{"name":85,"role":34,"phone":21,"phoneExt":21,"email":86},"Claudia Castellino","castellino.c@ospedale.cuneo.it",{"name":85,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":89,"status":44,"city":90,"state":21,"zip":91,"country":46,"countryCode":48,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi","Florence","50141",{"type":50,"coordinates":93},[94,95],11.24626,43.77925,{"lat":95,"lon":94},[98,101],{"name":99,"role":34,"phone":21,"phoneExt":21,"email":100},"Luca Nassi","nassil@aou-careggi.toscana.it",{"name":99,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":103,"status":44,"city":104,"state":21,"zip":105,"country":46,"countryCode":48,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Ematologia - Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia","Genova","16132",{"type":50,"coordinates":107},[108,109],11.87211,45.21604,{"lat":109,"lon":108},[112,115],{"name":113,"role":34,"phone":21,"phoneExt":21,"email":114},"Chiara Ghiggi","chiara.ghiggi@hsanmartino.it",{"name":113,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":117,"status":44,"city":118,"state":21,"zip":119,"country":46,"countryCode":48,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Ematologia - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano","Milan","20133",{"type":50,"coordinates":121},[122,123],12.59836,42.78235,{"lat":123,"lon":122},[126,129],{"name":127,"role":34,"phone":21,"phoneExt":21,"email":128},"Paolo Corradini","paolo.corradini@unimi.it",{"name":127,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":131,"status":44,"city":118,"state":21,"zip":132,"country":46,"countryCode":48,"cosmosGeoPoint":133,"geoPoint":135,"contacts":136},"S.C. Ematologia - ASST Grande Ospedale Metropolitano Niguarda","20162",{"type":50,"coordinates":134},[122,123],{"lat":123,"lon":122},[137,140],{"name":138,"role":34,"phone":21,"phoneExt":21,"email":139},"Vittorio Ruggiero Zilioli","vittorioruggero.zilioli@ospedaleniguarda.it",{"name":138,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":142,"status":44,"city":143,"state":21,"zip":144,"country":46,"countryCode":48,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"UOC Ematologia Oncologica - Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale","Naples","80131",{"type":50,"coordinates":146},[147,148],14.26811,40.85216,{"lat":148,"lon":147},[151,154],{"name":152,"role":34,"phone":21,"phoneExt":21,"email":153},"Antonio Pinto","a.pinto@istitutotumori.na.it",{"name":152,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":156,"status":44,"city":157,"state":21,"zip":158,"country":46,"countryCode":48,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"SCDU Ematologia - AOU Maggiore della Carità di Novara","Novara","28100",{"type":50,"coordinates":160},[161,162],8.62118,45.44694,{"lat":162,"lon":161},[165,168],{"name":166,"role":34,"phone":21,"phoneExt":21,"email":167},"Riccardo Bruna","riccardo.bruna@med.uniupo.it",{"name":166,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":170,"status":44,"city":171,"state":21,"zip":172,"country":46,"countryCode":48,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello","Palermo","90146",{"type":50,"coordinates":174},[175,176],13.3636,38.1166,{"lat":176,"lon":175},[179,182],{"name":180,"role":34,"phone":21,"phoneExt":21,"email":181},"Caterina Patti","k.patti@villasofia.it",{"name":180,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":184,"status":44,"city":185,"state":21,"zip":186,"country":46,"countryCode":48,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Divisione di Ematologia - IRCCS Policlinico S. Matteo di Pavia","Pavia","27100",{"type":50,"coordinates":188},[189,190],9.15917,45.19205,{"lat":190,"lon":189},[193,196],{"name":194,"role":34,"phone":21,"phoneExt":21,"email":195},"Luca Arcaini","luca.arcaini@unipv.it",{"name":194,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":198,"status":44,"city":199,"state":21,"zip":200,"country":46,"countryCode":48,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Ematologia - Ospedale delle Croci","Ravenna","48121",{"type":50,"coordinates":202},[203,204],12.20121,44.41344,{"lat":204,"lon":203},[207,210],{"name":208,"role":34,"phone":21,"phoneExt":21,"email":209},"Monica Tani","monica.tani@auslromagna.it",{"name":208,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":212,"status":44,"city":213,"state":21,"zip":214,"country":46,"countryCode":48,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova","Reggio Emilia","42123",{"type":50,"coordinates":216},[217,218],10.63125,44.69825,{"lat":218,"lon":217},[221,224],{"name":222,"role":34,"phone":21,"phoneExt":21,"email":223},"Angela Ferrari","ferrari.angela@ausl.re.it",{"name":222,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":226,"status":44,"city":227,"state":21,"zip":228,"country":46,"countryCode":48,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"U.O. di Ematologia - Ospedale degli Infermi di Rimini","Rimini","47923",{"type":50,"coordinates":230},[231,232],12.56528,44.05755,{"lat":232,"lon":231},[235,238],{"name":236,"role":34,"phone":21,"phoneExt":21,"email":237},"Melania Celli","melania.celli@auslromagna.it",{"name":236,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":240,"status":44,"city":241,"state":21,"zip":242,"country":46,"countryCode":48,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università \"La Sapienza\" Istituto Ematologia","Roma","00161",{"type":50,"coordinates":244},[245,246],11.10642,44.99364,{"lat":246,"lon":245},[249,252],{"name":250,"role":34,"phone":21,"phoneExt":21,"email":251},"Alice Di Rocco","dirocco@bce.uniroma1.it",{"name":250,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":254,"status":44,"city":255,"state":21,"zip":256,"country":46,"countryCode":48,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"U.O. Ematologia - Istituto Clinico Humanitas","Rozzano","20089",{"type":50,"coordinates":258},[259,260],9.1559,45.38193,{"lat":260,"lon":259},[263,266],{"name":264,"role":34,"phone":21,"phoneExt":21,"email":265},"Monica Balzarotti","dottbalza@gmail.com",{"name":264,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":268,"status":44,"city":269,"state":21,"zip":270,"country":46,"countryCode":48,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"S.C. Ematologia Universitaria - A.O.U. Città della Salute e della Scienza di Torino","Torino","10126",{"type":50,"coordinates":272},[273,274],11.99138,44.88856,{"lat":274,"lon":273},[277,280],{"name":278,"role":34,"phone":21,"phoneExt":21,"email":279},"Simone Ferrero","simone.ferrero@unito.it",{"name":278,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":282,"status":44,"city":283,"state":21,"zip":284,"country":46,"countryCode":48,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"S.C di Ematologia - Ospedale Ca Foncello","Treviso","31100",{"type":50,"coordinates":286},[287,288],12.2416,45.66673,{"lat":288,"lon":287},[291,294],{"name":292,"role":34,"phone":21,"phoneExt":21,"email":293},"Piero Maria Stefani","pieromaria.stefani@aulss2.veneto.it",{"name":292,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":296,"status":44,"city":297,"state":21,"zip":298,"country":46,"countryCode":48,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"U.O.C Ematologia e Trapianto - A.O. C. Panico","Tricase","73039",{"type":50,"coordinates":300},[301,302],18.35421,39.93018,{"lat":302,"lon":301},[305,308],{"name":306,"role":34,"phone":21,"phoneExt":21,"email":307},"Vincenzo Pavone","salentoematologia@piafondazionepanico.it",{"name":306,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":310,"status":44,"city":311,"state":21,"zip":312,"country":46,"countryCode":48,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"SC Ematologia - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)","Trieste","34121",{"type":50,"coordinates":314},[315,316],13.77678,45.64953,{"lat":316,"lon":315},[319,322],{"name":320,"role":34,"phone":21,"phoneExt":21,"email":321},"Francesco Zaja","francesco.zaja@asugi.sanita.fvg.it",{"name":320,"role":30,"phone":21,"phoneExt":21,"email":21},{"facility":324,"status":44,"city":325,"state":21,"zip":326,"country":46,"countryCode":48,"cosmosGeoPoint":327,"geoPoint":331,"contacts":332},"U.O. Ematologia - AOU Integrata di Verona","Verona","37134",{"type":50,"coordinates":328},[329,330],10.9938,45.43854,{"lat":330,"lon":329},[333,336],{"name":334,"role":34,"phone":21,"phoneExt":21,"email":335},"Carlo Visco","carlo.visco@univr.it",{"name":334,"role":30,"phone":21,"phoneExt":21,"email":21},{"type":338,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100458464","phase-2-consolidation-with-loncastuximab-tesirine-after-a-short-course-of-immunochemotherapy-in-btki-treated-or-intolerant-relapsedrefractory-mantle-cell-lymphoma-patients-100458464",false,"NCT05249959","Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed\u002FRefractory Mantle Cell Lymphoma Patients.","Consolidation With ADCT-402 (Loncastuximab Tesirine) After a Short Course of Immunochemotherapy: a Phase II Study in BTKi-treated (or BTKi Intolerant) Relapsed\u002FRefractory (R\u002FR) Mantle Cell Lymphoma (MCL) Patients","FIL_COLUMN","Inclusion Criteria:\n\n* Histologically documented diagnosis of MCL as defined in the 2017 edition of the World Health Organization (WHO) classification\n* Age ≥ 18 and \\\u003C 85 years\n* Relapsed\u002FRefractory disease after one, two, three or four lines of treatment\n* Bendamustine-naive or relapsed after at least one year after the last cycle of a bendamustine-containing regimen\n* Previous treatment with BTKi (Bruton Tyrosine Kinase inhibitors) monotherapy or BTKi containing regimens with R\u002FR disease; and\u002For patients who discontinued BTKi monotherapy or BTKi containing regimens for adverse events and have active disease necessitating treatment.\n* Previous treatment with any anti-CD19 agents is allowed (included CAR-T treatment) If previous anti-CD19 treatment has occurred, tissue CD19 expression must be assessed by histology or flow cytometry\n* Venetoclax treated patients are allowed.\n* Stem cell transplant eligible patients are allowed.\n* Measurable nodal or extranodal disease ≥ 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions. Note: Patients with bone marrow involvement only are eligible. In case of bone marrow infiltration only, bone marrow aspiration and biopsy are mandatory for all staging evaluations\n* ECOG (Eastern Cooperative Oncology Group)\u002FWHO (World Health Organization) performance status ≤ 2 (unless MCL-related)\n* The following laboratory values at screening (unless due to bone marrow involvement by lymphoma):\n\n  * Absolute Neutrophil count (ANC) \\> 1.0×109\u002FL\n  * Platelet count ≥ 75.000\u002Fmm3\n  * Creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault formula)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN (upper limit of normal)\n  * Bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non- hepatic origin)\n* Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee (IEC), prior to the initiation of any screening or study-specific procedures.\n* Subject must be able to adhere to the study visit schedule and other protocol requirements.\n* Life expectancy ≥ 3 months.\n* Women of childbearing potential (WOCBP) and men must agree to use effective contraception if sexually active.This applies for the time period between signing of the informed consent form and at least 10 months after last loncastuximab tesirine (ADCT-402) dose. Men with female partners who are of childbearing potential must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and at least 7 months after last loncastuximab tesirine (ADCT-402) dose.\n\nExclusion Criteria:\n\n* Subjects who have received a bendamustine containing regimen and relapsed less than one year after the end of treatment.\n* Known history of hypersensitivity to human antibodies.\n* Allogenic stem cell transplant within 6 months prior to start of first study drug.\n* Allogenic stem cell transplant with active \u002F uncontrolled graft-versus-host disease.\n* Previous treatment with CD19 targeting agents.\n* More than four lines of previous treatment (autologous stem cell transplant performed as part of consolidation to a previous line of therapy should not be considered as a line of therapy).\n* Active second malignancy in the last three years other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or any other tumor that the Sponsor and Coordinating Investigator agree and document should not be considered preclusive to participate in the study.\n* Major surgery or any anticancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to start of study drug (R-BAC). A shorter interval in special settings must be approved by the Sponsor and\u002For Investigator.\n* Cardiovascular disease (NYHA, New York Heart Association, class ≥2).\n* Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent.\n* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n  * Uncontrolled and\u002For active systemic infection (viral including COVID 19, bacterial or fungal);\n  * Chronic or acute hepatitis B (HBV) or hepatitis C (HCV) requiring treatment. Note:\n\nsubjects with serologic evidence of prior vaccination to HBV (i.e., HBsAg negative, HBsAb positive and HBcAb negative) or positive HBcAb from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV DNA) are eligible. Patients with presence of HCV antibody are eligible only if PCR results (polimerase chain reaction) negative for HCV RNA.\n\n* HIV seropositivity.\n* Lymphoma with active CNS (central nervous system) involvement at the time of screening, including leptomeningeal disease.\n* Congenital long QT syndrome or a corrected QTcF interval of \\>480 msec at screening (unless secondary to pacemaker or bundle branch block).\n* Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk.\n* If female, the patient is pregnant or breast-feeding.","ALL","18 Years","79 Years",{"count":351,"type":352},49,"ESTIMATED","INTERVENTIONAL",[355],"PHASE2","This is a prospective, phase 2, multicenter, open-label, single-arm study. Primary objective is to assess the efficacy of loncastuximab tesirine given as consolidation therapy after salvage immunochemotherapy in BTKi (Bruton Tyrosine Kinase inhibitors) -treated (or BTKi intolerant) R\u002FR (Relapse or Refractory) MCL (Mantle Cell Lymphoma) patients. The sponsor of this clinical trial is Fondazione Italiana Linfomi - ETS (FIL ETS).",[358,359],"Relapsed Mantle Cell Lymphoma","Refractory Mantle Cell Lymphoma",[361,362,363,364],"Relapsed\u002FRefractory Mantle Cell Lymphoma (MCL)","ADCT-402 (loncastuximab tesirine)","BTKi (Bruton Tyrosine Kinase inhibitors) - treated","BTKi (Bruton Tyrosine Kinase inhibitors) intolerant","2025-12-31",{"date":367,"type":368},"2026-01-05","ACTUAL",{"date":370,"type":368},"2022-03-21",{"date":372,"type":352},"2029-03",{"name":5,"class":6},21]