[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100433195":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":30,"locations":36,"responsibleParty":277,"collaborators":279,"id":282,"slug":283,"hasResults":284,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":284,"sex":290,"minAge":291,"maxAge":24,"enrollmentInfo":292,"targetDuration":24,"studyType":295,"phases":296,"briefSummary":298,"conditions":299,"keywords":24,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":310},{"fullName":5,"class":6},"Maria Sklodowska-Curie National Research Institute of Oncology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Obinutuzumab","EXPERIMENTAL","Patients in reference arm (Arm A) will receive rituximab. Patients in experimental arm (Arm B) will receive obinutuzumab instead of rituximab in the same time-points.",[13],"Drug: Obinutuzumab",{"label":15,"type":16,"description":11,"interventionNames":17},"Rituximab","ACTIVE_COMPARATOR",[18],"Drug: Rituximab",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland. Patients in experimental arm will receive obinutuzumab .Obinutuzumab: 1000 mg i.v. (first infusion divided into 100 mg on d. 1 and 900 mg on d. 2).",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":28},"Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland.The protocol includes the use of rituximab in combination chemotherapy. Rituximab: 375 mg\u002Fm2 intravenously (i.v.)",[15],[29],"Activ comparator",[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Sebastian Giebel, prof. dr n.med.","CONTACT","32 278 85 23","Sebastian.Giebel@io.gliwice.pl",[37,54,67,81,94,107,120,133,146,159,169,182,195,208,221,234,244,254,267],{"facility":38,"status":39,"city":40,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego","RECRUITING","Bialystok","Poland","PL",{"type":44,"coordinates":45},"Point",[46,47],23.16433,53.13333,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":52,"phoneExt":24,"email":53},"Jarosław Piszcz, Dr hab.med.","85 831 82 30","jaroslaw.piszcz@gmail.com",{"facility":55,"status":39,"city":56,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Oddział Hematologii Onkologicznej Podkarpacki Ośrodek Onkologiczny","Brzozów",{"type":44,"coordinates":58},[59,60],22.01926,49.69501,{"lat":60,"lon":59},[63],{"name":64,"role":33,"phone":65,"phoneExt":24,"email":66},"Jacek Krzanowski, dr n.med","13 4309728","hematologia-sek@szpital-brzozow.pl",{"facility":68,"status":39,"city":69,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach","Gliwice",{"type":44,"coordinates":71},[72,73],18.67658,50.29761,{"lat":73,"lon":72},[76,78],{"name":77,"role":33,"phone":34,"phoneExt":24,"email":35},"Sebastian Giebel, prof. n.med.",{"name":79,"role":33,"phone":80,"phoneExt":24,"email":24},"Aleksandra Żuczek","32 278 85 28",{"facility":82,"status":39,"city":83,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Klinika Hematologii i Transplantacji Szpiku, Samodzielny Publiczny Szpital Kliniczny","Katowice",{"type":44,"coordinates":85},[86,87],19.02173,50.2597,{"lat":87,"lon":86},[90],{"name":91,"role":33,"phone":92,"phoneExt":24,"email":93},"Grzegorz Helbig, Prof. dr hab. n. med","32 2591 281","ohits@spskm.katowice.pl",{"facility":95,"status":39,"city":96,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii","Kielce",{"type":44,"coordinates":98},[99,100],20.62752,50.87033,{"lat":100,"lon":99},[103],{"name":104,"role":33,"phone":105,"phoneExt":24,"email":106},"Ewa Sierlecka, lek.med.","41 367 4841","hematologia@onkol.kielce.pl",{"facility":108,"status":39,"city":109,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Oddział Hematologii i Chorób Wewnętrznych z Pododdziałem Dziennym Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o.","Krakow",{"type":44,"coordinates":111},[112,113],19.93658,50.06143,{"lat":113,"lon":112},[116],{"name":117,"role":33,"phone":118,"phoneExt":24,"email":119},"Małgorzata Raźny Dr n. med.","+48602731744","mrazny@rydygierkrakow.pl",{"facility":121,"status":39,"city":122,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Oddział Hematologiczny Wojewódzkiego Szpitala Specjalistycznego w Legnicy","Legnica",{"type":44,"coordinates":124},[125,126],16.1619,51.21006,{"lat":126,"lon":125},[129],{"name":130,"role":33,"phone":131,"phoneExt":24,"email":132},"Jadwiga Hołojda, Dr n. med.","505 149 579","jadwiga.holojda@szpital.legnica.pl",{"facility":134,"status":39,"city":135,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi","Lodz",{"type":44,"coordinates":137},[138,139],19.47395,51.77058,{"lat":139,"lon":138},[142],{"name":143,"role":33,"phone":144,"phoneExt":24,"email":145},"Anna Szmigielska-Kapłon, Dr hab. n. med","426895486","a.szmigielska-kaplon@kopernik.lodz.pl",{"facility":147,"status":39,"city":148,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Klinika Hematoonkologii I Transplantacji Szpiku, Uniwersytet Medyczny w Lublinie","Lublin",{"type":44,"coordinates":150},[151,152],22.57009,51.25058,{"lat":152,"lon":151},[155],{"name":156,"role":33,"phone":157,"phoneExt":24,"email":158},"Marek Hus, Prof.dr hab.n.med.","81 53 45 468","marekhus@umlub.pl",{"facility":160,"status":39,"city":148,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":161,"geoPoint":163,"contacts":164},"Oddział Hematologii i Transplantacji Szpiku Centrum Onkologii Ziemi Lubelskiej im. Św. Jana z Dukli w Lublinie",{"type":44,"coordinates":162},[151,152],{"lat":152,"lon":151},[165],{"name":166,"role":33,"phone":24,"phoneExt":167,"email":168},"Wojciech Legieć, Dr n. med","502074194","wlegiec@cozl.pl",{"facility":170,"status":39,"city":171,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Oddział Kliniczny Hematologii Samodzielnego Publicznego Zakładu Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie","Olsztyn",{"type":44,"coordinates":173},[174,175],20.49272,53.78376,{"lat":175,"lon":174},[178],{"name":179,"role":33,"phone":180,"phoneExt":24,"email":181},"Janusz Hałka, dr n.med.","89 539 81 30","ord.hematologia@poliklinika.net",{"facility":183,"status":39,"city":184,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Klinika Hematologii i Chorób Rozrostowych Układu Krwiotwórczego Uniwersytetu Medycznego w Poznaniu","Poznan",{"type":44,"coordinates":186},[187,188],16.92993,52.40692,{"lat":188,"lon":187},[191],{"name":192,"role":33,"phone":193,"phoneExt":24,"email":194},"Lidia Gil, Prof. dr hab. n. med.","61 854 93 83","hematologia.sekretariat@skpp.edu.pl",{"facility":196,"status":39,"city":197,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Klinika Hematologii Pomorskiego Uniwersytetu Medycznego","Szczecin",{"type":44,"coordinates":199},[200,201],14.55302,53.42894,{"lat":201,"lon":200},[204],{"name":205,"role":33,"phone":206,"phoneExt":24,"email":207},"Barbara Zdziarska, Prof.dr hab.n.med.","091 4253347","sekr.hemat@spsk1.szn.pl",{"facility":209,"status":39,"city":210,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Oddział Hematologii, Specjalistyczny Szpital Miejski","Torun",{"type":44,"coordinates":212},[213,214],18.59814,53.01375,{"lat":214,"lon":213},[217],{"name":218,"role":33,"phone":219,"phoneExt":24,"email":220},"Edyta Cichocka, Dr n.med.","56 61 00 411","hematologia@med.torun.pl",{"facility":222,"status":39,"city":223,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Klinika Chorób Wewnętrznych i Hematologii Wojskowy Instytut Medyczny","Warsaw",{"type":44,"coordinates":225},[226,227],21.01178,52.22977,{"lat":227,"lon":226},[230],{"name":231,"role":33,"phone":232,"phoneExt":24,"email":233},"Krzysztof Gawroński, Prof. dr hab. n. med.","22 261 817 160","kgawronski@wim.mil.pl",{"facility":235,"status":39,"city":223,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":236,"geoPoint":238,"contacts":239},"Klinika Hematologii, Instytut Hematologii i Transfuzjologii",{"type":44,"coordinates":237},[226,227],{"lat":227,"lon":226},[240],{"name":241,"role":33,"phone":242,"phoneExt":24,"email":243},"Ewa Lech - Marańda, Prof. dr hab. n. med.","22 349 63 34","hemsek@ihit.waw.pl",{"facility":245,"status":39,"city":223,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":246,"geoPoint":248,"contacts":249},"Klinika Hematologii, Onkologii i Chorób Wewnętrznych Warszawskiego Uniwersytetu Medycznego",{"type":44,"coordinates":247},[226,227],{"lat":227,"lon":226},[250],{"name":251,"role":33,"phone":252,"phoneExt":24,"email":253},"Grzegorz Basak, Prof. dr hab. n. med.","22 599 28 18","kho@spcsk.pl",{"facility":255,"status":39,"city":256,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku","Wroclaw",{"type":44,"coordinates":258},[259,260],17.03006,51.10286,{"lat":260,"lon":259},[263],{"name":264,"role":33,"phone":265,"phoneExt":24,"email":266},"Anna Czyż, Dr n.med.","71 784 25 76","khn@usk.wroc.pl",{"facility":268,"status":39,"city":256,"state":24,"zip":24,"country":41,"countryCode":42,"cosmosGeoPoint":269,"geoPoint":271,"contacts":272},"Oddział Hematologiczny Z Oddziałem Nowotworów Krwi Dolnośląskie Centrum Transplantacji Komórkowych Z Krajowym Bankiem Dawców Szpiku",{"type":44,"coordinates":270},[259,260],{"lat":260,"lon":259},[273],{"name":274,"role":33,"phone":275,"phoneExt":24,"email":276},"Jarosław Dybko, dr n.med.","71 78 313 75","jdybko@dctk.wroc.pl",{"type":278,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[280],{"name":281,"class":6},"KCRI","100433195","phase-2-obinutuzumab-versus-rituximab-for-acute-lymphoblastic-leukemiapalg-all7-overall-100433195",false,"NCT04920968","Obinutuzumab Versus Rituximab for Acute Lymphoblastic Leukemia\u002FPALG ALL7 \"OVERALL\"","Efficacy and Safety of Obinutuzumab Versus Rituximab in Combination With Chemotherapy for Adult Patients With Newly Diagnosed CD20-positive Acute Lymphoblastic Leukemia","OVERALL","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Newly diagnosed Acute lymphoblastic leukemia with CD20 expression on at least 20% of blasts.\n3. Signed written informed consent.\n4. Adequate contraception in case of women with child-bearing potential\n\nExclusion Criteria:\n\n1. Lymphoblastic lymphoma with bone marrow blasts\\\u003C20%.\n2. Patients with a history of chronic myeloid leukemia or other myeloproliferative disease.\n3. Major surgery within 4 weeks before enrollment.\n4. Impaired cardiac function: ejection fraction \\\u003C40% on echocardiography, QTc interval \\> 450 ms on baseline electrocardiogram. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).\n5. Active infection e.g. hepatitis B virus, hepatitis C virus, human immunodeficiency virus\n6. Other concurrent severe and\u002For uncontrolled medical conditions: patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and\u002For life-threatening medical disease.\n7. Serum creatinine \\> 2 times the upper normal limit of the laboratory, total bilirubin\\> 2.5 upper normal limit unless related to Acute lymphoblastic leukemia, aspartate aminotransferase or alanine aminotransferase \\> 5 upper normal limit, unless related to Acute lymphoblastic leukemia\n8. Intolerance to treatment with monoclonal antibody.\n9. Positive pregnancy test (beta human chorionic gonadotropin) for women of childbearing age.\n10. Inability to obtain written informed consent.\n11. Inability to comply with regular monitoring.","ALL","18 Years",{"count":293,"type":294},124,"ESTIMATED","INTERVENTIONAL",[297],"PHASE2","A multicenter, prospective, randomized and controlled study to compare the efficacy and safety of obinutuzumab and rituximab in adult ALL patients with CD20 expression.Study population is 124 patients (62 in each study group).",[300],"CD20-positive Acute Lymphoblastic Leukemia","2025-04-21",{"date":303,"type":304},"2025-04-24","ACTUAL",{"date":306,"type":304},"2021-10-05",{"date":308,"type":294},"2025-12-31",{"name":5,"class":6},19]