A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Indikation (Clinical Trials):
Lymphoma, Lymphoma, B-Cell, Marginal Zone
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 3
Sponsor:
BeiGene
Collaborator:
-
Studienleiter
Study Director Study Director BeiGene Study Director Principal Investigator BeiGene
Kontakt
Study Director BeiGene Kontakt: Phone: 1-877-828-5568 E-Mail: clinicaltrials@beigene.com» Kontaktdaten anzeigen
Studienlocations (3 von 171)
Kaiser Permanente Southern California 92618 Irvine United StatesRekrutierend» Google-MapsLos Angeles Cancer Network 90017 Los Angeles United StatesRekrutierend» Google-MapsValkyrie Clinical Trials 90067 Los Angeles United StatesRekrutierend» Google-Maps
Scripps Health 92103 San Diego United StatesRekrutierend» Google-MapsBaptist Md Anderson Cancer Center 32207 Jacksonville United StatesRekrutierend» Google-MapsAscension Sacred Heart 32504 Pensacola United StatesRekrutierend» Google-MapsNorthwest Georgia Oncology Centers Marietta 30060 Marietta United StatesRekrutierend» Google-MapsFort Wayne Medical Oncology and Hematology 46804 Fort Wayne United StatesRekrutierend» Google-MapsMission Cancer and Blood 50309 Des Moines United StatesRekrutierend» Google-MapsCotton Oneil Cancer Center 66606 Topeka United StatesRekrutierend» Google-MapsUniversity of Maryland Greenebaum Comprehensive Cancer Center 21201 Baltimore United StatesRekrutierend» Google-MapsAmerican Oncology Partners of Maryland Pa 20817 Bethesda United StatesRekrutierend» Google-MapsHenry Ford Hospital 48202 Detroit United StatesRekrutierend» Google-MapsHattiesburg Hematology and Oncology Clinic 39401 Hattiesburg United StatesRekrutierend» Google-MapsUniversity of Missouri Hospital, Ellis Fischel Cancer Center 65212 Columbia United StatesRekrutierend» Google-MapsOncology Hematology Associates 65807 Springfield United StatesRekrutierend» Google-MapsSt Vincent Frontier Cancer Center 59102 Billings United StatesRekrutierend» Google-MapsNebraska Cancer Specialists (Satellite Site) 68803 Grand Island United StatesRekrutierend» Google-MapsNebraska Cancer Specialists 68803 Grand Island United StatesRekrutierend» Google-MapsSummit Medical Group 07932 Florham Park United StatesRekrutierend» Google-MapsClinical Research Alliance, Inc 11590 Westbury United StatesRekrutierend» Google-MapsVa Northeast Ohio Healthcare System 44106 Cleveland United StatesRekrutierend» Google-MapsToledo Clinic Cancer Center 43623 Toledo United StatesRekrutierend» Google-MapsMainline Health Lankenau Institute For Medical Research 19096 Wynnewood United StatesRekrutierend» Google-MapsCancer Care Associates of York 17403 York United StatesRekrutierend» Google-MapsPrairie Lakes Healthcare System 57201 Watertown United StatesRekrutierend» Google-MapsTexas Oncology Baylorcharles A Sammons Cancer Center 75246 Dallas United StatesRekrutierend» Google-MapsMd Anderson Cancer Center 77030 Houston United StatesRekrutierend» Google-MapsMedical Oncology Associates 99208 Spokane United StatesRekrutierend» Google-MapsHospital Italiano de Buenos Aires C1199ABB Buenos Aires ArgentinaRekrutierend» Google-MapsConcord Repatriation General Hospital 2139 Concord AustraliaRekrutierend» Google-MapsGosford Hospital 2250 Gosford AustraliaRekrutierend» Google-MapsSt George Hospital 2217 Kogarah AustraliaRekrutierend» Google-MapsOrange Health Hospital 2800 Orange AustraliaRekrutierend» Google-MapsPort Macquarie Base Hospital 2444 Port Macquarie AustraliaRekrutierend» Google-MapsWestmead Hospital 2145 Westmead AustraliaRekrutierend» Google-MapsSunshine Coast Hospital and Health Service 4575 Birtinya AustraliaRekrutierend» Google-MapsTownsville University Hospital 4814 Douglas AustraliaRekrutierend» Google-MapsMonash Health 3168 Clayton AustraliaRekrutierend» Google-MapsSt Vincents Hospital Melbourne 3065 Fitzroy AustraliaRekrutierend» Google-MapsAustin Health 3084 Heidelberg AustraliaRekrutierend» Google-MapsCabrini Hospital Malvern 3144 Malvern AustraliaRekrutierend» Google-MapsEpworth Freemasons 3002 Melbourne AustraliaRekrutierend» Google-MapsThe Alfred Hospital 3004 Melbourne AustraliaRekrutierend» Google-MapsPerth Blood Institute 6005 West Perth AustraliaRekrutierend» Google-MapsLa Trobe Regional Hospital 3844 Melbourne AustraliaRekrutierend» Google-MapsUk St Poelten 3100 St Poelten AustriaRekrutierend» Google-MapsMedical Univeristy Vienna 1090 Wien AustriaRekrutierend» Google-MapsHospital de Amor Barretos 14784-400 Barretos BrazilRekrutierend» Google-MapsClinica de Oncologia Reichow 89010-340 Blumenau BrazilRekrutierend» Google-MapsUnesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu 18618687 Botucatu BrazilRekrutierend» Google-MapsInstituto Dor de Pesquisa E Ensino Distrito Federal 70390140 Brasilia BrazilRekrutierend» Google-MapsUniversidade de Campinas Centro de Hematologia E Hemoterapia 13083-878 Campinas BrazilRekrutierend» Google-MapsFundacao Universidade de Caxias Do Sul 95070-560 Caxias do Sul BrazilRekrutierend» Google-MapsCentro Integrado de Oncologia de Curitiba Ss Cionc 80810-050 Curitiba BrazilRekrutierend» Google-MapsHospital Erasto Gaertner 81520-060 Curitiba BrazilRekrutierend» Google-MapsCentro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen) 88020-210 Florianopolis BrazilRekrutierend» Google-MapsHospital Ernesto Dornelles 90160-093 Porto Alegre BrazilRekrutierend» Google-MapsCentro Gaucho Integrado de Oncologia Hospital Mae de Deus 90850-170 Porto Alegre BrazilRekrutierend» Google-MapsInstituto Dor de Pesquisa E Ensino 50070170 Recife BrazilRekrutierend» Google-MapsHospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp 14051-140 Ribeirao Preto BrazilRekrutierend» Google-MapsOncoclinicas Rio de Janeiro Sa 22250-905 Rio de Janeiro BrazilRekrutierend» Google-MapsInstituto Americas Ensino, Pesquisa E Inovacao 22775-001 Rio de Janeiro BrazilRekrutierend» Google-MapsComplexo Hospitalar de Niteroi 24020-096 Rio de Janeiro BrazilRekrutierend» Google-MapsEnsino E Terapia de Inovacao Clinica Amo Etica 41950640 Salvador BrazilRekrutierend» Google-MapsInstituto Dor de Pesquisa E Ensino Sao Paulo 01401-002 Sao Paulo BrazilRekrutierend» Google-MapsHospital Nove de Julho Dasa 01409-902 Sao Paulo BrazilRekrutierend» Google-MapsSociedade Beneficente Israelita Brasileira Hospital Albert Einstein 05653-120 Sao Paulo BrazilRekrutierend» Google-MapsHospital Santa Rita de Cassia Afecc 29043260 Vitoria BrazilRekrutierend» Google-MapsThe First Affiliated Hospital of Wannan Medical College 241001 Wuhu ChinaRekrutierend» Google-MapsBeijing Friendship Hospital, Capital Medical University 100050 Beijing ChinaRekrutierend» Google-MapsBeijing Cancer Hospital 100142 Beijing ChinaRekrutierend» Google-MapsChongqing Cancer Hospital 400030 Chongqing ChinaRekrutierend» Google-MapsFoshan First Peoples Hospital 528000 Foshan ChinaRekrutierend» Google-MapsSun Yat Sen University Cancer Center 510060 Guangzhou ChinaRekrutierend» Google-MapsHuizhou Central Peoples Hospital 516001 Huizhou ChinaRekrutierend» Google-MapsMeizhou People Hospital 514031 Meizhou ChinaRekrutierend» Google-MapsAffiliated Hospital of Guangdong Medical University 524000 Zhanjiang ChinaRekrutierend» Google-MapsHarbin Medical University Cancer Hospital 150000 Harbin ChinaRekrutierend» Google-MapsAnyang Cancer Hospital 455001 Anyang ChinaRekrutierend» Google-MapsHenan Cancer Hospital 450000 Zhengzhou ChinaRekrutierend» Google-MapsUnion Hospital of Tongji Medical College, Huazhong University of Science and Technology 430022 Wuhan ChinaRekrutierend» Google-MapsTongji Hospital of Tongji Medical College Huazhong University of Science and Technology 430030 Wuhan ChinaRekrutierend» Google-MapsThe First Peoples Hospital of Changde City 415000 Changde ChinaRekrutierend» Google-MapsAffiliated Hospital of Nantong University 201203 Nantong ChinaRekrutierend» Google-MapsThe First Affiliated Hospital of Soochow University 215006 Suzhou ChinaRekrutierend» Google-MapsWuxi Peoples Hospital 214023 Wuxi ChinaRekrutierend» Google-MapsJiangxi Province Cancer Hospital 330029 Nanchang ChinaRekrutierend» Google-MapsThe First Affiliated Hospital of Nanchang University Branch Xianghu 332000 Nanchang ChinaRekrutierend» Google-MapsThe First Hospital of Jilin University 130021 Changchun ChinaRekrutierend» Google-MapsShengjing Hospital of China Medical University 110004 Shenyang ChinaRekrutierend» Google-MapsPeoples Hospital of Rizhao 276827 Rizhao ChinaRekrutierend» Google-MapsThe Second Affiliated Hospital of Shandong First Medical University 271099 Taian ChinaRekrutierend» Google-MapsShanxi Provincial Cancer Hospital 030013 Taiyuan ChinaRekrutierend» Google-MapsWest China Hospital, Sichuan University 610041 Chengdu ChinaRekrutierend» Google-MapsDongyang Peoples Hospital 322103 Dongyang ChinaRekrutierend» Google-MapsZhejiang Cancer Hospital 310022 Hangzhou ChinaRekrutierend» Google-MapsThe First Hospital of Jiaxing 314001 Jiaxing ChinaRekrutierend» Google-MapsJinhua Municipal Central Hospital 321000 Jinhua ChinaRekrutierend» Google-MapsThe First Affiliated Hospital of Wenzhou Medical University 325000 Wenzhou ChinaRekrutierend» Google-MapsFakultni Nemocnice Hradec Kralove 50005 Hradec Kralove CzechiaRekrutierend» Google-MapsFakultni Nemocnice Olomouc 77900 Olomouc CzechiaRekrutierend» Google-MapsHopital Prive Dantony, Departement Dhemathologie 92160 Antony FranceRekrutierend» Google-MapsCentre Hospitalier Le Mans 72037 Le Mans FranceRekrutierend» Google-MapsChu Montpellier Hopital Saint Eloi 34295 Montpellier Cedex FranceRekrutierend» Google-MapsHopital Larchet Chu Nice 6200 Nice FranceRekrutierend» Google-MapsInstitut Curie 75005 Paris FranceRekrutierend» Google-MapsNecker University Hospital 75015 Paris FranceRekrutierend» Google-MapsIcans Institut de Cancerologie Strasbourg Europe 67033 Strasbourg FranceRekrutierend» Google-MapsCentre Hospitalier Universitaire de Nancy Hopital de Brabois 54511 VandoeuvrelesNancy FranceRekrutierend» Google-MapsSt Jamess Hospital D8 Dublin IrelandRekrutierend» Google-MapsUniversity Hospital Waterford X91 ER8E Waterford IrelandRekrutierend» Google-MapsAssuta Ashdod Medical Center 7747629 Ashdod IsraelRekrutierend» Google-MapsShaare Zedek Medical Center 9103102 Jerusalem IsraelRekrutierend» Google-MapsHadassah En Karem Medical Center 9112001 Jerusalem IsraelRekrutierend» Google-MapsRabin Medical Center 49100 Petach Tikva IsraelRekrutierend» Google-MapsChaim Sheba Medical Center 5265601 Ramat gan IsraelRekrutierend» Google-MapsAssuta Medical Center 69714 Tel Aviv IsraelRekrutierend» Google-MapsCro Irccs Aviano 33081 Aviano ItalyRekrutierend» Google-MapsIrccs Azienda Ospedaliero Universitaria Bologna 40138 Bologna ItalyRekrutierend» Google-MapsIstituto Europeo Di Oncologia 20141 Milano ItalyRekrutierend» Google-MapsAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda 20162 Milano ItalyRekrutierend» Google-MapsAou Maggiore Della Carita 28100 Novara ItalyRekrutierend» Google-MapsIrccs Policlinico San Matteo, Universita Degli Studi Di Pavi 27100 Pavia ItalyRekrutierend» Google-MapsArcispedale S Maria Nuova Ausl Reggio Emilia Hematology Unit 42123 Reggio Emilia ItalyRekrutierend» Google-MapsAou Santa Maria Della Misericordia Di Udine 33100 Udine ItalyRekrutierend» Google-MapsOspedale Di Circolo E Fondazione Macchi 21100 Varese ItalyRekrutierend» Google-MapsInje University Busan Paik Hospital 47392 Busan Korea, Republic ofRekrutierend» Google-MapsDong A University Hospital 49201 Busan Korea, Republic ofRekrutierend» Google-MapsPusan National University Hospital 49241 Busan Korea, Republic ofRekrutierend» Google-MapsSeoul National University Bundang Hospital 13620 Seongnamsi Korea, Republic ofRekrutierend» Google-MapsKorea University Anam Hospital 02841 Seoul Korea, Republic ofRekrutierend» Google-MapsKyungpook National University Chilgok Hospital 41404 Daegu Korea, Republic ofRekrutierend» Google-MapsGyeongsang National University Hospital 52727 Jinjusi Korea, Republic ofRekrutierend» Google-MapsChonnam National University Hwasun Hospital 58128 Hwasungun Korea, Republic ofRekrutierend» Google-MapsSeoul National University Hospital 03080 Seoul Korea, Republic ofRekrutierend» Google-MapsSeverance Hospital Yonsei University Health System 03722 Seoul Korea, Republic ofRekrutierend» Google-MapsSoon Chun Hyang University Hospital Seoul 04401 Seoul Korea, Republic ofRekrutierend» Google-MapsAsan Medical Center 05505 Seoul Korea, Republic ofRekrutierend» Google-MapsSamsung Medical Center 06351 Seoul Korea, Republic ofRekrutierend» Google-MapsThe Catholic University of Korea, Seoul St Marys Hospital 06591 Seoul Korea, Republic ofRekrutierend» Google-MapsPan American Oncology Trials, Llc 00935 Rio Piedras Puerto RicoRekrutierend» Google-MapsAuxilio Mutuo Cancer Center 00917 San Juan Puerto RicoRekrutierend» Google-MapsColtea Clinical Hospital 30171 Bucharest RomaniaRekrutierend» Google-MapsInstitutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca 400015 ClujNapoca RomaniaRekrutierend» Google-MapsInstitutul Regional de Oncologie Iasi 700483 Iasi RomaniaRekrutierend» Google-MapsSpitalul Clinic Judetean de Urgenta Bihor 410469 Oradea RomaniaRekrutierend» Google-MapsIco Badalona 08916 Badalona SpainRekrutierend» Google-MapsHospital Universitario de Burgos 09006 Burgos SpainRekrutierend» Google-MapsHospital Universitario Puerta Del Mar 11009 Cadiz SpainRekrutierend» Google-MapsHospital Universitario Virgen de Las Nieves 18014 Granada SpainRekrutierend» Google-MapsInstitut Catala Doncologia Hospital Duran I Reynals 8908 Hospitalet de LLobregat SpainRekrutierend» Google-MapsComplejo Asistencial Universitario de Leon 24071 Leon SpainRekrutierend» Google-MapsHospital de La Princesa 28006 Madrid SpainRekrutierend» Google-MapsClinica Universidad de Navarra 28027 Madrid SpainRekrutierend» Google-MapsHospital Universitario Infanta Leonor 28031 Madrid SpainRekrutierend» Google-MapsHospital Universitario Ramon Y Cajal 28034 Madrid SpainRekrutierend» Google-MapsH Puerta de Hierro Majadahonda 28222 Madrid SpainRekrutierend» Google-MapsHospital Clinico Universitario Virgen de La Arrixaca 30120 Murcia SpainRekrutierend» Google-MapsClinica Universidad de Navarra Pamplona 31008 Pamplona SpainRekrutierend» Google-MapsHospital Universitario Quironsalud Madrid 28223 Pozuelo de Alarcon SpainRekrutierend» Google-MapsHospital Universitario de Salamanca 37007 Salamanca SpainRekrutierend» Google-MapsHospital Universitario Virgen Del Rocio 41013 Sevilla SpainRekrutierend» Google-MapsHospital Universitari Mutua Terrassa 8221 Terassa SpainRekrutierend» Google-MapsBeatson West of Scotland Cancer Centre G12 0YN Glasgow United KingdomRekrutierend» Google-MapsThe Christie Hospital M20 4BX Greater Manchester United KingdomRekrutierend» Google-MapsHuddersfield Royal Infirmary HD3 3EA Huddersfield United KingdomRekrutierend» Google-MapsThe Leeds Teaching Hospitals Nhs Trust LS9 7TF Leeds United KingdomRekrutierend» Google-MapsUniversity College Hospital NW1 2PG London United KingdomRekrutierend» Google-MapsDerriford Hospital PL6 8DH Plymouth United KingdomRekrutierend» Google-MapsSouthampton General Hospital SO16 6YD Southampton United KingdomRekrutierend» Google-Maps
1. Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC) (Time Frame - Approximately 78 months)
Secondary outcome:
1. Progression-free Survival As Determined By Investigator Assessment (Time Frame - Approximately 87 months)
2. Duration Of Response As Determined By BIRC And By Investigator Assessment (Time Frame - Approximately 87 months)
3. Overall Response Rate As Determined By BIRC And By Investigator Assessment (Time Frame - Approximately 87 months)
4. Complete Response Rate As Determined By BIRC And By Investigator Assessment (Time Frame - Approximately 87 months)
5. Time To Response As Determined By BIRC And By Investigator Assessment (Time Frame - Approximately 87 months)
6. Time to Next Ant-Lymphoma Treatment (Time Frame - Approximately 87 months)
7. Overall Survival (Time Frame - Approximately 87 months)
8. Health-related Quality Of Life (HRQoL) Using EORTC QLQ-C30) (Time Frame - Approximately 87 months): HRQ0L assessed by The European Organization For Research On Treatment Of Cancer Quality Of Life Questionnaire-core 30 (EORTC QLQ-C30) consists of 30 questions that are associated with 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and 6 single symptom items ( dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The scores range from 0 to 100 and higher score indicates better quality of life.
9. HRQoL Using European Quality of Life 5 Dimension 5 Level Questionnaire [EQ 5D 5L) (Time Frame - Approximately 87 months): The EQ-5D-5L is comprised of a descriptive module and a visual analogue scale. The EQ-5D-5L descriptive module comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale records the respondent's self-rated health on a 0 to 100 scale, with 100 labeled "the best health you can imagine" and 0 labeled "the worst health you can imagine. Higher scores indicate better quality of life.
10. HRQoL Using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 [FLymSI 18) (Time Frame - Approximately 87 months): The FLymSI-18 is comprised of 18 questions which cover 4 sub-scales: physical symptoms, emotional symptoms, side effects, and functional well-being. Scores are based on the 5-level Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score. Higher score indicates better quality of life.
11. Number of Participants Experiencing Adverse Events (AEs) (Time Frame - From first dose to 28 days after the last dose of zanubrutinib or lenalidomide, 90 days after the last dose of obinutuzumab or rituximab, or until the date of confirmed disease progression, whichever comes later (Approximately 87 months))
Experimental: Follicular Lymphoma Arm A: Zanubrutinib plus Obinutuzumab Participants will receive zanubrutinib and Obinutuzumab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.
Active Comparator: Follicular Lymphoma Arm B: Lenalidomide plus Rituximab Participants will receive lenalidomide and rituximab.
Experimental: Marginal Zone Lymphoma Arm C: Zanubrutinib plus Rituximab Participants will receive zanubrutinib and rituximab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.
Active Comparator: Marginal Zone Lymphoma Arm D: Lenalidomide plus Rituximab Participants will receive lenalidomide and rituximab.
Zanubrutinib (BGB-3111 / Brukinsa / ): Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day) or four 80-mg capsules once a day (320 mg once a day) continuously in repeated 28-day cycles.
Rituximab (Rituxan / MabThera / Ruxience / Truxima / ): Rituximab will be administered intravenously at a dose of 375 mg/meter squared on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. Each cycle is 28 days in length.
Lenalidomide (Revlimid): Lenalidomide will be administered orally as 20-mg capsules (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) once a day on Days 1 to 21 of each 28-day cycle for a total of 12 cycles.
Obinutuzumab: Obinutuzumab will be administered at a dose of 1000 mg on Cycle 1 Days 1, 8, 15 and then on Cycles 2 to 6 Day 1.
Quelle: ClinicalTrials.gov
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"A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma"
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