Study of Tazemetostat Versus Placebo When Given in Combination With Lenalidomide and Rituximab in Participants With Relapsed/Refractory Follicular Lymphoma
研究单位：[1]Epizyme, Inc.[2],Korea, Republic of,06591[3]Southern Cancer Center,Mobile,Alabama,United States,36608[4]Arizona Oncology Associates - Tuscon-Rusadill Road,Tucson,Arizona,United States,85704[5]TOI - Clinical Research,Cerritos,California,United States,90703[6]UCSF Fresno,Clovis,California,United States,93611[7]UC San Diego Health Sciences,La Jolla,California,United States,92093[8]UCLA Clinical Research Unit Hematology/Oncology,Santa Monica,California,United States,90404[9]Rocky Mountain Cancer Centers (RMCC) - Boulder,Boulder,Colorado,United States,80303[10]St. Mary''s Hospital and Regional Medical Center - St. Mary''s,Grand Junction,Colorado,United States,81501[11]SCL Health Lutheran Medical Center,Greeley,Colorado,United States,80033[12]Cancer Specialists of North Florida,Fleming Island,Florida,United States,32003[13]Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center,Fort Myers,Florida,United States,33908[14]Mayo Clinic - Cancer Clinical Research Office,Jacksonville,Florida,United States,32224[15]Mayo Clinic,Jacksonville,Florida,United States,32224[16]Miami Cancer Institute,Miami,Florida,United States,33176[17]Florida Cancer Affiliates/Ocala Oncology - Clinic,Ocala,Florida,United States,34474[18]BRCR Medical Center, INC,Plantation,Florida,United States,33322[19]Florida Cancer Specialists,Saint Petersburg,Florida,United States,33705[20]Florida Cancer Specialists - Panhandle,Tallahassee,Florida,United States,32308[21]H Lee Moffitt Cancer Center and Research Institute I,Tampa,Florida,United States,33612[22]Florida Cancer Specialists & Research Institute (FCS) - Atlantis,West Palm Beach,Florida,United States,33401[23]Kaiser Permanente Hawaii Moanalua Medical Center,Honolulu,Hawaii,United States,96819[24]University of Chicago,Chicago,Illinois,United States,60637[25]Illinois Cancer Specialists,Niles,Illinois,United States,60714[26]June E. Nylen Cancer Center,Sioux City,Iowa,United States,51101[27]The University of Kansas Cancer Center,Overland Park,Kansas,United States,66210[28]University of Maryland,Baltimore,Maryland,United States,21201[29]The office of Frederick P. Smith, MD, P.C.,Chevy Chase,Maryland,United States,20815-6908[30]Mass General Cancer Center at Newton-Wellesley,Newton,Massachusetts,United States,02462[31]University of Michigan Comprehensive Cancer Center,Ann Arbor,Michigan,United States,48109[32]St. Joseph Mercy Hospital,Ypsilanti,Michigan,United States,48197[33]Mayo Clinic - Rochester,Rochester,Minnesota,United States,55901[34]Saint Louis University Cancer Center,Saint Louis,Missouri,United States,63110[35]University Of Nebraska Medical Center,Omaha,Nebraska,United States,68198[36]Astera Cancer Care,East Brunswick,New Jersey,United States,08816[37]Astera Cancer Center,East Brunswick,New Jersey,United States,08816[38]Regional Cancer Care Associates-Freehold,Freehold,New Jersey,United States,07728[39]Hackensack University Medical John Theurer Cancer Center,Hackensack,New Jersey,United States,07601[40]Regional Cancer Care Associates LLC - Howell,Howell,New Jersey,United States,07731[41]Regional Cancer Care Associates LLC - Little Silver,Little Silver,New Jersey,United States,07739[42]New Mexico Cancer Care Alliance,Albuquerque,New Mexico,United States,87131-0001[43]New York Oncology Hematology, P.C.,Albany,New York,United States,12206[44]Northwell Health/Monter Cancer Center,Lake Success,New York,United States,11042[45]Weill Cornell Medicine-New York Presbyterian Hospital,New York,New York,United States,10021[46]Columbia U - Herbert Irving Comprehensive Cancer Center,New York,New York,United States,10032[47]Memorial Sloan-Kettering Cancer Center,New York,New York,United States,10065[48]Hematology Oncology Associates of Rockland, P.C.,Nyack,New York,United States,10960[49]Messino Cancer Center,Asheville,North Carolina,United States,28806[50]Levine Cancer Institute - Concord,Concord,North Carolina,United States,28205[51]FirstHealth of the Carolinas,Pinehurst,North Carolina,United States,28374[52]Gabrail Cancer Center Research,Canton,Ohio,United States,44718[53]Oncology Hematology Care (OHC), Inc. - Kenwood Office,Cincinnati,Ohio,United States,45236[54]Willamette Valley Cancer Institute and Research Center - Oncology,Eugene,Oregon,United States,97401[55]University of Pittsburgh Medical Center - Oncology,Pittsburgh,Pennsylvania,United States,15232[56]Western Pennsylvania Hospital Hematology & Cellular Therapy,Pittsburgh,Pennsylvania,United States,15524[57]Tennessee Oncology, PLLC,Chattanooga,Tennessee,United States,37404[58]University of Tennessee Medical Center - Cancer Institute,Knoxville,Tennessee,United States,37920[59]Sarah Cannon Research Institute,Nashville,Tennessee,United States,37203[60]Texas Oncology - Amarillo,Amarillo,Texas,United States,79124[61]Texas Oncology-Austin Midtown,Austin,Texas,United States,78705[62]Texas Oncology - Medical City Dallas Pediatric Hematology,Dallas,Texas,United States,75230[63]Texas Oncology-Baylor Charles A. Sammons Cancer Center,Dallas,Texas,United States,75246[64]The University of Texas MD Anderson Cancer Center,Houston,Texas,United States,77030[65]Millennium Physicians - Oncology,Houston,Texas,United States,77090[66]Texas Oncology,Plano,Texas,United States,75075[67]Mays Cancer Center,San Antonio,Texas,United States,78229[68]UT Health East Texas HOPE Cancer Center - Tyler,Tyler,Texas,United States,75701[69]USO Texas Oncology - Tyler,Tyler,Texas,United States,75702[70]Texas Oncology- Weslaco,Weslaco,Texas,United States,78596[71]Utah Cancer Specialists/ IHO Corp,Salt Lake City,Utah,United States,84106[72]Huntsman Cancer Institute[73]The University of Utah,Salt Lake City,Utah,United States,84112[74]Peninsula Cancer Institute,Chesapeake,Virginia,United States,23320[75]Virginia Cancer Specialists,Gainesville,Virginia,United States,22155[76]Oncology and Hematology Associates of Southwest Virginia Inc.,Roanoke,Virginia,United States,24014[77]MC Rockwood Cancer Bl Specialty Ctr - North,Spokane,Washington,United States,99218[78]Yakima Valley Memorial Hospital - North Star Lodge Cancer Center,Yakima,Washington,United States,98902[79]Royal Adelaide Hospital,Adelaide,South Australia,Australia,5000[80]Flinders Medical Centre,Bedford Park,South Australia,Australia,5042[81]Monash Health,Clayton,Victoria,Australia,3168[82]Barwon Health, University Hospital Geelong,Geelong,Victoria,Australia,3220[83]Hollywood Private Hospital,Nedlands,Western Australia,Australia,6009[84]CHU Dinant Godinne UCL Namur,Yvoir,Namur,Belgium,5530[85]Universitair Ziekenhuis Gent,Gent,Oost-Vlaanderen,Belgium,9000[86]UZ Leuven - Campus Gasthuisberg,Leuven,Vlaams Brabant,Belgium,3000[87]University Health Network Princess Margaret Hospital,Toronto,Ontario,Canada,M5G 2M9[88]Centre Hospitalier de l''Universite de Montreal (CHUM),Montréal,Quebec,Canada,H2X 3E4[89]Sir Mortimer B Davis/Jewish General Hospital,Montréal,Quebec,Canada,H3T 1E2[90]Fujian Medical University Union Hospital,Fuzhou,Fujian,China,350001[91]The First Affiliated Hospital of Xiamen University,Xiamen,Fujian,China,361003[92]The Affiliated Hospital of Guizhou Medical University,Guiyang,Guizhou,China,550004[93]The Second Affiliated Hospital Zhejiang University School of Medicine,Zhejiang,Hangzhou,China,310000[94]The Fourth Hospital of Hebei Medical University,Shijiazhuang,Hebei,China,050011[95]Henan Provincial People''s Hospital,Zhengzhou,Henan,China,450008[96]Henan Cancer Hospital,Zhengzhou,Henan,China,45008[97]Hunan Cancer Hospital,Changsha,Hunan,China,410013[98]The First Bethune Hospital of Jilin University,Changchun,Jinlin,China,130021[99]The Affiliated Hospital of Qingdao University,Qingdao,Shandong,China,266071[100]Ruijin Hospital, Shanghai Jiaotong University School of Medicine,Shanghai,Shanghai,China,20025[101]Shanxi Bethune Hospital,Taiyuan,Shanxi,China,30032[102]Peking University Third Hospital,Beijing,China,100191[103]Tianjin Medical University Cancer Institute & Hospital,Tianjin,China,300060[104]Centre Hospitalier Universitaire de Bordeaux-Hopital du Haut Leveque,Pessac Cedex,Aquitaine,France,33600[105]CHRU Brest Hôp Morvan,Brest,Bretagne,France,29609[106]Institut Bergonie,Bordeaux,Gironde,France,33000[107]Centre Hosp Mulh Hop Emile Muller,Mulhouse,Haut-Rhin,France,68100[108]Centre Henri Becquerel,Rouen,Haute-Normandie,France,76038[109]CHU de Limoges Dupuytren,Limoges,Haute-Vienne,France,87042[110]CHU de Grenoble - Hopital Albe,La Tronche,Isere,France,38700[111]CHU de Nantes - Hematologie,Nantes,Loire-Atlantique,France,44000[112]CHRU de Lille Hop Claude Huriez,Lille,Nord,France,59037[113]Centre Hospitalier Le Mans,Le Mans,Sarthe,France,72000[114]CHRU de Besançon- Hopital Jean Minjoz,Besancon,France,25000[115]CHU Caen,Caen,France,14000[116]CHU de Clermont-Ferrand, site Estaing,Clermont-Ferrand,France,63000[117]Hopital Saint Louis,Paris,France,75010[118]CHU de Nancy Brabois,Vandœuvre-lès-Nancy,France,54511[119]Centre Hospitalier Bretagne Atlantique,Vannes,France,56017[120]Hopital Henri Mondor - Hemopathies Lymphoides,Créteil,Île-de-France,France,94010[121]Diakoneo Diak Schwaebisch Hall gGmbH,Schwäbisch Hall,Baden-Württemberg,Germany,74523[122]Klinikum Der Universität München AöR,München,Bayern,Germany,81377[123]Klinikum rechts der Isar der Technischen Universitat Muenche,München,Bayern,Germany,81675[124]Universitätsmedizin Mainz,Mainz,Hessen,Germany,55131[125]Universitaetsklinikum Bonn AöR,Bonn,Nordrhein-Westfalen,Germany,53127[126]Kliniken Maria Hilf GmbH,Moenchengladbach,Nordrhein-Westfalen,Germany,41063[127]Städt. Krankenhaus Kiel,Kiel,Schleswig-Holstein,Germany,24116[128]Debreceni Egyetem Klinikai Központ,Debrecen,Hajdú-Bihar,Hungary,4032[129]Semmelweis Egyetem Általános Orvostudományi Kar,Budapest,Hungary,1088[130]Országos Onkológiai Intézet,Budapest,Hungary,1122[131]Del-pesti Centrumkorhaz Orszagos Hematologiai és Infektologiai Intezet,Budapest,Hungary,H-1097[132]AOU Federico II,Napoli,Campania,Italy,80122[133]Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS,Meldola,Forli-Cesena,Italy,47014[134]ASST Spedali Civili di Brescia,Brescia,Italy,25123[135]PO Garibaldi-Nesima, ARNAS Garibaldi,Catania,Italy,95122[136]AOU Careggi,Firenze,Italy,50134[137]Catholic University Of Sacred Heart,Roma,Italy,00168[138]Azienda Ospedaliera Santa Maria di Terni,Terni,Italy,05100[139]Severance Hospital, Yonsei University Health System,Seoul,Seoul Teugbyeolsi [Seoul-T''ukp,Korea, Republic of,03722[140]Samsung Medical Center,Seoul,Seoul Teugbyeolsi [Seoul-T''ukp,Korea, Republic of,06351[141]Seoul National University Hospital,Seoul,Seoul Teugbyeolsi,Korea, Republic of,03080[142]Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy,Warszawa,Mazowieckie,Poland,02-781[143]Centrum Medyczne Pratia Poznan,Skorzewo,Wielkopolskie,Poland,60-185[144]Pratia MCM Krakow,Kraków,Poland,30-727[145]Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. Z o.o.,Słupsk,Poland,76-200[146]MICS Centrum Medyczne Torun,Torun,Poland,87-100[147]Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu,Wroclaw,Poland,50-367[148]Hospital Universitari Vall d''Hebrón,Barcelona,Cataluny,Spain,08035[149]Hospital Costa del Sol,Marbella,Málaga,Spain,29603[150]Hospital Del Mar,Barcelona,Spain,08003[151]Hospital Univ. Infanta Leonor,Madrid,Spain,28031[152]Hospital Universitario La Paz,Madrid,Spain,28046[153]Hospital Universitario de Salamanca,Salamanca,Spain,37007[154]Hospital Universitario Nuestra Señora de Valme,Sevilla,Spain,41014[155]Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology,Kaohsiung,Taiwan,833[156]Taichung Veterans General Hospital,Taichung,Taiwan,40705[157]National Cheng Kung University Hospital,Tainan,Taiwan,704[158]National Taiwan University Hospital,Taipei,Taiwan[159]Western General Hospital - Haematology,Edinburgh,Edinburgh, City Of,United Kingdom,EH4 2XU[160]Imperial College Healthcare NHS Trust - Hammersmith Hospital,London,London City,United Kingdom,W12 0HS[161]St Bartholomew''s Hospital Barts Health NHS Trust,London,London, City Of,United Kingdom,EC1A 7BE[162]Beatson West of Scotland Cancer Centre,Glasgow,United Kingdom,G12 0YN
The participants of this study would have relapsed/refractory follicular lymphoma. Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after treatment and 'refractory' when treatment no longer works. Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment.
