612
Participants
Start Date
June 11, 2020
Primary Completion Date
March 1, 2026
Study Completion Date
March 1, 2029
Tazemetostat
"Stage 1 (Phase 1b):~Tazemetostat was escalated from a starting dose of 400 mg orally twice daily to 600 mg orally twice daily to 800 mg PO twice daily in 28-day cycles as tolerated in a standard 3 + 3 design. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy."
Tazemetostat
"Stage 2:~Tazemetostat 800 mg administered orally twice daily in continuous 28-day cycles for 12 cycles. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy."
Placebo oral tablet
"Stage 2:~Placebo administered orally twice daily in continuous 28-day cycles. Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy."
Lenalidomide
Lenalidomide 20 mg capsules or 10 mg capsules (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.
Rituximab
Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.
RECRUITING
National Cheng Kung University Hospital, Tainan City
RECRUITING
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology, Kaohsiung City
RECRUITING
Semmelweis Egyetem Általános Orvostudományi Kar, Budapest
RECRUITING
Országos Onkológiai Intézet, Budapest
RECRUITING
UZ Leuven - Campus Gasthuisberg, Leuven
RECRUITING
Monash Health, Clayton
RECRUITING
Barwon Health, University Hospital Geelong, Geelong
RECRUITING
Debreceni Egyetem Klinikai Központ, Debrecen
RECRUITING
Royal Adelaide Hospital, Adelaide
RECRUITING
Flinders Medical Centre, Bedford Park
WITHDRAWN
CHU Dinant Godinne UCL Namur, Yvoir
RECRUITING
Hollywood Private Hospital, Nedlands
RECRUITING
Universitair Ziekenhuis Gent, Ghent
RECRUITING
Weill Cornell Medicine-New York Presbyterian Hospital, New York
RECRUITING
Columbia U - Herbert Irving Comprehensive Cancer Center, New York
RECRUITING
Memorial Sloan-Kettering Cancer Center, New York
RECRUITING
Hematology Oncology Associates of Rockland, P.C., Nyack
WITHDRAWN
Northwell Health/Monter Cancer Center, Lake Success
WITHDRAWN
New York Oncology Hematology, P.C., Albany
WITHDRAWN
CHU Caen, Caen
WITHDRAWN
University of Pittsburgh Medical Center - Oncology, Pittsburgh
RECRUITING
Western Pennsylvania Hospital Hematology & Cellular Therapy, Pittsburgh
RECRUITING
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
WITHDRAWN
University of Maryland, Baltimore
RECRUITING
Virginia Cancer Specialists, Gainesville
WITHDRAWN
Peninsula Cancer Institute, Chesapeake
RECRUITING
Oncology and Hematology Associates of Southwest Virginia Inc., Roanoke
RECRUITING
Städt. Krankenhaus Kiel, Kiel
RECRUITING
CHRU de Besançon- Hopital Jean Minjoz, Besançon
RECRUITING
ASST Spedali Civili di Brescia, Brescia
RECRUITING
Wheeling Hospital, Wheeling
RECRUITING
Hospital Univ. Infanta Leonor, Madrid
RECRUITING
Hospital Universitario La Paz, Madrid
RECRUITING
Levine Cancer Institute - Concord, Concord
RECRUITING
FirstHealth of the Carolinas, Pinehurst
RECRUITING
Messino Cancer Center, Asheville
RECRUITING
Hospital Costa del Sol, Marbella
RECRUITING
CHRU Brest Hôp Morvan, Brest
RECRUITING
Shanxi Bethune Hospital, Taiyuan
RECRUITING
Cancer Specialists of North Florida, Fleming Island
WITHDRAWN
Mayo Clinic - Cancer Clinical Research Office, Jacksonville
RECRUITING
Mayo Clinic, Jacksonville
RECRUITING
Florida Cancer Specialists - Panhandle, Tallahassee
RECRUITING
Institut Bergonie, Bordeaux
WITHDRAWN
Miami Cancer Institute, Miami
RECRUITING
BRCR Medical Center, INC, Plantation
RECRUITING
Florida Cancer Specialists & Research Institute (FCS) - Atlantis, West Palm Beach
RECRUITING
Centre Hospitalier Universitaire de Bordeaux-Hopital du Haut Leveque, Pessac
RECRUITING
H Lee Moffitt Cancer Center and Research Institute I, Tampa
RECRUITING
Florida Cancer Specialists, St. Petersburg
TERMINATED
Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center, Fort Myers
RECRUITING
Florida Cancer Affiliates/Ocala Oncology - Clinic, Ocala
RECRUITING
Southern Cancer Center, Mobile
RECRUITING
Hospital Universitario de Salamanca, Salamanca
RECRUITING
Sarah Cannon Research Institute, Nashville
WITHDRAWN
Tennessee Oncology, PLLC, Chattanooga
WITHDRAWN
University of Tennessee Medical Center - Cancer Institute, Knoxville
RECRUITING
CHU de Grenoble - Hopital Albe, La Tronche
RECRUITING
Taichung Veterans General Hospital, Taichung
RECRUITING
Hospital Universitario Nuestra Señora de Valme, Seville
RECRUITING
Kliniken Maria Hilf GmbH, Mönchengladbach
RECRUITING
CHU de Nantes - Hematologie, Nantes
RECRUITING
L'Hôpital Privé Confluent, Nantes
RECRUITING
Gabrail Cancer Center Research, Canton
RECRUITING
Henan Cancer Hospital, Zhengzhou
RECRUITING
Oncology Hematology Care (OHC), Inc. - Kenwood Office, Cincinnati
RECRUITING
Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS, Meldola
RECRUITING
University of Michigan Comprehensive Cancer Center, Ann Arbor
RECRUITING
St. Joseph Mercy Hospital, Ypsilanti
RECRUITING
AOU Careggi, Florence
WITHDRAWN
June E. Nylen Cancer Center, Sioux City
RECRUITING
Universitaetsklinikum Bonn AöR, Bonn
RECRUITING
CHU de Nancy Brabois, Vandœuvre-lès-Nancy
RECRUITING
Universitätsmedizin Mainz, Mainz
RECRUITING
Mayo Clinic - Rochester, Rochester
RECRUITING
Centre Hospitalier Bretagne Atlantique, Vannes
RECRUITING
CHRU de Lille Hop Claude Huriez, Lille
RECRUITING
University of Chicago, Chicago
RECRUITING
Illinois Cancer Specialists, Niles
RECRUITING
CHU de Clermont-Ferrand, site Estaing, Clermont-Ferrand
WITHDRAWN
Saint Louis University Cancer Center, St Louis
WITHDRAWN
The University of Kansas Cancer Center, Overland Park
RECRUITING
Centre Hosp Mulh Hop Emile Muller, Mulhouse
RECRUITING
University Of Nebraska Medical Center, Omaha
RECRUITING
Centre Hospitalier Le Mans, Le Mans
RECRUITING
Diakoneo Diak Schwaebisch Hall gGmbH, Schwäbisch Hall
RECRUITING
Hopital Saint Louis, Paris
RECRUITING
Texas Oncology, Plano
RECRUITING
Texas Oncology - Medical City Dallas Pediatric Hematology, Dallas
RECRUITING
Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas
RECRUITING
UT Health East Texas HOPE Cancer Center - Tyler, Tyler
RECRUITING
USO Texas Oncology - Tyler, Tyler
RECRUITING
Centre Henri Becquerel, Rouen
RECRUITING
The University of Texas MD Anderson Cancer Center, Houston
RECRUITING
Millennium Physicians - Oncology, Houston
RECRUITING
Mays Cancer Center, San Antonio
RECRUITING
Texas Oncology- Weslaco, Weslaco
RECRUITING
Texas Oncology-Austin Midtown, Austin
RECRUITING
Texas Oncology - Amarillo, Amarillo
WITHDRAWN
SCL Health Lutheran Medical Center, Greeley
RECRUITING
AOU Federico II, Napoli
RECRUITING
Rocky Mountain Cancer Centers (RMCC) - Boulder, Boulder
RECRUITING
Klinikum Der Universität München AöR, München
RECRUITING
St. Mary's Hospital and Regional Medical Center - St. Mary's, Grand Junction
WITHDRAWN
Klinikum rechts der Isar der Technischen Universitat Muenche, München
RECRUITING
Utah Cancer Specialists/ IHO Corp, Salt Lake City
RECRUITING
Huntsman Cancer Institute; The University of Utah, Salt Lake City
RECRUITING
Arizona Oncology Associates - Tuscon-Rusadill Road, Tucson
RECRUITING
CHU de Limoges Dupuytren, Limoges
RECRUITING
UCLA Clinical Research Unit Hematology/Oncology, Santa Monica
RECRUITING
TOI - Clinical Research, Cerritos
RECRUITING
UC San Diego Health Sciences, La Jolla
RECRUITING
UCSF Fresno, Clovis
RECRUITING
Hopital Henri Mondor - Hemopathies Lymphoides, Créteil
RECRUITING
PO Garibaldi-Nesima, ARNAS Garibaldi, Catania
WITHDRAWN
Kaiser Permanente Hawaii Moanalua Medical Center, Honolulu
RECRUITING
Willamette Valley Cancer Institute and Research Center - Oncology, Eugene
WITHDRAWN
Yakima Valley Memorial Hospital - North Star Lodge Cancer Center, Yakima
WITHDRAWN
MC Rockwood Cancer Bl Specialty Ctr - North, Spokane
RECRUITING
Peking University Third Hospital, Beijing
RECRUITING
The First Bethune Hospital of Jilin University, Changchun
RECRUITING
The Affiliated Hospital of Qingdao University, Qingdao
RECRUITING
Tianjin Medical University Cancer Institute & Hospital, Tianjin
RECRUITING
The Second Affiliated Hospital Zhejiang University School of Medicine, Zhejiang
RECRUITING
Fujian Medical University Union Hospital, Fuzhou
RECRUITING
The First Affiliated Hospital of Xiamen University, Xiamen
RECRUITING
Hunan Cancer Hospital, Changsha
RECRUITING
Henan Provincial People's Hospital, Zhengzhou
RECRUITING
The Affiliated Hospital of Guizhou Medical University, Guiyang
WITHDRAWN
The office of Frederick P. Smith, MD, P.C., Chevy Chase
WITHDRAWN
Mass General Cancer Center at Newton-Wellesley, Newton
RECRUITING
Astera Cancer Care, East Brunswick
RECRUITING
Astera Cancer Center, East Brunswick
RECRUITING
Regional Cancer Care Associates-Freehold, Freehold
WITHDRAWN
Hackensack University Medical John Theurer Cancer Center, Hackensack
WITHDRAWN
Regional Cancer Care Associates LLC - Howell, Howell Township
RECRUITING
Regional Cancer Care Associates LLC - Little Silver, Little Silver
RECRUITING
New Mexico Cancer Care Alliance, Albuquerque
RECRUITING
GenesisCare - St Andrew's, Adelaide
RECRUITING
Peninsula Health - Frankston, Frankston
RECRUITING
Royal Hobart Hospital, Hobart
RECRUITING
Gold Coast University Hosptial, Southport
RECRUITING
Hospital Santa Cruz, Curitiba
RECRUITING
HC-UFG - Hospital das CLINICAS da Universidade Federal de Go, Goiânia
RECRUITING
Association Hospital de Caridade de Iju, Ijuí
RECRUITING
Liga Norte Riograndense Contra o Cancer, Natal
RECRUITING
Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica, Porto Alegre
RECRUITING
Instituto D'Or de Pesquisa e Ensino- Recife, Recife
RECRUITING
Instituto de Psiquiatria - UFRJ, Rio de Janeiro
RECRUITING
Instituto Nacional de Câncer - INCA, Rio de Janeiro
RECRUITING
Instituto de Oncologia e Hematologia - HEMOMED, São Paulo
RECRUITING
Irmandade Santa Casa de Misericordia de Sao Paulo, São Paulo
RECRUITING
Sunnybrook Health Sciences Centre Odette Cancer Centre, Ottawa
RECRUITING
Tongji Hospital of Tongji Medical College of HUST, Hangzhou
RECRUITING
Jiangxi Cancer Hospital, Nanchang
RECRUITING
Shandong Cancer Hospital, Shandong
RECRUITING
Tongji Hospital of Tongji University, Shanghai
RECRUITING
Sichuan Provincial People's Hospital, Sichuan
RECRUITING
Centre Hospitalier Universitaire D'Angers - Hématologie Clinique, Angers
RECRUITING
Centre Hospitalier Docteur Schaffner, Lens
RECRUITING
L'hôpital Privé du Concluent, Nantes
RECRUITING
Centre Hospitalier - Hôpital de jour d'Hématologie, Périgueux
RECRUITING
Centre Hospitalier Universitaire de Poitiers, Poitiers
RECRUITING
Institut Gustave Roussy, Villejuif
RECRUITING
Vivantes Klinikum am Urban Hämatologie und Onkologie, Berlin
RECRUITING
University Medical Center Schleswig Holstein, Kiel
RECRUITING
Ospedale Vito Fazzi, ASL Lecce, Lecce
RECRUITING
IEO - Istituto Europeo di Oncologia, IRCCS, Milan
RECRUITING
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda, Milan
RECRUITING
Ospedale Niguarda, ASST Grande Ospedale Metropolitano Niguarda, Milan
RECRUITING
Ospedale San Gerardo, ASST di Monza, Monza
RECRUITING
Ospedale Civile S.Spirito, PO di Pescara, AUSL Pescara, Pescara
RECRUITING
Ospedale Infermi di Rimini, AUSL Rimini, Distretto di Rimini, Presidio di Rimini, Santarcangelo di Romagna e Novafeltria, Rimini
RECRUITING
PU Campus Bio-Medico di Roma, Roma
RECRUITING
Regina Elena, Istituto Nazionale dei Tumori , IFO, IRCCS, Roma
RECRUITING
Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Umberto I di Torino, Torino
RECRUITING
Ospedale S.Giacomo Apostolo, PO Castelfranco Veneto, AULSS 2 Marca Trevigiana, Treviso
RECRUITING
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), Ospedale Maggiore, Trieste
RECRUITING
Pratia Onkologia Katowice, Katowice
RECRUITING
MTZ Clinical Research powered by Pratia, Warsaw
RECRUITING
National Cancer Center Singapore, Singapore
RECRUITING
Tan Tock Seng Hospital, Singapore
RECRUITING
Pusan National University Hospital, Busan
RECRUITING
Gachon University Gil Medical Center, Incheon
RECRUITING
Ajou University Hospital, Suwon
RECRUITING
Hospital Virgen de la Arrixaca, El Palmar
RECRUITING
Clínica Universidad de Navarra, Madrid
RECRUITING
C.H. de Navarra, Pamplona
RECRUITING
Hospital Universitario Virgen De La Macarena, Seville
RECRUITING
Buddihist Tzu Chi Medical Foundation- Hualien Tzu Chi Hospital, Hualien City
RECRUITING
National Taiwan University Hospital, Taipei
RECRUITING
Ankara University Medical Faculty - Hematology, Ankara
RECRUITING
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research, Ankara
RECRUITING
Gazi University Medical Faculty, Ankara
RECRUITING
Medipol Bagcilar Mega Hospital, Istanbul
RECRUITING
Ondokuz Mayis University Medical Faculty - Hematology, Samsun
RECRUITING
The Clatterbridge Cancer Centre NHS Foundation Trust - Clatterbridge Cancer Centre, Bebington
RECRUITING
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital, Cornwell
RECRUITING
Northwick Park Hospital Middlesex, United Kindgom, HA1 3UJ, Middlesex
RECRUITING
University Health Network Princess Margaret Hospital, Toronto
RECRUITING
Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal
RECRUITING
Sir Mortimer B Davis/Jewish General Hospital, Montreal
RECRUITING
The Fourth Hospital of Hebei Medical University, Shijiazhuang
WITHDRAWN
Del-pesti Centrumkorhaz Orszagos Hematologiai és Infektologiai Intezet, Budapest
RECRUITING
Catholic University Of Sacred Heart, Roma
RECRUITING
Azienda Ospedaliera Santa Maria di Terni, Terni
RECRUITING
Centrum Medyczne Pratia Poznan, Skórzewo
RECRUITING
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warsaw
RECRUITING
Pratia MCM Krakow, Krakow
WITHDRAWN
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Słupsk
RECRUITING
MICS Centrum Medyczne Torun, Torun
RECRUITING
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu, Wroclaw
RECRUITING
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul
RECRUITING
Severance Hospital, Yonsei University Health System, Seoul
RECRUITING
Samsung Medical Center, Seoul
RECRUITING
Seoul National University Hospital, Seoul
RECRUITING
Hospital Universitari Vall d'Hebrón, Barcelona
RECRUITING
Hospital Del Mar, Barcelona
RECRUITING
Western General Hospital - Haematology, Edinburgh
RECRUITING
Imperial College Healthcare NHS Trust - Hammersmith Hospital, London
RECRUITING
St Bartholomew's Hospital Barts Health NHS Trust, London
RECRUITING
Beatson West of Scotland Cancer Centre, Glasgow
Lead Sponsor
Epizyme, Inc.
INDUSTRY