A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma.
SYMPHONY-1
Symphony-1: A Phase 1b/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study Of Tazemetostat Or Placebo In Combination With Lenalidomide Plus Rituximab In Subjects With Relapsed/Refractory Follicular Lymphoma
3 other identifiers
interventional
555
17 countries
204
Brief Summary
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 a period of improvement after that follows a treatment regimen 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 1 of the study is completed. Stages 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2020
Longer than P75 for phase_3
204 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedStudy Start
First participant enrolled
June 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
April 20, 2026
April 1, 2026
6.7 years
December 12, 2019
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2)
The safety and tolerability of tazemetostat in combination with R2 in subjects with R/R FL will be evaluated. RP3D of tazemetostat for further evaluation in phase 3 will be selected as assessed by the occurrence of treatment-emergent dose-limiting toxicities (DLTs) and adverse events (AEs).
Subjects are evaluated for DLTs during the first 28-day cycle. The RP3D for Phase 3 was selected at the end of Stage 1
Progression-Free Survival (PFS) in the Intent-to-treat wild-type (ITT-WT) population
PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by Investigators.
Stage 2: Up to 72 months
PFS in the Intent-to-treat mutant-type (ITT-MT) population
PFS is defined as the time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification or death, whichever occurs first, as assessed by Investigators.
Stage 2: Up to 72 months
Secondary Outcomes (38)
Pharmacokinetics (PK) of tazemetostat: Maximum (peak) Observed Plasma Drug Concentration (Cmax).
Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
PK of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit: Time to Maximum Observed Drug Concentration (Tmax)
Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
PK of tazemetostat: area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration [AUC(0-t)],
Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
PK of tazemetostat: area under the plasma concentration-time curve (AUC) from time 0 to infinity [AUC(0-∞)]
Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
The apparent terminal elimination half-life (t1/2) of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit
Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
- +33 more secondary outcomes
Study Arms (2)
Tazemetostat + R2 arm
EXPERIMENTALStage 1 (Phase 1b): This phase is now completed. * Tazemetostat was escalated from a starting dose of 400 mg PO twice daily to 600 mg PO twice daily to 800 mg PO twice daily in 28-day cycles. * Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. * Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administred PO QD on days 1 to 21 for 12 cycles. Stage 2: * Tazemetostat 800 mg administered PO twice daily in continuous 28-day cycles. * Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. * Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), PO QD on days 1 to 21 for 12 cycles. Maintenance Therapy (Stages 1 and 2): 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 + R2 Arm
PLACEBO COMPARATORStage 2: * Placebo administered PO twice daily in continuous 28-day cycles. * Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. * Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles. Maintenance Therapy (Stage 2): Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy. During maintenance, placebo will be continued until disease progression or unacceptable toxicity, or participant withdraws consent.
Interventions
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 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 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.
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.
Eligibility Criteria
You may qualify if:
- Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol.
- Males or females are ≥18 years of age, or per country adult legal age regulations, at the time of providing voluntary written informed consent.
- Life expectancy ≥3 months before enrollment.
- Meet requirement for hepatitis and human immunodeficiency virus (HIV) infection as follows
- Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection Note: Participants whose HBV infection status could not be determined by serologic test results have to be negative for HBV-DNA by PCR to be eligible for study participation. Participants seropositive for HBV with undetectable HBV DNA by PCR are permitted with appropriate antiviral prophylaxis.
- Negative test results for hepatitis C virus (HCV) Note: Participants who are positive for HCV antibody must be negative for HCV RNA by PCR to be eligible for study participation
You may not qualify if:
- Have histologically confirmed FL, Grades 1 to 3A.
- Must have been previously treated with at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy:
- a. Systemic therapy includes treatments such as:
- i. Rituximab monotherapy
- ii. Chemotherapy given with or without rituximab
- iii. Radioimmunoconjugates such as 90Y-ibritumomab tiuxetan and 131I-tositumomab.
- b. Systemic therapy does not include, for example:
- i. Local involved field radiotherapy for limited-stage disease
- ii. Helicobacter pylori eradication
- d. Prior autologous/allogeneic hematopoietic stem cell transplant (HSCT) will be allowed.
- e. Prior chimeric antigen receptor T-cell therapy (CAR T) will be allowed.
- Must have documented relapsed, refractory, or PD after treatment with systemic therapy (refractory defined as less than PR or disease progression \<6 months after last dose).
- Have measurable disease as defined by the Lugano Classification (Cheson, 2014; Appendix 5).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Within 7 days prior to randomization, all clinically significant toxicity related to a prior anticancer treatment (ie, chemotherapy, immunotherapy, and/or radiotherapy must have either resolved to Grade 1 per NCI CTCAE Version 5.0 OR are clinically stable and no longer clinically significant.
- +63 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epizyme, Inc.lead
Study Sites (204)
Southern Cancer Center
Mobile, Alabama, 36608, United States
Arizona Oncology Associates - Tuscon-Rusadill Road
Tucson, Arizona, 85704, United States
TOI - Clinical Research
Cerritos, California, 90703, United States
UCSF Fresno
Clovis, California, 93611, United States
UC San Diego Health Sciences
La Jolla, California, 92093, United States
UCLA Clinical Research Unit Hematology/Oncology
Santa Monica, California, 90404, United States
Rocky Mountain Cancer Centers (RMCC) - Boulder
Boulder, Colorado, 80303, United States
St. Mary's Hospital and Regional Medical Center - St. Mary's
Grand Junction, Colorado, 81501, United States
Cancer Specialists of North Florida
Fleming Island, Florida, 32003, United States
Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center
Fort Myers, Florida, 33908, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Florida Cancer Affiliates/Ocala Oncology - Clinic
Ocala, Florida, 34474, United States
BRCR Medical Center, INC
Plantation, Florida, 33322, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists - Panhandle
Tallahassee, Florida, 32308, United States
H Lee Moffitt Cancer Center and Research Institute I
Tampa, Florida, 33612, United States
Florida Cancer Specialists & Research Institute (FCS) - Atlantis
West Palm Beach, Florida, 33401, United States
University of Chicago
Chicago, Illinois, 60637, United States
Illinois Cancer Specialists
Niles, Illinois, 60714, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
St. Joseph Mercy Hospital
Ypsilanti, Michigan, 48197, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55901, United States
University Of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Astera Cancer Care
East Brunswick, New Jersey, 08816, United States
Astera Cancer Center
East Brunswick, New Jersey, 08816, United States
Regional Cancer Care Associates-Freehold
Freehold, New Jersey, 07728, United States
Regional Cancer Care Associates LLC - Little Silver
Little Silver, New Jersey, 07739, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87131-0001, United States
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, 10021, United States
Columbia U - Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Hematology Oncology Associates of Rockland, P.C.
Nyack, New York, 10960, United States
Messino Cancer Center
Asheville, North Carolina, 28806, United States
Levine Cancer Institute - Concord
Concord, North Carolina, 28205, United States
FirstHealth of the Carolinas
Pinehurst, North Carolina, 28374, United States
Regional Medical Oncology Center
Wilson, North Carolina, 27895, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
Oncology Hematology Care (OHC), Inc. - Kenwood Office
Cincinnati, Ohio, 45236, United States
Willamette Valley Cancer Institute and Research Center - Oncology
Eugene, Oregon, 97401, United States
Western Pennsylvania Hospital Hematology & Cellular Therapy
Pittsburgh, Pennsylvania, 15524, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Texas Oncology - Amarillo
Amarillo, Texas, 79124, United States
Texas Oncology-Austin Midtown
Austin, Texas, 78705, United States
Texas Oncology - Medical City Dallas Pediatric Hematology
Dallas, Texas, 75230, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Millennium Physicians - Oncology
Houston, Texas, 77090, United States
Texas Oncology
Plano, Texas, 75075, United States
Mays Cancer Center
San Antonio, Texas, 78229, United States
UT Health East Texas HOPE Cancer Center - Tyler
Tyler, Texas, 75701, United States
USO Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Texas Oncology- Weslaco
Weslaco, Texas, 78596, United States
Utah Cancer Specialists/ IHO Corp
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute; The University of Utah
Salt Lake City, Utah, 84112, United States
Virginia Cancer Specialists
Gainesville, Virginia, 22155, United States
Oncology and Hematology Associates of Southwest Virginia Inc.
Roanoke, Virginia, 24014, United States
Wheeling Hospital
Wheeling, West Virginia, 26003, United States
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Barwon Health, University Hospital Geelong
Geelong, Victoria, 3220, Australia
Hollywood Private Hospital
Nedlands, Western Australia, 6009, Australia
GenesisCare - St Andrew's
Adelaide, Australia
Peninsula Health - Frankston
Frankston, Australia
Royal Hobart Hospital
Hobart, Australia
Gold Coast University Hosptial
Southport, Australia
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, Vlaams Brabant, 3000, Belgium
Hospital Haroldo Juacaba - Instituto do Cancer do Ceara
Ceará, Brazil
Hospital Santa Cruz
Curitiba, Brazil
HC-UFG - Hospital das CLINICAS da Universidade Federal de Go
Goiânia, Brazil
Association Hospital de Caridade de Iju
Ijuí, Brazil
Liga Norte Riograndense Contra o Cancer
Natal, Brazil
Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
Porto Alegre, Brazil
Instituto D'Or de Pesquisa e Ensino- Recife
Recife, Brazil
Instituto de Psiquiatria - UFRJ
Rio de Janeiro, Brazil
Instituto Nacional de Câncer - INCA
Rio de Janeiro, Brazil
Fundacao Antonio Prudente - Hospital A.C.Camargo Cancer Center
São Paulo, Brazil
Hospital Alemao Oswaldo Cruz (HAOC)
São Paulo, Brazil
Instituto D'or de Pesquisa e Ensino
São Paulo, Brazil
Instituto de Oncologia e Hematologia - HEMOMED
São Paulo, Brazil
Irmandade Santa Casa de Misericordia de Sao Paulo
São Paulo, Brazil
University Health Network Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, H2X 3E4, Canada
Sir Mortimer B Davis/Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Nova Scotia Health Centre for Clinical Research
Nova Scotia, Canada
Sunnybrook Health Sciences Centre Odette Cancer Centre
Ottawa, Canada
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, Hangzhou, 310000, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450008, China
Henan Cancer Hospital
Zhengzhou, Henan, 45008, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The First Bethune Hospital of Jilin University
Changchun, Jinlin, 130021, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266071, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 20025, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 30032, China
Peking University Third Hospital
Beijing, 100191, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Tongji Hospital of Tongji Medical College of HUST
Hangzhou, China
Jiangxi Cancer Hospital
Nanchang, China
Shandong Cancer Hospital
Shandong, China
Tongji Hospital of Tongji University
Shanghai, China
Sichuan Provincial People's Hospital
Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300060, China
Centre Hospitalier Universitaire de Bordeaux-Hopital du Haut Leveque
Pessac, Aquitaine, 33600, France
CHRU Brest Hôp Morvan
Brest, Brittany Region, 29609, France
Institut Bergonie
Bordeaux, Gironde, 33000, France
Centre Hosp Mulh Hop Emile Muller
Mulhouse, Haut-Rhin, 68100, France
Centre Henri Becquerel
Rouen, Haute-Normandie, 76038, France
CHU de Limoges Dupuytren
Limoges, Haute-Vienne, 87042, France
CHU de Grenoble - Hopital Albe
La Tronche, Isere, 38700, France
CHU de Nantes - Hematologie
Nantes, Loire-Atlantique, 44000, France
CHRU de Lille Hop Claude Huriez
Lille, Nord, 59037, France
Centre Hospitalier Le Mans
Le Mans, Sarthe, 72000, France
Centre Hospitalier Universitaire D'Angers - Hématologie Clinique
Angers, France
CHRU de Besançon- Hopital Jean Minjoz
Besançon, 25000, France
CHU de Clermont-Ferrand, site Estaing
Clermont-Ferrand, 63000, France
Centre Hospitalier Docteur Schaffner
Lens, France
L'Hôpital Privé Confluent
Nantes, 44202, France
L'hôpital Privé du Concluent
Nantes, France
Hopital Saint Louis
Paris, 75010, France
Centre Hospitalier - Hôpital de jour d'Hématologie
Périgueux, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
CHU de Nancy Brabois
Vandœuvre-lès-Nancy, 54511, France
Centre Hospitalier Bretagne Atlantique
Vannes, 56017, France
Institut Gustave Roussy
Villejuif, France
Hopital Henri Mondor - Hemopathies Lymphoides
Créteil, Île-de-France Region, 94010, France
Diakoneo Diak Schwaebisch Hall gGmbH
Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
Klinikum Der Universität München AöR
München, Bavaria, 81377, Germany
Universitätsmedizin Mainz
Mainz, Hesse, 55131, Germany
Universitaetsklinikum Bonn AöR
Bonn, North Rhine-Westphalia, 53127, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, North Rhine-Westphalia, 41063, Germany
Städt. Krankenhaus Kiel
Kiel, Schleswig-Holstein, 24116, Germany
Vivantes Klinikum am Urban Hämatologie und Onkologie
Berlin, Germany
University Medical Center Schleswig Holstein
Kiel, Germany
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, 4032, Hungary
Semmelweis Egyetem Általános Orvostudományi Kar
Budapest, 1088, Hungary
Országos Onkológiai Intézet
Budapest, 1122, Hungary
AOU Federico II
Naples, Campania, 80122, Italy
Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS
Meldola, Forli-Cesena, 47014, Italy
ASST Spedali Civili di Brescia
Brescia, 25123, Italy
PO Garibaldi-Nesima, ARNAS Garibaldi
Catania, 95122, Italy
AOU Careggi
Florence, 50134, Italy
Ospedale Vito Fazzi, ASL Lecce
Lecce, Italy
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, Italy
Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
Milan, Italy
Ospedale Niguarda, ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Ospedale San Gerardo, ASST di Monza
Monza, Italy
Ospedale Civile S.Spirito, PO di Pescara, AUSL Pescara
Pescara, Italy
Ospedale Infermi di Rimini, AUSL Rimini, Distretto di Rimini, Presidio di Rimini, Santarcangelo di Romagna e Novafeltria
Rimini, Italy
Catholic University Of Sacred Heart
Roma, 00168, Italy
PU Campus Bio-Medico di Roma
Roma, Italy
Regina Elena, Istituto Nazionale dei Tumori , IFO, IRCCS
Roma, Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, 05100, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Umberto I di Torino
Torino, Italy
Ospedale S.Giacomo Apostolo, PO Castelfranco Veneto, AULSS 2 Marca Trevigiana
Treviso, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), Ospedale Maggiore
Trieste, Italy
Centrum Medyczne Pratia Poznan
Skórzewo, Greater Poland Voivodeship, 60-185, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, 02-781, Poland
Pratia Onkologia Katowice
Katowice, Poland
Pratia MCM Krakow
Krakow, 30-727, Poland
MICS Centrum Medyczne Torun
Torun, 87-100, Poland
MTZ Clinical Research powered by Pratia
Warsaw, Poland
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
Wroclaw, 50-367, Poland
National Cancer Center Singapore
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], 06591, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 03722, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, 06351, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Pusan National University Hospital
Busan, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Ajou University Hospital
Suwon, South Korea
Hospital Universitari Vall d'Hebrón
Barcelona, Cataluny, 08035, Spain
Hospital Costa del Sol
Marbella, Málaga, 29603, Spain
Hospital Del Mar
Barcelona, 08003, Spain
Hospital Virgen de la Arrixaca
El Palmar, Spain
Hospital Univ. Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Clínica Universidad de Navarra
Madrid, Spain
C.H. de Navarra
Pamplona, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Nuestra Señora de Valme
Seville, 41014, Spain
Hospital Universitario Virgen De La Macarena
Seville, Spain
Buddihist Tzu Chi Medical Foundation- Hualien Tzu Chi Hospital
Hualien City, Taiwan
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
Kaohsiung City, 833, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Ankara University Medical Faculty - Hematology
Ankara, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research
Ankara, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, Turkey (Türkiye)
Medipol Bagcilar Mega Hospital
Istanbul, Turkey (Türkiye)
Ondokuz Mayis University Medical Faculty - Hematology
Samsun, Turkey (Türkiye)
Western General Hospital - Haematology
Edinburgh, Edinburgh, City of, EH4 2XU, United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, London City, W12 0HS, United Kingdom
St Bartholomew's Hospital Barts Health NHS Trust
London, London, City of, EC1A 7BE, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust - Clatterbridge Cancer Centre
Bebington, United Kingdom
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Cornwell, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Northwick Park Hospital Middlesex, United Kindgom, HA1 3UJ
Middlesex, United Kingdom
Related Publications (1)
Cao J, Chen G, Qiu L, Zhang L, Jiang M, Cheng Y, Zhang Q, Liu L, Li P, Shuang Y, Wang H, Xue H, Wu H, Zheng M, Zhou K, Li Z, Jing H, Yang W, Zhu Z, Li W, Wangwu J, Huang H, Jia Q, Chen D, Fan S, Shi MM, Su W. Efficacy and safety of tazemetostat, an EZH2 inhibitor, in Chinese patients with relapsed/refractory follicular lymphoma: a multicentre, single-arm, phase 2 study. EClinicalMedicine. 2025 Aug 18;87:103399. doi: 10.1016/j.eclinm.2025.103399. eCollection 2025 Sep.
PMID: 40896460DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2019
First Posted
January 13, 2020
Study Start
June 11, 2020
Primary Completion (Estimated)
February 13, 2027
Study Completion (Estimated)
March 1, 2029
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
- Access Criteria
- Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.