再発/難治性濾胞性リンパ腫の被験者における研究 (SYMPHONY-1)
SYMPHONY-1: 再発/難治性濾胞性リンパ腫の被験者を対象に、タゼメトスタットまたはプラセボとレナリドマイドおよびリツキシマブを併用した、第 1b/3 相二重盲検無作為化実薬対照 3 段階バイオマーカー適応試験
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 studied 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 were designed to 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. However, following an urgent safety measure, treatment with tazemetostat and placebo was discontinued, enrollment was stopped, and the study was unblinded. As a result, post-urgent safety measure analyses are descriptive in nature.
調査の概要
状態
詳細な説明
In Stage 2, participants were enrolled into study cohorts based on whether they have a specific genetic mutation in the EZH2 gene. All participants received treatment in 28-day cycles. After 12 cycles, they continued with maintenance treatment using either the study drug or placebo, depending on their original treatment group. However, following the urgent safety measure, treatment was permanently discontinued and no further interventional procedures are being conducted.
The study included participants with and without the mutation in EZH2 gene. Enrollment was to be completed separately for each group. In China, some participants also had extra blood tests to better understand how the drug behaves in the body; no further pharmacokinetic data are being collected following the urgent safety measure.
Stage 3 focuses on long-term safety monitoring after the urgent safety measure. Participants treated with tazemetostat will be followed for up to 5 years after the last dose of tazemetostat
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Alabama
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Mobile、Alabama、アメリカ、36608
- Southern Cancer Center
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Arizona
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Tucson、Arizona、アメリカ、85704
- Arizona Oncology Associates - Tuscon-Rusadill Road
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California
-
Cerritos、California、アメリカ、90703
- TOI - Clinical Research
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Clovis、California、アメリカ、93611
- UCSF Fresno
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La Jolla、California、アメリカ、92093
- UC San Diego Health Sciences
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Santa Monica、California、アメリカ、90404
- UCLA Clinical Research Unit Hematology/Oncology
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Colorado
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Boulder、Colorado、アメリカ、80303
- Rocky Mountain Cancer Centers (RMCC) - Boulder
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Grand Junction、Colorado、アメリカ、81501
- St. Mary's Hospital and Regional Medical Center - St. Mary's
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Florida
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Fleming Island、Florida、アメリカ、32003
- Cancer Specialists of North Florida
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Fort Myers、Florida、アメリカ、33908
- Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center
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Jacksonville、Florida、アメリカ、32224
- Mayo Clinic
-
Ocala、Florida、アメリカ、34474
- Florida Cancer Affiliates/Ocala Oncology - Clinic
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Plantation、Florida、アメリカ、33322
- BRCR Medical Center, INC
-
St. Petersburg、Florida、アメリカ、33705
- Florida Cancer Specialists
-
Tallahassee、Florida、アメリカ、32308
- Florida Cancer Specialists - Panhandle
-
Tampa、Florida、アメリカ、33612
- H Lee Moffitt Cancer Center and Research Institute I
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West Palm Beach、Florida、アメリカ、33401
- Florida Cancer Specialists & Research Institute (FCS) - Atlantis
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Illinois
-
Chicago、Illinois、アメリカ、60637
- University of Chicago
-
Niles、Illinois、アメリカ、60714
- Illinois Cancer Specialists
-
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Michigan
-
Ann Arbor、Michigan、アメリカ、48109
- University of Michigan Comprehensive Cancer Center
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Ypsilanti、Michigan、アメリカ、48197
- St. Joseph Mercy Hospital
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Minnesota
-
Rochester、Minnesota、アメリカ、55901
- Mayo Clinic - Rochester
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-
Nebraska
-
Omaha、Nebraska、アメリカ、68198
- University Of Nebraska Medical Center
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New Jersey
-
East Brunswick、New Jersey、アメリカ、08816
- Astera Cancer Care
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East Brunswick、New Jersey、アメリカ、08816
- Astera Cancer Center
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Freehold、New Jersey、アメリカ、07728
- Regional Cancer Care Associates-Freehold
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Little Silver、New Jersey、アメリカ、07739
- Regional Cancer Care Associates LLC - Little Silver
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New Mexico
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Albuquerque、New Mexico、アメリカ、87131-0001
- New Mexico Cancer Care Alliance
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New York
-
New York、New York、アメリカ、10065
- Memorial Sloan-Kettering Cancer Center
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New York、New York、アメリカ、10021
- Weill Cornell Medicine-New York Presbyterian Hospital
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New York、New York、アメリカ、10032
- Columbia U - Herbert Irving Comprehensive Cancer Center
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Nyack、New York、アメリカ、10960
- Hematology Oncology Associates of Rockland, P.C.
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North Carolina
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Asheville、North Carolina、アメリカ、28806
- Messino Cancer Center
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Concord、North Carolina、アメリカ、28205
- Levine Cancer Institute - Concord
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Pinehurst、North Carolina、アメリカ、28374
- FirstHealth of the Carolinas
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Wilson、North Carolina、アメリカ、27895
- Regional Medical Oncology Center
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Ohio
-
Canton、Ohio、アメリカ、44718
- Gabrail Cancer Center Research
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Cincinnati、Ohio、アメリカ、45236
- Oncology Hematology Care (OHC), Inc. - Kenwood Office
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Oregon
-
Eugene、Oregon、アメリカ、97401
- Willamette Valley Cancer Institute and Research Center - Oncology
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Pennsylvania
-
Pittsburgh、Pennsylvania、アメリカ、15524
- Western Pennsylvania Hospital Hematology & Cellular Therapy
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Tennessee
-
Nashville、Tennessee、アメリカ、37203
- Sarah Cannon Research Institute
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Texas
-
Amarillo、Texas、アメリカ、79124
- Texas Oncology - Amarillo
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Austin、Texas、アメリカ、78705
- Texas Oncology-Austin Midtown
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Dallas、Texas、アメリカ、75246
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
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Dallas、Texas、アメリカ、75230
- Texas Oncology - Medical City Dallas Pediatric Hematology
-
Houston、Texas、アメリカ、77030
- The University of Texas MD Anderson Cancer Center
-
Houston、Texas、アメリカ、77090
- Millennium Physicians - Oncology
-
Plano、Texas、アメリカ、75075
- Texas Oncology
-
San Antonio、Texas、アメリカ、78229
- Mays Cancer Center
-
Tyler、Texas、アメリカ、75702
- USO Texas Oncology - Tyler
-
Tyler、Texas、アメリカ、75701
- UT Health East Texas HOPE Cancer Center - Tyler
-
Weslaco、Texas、アメリカ、78596
- Texas Oncology- Weslaco
-
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Utah
-
Salt Lake City、Utah、アメリカ、84106
- Utah Cancer Specialists/ IHO Corp
-
Salt Lake City、Utah、アメリカ、84112
- Huntsman Cancer Institute; The University of Utah
-
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Virginia
-
Gainesville、Virginia、アメリカ、22155
- Virginia Cancer Specialists
-
Roanoke、Virginia、アメリカ、24014
- Oncology and Hematology Associates of Southwest Virginia Inc.
-
-
West Virginia
-
Wheeling、West Virginia、アメリカ、26003
- Wheeling Hospital
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-
-
-
-
Bebington、イギリス
- The Clatterbridge Cancer Centre NHS Foundation Trust - Clatterbridge Cancer Centre
-
Cornwell、イギリス
- Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
-
Glasgow、イギリス、G12 0YN
- Beatson West of Scotland Cancer Centre
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Middlesex、イギリス
- Northwick Park Hospital Middlesex, United Kindgom, HA1 3UJ
-
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Edinburgh, City of
-
Edinburgh、Edinburgh, City of、イギリス、EH4 2XU
- Western General Hospital - Haematology
-
-
London City
-
London、London City、イギリス、W12 0HS
- Imperial College Healthcare NHS Trust - Hammersmith Hospital
-
-
London, City of
-
London、London, City of、イギリス、EC1A 7BE
- St Bartholomew's Hospital Barts Health NHS Trust
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-
-
-
-
Brescia、イタリア、25123
- ASST Spedali Civili di Brescia
-
Catania、イタリア、95122
- PO Garibaldi-Nesima, ARNAS Garibaldi
-
Florence、イタリア、50134
- AOU Careggi
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Lecce、イタリア
- Ospedale Vito Fazzi, ASL Lecce
-
Milan、イタリア
- Ospedale Niguarda, ASST Grande Ospedale Metropolitano Niguarda
-
Milan、イタリア
- IEO - Istituto Europeo di Oncologia, IRCCS
-
Milan、イタリア
- Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
-
Monza、イタリア
- Ospedale San Gerardo, ASST di Monza
-
Pescara、イタリア
- Ospedale Civile S.Spirito, PO di Pescara, AUSL Pescara
-
Rimini、イタリア
- Ospedale Infermi di Rimini, AUSL Rimini, Distretto di Rimini, Presidio di Rimini, Santarcangelo di Romagna e Novafeltria
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Roma、イタリア、00168
- Catholic University Of Sacred Heart
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Roma、イタリア
- PU Campus Bio-Medico di Roma
-
Roma、イタリア
- Regina Elena, Istituto Nazionale dei Tumori , IFO, IRCCS
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Terni、イタリア、05100
- Azienda Ospedaliera Santa Maria di Terni
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Torino、イタリア
- Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Umberto I di Torino
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Treviso、イタリア
- Ospedale S.Giacomo Apostolo, PO Castelfranco Veneto, AULSS 2 Marca Trevigiana
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Trieste、イタリア
- Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), Ospedale Maggiore
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Campania
-
Naples、Campania、イタリア、80122
- AOU Federico II
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Forli-Cesena
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Meldola、Forli-Cesena、イタリア、47014
- Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS
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-
-
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Adelaide、オーストラリア
- GenesisCare - St Andrew's
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Frankston、オーストラリア
- Peninsula Health - Frankston
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Hobart、オーストラリア
- Royal Hobart Hospital
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Southport、オーストラリア
- Gold Coast University Hosptial
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South Australia
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Adelaide、South Australia、オーストラリア、5000
- Royal Adelaide Hospital
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Bedford Park、South Australia、オーストラリア、5042
- Flinders Medical Centre
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Victoria
-
Clayton、Victoria、オーストラリア、3168
- Monash Health
-
Geelong、Victoria、オーストラリア、3220
- Barwon Health, University Hospital Geelong
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Western Australia
-
Nedlands、Western Australia、オーストラリア、6009
- Hollywood Private Hospital
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-
-
-
-
Nova Scotia、カナダ
- Nova Scotia Health Centre for Clinical Research
-
Ottawa、カナダ
- Sunnybrook Health Sciences Centre Odette Cancer Centre
-
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Ontario
-
Toronto、Ontario、カナダ、M5G 2M9
- University Health Network Princess Margaret Hospital
-
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Quebec
-
Montreal、Quebec、カナダ、H3T 1E2
- Sir Mortimer B Davis/Jewish General Hospital
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Montreal、Quebec、カナダ、H2X 3E4
- Centre Hospitalier de l'Universite de Montreal (CHUM)
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-
-
-
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Singapore、シンガポール
- Tan Tock Seng Hospital
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Singapore、シンガポール
- National Cancer Center Singapore
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-
-
-
-
Barcelona、スペイン、08003
- Hospital Del Mar
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El Palmar、スペイン
- Hospital Virgen de la Arrixaca
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Madrid、スペイン、28046
- Hospital Universitario La Paz
-
Madrid、スペイン、28031
- Hospital Univ. Infanta Leonor
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Madrid、スペイン
- Clínica Universidad de Navarra
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Pamplona、スペイン
- C.H. de Navarra
-
Salamanca、スペイン、37007
- Hospital Universitario de Salamanca
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Seville、スペイン、41014
- Hospital Universitario Nuestra Señora de Valme
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Seville、スペイン
- Hospital Universitario Virgen De La Macarena
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Cataluny
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Barcelona、Cataluny、スペイン、08035
- Hospital Universitari Vall d'Hebrón
-
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Málaga
-
Marbella、Málaga、スペイン、29603
- Hospital Costa del Sol
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-
-
-
-
Ankara、トルコ（Türkiye）
- Gazi University Medical Faculty
-
Ankara、トルコ（Türkiye）
- Ankara University Medical Faculty - Hematology
-
Ankara、トルコ（Türkiye）
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research
-
Istanbul、トルコ（Türkiye）
- Medipol Bagcilar Mega Hospital
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Samsun、トルコ（Türkiye）
- Ondokuz Mayis University Medical Faculty - Hematology
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-
-
-
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Berlin、ドイツ
- Vivantes Klinikum am Urban Hämatologie und Onkologie
-
Kiel、ドイツ
- University Medical Center Schleswig Holstein
-
-
Baden-Wurttemberg
-
Schwäbisch Hall、Baden-Wurttemberg、ドイツ、74523
- Diakoneo Diak Schwaebisch Hall gGmbH
-
-
Bavaria
-
München、Bavaria、ドイツ、81377
- Klinikum Der Universität München AöR
-
-
Hesse
-
Mainz、Hesse、ドイツ、55131
- Universitätsmedizin Mainz
-
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North Rhine-Westphalia
-
Bonn、North Rhine-Westphalia、ドイツ、53127
- Universitaetsklinikum Bonn AöR
-
Mönchengladbach、North Rhine-Westphalia、ドイツ、41063
- Kliniken Maria Hilf GmbH
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Schleswig-Holstein
-
Kiel、Schleswig-Holstein、ドイツ、24116
- Städt. Krankenhaus Kiel
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-
-
-
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Budapest、ハンガリー、1122
- Országos Onkológiai Intézet
-
Budapest、ハンガリー、1088
- Semmelweis Egyetem Általános Orvostudományi Kar
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Hajdú-Bihar
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Debrecen、Hajdú-Bihar、ハンガリー、4032
- Debreceni Egyetem Klinikai Központ
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-
-
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Angers、フランス
- Centre Hospitalier Universitaire D'Angers - Hématologie Clinique
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Besançon、フランス、25000
- CHRU de Besançon- Hopital Jean Minjoz
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Clermont-Ferrand、フランス、63000
- CHU de Clermont-Ferrand, site Estaing
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Lens、フランス
- Centre Hospitalier Docteur Schaffner
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Nantes、フランス、44202
- L'Hôpital Privé Confluent
-
Nantes、フランス
- L'hôpital Privé du Concluent
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Paris、フランス、75010
- Hopital Saint Louis
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Poitiers、フランス
- Centre Hospitalier Universitaire de Poitiers
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Périgueux、フランス
- Centre Hospitalier - Hôpital de jour d'Hématologie
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Vandœuvre-lès-Nancy、フランス、54511
- CHU de Nancy Brabois
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Vannes、フランス、56017
- Centre Hospitalier Bretagne Atlantique
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Villejuif、フランス
- Institut Gustave Roussy
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Aquitaine
-
Pessac、Aquitaine、フランス、33600
- Centre Hospitalier Universitaire de Bordeaux-Hopital du Haut Leveque
-
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Brittany Region
-
Brest、Brittany Region、フランス、29609
- CHRU Brest Hôp Morvan
-
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Gironde
-
Bordeaux、Gironde、フランス、33000
- Institut Bergonie
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Haut-Rhin
-
Mulhouse、Haut-Rhin、フランス、68100
- Centre Hosp Mulh Hop Emile Muller
-
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Haute-Normandie
-
Rouen、Haute-Normandie、フランス、76038
- Centre Henri Becquerel
-
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Haute-Vienne
-
Limoges、Haute-Vienne、フランス、87042
- CHU de Limoges Dupuytren
-
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Isere
-
La Tronche、Isere、フランス、38700
- CHU de Grenoble - Hopital Albe
-
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Loire-Atlantique
-
Nantes、Loire-Atlantique、フランス、44000
- CHU de Nantes - Hematologie
-
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Nord
-
Lille、Nord、フランス、59037
- CHRU de Lille Hop Claude Huriez
-
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Sarthe
-
Le Mans、Sarthe、フランス、72000
- Centre Hospitalier Le Mans
-
-
Île-de-France Region
-
Créteil、Île-de-France Region、フランス、94010
- Hopital Henri Mondor - Hemopathies Lymphoides
-
-
-
-
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Ceará、ブラジル
- Hospital Haroldo Juacaba - Instituto do Cancer do Ceara
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Curitiba、ブラジル
- Hospital Santa Cruz
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Goiânia、ブラジル
- HC-UFG - Hospital das CLINICAS da Universidade Federal de Go
-
Ijuí、ブラジル
- Association Hospital de Caridade de Iju
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Natal、ブラジル
- Liga Norte Riograndense Contra o Cancer
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Porto Alegre、ブラジル
- Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
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Recife、ブラジル
- Instituto D'Or de Pesquisa e Ensino- Recife
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Rio de Janeiro、ブラジル
- Instituto de Psiquiatria - UFRJ
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Rio de Janeiro、ブラジル
- Instituto Nacional de Câncer - INCA
-
São Paulo、ブラジル
- Fundacao Antonio Prudente - Hospital A.C.Camargo Cancer Center
-
São Paulo、ブラジル
- Hospital Alemao Oswaldo Cruz (HAOC)
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São Paulo、ブラジル
- Instituto de Oncologia e Hematologia - HEMOMED
-
São Paulo、ブラジル
- Irmandade Santa Casa de Misericordia de Sao Paulo
-
São Paulo、ブラジル
- Instituto D'or de Pesquisa e Ensino
-
-
-
-
Oost-Vlaanderen
-
Ghent、Oost-Vlaanderen、ベルギー、9000
- Universitair Ziekenhuis Gent
-
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Vlaams Brabant
-
Leuven、Vlaams Brabant、ベルギー、3000
- UZ Leuven - Campus Gasthuisberg
-
-
-
-
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Katowice、ポーランド
- Pratia Onkologia Katowice
-
Krakow、ポーランド、30-727
- Pratia MCM Krakow
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Torun、ポーランド、87-100
- MICS Centrum Medyczne Torun
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Warsaw、ポーランド
- MTZ Clinical Research powered by Pratia
-
Wroclaw、ポーランド、50-367
- Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
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Greater Poland Voivodeship
-
Skórzewo、Greater Poland Voivodeship、ポーランド、60-185
- Centrum Medyczne Pratia Poznan
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Masovian Voivodeship
-
Warsaw、Masovian Voivodeship、ポーランド、02-781
- Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
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-
-
-
-
Beijing、中国、100191
- Peking University Third Hospital
-
Hangzhou、中国
- The First Affiliated Hospital Zhejiang University School of Medicine
-
Hangzhou、中国
- Tongji Hospital of Tongji Medical College of HUST
-
Nanchang、中国
- Jiangxi Cancer Hospital
-
Shandong、中国
- Shandong Cancer Hospital
-
Shanghai、中国
- Tongji Hospital of Tongji University
-
Sichuan、中国
- Sichuan Provincial People's Hospital
-
Tianjin、中国、300060
- Tianjin Medical University Cancer Institute & Hospital
-
-
Fujian
-
Fuzhou、Fujian、中国、350001
- Fujian Medical University Union Hospital
-
Xiamen、Fujian、中国、361003
- The First Affiliated Hospital of Xiamen University
-
-
Guizhou
-
Guiyang、Guizhou、中国、550004
- The Affiliated Hospital of Guizhou Medical University
-
-
Hangzhou
-
Zhejiang、Hangzhou、中国、310000
- The Second Affiliated Hospital Zhejiang University School of Medicine
-
-
Hebei
-
Shijiazhuang、Hebei、中国、050011
- The Fourth Hospital of Hebei Medical University
-
-
Henan
-
Zhengzhou、Henan、中国、45008
- Henan Cancer Hospital
-
Zhengzhou、Henan、中国、450008
- Henan Provincial People's Hospital
-
-
Hunan
-
Changsha、Hunan、中国、410013
- Hunan Cancer Hospital
-
-
Jinlin
-
Changchun、Jinlin、中国、130021
- The First Bethune Hospital of Jilin University
-
-
Shandong
-
Qingdao、Shandong、中国、266071
- The Affiliated Hospital of Qingdao University
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、20025
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
-
-
Shanxi
-
Taiyuan、Shanxi、中国、30032
- Shanxi Bethune Hospital
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-
-
-
-
Hualien City、台湾
- Buddihist Tzu Chi Medical Foundation- Hualien Tzu Chi Hospital
-
Kaohsiung City、台湾、833
- Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
-
Taichung、台湾、40705
- Taichung Veterans General Hospital
-
Tainan、台湾、704
- National Cheng Kung University Hospital
-
Taipei、台湾
- National Taiwan University Hospital
-
-
-
-
-
Busan、韓国
- Pusan National University Hospital
-
Incheon、韓国
- Gachon University Gil Medical Center
-
Suwon、韓国
- Ajou University Hospital
-
-
Seoul Teugbyeolsi
-
Seoul、Seoul Teugbyeolsi、韓国、03080
- Seoul National University Hospital
-
-
Seoul Teugbyeolsi [Seoul-T'ukp
-
Seoul、Seoul Teugbyeolsi [Seoul-T'ukp、韓国、03722
- Severance Hospital, Yonsei University Health System
-
Seoul、Seoul Teugbyeolsi [Seoul-T'ukp、韓国、06351
- Samsung Medical Center
-
-
Seoul Teugbyeolsi [Seoul-T'ukp]
-
Seoul、Seoul Teugbyeolsi [Seoul-T'ukp]、韓国、06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
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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
- If HIV positive, HIV infection is controlled. Based on Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections - Guidance for Industry (https://www.fda.gov/media/121319/download), patients with HIV should be considered eligible if they have CD4+ T-cell counts ≥ 350 cells/uL and in general, if they have not had an opportunistic infection within the past 12 months. Other exclusion criteria should be considered regarding the drug-drug interaction if antiviral drugs are used. Therefore, in case of controlled HIV infection, since antiviral drugs are used, trial patients should be on established ART for at least 4 weeks and have an HIV viral load less than 400 copies/mL prior to enrolment.
-
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
c. Prior investigational therapies will be allowed provided the subject has received at least 1 prior systemic therapy as discussed in Inclusion Criterion #6a.
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.
-
Have provided sufficient tumor tissue block or unstained slides for EZH2 mutation testing in all subjects to allow for stratification
a. If EZH2 mutation status is known from site-specific testing, subjects can be enrolled. Tumor tissue will be required for confirmatory testing of EZH2 status at study-specific laboratories. If the archival tumor sample was collected more than 24 months prior to the anticipated administration of the first dose (cycle 1 day 1), then a fresh biopsy must be provided. Fresh tumor biopsy is appropriate except for procedures deemed to result in unacceptable risk because of the anatomical location including brain, lung/mediastinum, pancreas, or endoscopic procedures extending beyond the esophagus, stomach, or bowel. Archival tumor biopsy sections mounted on slides are also acceptable.
NOTE: Confirmatory testing will also be performed for Stage 1, if local EZH2 testing is conducted, unless there is insufficient tumor tissue to perform testing after discussion with the Sponsor's or Designee Medical Monitor.
-
Time between prior anticancer therapy and first dose of tazemetostat as follows:
- Cytotoxic chemotherapy - At least 21 days.
- Noncytotoxic chemotherapy (eg, small molecule inhibitor) - At least 14 days.
- Nitrosoureas - At least 6 weeks.
- Monoclonal and/or bispecific antibodies or CAR T - At least 28 days.
- Radiotherapy - At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation.
-
Adequate renal function defined as calculated creatinine clearance ≥30 mL/minute per the Cockcroft and Gault formula.
-
Adequate bone marrow function:
a. Absolute neutrophil count (ANC) ≥1000/mm3 (≥1.0 × 10^9/L) if no lymphoma infiltration of bone marrow OR ANC ≥750/mm3 (≥75 × 10^9/L) with bone marrow infiltration
-
Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days.
b. Platelets ≥75,000/mm3 (≥75 × 10^9/L)
-
Evaluated at least 7 days after last platelet transfusion.
c. Hemoglobin ≥9.0 g/dL
-
May receive transfusion
-
-
Adequate liver function:
- Total bilirubin ≤1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome.
- Alkaline phosphatase (ALP) (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if subject has liver infilration).
-
International normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless on warfarin, then INR ≤3.0). In subjects with thromboembolism risk, prophylactic anticoagulation, or antiplatelet therapy at investigator discretion is recommended.
-
Females of childbearing potential (FCBP) must have a negative urine or serum pregnancy tests (beta-human chorionic gonadotropin [β-hCG] tests with a minimum sensitivity of 25 mIU/mL or equivalent units of β-hCG) at screening within 10 to 14 days prior to first dose of study drug. The subject may not receive study drug until the study doctor has verified that the results of pregnancy tests are negative. All females will be considered to be of childbearing potential unless they are naturally postmenopausal (at least 24 months consecutively amenorrhoeic [amenorrhea following cancer therapy does not rule out childbearing potential] and without other known or suspected cause) or have been sterilized surgically (ie, total hysterectomy and/or bilateral oophorectomy, with surgery completed at least 1 month before dosing).
-
Females of childbearing potential (FCBP) enrolled must either practice complete abstinence or agree to use two reliable methods of contraception simultaneously. This includes ONE highly effective method of contraception and ONE additional effective contraceptive method. Contraception must begin at least 28 days prior to first dose of study drug, continue during study treatment (including during dose interruptions), and for 12 months after study drug discontinuation. Female subjects must also refrain from breastfeeding for 12 months following last dose of study drug. If the below contraception methods are not appropriate for the FCBP, she must be referred to a qualified contraception provider to determine the medically effective contraception method appropriate for the subject. The following are examples of highly effective and additional effective methods of contraception:
Examples of highly effective methods:
- Intrauterine device (IUD)
- Hormonal (ovulation inhibitory combined [estrogen and progesterone] birth control pills or intravaginal/transdermal system, injections, implants, levonorgestrel-releasing intrauterine system [IUS], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills [e.g. desogestrel]) NOTE: There is a potential for tazemetostat interference with hormonal contraception methods due to enzymatic induction.
- Bilateral tubal ligation
- Partner's vasectomy (if medically confirmed [azoospermia] and sole sexual partner).
Examples of additional effective methods:
- Male latex or synthetic condom,
- Diaphragm,
- Cervical Cap
NOTE: Female subjects of childbearing potential exempt from these contraception requirements are subjects who practice complete abstinence from heterosexual sexual contact. True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.
-
All study participants enrolled must be registered into the applicable pregnancy prevention program (e.g. REVLIMID REMS in the US, Pregnancy Prevention Programme [PPP] in Europe) for lenalidomide to be administered and be willing and able to comply with the requirements of the applicable program as appropriate for the country in which the drug is being used.
a. Female subjects of childbearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in theapplicable pregnancy prevention program. During study treatment, FCBP must agree to have pregnancy testing weekly for the first 28 days of study participation and then every 28 days for FCBP with regular or no menstrual cycles OR every 14 days for FCBP with irregular menstrual cycles. FCBP must also have a pregnancy test at end of lenalidomide treatment, at day 14 (for FCBP with irregular menstrual cycles) and day 28 following the last dose of lenalidomide and at overall treatment discontinuation (at the End-of-Treatment/30-day safety Follow-up visit). Female subjects exempt from this requirement are subjects who have been naturally postmenopausal for at least 24 consecutive months OR are surgically sterilized (ie, total hysterectomy or bilateral oophorectomy) with surgery at least 1 month before the first dose of study treatment.
-
Male subjects must either practice complete abstinence or agree to use a latex or synthetic condom, even with a successful vasectomy (medically confirmed azoospermia), during sexual contact with a pregnant female or FCBP from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.
NOTE: Male subjects must not donate semen or sperm from first dose of study drug, during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation.
Exclusion Criteria:
All Subjects
-
Prior exposure to tazemetostat or other inhibitor(s) of EZH2.
-
Prior exposure to lenalidomide or drugs of the same class.
-
Grade 3b, mixed histology, or FL that has histologically transformed to diffuse large B-cell lymphoma (DLBCL) (subjects transformed from DLBCL to FL may be enrolled).
-
Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE Version 5.0 criteria) or any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or myeloproliferative neoplasm (MPN).
-
Has a prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL) or B-cell acute lymphoblastic leukemia (B-ALL).
-
Subjects with uncontrolled leptomeningeal metastases or brain metastases or history of previously treated brain metastases.
-
Subjects taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers (including St. John's wort).
-
Are unwilling to exclude grapefruit juice, Seville oranges, and grapefruits from the diet and/or consumed within 1 week of the first dose of study drug and for the duration of the study.
-
Major surgery within 4 weeks before the first dose of study drug.
a. Note: Minor surgery (eg, minor biopsy of extracranial site, central venous catheter placement, shunt revision) is permitted within 3 weeks prior to enrollment.
-
Are unable to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, vomiting) that might impair the bioavailability of tazemetostat.
-
Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia.
-
Prolongation of corrected QT interval using Fridericia's formula (QTcF) to ≥480 msec at screening or history of long QT syndrome.
-
Venous thrombosis or pulmonary embolism within the last 3 months before starting tazemetostat.
a. Note: Participants who have experienced deep vein thrombosis/pulmonary embolism more than 3 months before enrollment are eligible but are recommended to receive prophylaxis.
-
Have an active infection requiring systemic therapy.
-
Known hypersensitivity to any component of tazemetostat or lenalidomide; known severe hypersensitivity to any component of rituximab requiring hospitalization or resuscitation.
-
Active viral infection with or seropositive for HBV: HBV surface antigen (HBsAg) positive OR HBsAg negative, anti-HBs positive and/or anti-HBc positive with detectable HBV DNA.
NOTE: Subjects who are HBsAg negative, anti-HBs positive and/or anti-HBc positive, but with undetectable viral DNA and normal ALT are eligible. Subjects who are seropositive due to HBV vaccination (HBsAg negative, HBV surface antibody [anti-HBs] positive, and HBV core antibody [anti-HBc] negative) are eligible.
-
Active viral infection with hepatitis C virus (as measured by positive HCV antibody and detectable viral RNA, HIV), or known active infection with human T-cell lymphotropic virus.
NOTE: Subjects with a history of hepatitis C infection (HCV antibody reactive) who have normal ALT and undetectable HCV RNA are eligible.
-
Any other medical or social condition that, in the Investigator's judgment, will interfere with a participant's ability to provide informed consent, to receive study drugs, or meet study demands, or that substantially increases the risk associated with the subject's participation in the study, or that may interfere with interpretation of results.
-
Female subjects who are pregnant or lactating/breastfeeding.
-
Subjects who have undergone a solid organ transplant.
-
Subjects with malignancies other than FL. a. Exception: Subjects with another malignancy who have been disease-free for 3 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Tazemetostat + R2 arm
Stage 1 (Phase 1b): completed
Stage 2:
Maintenance Therapy (Stages 1&2): Tazemetostat 800mg PO BD dose for up to 2 years after the initial 12 months of combination therapy. Following an Independent Data Monitoring Committee review, an urgent safety measure was implemented and administration of tazemetostat was permanently discontinued. No further investigational treatment is administered. Participants previously exposed to tazemetostat enter protocol-specified long-term safety follow-up |
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. Following implementation of the urgent safety measure, tazemetostat administration was discontinued. No further dosing is performed.
他の名前：
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.
他の名前：
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. |
|
プラセボコンパレーター：Placebo + R2 Arm
Participants were assigned to receive placebo in combination with lenalidomide and rituximab. Following implementation of the urgent safety measure, placebo administration was permanently discontinued. No further investigational treatment is administered. Stage 2:
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. |
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 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. Following implementation of the urgent safety measure, placebo administration was discontinued. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase 1b: Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2)
時間枠：Subjects are evaluated for DLTs during the first 28-day cycle. The RP3D for Phase 3 was selected at the end of Stage 1
|
The safety and tolerability of tazemetostat in combination with R2 in subjects with R/R FL were evaluated. RP3D of tazemetostat for further evaluation in phase 3 was 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
|
|
Phase 3: Progression-Free Survival (PFS) in the Intent-to-treat wild-type (ITT-WT) populations
時間枠：Stage 2: Up to 72 months
|
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. PFS will be assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further efficacy data are collected, and any post-urgent safety measure analyses are descriptive in nature. |
Stage 2: Up to 72 months
|
|
Phase 3: PFS in the Intent-to-treat mutant-type (ITT-MT) population
時間枠：Stage 2: Up to 72 months
|
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
|
|
Phase 3: PFS in the R/R FL population regardless of mutation status by Investigator assessment
時間枠：Stage 2: Up to 72 months
|
PFS is defined as the time from the date of randomization to the first observation of documented objective disease progression per the 2014 Lugano Classification or death due to any cause, whichever occurs first. 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
|
|
Phase 3: Progression-Free Survival (PFS) in the all comer (ITT-All) populations.
時間枠：Stage 2: Up to 72 months
|
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. PFS will be assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further efficacy data are collected, and any post-urgent safety measure analyses are descriptive in nature. |
Stage 2: Up to 72 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase 1b: PK of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit: Time to Maximum Observed Drug Concentration (Tmax)
時間枠：Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
|
Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
|
|
|
Phase 1b: 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)],
時間枠：Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
|
Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
|
|
|
Phase 1b: PK of tazemetostat: area under the plasma concentration-time curve (AUC) from time 0 to infinity [AUC(0-∞)]
時間枠：Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
|
Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
|
|
|
Phase 1b: The apparent terminal elimination half-life (t1/2) of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit
時間枠：Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
|
Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
|
|
|
Phase 3: OS in the ITT-MT population
時間枠：Stage 2: Up to 96 months
|
Stage 2: Up to 96 months
|
|
|
Phase 3: OS in the R/R FL population regardless of mutation status
時間枠：Stage 2: Up to 96 months
|
Stage 2: Up to 96 months
|
|
|
Phase 3: PFS in the ITT-WT population, assessed by a blinded IRC
時間枠：Stage 2: Up to 96 months
|
Stage 2: Up to 96 months
|
|
|
Phase 3: PFS in the ITT-MT population, assessed by a blinded IRC
時間枠：Stage 2: Up to 96 months
|
Stage 2: Up to 96 months
|
|
|
Phase 3: PFS in the R/R FL population regardless of mutation status, assessed by a blinded IRC
時間枠：Stage 2: Up to 96 months
|
Stage 2: Up to 96 months
|
|
|
Phase 1b: Pharmacokinetics (PK) of tazemetostat: Maximum (peak) Observed Plasma Drug Concentration (Cmax).
時間枠：Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
|
Cmax will be recorded from the PK blood samples collected. |
Stage 1: In cycles 1 and 2 on days 1 and 15 (28 days cycle)
|
|
Phase 3: Complete Response Rate (CRR) in ITT-WT population
時間枠：Stage 2: Up to 96 months
|
CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded Independent Review Committee (IRC). CRR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature. |
Stage 2: Up to 96 months
|
|
Phase 3: CRR in ITT-MT population
時間枠：Stage 2: Up to 96 months
|
CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC. CRR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature. |
Stage 2: Up to 96 months
|
|
Phase 3: CRR in the Relapsed/Refractory (R/R) Follicular Lymphoma (FL) population regardless of mutation status
時間枠：Stage 2: Up to 96 months
|
CRR is defined as the proportion of participants achieving CR according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC. CRR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature. |
Stage 2: Up to 96 months
|
|
Phase 3: Objective Response Rate (ORR) in the ITT-WT population
時間枠：Stage 2: Up to 96 months
|
ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC. ORR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature. |
Stage 2: Up to 96 months
|
|
Phase 3: ORR in the ITT-MT population
時間枠：Stage 2: Up to 96 months
|
ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC. ORR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature. |
Stage 2: Up to 96 months
|
|
Phase 3: ORR in the R/R FL population regardless of mutation status
時間枠：Stage 2: Up to 96 months
|
ORR is defined as the proportion of participants achieving a best overall response (BOR) of partial response (PR) or complete response (CR) according to the 2014 Lugano Classification, as assessed by the Investigator and a blinded IRC. ORR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature. |
Stage 2: Up to 96 months
|
|
Phase 3: Overall Survival (OS) in the ITT-WT population
時間枠：Stage 2: Up to 96 months
|
OS is defined as the time from the date of randomization until death due to any cause. |
Stage 2: Up to 96 months
|
|
Phase 3: Duration Of Response (DOR) in the ITT-WT population
時間枠：Stage 2: Up to 96 months
|
DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC. DOR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature. |
Stage 2: Up to 96 months
|
|
Phase 3: DOR in the ITT-MT population
時間枠：Stage 2: Up to 96 months
|
DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC. DOR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature. |
Stage 2: Up to 96 months
|
|
Phase 3: DOR in the R/R FL population regardless of mutation status
時間枠：Stage 2: Up to 96 months
|
DOR is defined as the time from initial CR or PR to documented progression or death due to any cause, whichever occurs first, for those participants with a CR or PR, as assessed by the Investigator and by a blinded IRC. DOR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature. |
Stage 2: Up to 96 months
|
|
Phase 3: Disease Control Rate (DCR) in the ITT-WT population
時間枠：Stage 2: Up to 96 months
|
DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC. DCR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature. |
Stage 2: Up to 96 months
|
|
Phase 3: DCR in the ITT-MT population
時間枠：Stage 2: Up to 96 months
|
DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC. DCR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature. |
Stage 2: Up to 96 months
|
|
Phase 3: DCR in the R/R FL population regardless of mutation status
時間枠：Stage 2: Up to 96 months
|
DCR, defined as the proportion of participants with best overall response of CR, PR, or stable disease (SD) lasting 12 or more months, as assessed by the Investigator and by a blinded IRC. DCR is assessed based on data collected prior to treatment discontinuation as a result of the urgent safety measure. Following implementation of the urgent safety measure, no further response assessments are performed, and analyses are descriptive in nature. |
Stage 2: Up to 96 months
|
|
PK parameters will be summarized by plasma concentrations of tazemetostat and lenalidomide descriptively.
時間枠：Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle)
|
PK assessments will be conducted on samples collected until the urgent safety measure. No further PK analyses are performed post-urgent safety measure. |
Stage 2: In cycles 2, 4, 6, and 12 at Day 1 (28 days cycle)
|
|
Percentage of Participants Experiencing Adverse Events (AEs)
時間枠：Up to 36 months
|
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to 36 months
|
|
Percentage of Participants with Clinically Significant Changes in Physical Examination
時間枠：Up to 36 months
|
Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0. |
Up to 36 months
|
|
Percentage of Participants with Clinically Significant Changes in Vital Signs
時間枠：Up to 36 months
|
Percentage of participants with clinically significant changes in vital signs findings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0. |
Up to 36 months
|
|
Percentage of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Readings
時間枠：Up to 72 months
|
Percentage of participants with clinically significant changes in ECG Readings will be reported. The clinical significance will be graded by the investigator according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE) Version 5.0. |
Up to 72 months
|
|
Performance status evaluated by Eastern Cooperation Oncology Group (ECOG)
時間枠：Up to 72 months
|
ECOG is a 6-point performance status scale used to assess performance using PA as a key indicator (e.g., 0 = fully active, 2 = up and about more than 50% of walking hours, 5 = dead) Performance status will be assessed per usual clinical practice and will be recorded in the medical record. |
Up to 72 months
|
|
Duration of Study Drug Exposure
時間枠：Up to 36 months
|
Study drug exposure reflects administration prior to implementation of the urgent safety measure. No further investigational drug exposure occurs post-urgent safety measure. |
Up to 36 months
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Ipsen Medical Director、Ipsen
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EZH-302
- 2019-003333-42 (EudraCT番号)
- 2024-510690-16-00 (Ctis)
- 2019 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
IPD 共有時間枠
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.
IPD 共有アクセス基準
Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。