Badanie na osobach z nawracającym/opornym na leczenie chłoniakiem grudkowym (SYMPHONY-1)
SYMPHONY-1: Podwójnie ślepe, randomizowane, 3-etapowe badanie fazy 1b/3 z aktywną kontrolą i adaptacją biomarkerów tazemetostatu lub placebo w skojarzeniu z lenalidomidem i rytuksymabem u pacjentów z nawracającym/opornym na leczenie chłoniakiem grudkowym
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Adelaide, Australia
- GenesisCare - St Andrew's
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Frankston, Australia
- Peninsula Health - Frankston
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Hobart, Australia
- Royal Hobart Hospital
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Southport, Australia
- Gold Coast University Hosptial
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Bedford Park, South Australia, Australia, 5042
- Flinders Medical Centre
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Victoria
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Clayton, Victoria, Australia, 3168
- Monash Health
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Geelong, Victoria, Australia, 3220
- Barwon Health, University Hospital Geelong
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Hollywood Private Hospital
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgia, 9000
- Universitair Ziekenhuis Gent
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Vlaams Brabant
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Leuven, Vlaams Brabant, Belgia, 3000
- UZ Leuven - Campus Gasthuisberg
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Ceará, Brazylia
- Hospital Haroldo Juacaba - Instituto do Cancer do Ceara
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Curitiba, Brazylia
- Hospital Santa Cruz
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Goiânia, Brazylia
- HC-UFG - Hospital das CLINICAS da Universidade Federal de Go
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Ijuí, Brazylia
- Association Hospital de Caridade de Iju
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Natal, Brazylia
- Liga Norte Riograndense Contra o Cancer
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Porto Alegre, Brazylia
- Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica
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Recife, Brazylia
- Instituto D'Or de Pesquisa e Ensino- Recife
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Rio de Janeiro, Brazylia
- Instituto de Psiquiatria - UFRJ
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Rio de Janeiro, Brazylia
- Instituto Nacional de Câncer - INCA
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São Paulo, Brazylia
- Fundacao Antonio Prudente - Hospital A.C.Camargo Cancer Center
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São Paulo, Brazylia
- Hospital Alemao Oswaldo Cruz (HAOC)
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São Paulo, Brazylia
- Instituto de Oncologia e Hematologia - HEMOMED
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São Paulo, Brazylia
- Irmandade Santa Casa de Misericordia de Sao Paulo
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São Paulo, Brazylia
- Instituto D'or de Pesquisa e Ensino
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Beijing, Chiny, 100191
- Peking University Third Hospital
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Hangzhou, Chiny
- The First Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Chiny
- Tongji Hospital of Tongji Medical College of HUST
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Nanchang, Chiny
- Jiangxi Cancer Hospital
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Shandong, Chiny
- Shandong Cancer Hospital
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Shanghai, Chiny
- Tongji Hospital of Tongji University
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Sichuan, Chiny
- Sichuan Provincial People's Hospital
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Tianjin, Chiny, 300060
- Tianjin Medical University Cancer Institute & Hospital
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Fujian
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Fuzhou, Fujian, Chiny, 350001
- Fujian Medical University Union Hospital
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Xiamen, Fujian, Chiny, 361003
- The First Affiliated Hospital of Xiamen University
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Guizhou
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Guiyang, Guizhou, Chiny, 550004
- The Affiliated Hospital of Guizhou Medical University
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Hangzhou
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Zhejiang, Hangzhou, Chiny, 310000
- The Second Affiliated Hospital Zhejiang University School of Medicine
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Hebei
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Shijiazhuang, Hebei, Chiny, 050011
- The Fourth Hospital of Hebei Medical University
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Henan
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Zhengzhou, Henan, Chiny, 45008
- Henan Cancer Hospital
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Zhengzhou, Henan, Chiny, 450008
- Henan Provincial People's Hospital
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Hunan
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Changsha, Hunan, Chiny, 410013
- Hunan Cancer Hospital
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Jinlin
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Changchun, Jinlin, Chiny, 130021
- The First Bethune Hospital of Jilin University
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Shandong
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Qingdao, Shandong, Chiny, 266071
- The Affiliated Hospital of Qingdao University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chiny, 20025
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
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Shanxi
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Taiyuan, Shanxi, Chiny, 30032
- Shanxi Bethune Hospital
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Angers, Francja
- Centre Hospitalier Universitaire D'Angers - Hématologie Clinique
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Besançon, Francja, 25000
- CHRU de Besançon- Hopital Jean Minjoz
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Clermont-Ferrand, Francja, 63000
- CHU de Clermont-Ferrand, site Estaing
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Lens, Francja
- Centre Hospitalier Docteur Schaffner
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Nantes, Francja, 44202
- L'Hôpital Privé Confluent
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Nantes, Francja
- L'hôpital Privé du Concluent
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Paris, Francja, 75010
- Hopital Saint Louis
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Poitiers, Francja
- Centre Hospitalier Universitaire de Poitiers
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Périgueux, Francja
- Centre Hospitalier - Hôpital de jour d'Hématologie
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Vandœuvre-lès-Nancy, Francja, 54511
- CHU de Nancy Brabois
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Vannes, Francja, 56017
- Centre Hospitalier Bretagne Atlantique
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Villejuif, Francja
- Institut Gustave Roussy
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Aquitaine
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Pessac, Aquitaine, Francja, 33600
- Centre Hospitalier Universitaire de Bordeaux-Hopital du Haut Leveque
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Brittany Region
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Brest, Brittany Region, Francja, 29609
- CHRU Brest Hôp Morvan
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Gironde
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Bordeaux, Gironde, Francja, 33000
- Institut Bergonie
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Haut-Rhin
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Mulhouse, Haut-Rhin, Francja, 68100
- Centre Hosp Mulh Hop Emile Muller
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Haute-Normandie
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Rouen, Haute-Normandie, Francja, 76038
- Centre Henri Becquerel
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Haute-Vienne
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Limoges, Haute-Vienne, Francja, 87042
- CHU de Limoges Dupuytren
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Isere
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La Tronche, Isere, Francja, 38700
- CHU de Grenoble - Hopital Albe
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Loire-Atlantique
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Nantes, Loire-Atlantique, Francja, 44000
- CHU de Nantes - Hematologie
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Nord
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Lille, Nord, Francja, 59037
- CHRU de Lille Hop Claude Huriez
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Sarthe
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Le Mans, Sarthe, Francja, 72000
- Centre Hospitalier Le Mans
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Île-de-France Region
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Créteil, Île-de-France Region, Francja, 94010
- Hopital Henri Mondor - Hemopathies Lymphoides
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Barcelona, Hiszpania, 08003
- Hospital Del Mar
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El Palmar, Hiszpania
- Hospital Virgen de la Arrixaca
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Madrid, Hiszpania, 28046
- Hospital Universitario La Paz
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Madrid, Hiszpania, 28031
- Hospital Univ. Infanta Leonor
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Madrid, Hiszpania
- Clínica Universidad de Navarra
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Pamplona, Hiszpania
- C.H. de Navarra
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Salamanca, Hiszpania, 37007
- Hospital Universitario de Salamanca
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Seville, Hiszpania, 41014
- Hospital Universitario Nuestra Señora de Valme
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Seville, Hiszpania
- Hospital Universitario Virgen De La Macarena
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Cataluny
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Barcelona, Cataluny, Hiszpania, 08035
- Hospital Universitari Vall d'Hebrón
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Málaga
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Marbella, Málaga, Hiszpania, 29603
- Hospital Costa del Sol
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Nova Scotia, Kanada
- Nova Scotia Health Centre for Clinical Research
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Ottawa, Kanada
- Sunnybrook Health Sciences Centre Odette Cancer Centre
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Ontario
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Toronto, Ontario, Kanada, M5G 2M9
- University Health Network Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Kanada, H3T 1E2
- Sir Mortimer B Davis/Jewish General Hospital
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Montreal, Quebec, Kanada, H2X 3E4
- Centre Hospitalier de l'Universite de Montreal (CHUM)
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Busan, Korea Południowa
- Pusan National University Hospital
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Incheon, Korea Południowa
- Gachon University Gil Medical Center
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Suwon, Korea Południowa
- Ajou University Hospital
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Korea Południowa, 03080
- Seoul National University Hospital
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Seoul Teugbyeolsi [Seoul-T'ukp
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Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea Południowa, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Seoul Teugbyeolsi [Seoul-T'ukp, Korea Południowa, 06351
- Samsung Medical Center
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Seoul Teugbyeolsi [Seoul-T'ukp]
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Seoul, Seoul Teugbyeolsi [Seoul-T'ukp], Korea Południowa, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Berlin, Niemcy
- Vivantes Klinikum am Urban Hämatologie und Onkologie
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Kiel, Niemcy
- University Medical Center Schleswig Holstein
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Baden-Wurttemberg
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Schwäbisch Hall, Baden-Wurttemberg, Niemcy, 74523
- Diakoneo Diak Schwaebisch Hall gGmbH
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Bavaria
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München, Bavaria, Niemcy, 81377
- Klinikum Der Universität München AöR
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Hesse
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Mainz, Hesse, Niemcy, 55131
- Universitätsmedizin Mainz
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Niemcy, 53127
- Universitaetsklinikum Bonn AöR
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Mönchengladbach, North Rhine-Westphalia, Niemcy, 41063
- Kliniken Maria Hilf GmbH
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Schleswig-Holstein
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Kiel, Schleswig-Holstein, Niemcy, 24116
- Städt. Krankenhaus Kiel
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Katowice, Polska
- Pratia Onkologia Katowice
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Krakow, Polska, 30-727
- Pratia MCM Krakow
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Torun, Polska, 87-100
- MICS Centrum Medyczne Torun
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Warsaw, Polska
- MTZ Clinical Research powered by Pratia
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Wroclaw, Polska, 50-367
- Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu
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Greater Poland Voivodeship
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Skórzewo, Greater Poland Voivodeship, Polska, 60-185
- Centrum Medyczne Pratia Poznan
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polska, 02-781
- Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
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Singapore, Singapur
- Tan Tock Seng Hospital
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Singapore, Singapur
- National Cancer Center Singapore
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Alabama
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Mobile, Alabama, Stany Zjednoczone, 36608
- Southern Cancer Center
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Arizona
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Tucson, Arizona, Stany Zjednoczone, 85704
- Arizona Oncology Associates - Tuscon-Rusadill Road
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California
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Cerritos, California, Stany Zjednoczone, 90703
- TOI - Clinical Research
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Clovis, California, Stany Zjednoczone, 93611
- UCSF Fresno
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La Jolla, California, Stany Zjednoczone, 92093
- UC San Diego Health Sciences
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Santa Monica, California, Stany Zjednoczone, 90404
- UCLA Clinical Research Unit Hematology/Oncology
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Colorado
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Boulder, Colorado, Stany Zjednoczone, 80303
- Rocky Mountain Cancer Centers (RMCC) - Boulder
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Grand Junction, Colorado, Stany Zjednoczone, 81501
- St. Mary's Hospital and Regional Medical Center - St. Mary's
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Florida
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Fleming Island, Florida, Stany Zjednoczone, 32003
- Cancer Specialists of North Florida
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Fort Myers, Florida, Stany Zjednoczone, 33908
- Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center
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Jacksonville, Florida, Stany Zjednoczone, 32224
- Mayo Clinic
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Ocala, Florida, Stany Zjednoczone, 34474
- Florida Cancer Affiliates/Ocala Oncology - Clinic
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Plantation, Florida, Stany Zjednoczone, 33322
- BRCR Medical Center, INC
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St. Petersburg, Florida, Stany Zjednoczone, 33705
- Florida Cancer Specialists
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Tallahassee, Florida, Stany Zjednoczone, 32308
- Florida Cancer Specialists - Panhandle
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Tampa, Florida, Stany Zjednoczone, 33612
- H Lee Moffitt Cancer Center and Research Institute I
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West Palm Beach, Florida, Stany Zjednoczone, 33401
- Florida Cancer Specialists & Research Institute (FCS) - Atlantis
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60637
- University of Chicago
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Niles, Illinois, Stany Zjednoczone, 60714
- Illinois Cancer Specialists
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48109
- University of Michigan Comprehensive Cancer Center
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Ypsilanti, Michigan, Stany Zjednoczone, 48197
- St. Joseph Mercy Hospital
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Minnesota
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Rochester, Minnesota, Stany Zjednoczone, 55901
- Mayo Clinic - Rochester
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Nebraska
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Omaha, Nebraska, Stany Zjednoczone, 68198
- University Of Nebraska Medical Center
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New Jersey
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East Brunswick, New Jersey, Stany Zjednoczone, 08816
- Astera Cancer Care
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East Brunswick, New Jersey, Stany Zjednoczone, 08816
- Astera Cancer Center
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Freehold, New Jersey, Stany Zjednoczone, 07728
- Regional Cancer Care Associates-Freehold
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Little Silver, New Jersey, Stany Zjednoczone, 07739
- Regional Cancer Care Associates LLC - Little Silver
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New Mexico
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Albuquerque, New Mexico, Stany Zjednoczone, 87131-0001
- New Mexico Cancer Care Alliance
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New York
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New York, New York, Stany Zjednoczone, 10065
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Stany Zjednoczone, 10021
- Weill Cornell Medicine-New York Presbyterian Hospital
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New York, New York, Stany Zjednoczone, 10032
- Columbia U - Herbert Irving Comprehensive Cancer Center
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Nyack, New York, Stany Zjednoczone, 10960
- Hematology Oncology Associates of Rockland, P.C.
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North Carolina
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Asheville, North Carolina, Stany Zjednoczone, 28806
- Messino Cancer Center
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Concord, North Carolina, Stany Zjednoczone, 28205
- Levine Cancer Institute - Concord
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Pinehurst, North Carolina, Stany Zjednoczone, 28374
- FirstHealth of the Carolinas
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Wilson, North Carolina, Stany Zjednoczone, 27895
- Regional Medical Oncology Center
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Ohio
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Canton, Ohio, Stany Zjednoczone, 44718
- Gabrail Cancer Center Research
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Cincinnati, Ohio, Stany Zjednoczone, 45236
- Oncology Hematology Care (OHC), Inc. - Kenwood Office
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Oregon
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Eugene, Oregon, Stany Zjednoczone, 97401
- Willamette Valley Cancer Institute and Research Center - Oncology
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Pennsylvania
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15524
- Western Pennsylvania Hospital Hematology & Cellular Therapy
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Tennessee
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Nashville, Tennessee, Stany Zjednoczone, 37203
- Sarah Cannon Research Institute
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Texas
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Amarillo, Texas, Stany Zjednoczone, 79124
- Texas Oncology - Amarillo
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Austin, Texas, Stany Zjednoczone, 78705
- Texas Oncology-Austin Midtown
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Dallas, Texas, Stany Zjednoczone, 75246
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
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Dallas, Texas, Stany Zjednoczone, 75230
- Texas Oncology - Medical City Dallas Pediatric Hematology
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Houston, Texas, Stany Zjednoczone, 77030
- The University of Texas MD Anderson Cancer Center
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Houston, Texas, Stany Zjednoczone, 77090
- Millennium Physicians - Oncology
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Plano, Texas, Stany Zjednoczone, 75075
- Texas Oncology
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San Antonio, Texas, Stany Zjednoczone, 78229
- Mays Cancer Center
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Tyler, Texas, Stany Zjednoczone, 75702
- USO Texas Oncology - Tyler
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Tyler, Texas, Stany Zjednoczone, 75701
- UT Health East Texas HOPE Cancer Center - Tyler
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Weslaco, Texas, Stany Zjednoczone, 78596
- Texas Oncology- Weslaco
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Utah
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Salt Lake City, Utah, Stany Zjednoczone, 84106
- Utah Cancer Specialists/ IHO Corp
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Salt Lake City, Utah, Stany Zjednoczone, 84112
- Huntsman Cancer Institute; The University of Utah
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Virginia
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Gainesville, Virginia, Stany Zjednoczone, 22155
- Virginia Cancer Specialists
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Roanoke, Virginia, Stany Zjednoczone, 24014
- Oncology and Hematology Associates of Southwest Virginia Inc.
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West Virginia
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Wheeling, West Virginia, Stany Zjednoczone, 26003
- Wheeling Hospital
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-
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Hualien City, Tajwan
- Buddihist Tzu Chi Medical Foundation- Hualien Tzu Chi Hospital
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Kaohsiung City, Tajwan, 833
- Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
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Taichung, Tajwan, 40705
- Taichung Veterans General Hospital
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Tainan, Tajwan, 704
- National Cheng Kung University Hospital
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Taipei, Tajwan
- National Taiwan University Hospital
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-
-
-
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Ankara, Turcja (Türkiye)
- Gazi University Medical Faculty
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Ankara, Turcja (Türkiye)
- Ankara University Medical Faculty - Hematology
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Ankara, Turcja (Türkiye)
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research
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Istanbul, Turcja (Türkiye)
- Medipol Bagcilar Mega Hospital
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Samsun, Turcja (Türkiye)
- Ondokuz Mayis University Medical Faculty - Hematology
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-
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-
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Budapest, Węgry, 1122
- Országos Onkológiai Intézet
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Budapest, Węgry, 1088
- Semmelweis Egyetem Általános Orvostudományi Kar
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Hajdú-Bihar
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Debrecen, Hajdú-Bihar, Węgry, 4032
- Debreceni Egyetem Klinikai Központ
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-
-
-
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Brescia, Włochy, 25123
- ASST Spedali Civili di Brescia
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Catania, Włochy, 95122
- PO Garibaldi-Nesima, ARNAS Garibaldi
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Florence, Włochy, 50134
- AOU Careggi
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Lecce, Włochy
- Ospedale Vito Fazzi, ASL Lecce
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Milan, Włochy
- Ospedale Niguarda, ASST Grande Ospedale Metropolitano Niguarda
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Milan, Włochy
- IEO - Istituto Europeo di Oncologia, IRCCS
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Milan, Włochy
- Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda
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Monza, Włochy
- Ospedale San Gerardo, ASST di Monza
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Pescara, Włochy
- Ospedale Civile S.Spirito, PO di Pescara, AUSL Pescara
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Rimini, Włochy
- Ospedale Infermi di Rimini, AUSL Rimini, Distretto di Rimini, Presidio di Rimini, Santarcangelo di Romagna e Novafeltria
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Roma, Włochy, 00168
- Catholic University Of Sacred Heart
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Roma, Włochy
- PU Campus Bio-Medico di Roma
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Roma, Włochy
- Regina Elena, Istituto Nazionale dei Tumori , IFO, IRCCS
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Terni, Włochy, 05100
- Azienda Ospedaliera Santa Maria di Terni
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Torino, Włochy
- Azienda Ospedaliera Ordine Mauriziano di Torino, Ospedale Umberto I di Torino
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Treviso, Włochy
- Ospedale S.Giacomo Apostolo, PO Castelfranco Veneto, AULSS 2 Marca Trevigiana
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Trieste, Włochy
- Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), Ospedale Maggiore
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Campania
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Naples, Campania, Włochy, 80122
- AOU Federico II
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Forli-Cesena
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Meldola, Forli-Cesena, Włochy, 47014
- Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS
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Bebington, Zjednoczone Królestwo
- The Clatterbridge Cancer Centre NHS Foundation Trust - Clatterbridge Cancer Centre
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Cornwell, Zjednoczone Królestwo
- Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
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Glasgow, Zjednoczone Królestwo, G12 0YN
- Beatson West of Scotland Cancer Centre
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Middlesex, Zjednoczone Królestwo
- Northwick Park Hospital Middlesex, United Kindgom, HA1 3UJ
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Edinburgh, City of
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Edinburgh, Edinburgh, City of, Zjednoczone Królestwo, EH4 2XU
- Western General Hospital - Haematology
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London City
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London, London City, Zjednoczone Królestwo, W12 0HS
- Imperial College Healthcare NHS Trust - Hammersmith Hospital
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London, City of
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London, London, City of, Zjednoczone Królestwo, EC1A 7BE
- St Bartholomew's Hospital Barts Health NHS Trust
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
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Males or females are ≥18 years of age, or per country adult legal age regulations, at the time of providing voluntary written informed consent.
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Life expectancy ≥3 months before enrollment.
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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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
Inne nazwy:
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.
Inne nazwy:
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. |
|
Komparator placebo: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Phase 1b: Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Phase 1b: PK of tazemetostat, EPZ 6930 (desethyl metabolite), and lenalidomide as data permit: Time to Maximum Observed Drug Concentration (Tmax)
Ramy czasowe: 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)],
Ramy czasowe: 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-∞)]
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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).
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Ipsen Medical Director, Ipsen
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Nowotwory
- Choroby układu odpornościowego
- Nowotwory według typu histologicznego
- Choroby limfatyczne
- Zaburzenia limfoproliferacyjne
- Zaburzenia immunoproliferacyjne
- Chłoniak nieziarniczy
- Chłoniak
- Choroby hemowe i limfatyczne
- Chłoniak, Pęcherzykowy
- Aminokwasy, peptydy i białka
- Białka
- Organiczne chemikalia
- Związki heterocykliczne, 1-ring
- Związki heterocykliczne
- Związki heterocykliczne, 2-ring
- Związki heterocykliczne, sterowanie stopieniem
- Kwasy karboksylowe
- Piperydyny
- Przeciwciała, monoklonalne
- Przeciwciała
- Immunoglobuliny
- Immunoproteiny
- Białka krwi
- Globuliny w surowicy
- Globuliny
- Przeciwciała, monoklonalne, mysie
- Ftalimidy
- Kwasy ftaliczne
- Kwasy, karbocykliczne
- Piperidones
- Izoindoles
- Lenalidomid
- Rytuksymab
- tazemetostat
Inne numery identyfikacyjne badania
- EZH-302
- 2019-003333-42 (Numer EudraCT)
- 2024-510690-16-00 (Ctis)
- 2019 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Ramy czasowe udostępniania IPD
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.
Kryteria dostępu do udostępniania IPD
Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .