Un estudio de pirtobrutinib (LOXO-305) versus bendamustina más rituximab (BR) en pacientes no tratados con leucemia linfocítica crónica (LLC)/linfoma linfocítico de células pequeñas (SLL) (BRUIN-CLL-313)
24 de septiembre de 2026 actualizado por: Loxo Oncology, Inc.
Un estudio aleatorizado, abierto de fase 3 de pirtobrutinib (LOXO-305) versus bendamustina más rituximab en pacientes no tratados con leucemia linfocítica crónica/linfoma linfocítico de células pequeñas
The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.
Descripción general del estudio
Estado
Estado
Activo, no reclutando
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
Inscripción
282
Fase
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New South Wales
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Liverpool, New South Wales, Australia, 2170
- Liverpool Hospital
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Wentworthville, New South Wales, Australia, 2145
- Westmead Hospital
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Victoria
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Frankston, Victoria, Australia, 3199
- Peninsula Private Hospital
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Salzburg, Austria, 5020
- Uniklinikum Salzburg
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Vienna, Austria, 1160
- Klinik Ottakring
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brasil, 90050-170
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brasil, 90110270
- Centro Gaucho Integrado - Mae de Deus Center
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São Paulo
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Campinas, São Paulo, Brasil, 13083-878
- Hemocentro Unicamp
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Jaú, São Paulo, Brasil, 17210120
- Fundação Doutor Amaral Carvalho
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Plovdiv, Bulgaria, 4000
- UMHAT "Sveti Georgi" EAD
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Sofia, Bulgaria, 1431
- UMHAT 'Sv. Ivan Rilski', EAD
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Sofia, Bulgaria, 1797
- "SHATHD" EAD, Sofia
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Stara Zagora, Bulgaria, 6003
- UMHAT - Prof. Dr. Stoyan Kirkovich" AD
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Brno, Chequia, 62500
- Fakultni nemocnice Brno
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Hradec Králové, Chequia, 500 05
- Fakultni nemocnice Hradec Kralove
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Busan, Corea del Sur, 47392
- Inje Univ Busan Paik Hospital
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Incheon-gwangyeoksi [Incheon]
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Namdong-gu, Incheon-gwangyeoksi [Incheon], Corea del Sur, 21565
- Gachon University Gil Medical Center
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Seoul
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Seocho-Gu, Seoul, Corea del Sur, 06591
- The Catholic University of Korea-Seoul St. Mary's Hospital
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Seoul, Korea
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Seoul, Seoul, Korea, Corea del Sur, 03080
- Seoul National University Hospital
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Seoul-teukbyeolsi [Seoul]
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Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sur, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sur, 06351
- Samsung Medical Center
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Barcelona, España, 08041
- Hospital de la Santa Creu i Sant Pau
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Madrid, España, 28040
- Hospital Universitario Fundación Jiménez Díaz
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Seville, España, 41013
- Hospital Universitario Virgen del Rocío
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Seville, España, 41014
- Hospital Universitario Virgen de Valme
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, España, 28050
- Hospital Universitario HM Sanchinarro
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Principality of Asturias
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Oviedo, Principality of Asturias, España, 33011
- Hospital Universitario Central de Asturias
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California
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Los Angeles, California, Estados Unidos, 90027
- California Research Institute
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Whittier, California, Estados Unidos, 90603
- Innovative Clinical Research Institute
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Florida
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Coral Springs, Florida, Estados Unidos, 33065
- Oncology-Hematology Associates of West Broward
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New Jersey
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Brick, New Jersey, Estados Unidos, 08724
- New Jersey Center for Cancer Research
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New York
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Westbury, New York, Estados Unidos, 11590
- Clinical Research Alliance, Inc.
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Le Mans, Francia, 72000
- Hospitalier Le Mans
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Debrecen, Hungría, 4032
- Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
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Nyíregyháza, Hungría, 4400
- SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
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Székesfehérvár, Hungría, 8000
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
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Bergamo, Italia, 24127
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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Brescia, Italia, 25123
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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Meldola, Italia, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milan, Italia, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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Milan, Italia, 20162
- ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
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Monza, Italia, 20900
- Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
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Novara, Italia, 28100
- Azienda Ospedale Maggiore Della Carita
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Perugia, Italia, 06132
- Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
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Ravenna, Italia, 48020
- Ospedale Santa Maria delle Croci
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Terni, Italia, 05100
- Azienda Ospedaliera Santa Maria Terni
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Trieste, Italia, 34125
- Azienda sanitaria integrata università di Trieste
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Potenza
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Rionero in Vulture, Potenza, Italia, 85028
- Irccs Crob
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Aomori, Japón, 030-8553
- Aomori Prefectural Centeral Hospital
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Fukoka-ken, Japón, 806 8501
- JCHO Kyushu Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japón, 467-8602
- Nagoya City University Hospital
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Chiba
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Chiba, Chiba, Japón, 260-8717
- Chiba Cancer Center
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Fukui
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Yoshida-Gun, Fukui, Japón, 910-1193
- Fukui Medical University Hospital
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Hokkaido
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Sapporo, Hokkaido, Japón, 0030006
- Hokuyukai Sapporo Hokuyu Hospital
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Kochi
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Nankoku, Kochi, Japón, 783-8505
- Kochi Medical School Hospital
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Miyagi
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Sendai, Miyagi, Japón, 980-8574
- Tohoku University Hospital
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Sendai, Miyagi, Japón, 9838520
- NHO Sendai Medical Center
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Saitama
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Koshigaya, Saitama, Japón, 343 8555
- Dokkyo Medical University - Koshigaya Hospital
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Yamanshi
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Chūō, Yamanshi, Japón, 409-3821
- University of Yamanashi Hospital
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Christchurch, Nueva Zelanda, 8011
- Christchurch Hospital
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Papatoetoe, Nueva Zelanda, 2025
- Middlemore Clinical Trials
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Auckland
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Takapuna, Auckland, Nueva Zelanda, 0622
- North Shore Hospital, Haematology Research
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Bay of Plenty
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Tauranga, Bay of Plenty, Nueva Zelanda, 3112
- Tauranga Hospital
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Biała Podlaska, Polonia, 21500
- KO-MED Centra Kliniczne
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Bydgoszcz, Polonia, 85-168
- Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
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Katowice, Polonia, 40519
- Pratia Onkologia Katowice
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Krakow, Polonia, 30727
- Pratia MCM Krakow
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Lublin, Polonia, 20-090
- Centrum Onkologii Ziemi Lubelskiej
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Torun, Polonia, 87-100
- Nasz Lekarz Osrodek Badan Klinicznych
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Warsaw, Polonia, 02781
- Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy
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Wroclaw, Polonia, 50-367
- Uniwersytecki Szpital Kliniczny Klinika
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Legnica
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Iwaszkiewicza 5, Legnica, Polonia, 59-220
- Wojewodzki Szpital Specjalistyczny
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Lubelskie V
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Lublin, Lubelskie V, Polonia, 20081
- Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polonia, 80214
- Uniwersyteckie Centrum Kliniczne
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Poznan
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Skorzewo, Poznan, Polonia, 60 185
- Centrum Medyczne Pratia Poznan
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Beijing, Porcelana, 100730
- Beijing Hospital
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Chongqing, Porcelana, 400030
- Chongqing Cancer Hospital
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Zhengzhou, Porcelana, 450008
- Henan Cancer Hospital
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Anhui
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Hefei, Anhui, Porcelana, 233004
- Anhui Provincial Cancer Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100191
- Peking University Third Hospital
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Beijing, Beijing Municipality, Porcelana, 100034
- Peking University First Hospital
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Hubei
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Wuhan, Hubei, Porcelana, 430022
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Porcelana, 410013
- Hunan Cancer Hospital
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Changsha, Hunan, Porcelana, 410008
- Xiangya Hospital Central South University
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Inner Mongolia
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Hohhot, Inner Mongolia, Porcelana, 010050
- The Affiliated Hospital of Inner Mongolia Medical University
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Jiangxi
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Nanchang, Jiangxi, Porcelana, 330006
- The First Affiliated Hospital of Nanchang University
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Liaoning
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Shenyany, Liaoning, Porcelana, 110022
- Shengjing Hospital of China Medical University
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Nanjing
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Nanjing, Nanjing, Porcelana, 210029
- Jiangsu Province Hospital
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Shanghai Municipality
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Changning District, Shanghai Municipality, Porcelana, 200050
- Shanghai Tongren Hospital
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Sichuan
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Chengdu, Sichuan, Porcelana, 610041
- West China Hospital of Sichuan University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Tianjin, Tianjin Municipality, Porcelana, 300020
- Institute of hematology&blood disease hospital
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 311100
- The First People's Hospital of Hangzhou Linping District
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Braga, Portugal, 4710-243
- Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
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Lisbon, Portugal, 1649035
- Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
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Porto, Portugal, 4200-072
- Instituto Português de Oncologia do Porto Francisco Gentil, EPE
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England
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Birmingham, England, Reino Unido, B9 5SS
- Birmingham Heartlands Hospital
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Bucharest, Rumania, 022328
- Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular
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Cluj-Napoca, Rumania, 400015
- Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
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Iași, Rumania, 700483
- Institutului Regional de Oncologie IASI
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Dolj
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Craiova, Dolj, Rumania, 200143
- Spitalul Clinic Municipal Filantropia Craiova
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Saint Petersburg, Rusia, 197022
- Academician I.P. Pavlov First St-Petersburg State Medical University
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Changhua, Taiwán, 50544
- Chang Bing Show Chwan Memorial Hospital
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Taichung, Taiwán, 40447
- China Medical University Hospital
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Taipei, Taiwán, 10002
- National Taiwan University Hospital
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Taoyuan City, Taiwán, 333
- Chang Gung Memorial Hospital - Linkou
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Confirmed diagnosis of CLL/SLL requiring therapy, per iwCLL 2018 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Adequate organ function
- Platelets greater than or equal to (≥)75 x 10⁹/liter (L) (≥50 × 10⁹/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/L
- Kidney function: Estimated creatinine clearance ≥40 milliliters per minute (mL/min)
Exclusion Criteria:
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Known or suspected Richter's transformation at any time preceding enrollment
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Prior systemic therapy for CLL/SLL
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Presence of 17p deletion
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Central nervous system (CNS) involvement
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Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
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Significant cardiovascular disease
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Active hepatitis B or hepatitis C
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Active cytomegalovirus (CMV) infection
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Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
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Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
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Concurrent use of investigational agent or anticancer therapy except hormonal therapy
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Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
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Vaccination with a live vaccine within 28 days prior to randomization
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Patients with the following hypersensitivity:
- Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or bendamustine
- Prior significant hypersensitivity to rituximab
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Arm A - Pirtobrutinib
Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity. |
Oral
Otros nombres:
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Comparador activo: Arm B - Bendamustine Plus Rituximab
Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD). |
IV
Otros nombres:
IV
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Independent Review Committee (IRC)
Periodo de tiempo: From randomization until documented disease progression or death (up to 40 months)
|
PFS, as assessed by IRC, is defined as the time from randomization until documented disease progression as per iwCLL (International Workshop on Chronic Lymphocytic Leukemia) 2018 criteria, or death from any cause, whichever occurs first. |
From randomization until documented disease progression or death (up to 40 months)
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Investigator
Periodo de tiempo: From randomization until documented disease progression or death (up to 40 months)
|
PFS, as assessed by investigator, is defined as the time from randomization until documented disease progression as per iwCLL (International Workshop on Chronic Lymphocytic Leukemia) 2018 criteria, or death from any cause, whichever occurs first. |
From randomization until documented disease progression or death (up to 40 months)
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To Evaluate the Effectiveness of Arm A Compared to Arm B: Overall Survival (OS)
Periodo de tiempo: Up to approximately 5 years
|
Assessments of effectiveness include OS, assessed by investigator |
Up to approximately 5 years
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Arm A Compared to Arm B: Time to Next Treatment (TTNT), Assessed by Investigator
Periodo de tiempo: From randomization until initiation of the subsequent anticancer therapy or death (up to 41 months)
|
TTNT is defined as time from the date of randomization to the date of initiation of the subsequent anticancer therapy for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) including the first dose date of pirtobrutinib for Arm B participants who crossed over to receive pirtobrutinib if applicable or death due to any cause, whichever occurs first. |
From randomization until initiation of the subsequent anticancer therapy or death (up to 41 months)
|
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Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), Assessed by IRC
Periodo de tiempo: From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)
|
ORR, as assessed by IRC, is defined as number of participants who achieved a best overall response of complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR) or partial remission (PR) at or before the initiation of subsequent anticancer therapy, disease progression or death, divided by the total number of participants randomized to each treatment arm. |
From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)
|
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Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), Assessed by Investigator
Periodo de tiempo: From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)
|
ORR, as assessed by investigator, is defined as number of participants who achieved a best overall response of complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR) or partial remission (PR) at or before the initiation of subsequent anticancer therapy, disease progression or death, divided by the total number of participants randomized to each treatment arm. |
From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)
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Arm A Compared to Arm B: Duration of Response (DOR), Assessed by IRC
Periodo de tiempo: From first documented response until the first documented disease progression or death (up to 35 months)
|
DoR, as assessed by IRC, is defined as the time from the date of the first documented response (CR, CRi, nPR, or PR) until the first date of the documentation of disease progression as per iwCLL 2018 criteria, or the date of death from any cause, whichever occurs first. |
From first documented response until the first documented disease progression or death (up to 35 months)
|
|
Arm A Compared to Arm B: Duration of Response (DOR), Assessed by Investigator
Periodo de tiempo: From first documented response until the first documented disease progression or death (up to 35 months)
|
DoR, as assessed by investigator, is defined as the time from the date of the first documented response (CR, CRi, nPR, or PR) until the first date of the documentation of disease progression as per iwCLL 2018 criteria, or the date of death from any cause, whichever occurs first. |
From first documented response until the first documented disease progression or death (up to 35 months)
|
|
Arm A Compared to Arm B: Time to Worsening (TTW) of CLL/SLL-related Symptoms as Measured by the EORTC QLQ-C30 and IL-58
Periodo de tiempo: From randomization up to 37 months
|
A measure of CLL/SLL-related symptoms (CLL/SLL-related Symptoms score) was derived from 13 items: appetite loss, fatigue (3 items), pain, nausea, dyspnea, and insomnia from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), and night sweats, fever/chills, and fatigue (3 items) from selected items of the EORTC Item Library set 58 (IL-58). First, a raw score was calculated as mean of the item responses, then a linear transformation was applied to obtain standardized score ranging from 0 to 100, with higher score representing worse symptoms. TTW of CLL/SLL-related symptoms was defined as the time from randomization to the earliest date of the first sustained worsening in its score from baseline, meeting or exceeding the meaningful within-person change (MWPC) threshold of +5.12 points or death from any cause. Sustained worsening required that the threshold be met at two consecutive assessment timepoints. |
From randomization up to 37 months
|
|
Arm A Compared to Arm B: Time to Worsening (TTW) of Physical Functioning as Measured by the Physical Function Domain of the EORTC-QLQ-C30
Periodo de tiempo: From randomization up to 37 months
|
Physical Functioning was assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 items (QLQ-C30) Physical Function (PF) scale consisting of 5 items to measure the impact of the disease and its treatment on a participant's ability to perform everyday physical activities, calculated from responses to the five items, each scored on a 4 point scale (1 = not at all to 4 = very much). First, a raw score was calculated as mean of the item responses, then a linear transformation was applied to obtain standardized score ranging from 0 to 100, with higher score representing better functioning. TTW of PF was defined as the time from randomization to the earliest date of the first sustained worsening from baseline, with a decline in the meaningful within-person change (MWPC) threshold of -13.33 points or death from any cause. Sustained worsening required that the threshold be met at two consecutive assessment timepoints. |
From randomization up to 37 months
|
Otras medidas de resultado
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Arm A Compared to Arm B: Overall Survival, Assessed by Investigator
Periodo de tiempo: From randomization until death from any cause (up to 41 months)
|
Overall survival (OS) is defined as the time from randomization until death from any cause. A descriptive analysis of OS was pre-specified based on the primary endpoint data cutoff. |
From randomization until death from any cause (up to 41 months)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Director de estudio: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Eyre TA, Hess LM, Masoudi E, Jen MH, Abhyankar S, Graham-Clarke PL, Bhandari NR, Maguire P, Winfree KB, Tracey M, Taipale KL, Davids MS. Efficacy of Pirtobrutinib Monotherapy in Treatment-Naive Chronic Lymphocytic Leukemia: A Bayesian Network Meta-Analysis of Randomized Controlled Trials. Cancers (Basel). 2026 Feb 18;18(4):660. doi: 10.3390/cancers18040660.
- Jurczak W, Kwiatek M, Czyz J, Roberto de Mattos E, Eom KS, Egle A, Panovska A, Popova ZG, Shih HJ, Casado Montero LF, Sportoletti P, Hua VM, D'Olimpio JT, Iida S, Ito R, Bao K, Fink A, Su W, Ruppert AS, Levy A, Wrobel T. BRUIN CLL-313: Randomized Phase III Trial of Pirtobrutinib Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. J Clin Oncol. 2026 Feb 20;44(6):466-475. doi: 10.1200/JCO-25-02380. Epub 2025 Dec 9.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
23 de septiembre de 2021
Finalización primaria (Actual)
Finalización primaria
11 de julio de 2025
Finalización del estudio (Estimado)
Finalización del estudio
1 de octubre de 2027
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
24 de agosto de 2021
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
24 de agosto de 2021
Publicado por primera vez (Actual)
Publicado por primera vez
27 de agosto de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
25 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
24 de septiembre de 2026
Última verificación
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Neoplasias
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Leucemia de células B
- Linfoma
- Leucemia Linfoide
- Leucemia
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades hemic y linfáticas
- Linfoma de células B
- Leucemia Linfocítica Crónica De Células B
- Linfoma No Hodgkin
- Enfermedades hematológicas
- Aminoácidos, péptidos y proteínas
- Proteínas
- Químicos orgánicos
- Compuestos heterocíclicos
- Benzimidazoles
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Hidrocarburos
- Ácidos, acíclico
- Ácidos carboxílicos
- Anticuerpos, monoclonal
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Compuestos de mostaza de nitrógeno
- Compuestos de mostaza
- Hidrocarburos, halogenados
- Butiratos
- Anticuerpos, monoclonales, derivados de murino
- Clorhidrato de bendamustina
- Rituximab
- ptobrutinib
Otros números de identificación del estudio
Otros números de identificación del estudio
- 18088
- LOXO-BTK-20023 (Otro identificador: Eli Lilly and Company)
- J2N-OX-JZNP (Otro identificador: Eli Lilly and Company)
- 2024-511599-33-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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