En undersøgelse af Pirtobrutinib (LOXO-305) versus Bendamustine Plus Rituximab (BR) hos ubehandlede patienter med kronisk lymfatisk leukæmi (CLL)/lille lymfatisk lymfom (SLL) (BRUIN-CLL-313)
Et fase 3 åbent, randomiseret studie af Pirtobrutinib (LOXO-305) versus Bendamustine Plus Rituximab hos ubehandlede patienter med kronisk lymfatisk leukæmi/lille lymfatisk lymfom
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.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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New South Wales
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Liverpool, New South Wales, Australien, 2170
- Liverpool Hospital
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Wentworthville, New South Wales, Australien, 2145
- Westmead Hospital
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Victoria
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Frankston, Victoria, Australien, 3199
- Peninsula Private Hospital
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brasilien, 90050-170
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brasilien, 90110270
- Centro Gaucho Integrado - Mae de Deus Center
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São Paulo
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Campinas, São Paulo, Brasilien, 13083-878
- Hemocentro Unicamp
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Jaú, São Paulo, Brasilien, 17210120
- Fundação Doutor Amaral Carvalho
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Plovdiv, Bulgarien, 4000
- UMHAT "Sveti Georgi" EAD
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Sofia, Bulgarien, 1431
- UMHAT 'Sv. Ivan Rilski', EAD
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Sofia, Bulgarien, 1797
- "SHATHD" EAD, Sofia
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Stara Zagora, Bulgarien, 6003
- UMHAT - Prof. Dr. Stoyan Kirkovich" AD
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England
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Birmingham, England, Det Forenede Kongerige, B9 5SS
- Birmingham Heartlands Hospital
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California
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Los Angeles, California, Forenede Stater, 90027
- California Research Institute
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Whittier, California, Forenede Stater, 90603
- Innovative Clinical Research Institute
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Florida
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Coral Springs, Florida, Forenede Stater, 33065
- Oncology-Hematology Associates of West Broward
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New Jersey
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Brick, New Jersey, Forenede Stater, 08724
- New Jersey Center for Cancer Research
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New York
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Westbury, New York, Forenede Stater, 11590
- Clinical Research Alliance, Inc.
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Le Mans, Frankrig, 72000
- Hospitalier Le Mans
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Bergamo, Italien, 24127
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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Brescia, Italien, 25123
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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Meldola, Italien, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milan, Italien, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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Milan, Italien, 20162
- ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
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Monza, Italien, 20900
- Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
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Novara, Italien, 28100
- Azienda Ospedale Maggiore Della Carita
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Perugia, Italien, 06132
- Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
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Ravenna, Italien, 48020
- Ospedale Santa Maria delle Croci
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Terni, Italien, 05100
- Azienda Ospedaliera Santa Maria Terni
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Trieste, Italien, 34125
- Azienda sanitaria integrata università di Trieste
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Potenza
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Rionero in Vulture, Potenza, Italien, 85028
- Irccs Crob
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Aomori, Japan, 030-8553
- Aomori Prefectural Centeral Hospital
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Fukoka-ken, Japan, 806 8501
- JCHO Kyushu Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 467-8602
- Nagoya City University Hospital
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Chiba
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Chiba, Chiba, Japan, 260-8717
- Chiba Cancer Center
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Fukui
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Yoshida-Gun, Fukui, Japan, 910-1193
- Fukui Medical University Hospital
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Hokkaido
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Sapporo, Hokkaido, Japan, 0030006
- Hokuyukai Sapporo Hokuyu Hospital
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Kochi
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Nankoku, Kochi, Japan, 783-8505
- Kochi Medical School Hospital
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Miyagi
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Sendai, Miyagi, Japan, 980-8574
- Tohoku University Hospital
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Sendai, Miyagi, Japan, 9838520
- NHO Sendai Medical Center
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Saitama
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Koshigaya, Saitama, Japan, 343 8555
- Dokkyo Medical University - Koshigaya Hospital
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Yamanshi
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Chūō, Yamanshi, Japan, 409-3821
- University of Yamanashi Hospital
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Beijing, Kina, 100730
- Beijing Hospital
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Chongqing, Kina, 400030
- Chongqing Cancer Hospital
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Zhengzhou, Kina, 450008
- Henan Cancer Hospital
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Anhui
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Hefei, Anhui, Kina, 233004
- Anhui Provincial Cancer Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100191
- Peking University Third Hospital
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Beijing, Beijing Municipality, Kina, 100034
- Peking University First Hospital
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Guangdong
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Guangzhou, Guangdong, Kina, 510120
- The First Affiliated Hospital of Guangzhou Medical University
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Hubei
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Wuhan, Hubei, Kina, 430022
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Kina, 410013
- Hunan Cancer Hospital
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Changsha, Hunan, Kina, 410008
- Xiangya Hospital Central South University
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Inner Mongolia
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Hohhot, Inner Mongolia, Kina, 010050
- The Affiliated Hospital of Inner Mongolia Medical University
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Jiangxi
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Nanchang, Jiangxi, Kina, 330006
- The First Affiliated Hospital of Nanchang University
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Liaoning
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Shenyany, Liaoning, Kina, 110022
- Shengjing Hospital of China Medical University
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Nanjing
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Nanjing, Nanjing, Kina, 210029
- Jiangsu Province Hospital
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Shanghai Municipality
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Changning District, Shanghai Municipality, Kina, 200050
- Shanghai Tongren Hospital
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- West China Hospital of Sichuan University
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Tianjin, Tianjin Municipality, Kina, 300020
- Institute of hematology&blood disease hospital
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Zhejiang
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Hangzhou, Zhejiang, Kina, 311100
- The First People's Hospital of Hangzhou Linping District
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Christchurch, New Zealand, 8011
- Christchurch Hospital
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Papatoetoe, New Zealand, 2025
- Middlemore Clinical Trials
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Auckland
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Takapuna, Auckland, New Zealand, 0622
- North Shore Hospital, Haematology Research
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Bay of Plenty
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Tauranga, Bay of Plenty, New Zealand, 3112
- Tauranga Hospital
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-
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Biała Podlaska, Polen, 21500
- KO-MED Centra Kliniczne
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Bydgoszcz, Polen, 85-168
- Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
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Katowice, Polen, 40519
- Pratia Onkologia Katowice
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Krakow, Polen, 30727
- Pratia MCM Krakow
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Lublin, Polen, 20-090
- Centrum Onkologii Ziemi Lubelskiej
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Torun, Polen, 87-100
- Nasz Lekarz Osrodek Badan Klinicznych
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Warsaw, Polen, 02781
- Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy
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Wroclaw, Polen, 50-367
- Uniwersytecki Szpital Kliniczny Klinika
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Legnica
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Iwaszkiewicza 5, Legnica, Polen, 59-220
- Wojewodzki Szpital Specjalistyczny
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Lubelskie V
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Lublin, Lubelskie V, Polen, 20081
- Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polen, 80214
- Uniwersyteckie Centrum Kliniczne
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Poznan
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Skorzewo, Poznan, Polen, 60 185
- Centrum Medyczne Pratia Poznan
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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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Bucharest, Rumænien, 022328
- Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular
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Cluj-Napoca, Rumænien, 400015
- Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
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Iași, Rumænien, 700483
- Institutului Regional de Oncologie IASI
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Dolj
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Craiova, Dolj, Rumænien, 200143
- Spitalul Clinic Municipal Filantropia Craiova
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Saint Petersburg, Rusland, 197022
- Academician I.P. Pavlov First St-Petersburg State Medical University
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Barcelona, Spanien, 08041
- Hospital de la Santa Creu i Sant Pau
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Madrid, Spanien, 28040
- Hospital Universitario Fundación Jiménez Díaz
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Seville, Spanien, 41013
- Hospital Universitario Virgen del Rocío
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Seville, Spanien, 41014
- Hospital Universitario Virgen de Valme
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spanien, 28050
- Hospital Universitario HM Sanchinarro
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Principality of Asturias
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Oviedo, Principality of Asturias, Spanien, 33011
- Hospital Universitario Central de Asturias
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Busan, Sydkorea, 47392
- Inje Univ Busan Paik Hospital
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Incheon-gwangyeoksi [Incheon]
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Namdong-gu, Incheon-gwangyeoksi [Incheon], Sydkorea, 21565
- Gachon University Gil Medical Center
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Seoul
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Seocho-Gu, Seoul, Sydkorea, 06591
- The Catholic University of Korea-Seoul St. Mary's Hospital
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Seoul, Korea
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Seoul, Seoul, Korea, Sydkorea, 03080
- Seoul National University Hospital
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Seoul-teukbyeolsi [Seoul]
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Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 06351
- Samsung Medical Center
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Changhua, Taiwan, 50544
- Chang Bing Show Chwan Memorial Hospital
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taoyuan City, Taiwan, 333
- Chang Gung Memorial Hospital - Linkou
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Brno, Tjekkiet, 62500
- Fakultni nemocnice Brno
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Hradec Králové, Tjekkiet, 500 05
- Fakultni nemocnice Hradec Kralove
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Debrecen, Ungarn, 4032
- Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
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Nyíregyháza, Ungarn, 4400
- SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
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Székesfehérvár, Ungarn, 8000
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
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Salzburg, Østrig, 5020
- Uniklinikum Salzburg
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Vienna, Østrig, 1160
- Klinik Ottakring
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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:
-
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Arm A - Pirtobrutinib
Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity. |
Oral
Andre navne:
|
|
Aktiv komparator: 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
Andre navne:
IV
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Independent Review Committee (IRC)
Tidsramme: 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)
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Investigator
Tidsramme: 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)
|
|
To Evaluate the Effectiveness of Arm A Compared to Arm B: Overall Survival (OS)
Tidsramme: Up to approximately 5 years
|
Assessments of effectiveness include OS, assessed by investigator |
Up to approximately 5 years
|
|
Arm A Compared to Arm B: Time to Next Treatment (TTNT), Assessed by Investigator
Tidsramme: 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)
|
|
Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), Assessed by IRC
Tidsramme: 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)
|
|
Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), Assessed by Investigator
Tidsramme: 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)
|
|
Arm A Compared to Arm B: Duration of Response (DOR), Assessed by IRC
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Arm A Compared to Arm B: Overall Survival, Assessed by Investigator
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Studieleder: 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
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer
- Kronisk sygdom
- Sygdomsegenskaber
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Lymfesygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Leukæmi, B-celle
- Lymfom
- Leukæmi, lymfoid
- Leukæmi
- Patologiske tilstande, tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Lymfom, B-celle
- Leukæmi, lymfatisk, kronisk, B-celle
- Lymfom, Non-Hodgkin
- Hæmatologiske sygdomme
- Aminosyrer, peptider og proteiner
- Proteiner
- Organiske kemikalier
- Heterocykliske forbindelser
- Benzimidazoler
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Kulbrinter
- Syrer, acyklisk
- Carboxylsyrer
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Nitrogen sennepsforbindelser
- Sennepsforbindelser
- Kulbrinter, halogeneret
- Butyrater
- Antistoffer, monoklonal, murint afledt
- Bendamustine hydrochlorid
- Rituximab
- Pirtobrutinib
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 18088
- LOXO-BTK-20023 (Anden identifikator: Eli Lilly and Company)
- J2N-OX-JZNP (Anden identifikator: Eli Lilly and Company)
- 2024-511599-33-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .