A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

309

Participants

Timeline

Start Date

September 23, 2021

Primary Completion Date

July 11, 2025

Study Completion Date

August 31, 2026

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Pirtobrutinib

Oral

DRUG

Bendamustine

IV

DRUG

Rituximab

IV

Trial Locations (108)

333

Chang Gung Memorial Hospital - Linkou, Taoyuan

1160

Klinik Ottakring, Vienna

1431

UMHAT 'Sv. Ivan Rilski', EAD, Sofia

1797

"SHATHD EAD, Sofia", Sofia

2025

Middlemore Clinical Trials, Papatoetoe

2145

Westmead Hospital, Wentworthville

2170

Liverpool Hospital, Liverpool

3112

Tauranga Hospital, Tauranga

3199

Peninsula Private Hospital, Frankston

4000

"UMHAT Sveti Georgi EAD", Plovdiv

4032

Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum, Debrecen

4400

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza

5020

Uniklinikum Salzburg, Salzburg

6003

"UMHAT - Prof. Dr. Stoyan Kirkovich AD", Stara Zagora

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8011

Christchurch Hospital, Christchurch

10002

National Taiwan University Hospital, Taipei

11590

Clinical Research Alliance, Inc., Westbury

20081

Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin, Lublin

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C, Milan

20900

Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), Monza

21500

KO-MED Centra Kliniczne, Biała Podlaska

21565

Gachon University Gil Medical Center, Namdong-gu

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo

25123

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia

28040

Hospital Universitario Fundación Jiménez Díaz, Madrid

28050

Hospital Universitario HM Sanchinarro, Madrid

28100

Azienda Ospedale Maggiore Della Carita, Novara

30727

Pratia MCM Krakow, Krakow

33011

Hospital Universitario Central de Asturias, Oviedo

33065

Oncology-Hematology Associates of West Broward, Coral Springs

34125

Azienda sanitaria integrata università di Trieste, Trieste

40447

China Medical University Hospital, Taichung

40519

Pratia Onkologia Katowice, Katowice

41013

Hospital Universitario Virgen del Rocío, Seville

41014

Hospital Universitario Virgen de Valme, Seville

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

47392

Inje Univ Busan Paik Hospital, Busan

48020

Ospedale Santa Maria delle Croci, Ravenna

50544

Chang Bing Show Chwan Memorial Hospital, Changhua

62500

Fakultni nemocnice Brno, Brno

72000

Hospitalier Le Mans, Le Mans

80214

Uniwersyteckie Centrum Kliniczne, Gdansk

85028

Irccs Crob, Rionero in Vulture

90027

California Research Institute, Los Angeles

90603

Innovative Clinical Research Institute, Whittier

100034

Peking University First Hospital, Beijing

100191

Peking University Third Hospital, Beijing

100730

Beijing Hospital, Beijing

110022

Shengjing Hospital of China Medical University, Shenyany

197022

Academician I.P. Pavlov First St-Petersburg State Medical University, Saint Petersburg

200050

Shanghai Tongren Hospital, Changning District

200143

Spitalul Clinic Municipal Filantropia Craiova, Craiova

210029

Jiangsu Province Hospital, Nanjing

233004

Anhui Provincial Cancer Hospital, Hefei

300020

Institute of hematology&blood disease hospital, Tianjin

300060

Tianjin Medical University Cancer Institute and Hospital, Tianjin

311100

The First People's Hospital of Hangzhou Linping District, Hangzhou

330006

The First Affiliated Hospital of Nanchang University, Nanchang

400015

"Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca", Cluj-Napoca

400030

Chongqing Cancer Hospital, Chongqing

410008

Xiangya Hospital Central South University, Changsha

410013

Hunan Cancer Hospital, Changsha

430022

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

450008

Henan Cancer Hospital, Zhengzhou

510120

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

610041

West China Hospital of Sichuan University, Chengdu

700483

Institutului Regional de Oncologie IASI, Iași

1649035

Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisbon

9838520

NHO Sendai Medical Center, Sendai

17210120

Fundação Doutor Amaral Carvalho, Jaú

90110270

Centro Gaucho Integrado - Mae de Deus Center, Porto Alegre

08724

New Jersey Center for Cancer Research, Brick

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

90050-170

Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre

13083-878

Hemocentro Unicamp, Campinas

010050

The Affiliated Hospital of Inner Mongolia Medical University, Hohhot

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

06132

Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich), Perugia

05100

Azienda Ospedaliera Santa Maria Terni, Terni

467-8602

Nagoya City University Hospital, Nagoya

260-8717

Chiba Cancer Center, Chiba

910-1193

Fukui Medical University Hospital, Yoshida-Gun

0030006

Hokuyukai Sapporo Hokuyu Hospital, Sapporo

783-8505

Kochi Medical School Hospital, Nankoku

980-8574

Tohoku University Hospital, Sendai

343 8555

Dokkyo Medical University - Koshigaya Hospital, Koshigaya

409-3821

University of Yamanashi Hospital, Chūō

030-8553

Aomori Prefectural Centeral Hospital, Aomori

806 8501

JCHO Kyushu Hospital, Fukoka-ken

0622

North Shore Hospital, Haematology Research, Takapuna

59-220

Wojewodzki Szpital Specjalistyczny, Iwaszkiewicza 5

60 185

Centrum Medyczne Pratia Poznan, Skorzewo

85-168

Szpital Uniwersytecki nr 1 im. Antoniego Jurasza, Bydgoszcz

20-090

Centrum Onkologii Ziemi Lubelskiej, Lublin

87-100

Nasz Lekarz Osrodek Badan Klinicznych, Torun

02781

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy, Warsaw

50-367

Uniwersytecki Szpital Kliniczny Klinika, Wroclaw

4710-243

Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga), Braga

4200-072

Instituto Português de Oncologia do Porto Francisco Gentil, EPE, Porto

022328

Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular, Bucharest

06591

The Catholic University of Korea-Seoul St. Mary's Hospital, Seocho-Gu

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

06351

Samsung Medical Center, Seoul

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

B9 5SS

Birmingham Heartlands Hospital, Birmingham

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Loxo Oncology, Inc.

INDUSTRY