A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
NCT ID: NCT05023980
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
309 participants
INTERVENTIONAL
2021-09-23
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (Pirtobrutinib)
Pirtobrutinib administered orally
Pirtobrutinib
Oral
Arm B (BR)
Bendamustine plus rituximab administered intravenously (IV)
Bendamustine
IV
Rituximab
IV
Interventions
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Pirtobrutinib
Oral
Bendamustine
IV
Rituximab
IV
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* Prior systemic therapy for CLL/SLL
* Presence of 17p deletion
* Central nervous system (CNS) involvement
* Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \[AIHA\], idiopathic thrombocytopenic purpura \[ITP\])
* Significant cardiovascular disease
* Active hepatitis B or hepatitis C
* Active cytomegalovirus (CMV) infection
* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
* Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
* Concurrent use of investigational agent or anticancer therapy except hormonal therapy
* Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
* Vaccination with a live vaccine within 28 days prior to randomization
* Patients with the following hypersensitivity:
* Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or bendamustine
* Prior significant hypersensitivity to rituximab
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Loxo Oncology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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California Research Institute
Los Angeles, California, United States
Innovative Clinical Research Institute
Whittier, California, United States
Oncology-Hematology Associates of West Broward
Coral Springs, Florida, United States
New Jersey Center for Cancer Research
Brick, New Jersey, United States
Clinical Research Alliance, Inc.
Westbury, New York, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Westmead Hospital
Wentworthville, New South Wales, Australia
Peninsula Private Hospital
Frankston, Victoria, Australia
Uniklinikum Salzburg
Salzburg, , Austria
Klinik Ottakring
Vienna, , Austria
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Centro Gaucho Integrado - Mae de Deus Center
Porto Alegre, Rio Grande do Sul, Brazil
Hemocentro Unicamp
Campinas, São Paulo, Brazil
Fundação Doutor Amaral Carvalho
Jaú, São Paulo, Brazil
UMHAT "Sveti Georgi" EAD
Plovdiv, , Bulgaria
UMHAT 'Sv. Ivan Rilski', EAD
Sofia, , Bulgaria
"SHATHD" EAD, Sofia
Sofia, , Bulgaria
UMHAT - Prof. Dr. Stoyan Kirkovich" AD
Stara Zagora, , Bulgaria
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyany, Liaoning, China
Jiangsu Province Hospital
Nanjing, Nanjing, China
Shanghai Tongren Hospital
Changning District, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First People's Hospital of Hangzhou Linping District
Hangzhou, Zhejiang, China
Beijing Hospital
Beijing, , China
Chongqing Cancer Hospital
Chongqing, , China
Henan Cancer Hospital
Zhengzhou, , China
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Hospitalier Le Mans
Le Mans, , France
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
Debrecen, , Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, , Hungary
Irccs Crob
Rionero in Vulture, Potenza, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
Milan, , Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza, , Italy
Azienda Ospedale Maggiore Della Carita
Novara, , Italy
Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
Perugia, , Italy
Ospedale Santa Maria delle Croci
Ravenna, , Italy
Azienda Ospedaliera Santa Maria Terni
Terni, , Italy
Azienda sanitaria integrata università di Trieste
Trieste, , Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Chiba Cancer Center
Chiba, Chiba, Japan
Fukui Medical University Hospital
Yoshida-Gun, Fukui, Japan
Hokuyukai Sapporo Hokuyu Hospital
Sapporo, Hokkaido, Japan
Kochi Medical School Hospital
Nankoku, Kochi, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
NHO Sendai Medical Center
Sendai, Miyagi, Japan
Dokkyo Medical University - Koshigaya Hospital
Koshigaya, Saitama, Japan
University of Yamanashi Hospital
Chūō, Yamanshi, Japan
Aomori Prefectural Centeral Hospital
Aomori, , Japan
JCHO Kyushu Hospital
Fukoka-ken, , Japan
North Shore Hospital, Haematology Research
Takapuna, Auckland, New Zealand
Tauranga Hospital
Tauranga, Bay of Plenty, New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Middlemore Clinical Trials
Papatoetoe, , New Zealand
Wojewodzki Szpital Specjalistyczny
Iwaszkiewicza 5, Legnica, Poland
Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin
Lublin, Lubelskie V, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Centrum Medyczne Pratia Poznan
Skorzewo, Poznan, Poland
KO-MED Centra Kliniczne
Biała Podlaska, , Poland
Szpital Uniwersytecki nr 1 im. Antoniego Jurasza
Bydgoszcz, , Poland
Pratia Onkologia Katowice
Katowice, , Poland
Pratia MCM Krakow
Krakow, , Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin, , Poland
Nasz Lekarz Osrodek Badan Klinicznych
Torun, , Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny Klinika
Wroclaw, , Poland
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
Braga, , Portugal
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, , Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto, , Portugal
Spitalul Clinic Municipal Filantropia Craiova
Craiova, Dolj, Romania
Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular
Bucharest, , Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Cluj-Napoca, , Romania
Institutului Regional de Oncologie IASI
Iași, , Romania
Academician I.P. Pavlov First St-Petersburg State Medical University
Saint Petersburg, , Russia
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [Incheon], South Korea
The Catholic University of Korea-Seoul St. Mary's Hospital
Seocho-Gu, Seoul, South Korea
Seoul National University Hospital
Seoul, Seoul, Korea, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Inje Univ Busan Paik Hospital
Busan, , South Korea
Hospital Universitario HM Sanchinarro
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Chang Bing Show Chwan Memorial Hospital
Changhua, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan, , Taiwan
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Countries
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Related Links
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A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-313)
Other Identifiers
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J2N-OX-JZNP
Identifier Type: OTHER
Identifier Source: secondary_id
LOXO-BTK-20023
Identifier Type: OTHER
Identifier Source: secondary_id
18088
Identifier Type: -
Identifier Source: org_study_id
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