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)

April 4, 2024 updated by: Loxo Oncology, Inc.

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
      • Wentworthville, New South Wales, Australia, 2145
        • Westmead Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Peninsula Private Hospital
  • Austria
      • Salzburg, Austria, 5020
        • Uniklinikum Salzburg
      • Vienna, Austria, 1160
        • Klinik Ottakring
  • Brazil
    • Paraná
      • Curitiba, Paraná, Brazil, 80810050
        • Centro Integrado de Oncologia de Curitiba
    • Rio Grande Do Sul
      • Passo Fundo, Rio Grande Do Sul, Brazil, 99010090
        • Instituto do Câncer - Hospital São Vicente de Paulo
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90110270
        • Centro Gaucho Integrado - Mae de Deus Center
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-878
        • Hemocentro Unicamp
      • Jaú, São Paulo, Brazil, 17210120
        • Fundacao Doutor Amaral Carvalho
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • UMHAT "Sveti Georgi" EAD
      • Sofia, Bulgaria, 1431
        • UMHAT 'Sv. Ivan Rilski', EAD
      • Sofia, Bulgaria, 1797
        • "SHATHD" EAD, Sofia
      • Stara Zagora, Bulgaria, 6003
        • UMHAT - Prof. Dr. Stoyan Kirkovich" AD
  • China
      • Beijing, China, 100730
        • Beijing Hospital
      • Chongqing, China, 400030
        • Chongqing Cancer Hospital
      • Haikou, China, 570311
        • Hainan General Hospital
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
    • Anhui
      • Hefei, Anhui, China, 233004
        • Anhui Provincial Cancer Hospital
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University first hospital
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 510000
        • Cancer Center of Guangzhou Medical University
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital Of Nanchang University
    • Liaoning
      • Shenyany, Liaoning, China, 110022
        • Shengjing Hospital of China Medical University
    • Nanjing
      • Nanjing, Nanjing, China, 210029
        • Jiangsu Province Hospital
    • Shanghai
      • Changning District, Shanghai, China, 200050
        • shanghai Tongren hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, Tianjin, China, 300020
        • Institute of hematology&blood disease hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 311100
        • The First People's Hospital of Hangzhou Linping District
  • Czechia
      • Brno, Czechia, 62500
        • Fakultni nemocnice Brno
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Praha 10, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Praha 2, Czechia, 12808
        • Vseobecna Fakultni Nemocnice V Praze
  • France
      • Le Mans, France, 72000
        • Hospitalier Le Mans
      • Nimes, France, 30900
        • Chu Nimes/Institut De Cancerologie Du Gard
    • Tours Cedex 9
      • Tours, Tours Cedex 9, France, 37044
        • CHRU De Tours
    • Vendee
      • La Roche-sur-Yon, Vendee, France, 85000
        • CHD Vendee
  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem
      • Budapest, Hungary, 1122
        • National Institute of Oncology
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
      • Nyíregyháza, Hungary, 4400
        • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
      • Székesfehérvár, Hungary, 8000
        • Fejér Megyei Szent György Egyetemi Oktató Kórház
  • Ireland
      • Dublin 7, Ireland
        • Mater Misericordiae Hospital
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
      • Firenze, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milano, Italy, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
      • Monza, Italy, 20900
        • Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
      • Novara, Italy, 28100
        • Azienda Ospedale Maggiore Della Carita
      • Palermo, Italy, 90146
        • Azienda Ospedaliera Vincenzo Cervello
      • Perugia, Italy, 06132
        • Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
      • Ravenna, Italy, 48020
        • Ospedale Santa Maria delle Croci
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli
      • Terni, Italy, 05100
        • Azienda Ospedaliera Santa Maria Terni
      • Torino, Italy, 10126
        • A.O.U. Citta' della Salute e della Scienza di Torino
      • Tricase (Le), Italy, 73039
        • Azienda Ospedaliera Card. G. Panico
      • Trieste, Italy, 34125
        • Azienda sanitaria integrata università di Trieste
    • BO
      • Bologna, BO, Italy, 40138
        • IRCCS - AOU di Bologna
    • PI
      • Pisa, PI, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
    • Potenza
      • Rionero In Vulture, Potenza, Italy, 85028
        • Irccs Crob
  • Japan
      • Fukoka-ken, Japan, 806 8501
        • JCHO Kyushu Hospital
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 467-8602
        • Nagoya City University Hospital
      • Nagoya, Aichi, Japan, 460-0001
        • Nagoya Medical Center
    • Chiba
      • Chiba-Shi, Chiba, Japan, 260-8717
        • Chiba Cancer Center
    • Fukui
      • Yoshida-Gun, Fukui, Japan, 910-1193
        • Fukui Medical University Hospital
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan, 807 8556
        • Hospital of University of Occupational and Environmental Health
    • Fukuoka-Ken
      • Kurume-shi, Fukuoka-Ken, Japan, 830 8543
        • Our Lady of the Snow St. Mary's Hospital
    • HigaShiibaraki-Gun
      • Ibaraki-machi, HigaShiibaraki-Gun, Japan, 311 3193
        • NHO Mito Medical Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
    • Kochi
      • Nankoku, Kochi, Japan, 783-8505
        • Kochi Medical School Hospital
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Saitama
      • Kawagoe, Saitama, Japan, 350-8550
        • Saitama Medical Center
      • Koshigaya, Saitama, Japan, 343 8555
        • Dokkyo Medical University - Koshigaya Hospital
    • Yamanshi
      • Chuo, Yamanshi, Japan, 409-3821
        • University of Yamanashi Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Inje Univ Busan Paik Hospital
    • Incheon-gwangyeoksi [Incheon]
      • Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 21565
        • Gachon University Gil Medical Center
    • Seoul
      • Seocho-Gu, Seoul, Korea, Republic of, 06591
        • The Catholic University of Korea-Seoul St. Mary's Hospital
    • Seoul, Korea
      • Seoul, Seoul, Korea, Korea, Republic of, 03080
        • Seoul National University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
      • Papatoetoe, New Zealand, 2025
        • Middlemore Clinical Trials
    • Auckland
      • Takapuna, Auckland, New Zealand, 0622
        • North Shore Hospital, Haematology Research
    • Bay Of Plenty
      • Tauranga, Bay Of Plenty, New Zealand, 3112
        • Tauranga Hospital
  • Poland
      • Biała Podlaska, Poland, 21500
        • KO-MED Centra Kliniczne
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii
      • Katowice, Poland, 40519
        • Pratia Onkologia Katowice
      • Kraków, Poland, 30-510
        • Pratia MCM Krakow
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi Lubelskiej
      • Opole, Poland, 45061
        • Szpital Wojewódzki w Opolu
      • Toruń, Poland, 87-100
        • Nasz Lekarz Ośrodek Badań Klinicznych
      • Warsaw, Poland, 02781
        • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy
      • Wrocław, Poland, 50-367
        • Uniwersytecki Szpital Kliniczny Klinika
    • Legnica
      • Iwaszkiewicza 5, Legnica, Poland, 59-220
        • Wojewodzki Szpital Specjalistyczny
    • Lubelskie V
      • Lublin, Lubelskie V, Poland, 20081
        • Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80214
        • Uniwersyteckie Centrum Kliniczne
    • Poznan
      • Skorzewo, Poznan, Poland, 60 185
        • Centrum Medyczne Pratia Poznan
  • Portugal
      • Braga, Portugal, 4710-243
        • Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
      • Lisboa, Portugal, 1649035
        • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
      • Porto, Portugal, 4200-072
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
      • Porto, Portugal, 4200-319
        • Hospital de Sao Joao E.P.E.
      • Vila Nova De Gaia, Portugal, 4434-536
        • Centro Hospitalar de Vila Nova de Gaia
  • Romania
      • Bucuresti, Romania, 020125
        • Spitalul Clinic Colentina
      • Bucuresti, Romania, 030171
        • Spitalul Clinic Coltea
      • Bucuresti, Romania, 022328
        • Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
      • Iasi, Romania, 700483
        • Institutului Regional de Oncologie IASI
      • Oradea, Romania, 410469
        • Spitalul Clinic Judetean de Urgenta Oradea
      • Targu Mures, Romania, 540136
        • Spitalul Clinic Judetean de Urgenta Targu Mures
    • Dolj
      • Craiova, Dolj, Romania, 200143
        • Spitalul Clinic Municipal Filantropia Craiova
  • Russian Federation
      • Penza, Russian Federation, 440071
        • Regional Oncology Dispensary
      • St-Petersburg, Russian Federation, 197022
        • Academician I.P. Pavlov First St-Petersburg State Medical University
    • Omskaya Oblast
      • Omsk, Omskaya Oblast, Russian Federation, 644013
        • Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
  • Spain
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i Sant Pau
      • L'Hospitalet De Llobregat, Spain, 08908
        • Hospital Duran I Reynals
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Sevilla, Spain, 41014
        • Hospital Universitario Virgen de Valme
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28050
        • Hospital Universitario HM Sanchinarro
  • Taiwan
      • Changhua, Taiwan, 50544
        • Chang Bing Show Chwan Memorial Hospital
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital - Linkou
  • United Kingdom
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
    • England
      • Birmingham, England, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • California Research Institute
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute
    • Florida
      • Tamarac, Florida, United States, 33321
        • Oncology-Hematology Associates of West Broward
    • Maine
      • Lewiston, Maine, United States, 04240
        • Central Maine Medical Center
    • Michigan
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Ascension St. John Hospital
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • New Jersey Center for Cancer Research
    • New York
      • Westbury, New York, United States, 11590
        • Clinical Research Alliance, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (Pirtobrutinib)
Pirtobrutinib administered orally
Drug: Pirtobrutinib
Oral
Other Names:
  • LOXO-305
  • LY3527727
Active Comparator: Arm B (BR)
Bendamustine plus rituximab administered intravenously (IV)
Drug: Rituximab
IV
Other Names:
  • Rituxan
  • MabThera
  • Riabni
  • Ruxience
  • Truxima
Drug: Bendamustine
IV
Other Names:
  • Treanda
  • Levact
  • Ribomustin
  • Treakisym

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B)
Time Frame: Up to approximately 5 years
Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms
Time Frame: Up to approximately 5 years
Based on time to worsening of CLL/SLL-related symptoms
Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning
Time Frame: Up to approximately 5 years
Based on time to worsening of physical functioning
Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Progression-free survival (PFS)
Time Frame: Up to approximately 5 years
Assessments of effectiveness include PFS, assessed by investigator
Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Overall survival (OS)
Time Frame: Up to approximately 5 years
Assessments of effectiveness include OS, assessed by investigator
Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Time to next treatment (TTNT)
Time Frame: Up to approximately 5 years
Assessments of effectiveness include TTNT, assessed by investigator
Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Overall response rate (ORR)
Time Frame: Up to approximately 5 years
Assessments of effectiveness include ORR, assessed by investigator and IRC
Up to approximately 5 years
To evaluate the effectiveness of Arm A compared to Arm B: Duration of Response (DOR)
Time Frame: Up to approximately 5 years
Assessments of effectiveness include DOR, assessed by investigator and IRC
Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loxo Oncology, Inc.

Collaborators

Eli Lilly and Company

Investigators

  • Study Director: Alex Levy, MD, Loxo Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2021

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOXO-BTK-20023
  • J2N-OX-JZNP (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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