A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
- Conditions
- Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
- Interventions
- Registration Number
- NCT05023980
- Lead Sponsor
- Loxo Oncology, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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)
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B (BR) Rituximab Bendamustine plus rituximab administered intravenously (IV) Arm A (Pirtobrutinib) Pirtobrutinib Pirtobrutinib administered orally Arm B (BR) Bendamustine Bendamustine plus rituximab administered intravenously (IV)
- Primary Outcome Measures
Name Time Method To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B) Up to approximately 5 years Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria
- Secondary Outcome Measures
Name Time Method To evaluate the effectiveness of Arm A compared to Arm B: Progression-free survival (PFS) Up to approximately 5 years Assessments of effectiveness include PFS, assessed by investigator
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms Up to approximately 5 years Based on time to worsening of CLL/SLL-related symptoms
To evaluate the effectiveness of Arm A compared to Arm B: Time to next treatment (TTNT) Up to approximately 5 years Assessments of effectiveness include TTNT, assessed by investigator
To evaluate the effectiveness of Arm A compared to Arm B: Overall survival (OS) Up to approximately 5 years Assessments of effectiveness include OS, assessed by investigator
To evaluate the effectiveness of Arm A compared to Arm B: Overall response rate (ORR) Up to approximately 5 years Assessments of effectiveness include ORR, assessed by investigator and IRC
To evaluate the effectiveness of Arm A compared to Arm B: Duration of Response (DOR) Up to approximately 5 years Assessments of effectiveness include DOR, assessed by investigator and IRC
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning Up to approximately 5 years Based on time to worsening of physical functioning
Trial Locations
- Locations (108)
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Centro Gaucho Integrado - Mae de Deus Center
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Kralove, Czechia
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Clinical Research Alliance, Inc.
🇺🇸Westbury, New York, United States
Oncology-Hematology Associates of West Broward
🇺🇸Coral Springs, Florida, United States
"SHATHD" EAD, Sofia
🇧🇬Sofia, Bulgaria
UMHAT - Prof. Dr. Stoyan Kirkovich" AD
🇧🇬Stara Zagora, Bulgaria
Anhui Provincial Cancer Hospital
🇨🇳Hefei, Anhui, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
🇨🇳Shenyany, Liaoning, China
Shanghai Tongren Hospital
🇨🇳Changning District, Shanghai, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
The First People's Hospital of Hangzhou Linping District
🇨🇳Hangzhou, Zhejiang, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Chongqing Cancer Hospital
🇨🇳Chongqing, China
Beijing Hospital
🇨🇳Beijing, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
Hospitalier Le Mans
🇫🇷Le Mans, France
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
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
🇮🇹Meldola, Italy
ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
🇮🇹Milano, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
🇮🇹Monza, Italy
Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
🇮🇹Perugia, Italy
Ospedale Santa Maria delle Croci
🇮🇹Ravenna, Italy
Azienda Ospedale Maggiore Della Carita
🇮🇹Novara, Italy
Azienda sanitaria integrata università di Trieste
🇮🇹Trieste, Italy
Chiba Cancer Center
🇯🇵Chiba-Shi, Chiba, Japan
Azienda Ospedaliera Santa Maria Terni
🇮🇹Terni, Italy
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
Fukui Medical University Hospital
🇯🇵Yoshida-Gun, Fukui, Japan
Hokuyukai Sapporo Hokuyu Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Kochi Medical School Hospital
🇯🇵Nankoku, Kochi, Japan
Tohoku University Hospital
🇯🇵Sendai-shi, Miyagi, Japan
Dokkyo Medical University - Koshigaya Hospital
🇯🇵Koshigaya, Saitama, Japan
University of Yamanashi Hospital
🇯🇵Chuo, Yamanshi, Japan
Aomori Prefectural Centeral Hospital
🇯🇵Aomori, Japan
Seoul National University Hospital
🇰🇷Seoul, Seoul, Korea, Korea, Republic of
JCHO Kyushu Hospital
🇯🇵Fukoka-ken, Japan
Gachon University Gil Medical Center
🇰🇷Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of
The Catholic University of Korea-Seoul St. Mary's Hospital
🇰🇷Seocho-Gu, Seoul, Korea, Republic of
Inje Univ Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Tauranga Hospital
🇳🇿Tauranga, Bay Of Plenty, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Wojewodzki Szpital Specjalistyczny
🇵🇱Iwaszkiewicza 5, Legnica, Poland
Middlemore Clinical Trials
🇳🇿Papatoetoe, New Zealand
Centrum Medyczne Pratia Poznan
🇵🇱Skorzewo, Poznan, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdańsk, Pomorskie, Poland
Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin
🇵🇱Lublin, Lubelskie V, 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
🇵🇱Kraków, Poland
Centrum Onkologii Ziemi Lubelskiej
🇵🇱Lublin, Poland
Nasz Lekarz Osrodek Badan Klinicznych
🇵🇱Toruń, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy
🇵🇱Warsaw, Poland
Uniwersytecki Szpital Kliniczny Klinika
🇵🇱Wrocław, Poland
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
Spitalul Clinic Municipal Filantropia Craiova
🇷🇴Craiova, Dolj, Romania
Institutul Clinic Fundeni - Centrul de Hematologie si Transplant Medular
🇷🇴Bucuresti, Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
🇷🇴Cluj-Napoca, Romania
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Universitario Virgen de Valme
🇪🇸Sevilla, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
North Shore Hospital, Haematology Research
🇳🇿Takapuna, Auckland, New Zealand
Innovative Clinical Research Institute
🇺🇸Whittier, California, United States
Uniklinikum Salzburg
🇦🇹Salzburg, Austria
California Research Institute
🇺🇸Los Angeles, California, United States
New Jersey Center for Cancer Research
🇺🇸Brick, New Jersey, United States
Westmead Hospital
🇦🇺Wentworthville, New South Wales, Australia
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Klinik Ottakring
🇦🇹Vienna, Austria
Jiangsu Province Hospital
🇨🇳Nanjing, Nanjing, China
Institute of hematology&blood disease hospital
🇨🇳Tianjin, Tianjin, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Debreceni Egyetem Orvos-es Egészsegtudomanyi Centrum
🇭🇺Debrecen, Hungary
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
🇮🇹Brescia, Italy
Samsung Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
🇵🇹Braga, Portugal
Institutului Regional de Oncologie IASI
🇷🇴Iasi, Romania
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
🇵🇹Porto, Portugal
Chang Gung Memorial Hospital - Linkou
🇨🇳Taoyuan City, Taiwan
Chang Bing Show Chwan Memorial Hospital
🇨🇳Changhua, Taiwan
Birmingham Heartlands Hospital
🇬🇧Birmingham, England, United Kingdom
NHO Sendai Medical Center
🇯🇵Sendai-shi, Miyagi-Ken, Japan
UMHAT "Sveti Georgi" EAD
🇧🇬Plovdiv, Bulgaria
Academician I.P. Pavlov First St-Petersburg State Medical University
🇷🇺St-Petersburg, Russian Federation
UMHAT 'Sv. Ivan Rilski', EAD
🇧🇬Sofia, Bulgaria
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Peninsula Private Hospital
🇦🇺Frankston, Victoria, Australia
Hemocentro Unicamp
🇧🇷Campinas, São Paulo, Brazil
Fundação Doutor Amaral Carvalho
🇧🇷Jaú, São Paulo, Brazil