Non Hodgkin Lymphoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT05023980

Recruitment Status:

Recruiting

Sponsor:

Loxo Oncology, Inc.

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There are 126 Locations for this study

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California Research Institute
Los Angeles California, 90027, United States More Info
Contact
323-660-6200
Ghassan Al-Jazayrly
Principal Investigator
Innovative Clinical Research Institute
Whittier California, 90603, United States More Info
Contact
562-693-4477
Richy Agajanian
Principal Investigator
Oncology-Hematology Associates of West Broward
Tamarac Florida, 33321, United States More Info
Contact
954-204-0052
Sumit Sawhney
Principal Investigator
Central Maine Medical Center
Lewiston Maine, 04240, United States More Info
Contact
207-782-9835
Daniel Rausch
Principal Investigator
Ascension St. John Hospital
Grosse Pointe Woods Michigan, 48236, United States More Info
Contact
313-343-3166
Daniel Lebovic
Principal Investigator
New Jersey Center for Cancer Research
Brick New Jersey, 08724, United States More Info
Contact
732-840-8880
Apurv Agrawal
Principal Investigator
Clinical Research Alliance, Inc.
Westbury New York, 11590, United States More Info
Contact
516-488-2918
Morton Coleman
Principal Investigator
Liverpool Hospital
Liverpool New South Wales, 2170, Australia More Info
Contact
61287385167
Vu Minh hua
Principal Investigator
Westmead Hospital
Wentworthville New South Wales, 2145, Australia More Info
Contact
61288905448
Gaurav Sutrave
Principal Investigator
Peninsula Private Hospital
Frankston Victoria, 3199, Australia More Info
Contact
0397883647
Patricia Walker
Principal Investigator
Uniklinikum Salzburg
Salzburg , 5020, Austria More Info
Contact
435725525822
Richard Greil
Principal Investigator
UMHAT "Sveti Georgi" EAD
Plovdiv , 4000, Bulgaria More Info
Contact
359888520139
Zhanet Grudeva-Popova
Principal Investigator
UMHAT 'Sv. Ivan Rilski', EAD
Sofia , 1431, Bulgaria More Info
Contact
35928582024
Atanas Radinoff
Principal Investigator
"SHATHD" EAD, Sofia
Sofia , 1797, Bulgaria More Info
Contact
359898719792
Tonya Yankova
Principal Investigator
UMHAT - Prof. Dr. Stoyan Kirkovich" AD
Stara Zagora , 6003, Bulgaria More Info
Contact
359884303483
Maria Todorova
Principal Investigator
Anhui Provincial Cancer Hospital
Hefei Anhui, 23300, China More Info
Contact
8613625520213
Kaiyang Ding
Principal Investigator
Peking University First Hospital
Beijing Beijing, 10003, China More Info
Contact
18330935797
Yujun Dong
Principal Investigator
Peking University Third Hospital
Beijing Beijing, 10019, China More Info
Contact
17778027193
Xiaoyan Ke
Principal Investigator
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou Guangdong, 51012, China More Info
Contact
8615625891843
Zhenqian Huang
Principal Investigator
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan Hubei, 43002, China More Info
Contact
15172405695
Guohui Cui
Principal Investigator
Hunan Cancer Hospital
Changsha Hunan, 41001, China More Info
Contact
8613007403888
Hui Zhou
Principal Investigator
The First Affiliated Hospital of Nanchang University
Nanchang Jiangxi, 33000, China More Info
Contact
13657914239
Fei Li
Principal Investigator
Shengjing Hospital of China Medical University
Shenyany Liaoning, 11002, China More Info
Contact
15942907003
Wei Yang
Principal Investigator
Jiangsu Province Hospital
Nanjing Nanjing, 21002, China More Info
Contact
8613951019464
Jianyong Li
Principal Investigator
Shanghai Tongren Hospital
Changning District Shanghai, 20005, China More Info
Contact
19921055257
Ligen Liu
Principal Investigator
West China Hospital of Sichuan University
Chengdu Sichuan, 61004, China More Info
Contact
15281706453
Liqun Zou
Principal Investigator
Institute of hematology&blood disease hospital
Tianjin Tianjin, 30002, China More Info
Contact
15222885931
Shuhua Yi
Principal Investigator
Tianjin Medical University Cancer Institute and Hospital
Tianjin Tianjin, 30006, China More Info
Contact
15022492653
Lihua Qiu
Principal Investigator
The First People's Hospital of Hangzhou Linping District
Hangzhou Zhejiang, 31110, China More Info
Contact
15372002536
Yuefeng Zhang
Principal Investigator
Beijing Hospital
Beijing , 10073, China More Info
Contact
13756513114
HUI LIU
Principal Investigator
Chongqing Cancer Hospital
Chongqing , 40003, China More Info
Contact
8618311611644
Jieping Li
Principal Investigator
Hainan General Hospital
Haikou , 57031, China More Info
Contact
8618889624097
Lie Lin
Principal Investigator
Henan Cancer Hospital
Zhengzhou , 45000, China More Info
Contact
18738196013
Keshu Zhou
Principal Investigator
Fakultni nemocnice Brno
Brno , 62500, Czechia More Info
Contact
420532232158
Jiri Mayer
Principal Investigator
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia More Info
Contact
420739330844
Martin Simkovic
Principal Investigator
Fakultni nemocnice Kralovske Vinohrady
Praha 10 , 100 3, Czechia More Info
Contact
420267163672
Jan Novak
Principal Investigator
Vseobecna fakultni nemocnice v Praze
Praha 2 , 12808, Czechia More Info
Contact
420224963117
Marek Trneny
Principal Investigator
CHRU De Tours
Tours Tours Cedex 9, 37044, France More Info
Contact
33218370609
Caroline Dartigeas
Principal Investigator
CHD Vendee
La Roche-sur-Yon Vendee, 85000, France More Info
Contact
33251446572
Bruno Villemagne
Principal Investigator
Hospitalier Le Mans
Le Mans , 72000, France More Info
Contact
330253040492
Kamel Laribi
Principal Investigator
Chu Nimes/Institut De Cancerologie Du Gard
Nimes , 30900, France More Info
Contact
33466683528
Agathe Waultier Rascalou
Principal Investigator
Semmelweis Egyetem
Budapest , 1088, Hungary More Info
Contact
209436465
ZSOLT NAGY
Principal Investigator
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest , 1097, Hungary More Info
Contact
36301864908
Gabor Mikala
Principal Investigator
National Institute of Oncology
Budapest , 1122, Hungary More Info
Contact
36203535763
Andras Masszi
Principal Investigator
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza , 4400, Hungary More Info
Contact
36209985123
Laszlo Rejto
Principal Investigator
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár , 8000, Hungary More Info
Contact
36305828330
Arpad Batai
Principal Investigator
Mater Misericordiae Hospital
Dublin 7 , , Ireland More Info
Contact
018034831
Anne Fortune
Principal Investigator
IRCCS - AOU di Bologna
Bologna BO, 40138, Italy More Info
Contact
390512143227
Pier Luigi Zinzani
Principal Investigator
Azienda Ospedaliero Universitaria Pisana
Pisa PI, 56126, Italy More Info
Contact
050993025
Sara Galimberti
Principal Investigator
Irccs Crob
Rionero In Vulture Potenza, 85028, Italy More Info
Giuseppe Pietrantuono
Principal Investigator
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo , 24127, Italy More Info
Contact
390357676186
Alessandro Rambaldi
Principal Investigator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia , 25123, Italy More Info
Contact
390303996416
Marina Motta
Principal Investigator
Azienda Ospedaliera Universitaria Careggi
Firenze , 50134, Italy More Info
Contact
390557949183
Alessandro Sanna
Principal Investigator
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola , 47014, Italy More Info
Contact
390543739442
Gerardo Musuraca
Principal Investigator
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano , 20122, Italy More Info
Contact
0255033421
Gianluigi Reda
Principal Investigator
ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
Milano , 20162, Italy More Info
Contact
0264442367
Anna Maria Frustaci
Principal Investigator
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza , 20900, Italy More Info
Contact
390392339883
Carlo Gambacorti-Passerini
Principal Investigator
Azienda Ospedale Maggiore Della Carita
Novara , 28100, Italy More Info
Contact
3903213732094
Gianluca Gaidano
Principal Investigator
Azienda Ospedaliera Vincenzo Cervello
Palermo , 90146, Italy More Info
Caterina Patti
Principal Investigator
Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
Perugia , 06132, Italy More Info
Contact
390755782447
Paolo Sportoletti
Principal Investigator
Ospedale Santa Maria delle Croci
Ravenna , 48020, Italy More Info
Contact
390544285206
Monica Tani
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli
Roma , 00168, Italy More Info
Contact
393333846463
Luca Laurenti
Principal Investigator
Azienda Ospedaliera Santa Maria Terni
Terni , 05100, Italy More Info
Contact
744205407
Anna Marina Liberati
Principal Investigator
A.O.U. Citta' della Salute e della Scienza di Torino
Torino , 10126, Italy More Info
Contact
390116334290
Marta Coscia
Principal Investigator
Azienda Ospedaliera Card. G. Panico
Tricase (Le) , 73039, Italy More Info
Contact
3908333773111
Vincenzo Pavone
Principal Investigator
Azienda sanitaria integrata università di Trieste
Trieste , 34125, Italy More Info
Contact
390403992897
Francesco Zaja
Principal Investigator
Nagoya Medical Center
Nagoya Aichi, 460-0, Japan More Info
Contact
81529511111
Hirokazu Nagai
Principal Investigator
Nagoya City University Hospital
Nagoya Aichi, 467-8, Japan More Info
Contact
81528587215
Shigeru Kusumoto
Principal Investigator
Chiba Cancer Center
Chiba-Shi Chiba, 260-8, Japan More Info
Contact
81432645431
Masahiro Takeuchi
Principal Investigator
Fukui Medical University Hospital
Yoshida-Gun Fukui, 910-1, Japan More Info
Contact
81776618529
Eiju Negoro
Principal Investigator
Hospital of University of Occupational and Environmental Health
Kitakyushu-shi Fukuoka, 807 8, Japan More Info
Contact
818057265225
Junichi Tsukada
Principal Investigator
NHO Mito Medical Center
Ibaraki-machi HigaShiibaraki-Gun, 311 3, Japan More Info
Contact
81292407711
Chikashi Yoshida
Principal Investigator
Hokkaido University Hospital
Sapporo Hokkaido, 060-8, Japan More Info
Contact
81117067600
Daigo Hashimoto
Principal Investigator
Kanagawa cancer center
Yokohama Kanagawa, 241-8, Japan More Info
Contact
81455202222
Rika Sakai
Principal Investigator
Kochi Medical School Hospital
Nankoku Kochi, 783-8, Japan More Info
Contact
81888802627
Kensuke Kojima
Principal Investigator
Tohoku University Hospital
Sendai-shi Miyagi, 980-8, Japan More Info
Contact
81227177772
Noriko Fukuhara
Principal Investigator
Saitama Medical Center
Kawagoe Saitama, 350-8, Japan More Info
Contact
818022948135
Masahiro Kizaki
Principal Investigator
Dokkyo Medical University - Koshigaya Hospital
Koshigaya Saitama, 343 8, Japan More Info
Contact
81489650658
Toru Kiguchi
Principal Investigator
University of Yamanashi Hospital
Chuo Yamanshi, 409-3, Japan More Info
Contact
08099724203
Ichiro Kawashima
Principal Investigator
JCHO Kyushu Hospital
Fukoka-ken , 806 8, Japan More Info
Contact
818098890085
Ryosuke Ogawa
Principal Investigator
Kagoshima University Hospital
Kagoshima , 890-8, Japan More Info
Contact
819025810311
Kenji Ishitsuka
Principal Investigator
Okayama University Hospital
Okayama , 700-8, Japan More Info
Contact
81862357991
Daisuke Ennishi
Principal Investigator
Gachon University Gil Medical Center
Namdong-gu Incheon-gwangyeoksi [Incheon], 21565, Korea, Republic of More Info
Contact
821085338019
JAE-HOON LEE
Principal Investigator
Seoul National University Hospital
Seoul Seoul, Korea, 03080, Korea, Republic of More Info
Contact
82260725179
Junshik Hong
Principal Investigator
Severance Hospital, Yonsei University Health System
Seoul Seoul-teukbyeolsi [Seoul], 03722, Korea, Republic of More Info
Contact
82222284245
Jin Seok Kim
Principal Investigator
Samsung Medical Center
Seoul Seoul-teukbyeolsi [Seoul], 06351, Korea, Republic of More Info
Contact
821053620760
Sang-Eun Yoon
Principal Investigator
The Catholic University of Korea-Seoul St. Mary's Hospital
Seocho-Gu Seoul, 06591, Korea, Republic of More Info
Contact
821072383089
Ki-Seong Eom
Principal Investigator
Inje Univ Busan Paik Hospital
Busan , 47392, Korea, Republic of More Info
Contact
82518905716
Won Sik Lee
Principal Investigator
North Shore Hospital, Haematology Research
Takapuna Auckland, 0622, New Zealand More Info
Contact
6494868900
Anna Elinder-Camburn
Principal Investigator
Tauranga Hospital
Tauranga Bay Of Plenty, 3112, New Zealand More Info
Contact
64075575225
Marie Hughes
Principal Investigator
Christchurch Hospital
Christchurch , 8011, New Zealand More Info
Contact
6433640386
Peter Ganly
Principal Investigator
Middlemore Clinical Trials
Papatoetoe , 2025, New Zealand More Info
Contact
64021689297
Sharon Jackson
Principal Investigator
Wojewodzki Szpital Specjalistyczny
Iwaszkiewicza 5 Legnica, 59-22, Poland More Info
Contact
48668446646
Jadwiga Holojda
Principal Investigator
Klinika Hematoonkologii i Transplantacji Szpiku SPSK1 Lublin
Lublin Lubelskie V, 20081, Poland More Info
Contact
48510312194
Hus Marek
Principal Investigator
Uniwersyteckie Centrum Kliniczne
Gdańsk Pomorskie, 80214, Poland More Info
Contact
48585844357
Jan Zaucha
Principal Investigator
Centrum Medyczne Pratia Poznan
Skorzewo Poznan, 60 18, Poland More Info
Contact
48512491461
Michal Kwiatek
Principal Investigator
KO-MED Centra Kliniczne
Biała Podlaska , 21500, Poland More Info
Contact
48603352601
Piotr Centkowski
Principal Investigator
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii
Bydgoszcz , 85-16, Poland More Info
Contact
48696181995
Jaroslaw Czyz
Principal Investigator
Pratia Onkologia Katowice
Katowice , 40519, Poland More Info
Contact
48501714089
Sabastian Grosicki
Principal Investigator
Pratia MCM Krakow
Kraków , 30-51, Poland More Info
Contact
48515687195
Wojciech Jurczak
Principal Investigator
Centrum Onkologii Ziemi Lubelskiej
Lublin , 20-09, Poland More Info
Contact
48814541221
Krzysztof Giannopoulos
Principal Investigator
Szpital Wojewodzki w Opolu
Opole , 45061, Poland More Info
Contact
48662197382
Dariusz Woszczyk
Principal Investigator
Nasz Lekarz Osrodek Badan Klinicznych
Toruń , 87-10, Poland More Info
Contact
48661658158
Dominik Chraniuk
Principal Investigator
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Cuire - Państwowy Instytut Badawczy
Warsaw , 02781, Poland More Info
Contact
48225462223
Jan Walewski
Principal Investigator
Uniwersytecki Szpital Kliniczny Klinika
Wrocław , 50-36, Poland More Info
Contact
48694015995
Tomasz Wrobel
Principal Investigator
Centro Clínico Académico - Braga (2CA-Braga) (Hospital de Braga)
Braga , 4710-, Portugal More Info
Contact
351925822122
Marques Herlander
Principal Investigator
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisboa , 16490, Portugal More Info
Daniela Alves
Principal Investigator
Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Porto , 4200-, Portugal More Info
Contact
351225084000
Sergio Chacim
Principal Investigator
Hospital de Sao Joao E.P.E.
Porto , 4200-, Portugal More Info
Contact
351964028416
Ines Carvalhais
Principal Investigator
Centro Hospitalar de Vila Nova de Gaia
Vila Nova De Gaia , 4434-, Portugal More Info
Contact
351914338411
Henrique Coelho
Principal Investigator
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
Omsk Omskaya Oblast, 64401, Russian Federation More Info
Contact
79620336767
Mikhail Dvorkin
Principal Investigator
Regional Oncology Dispensary
Penza , 44007, Russian Federation More Info
Contact
79093226196
Tatiana Chagorova
Principal Investigator
Academician I.P. Pavlov First St-Petersburg State Medical University
St-Petersburg , 19702, Russian Federation More Info
Contact
79213317702
Natalia Mikhailova
Principal Investigator
Hospital Universitario Central de Asturias
Oviedo Asturias, 33011, Spain More Info
Contact
34985652489
Ángel Ramírez
Principal Investigator
Hospital Universitario HM Sanchinarro
Madrid Madrid, Comunidad De, 28050, Spain More Info
Contact
34917567984
Jaime Perez de Oteyza
Principal Investigator
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda Madrid, 28222, Spain More Info
Contact
34911916880
Jose Antonio Garcia Marco
Principal Investigator
Hospital de la Santa Creu i Sant Pau
Barcelona , 08041, Spain More Info
Contact
34935565520
Carolina Moreno Atanasio
Principal Investigator
Hospital Duran I Reynals
L'Hospitalet De Llobregat , 08908, Spain More Info
Contact
932607333
Eva González Barca
Principal Investigator
Hospital Universitario Fundación Jiménez Díaz
Madrid , 28040, Spain More Info
Contact
915504800
Raul Córdoba Mascuñano
Principal Investigator
Hospital Universitario Virgen del Rocío
Sevilla , 41013, Spain More Info
Contact
34955013277
Fatima de la Cruz
Principal Investigator
Hospital Universitario Virgen de Valme
Sevilla , 41014, Spain More Info
Contact
34955015474
Eduardo Rios Herranz
Principal Investigator
Chang Bing Show Chwan Memorial Hospital
Changhua , 50544, Taiwan More Info
Contact
88647813888
Cheng-Shyong Chang
Principal Investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 807, Taiwan More Info
Hui-Hua Hsiao
Principal Investigator
China Medical University Hospital
Taichung , 40447, Taiwan More Info
Contact
886422052121
Su-Peng Yeh
Principal Investigator
National Taiwan University Hospital
Taipei , 10002, Taiwan More Info
Contact
886905925927
Shang-Ju Wu
Principal Investigator
Chang Gung Memorial Hospital - Linkou
Taoyuan City , 333, Taiwan More Info
Contact
886922483966
Hsuan-Jen Shih
Principal Investigator
Birmingham Heartlands Hospital
Birmingham England, B9 5S, United Kingdom More Info
Contact
01214242704
Shankara Paneesha
Principal Investigator
New Cross Hospital
Wolverhampton , WV10 , United Kingdom More Info
Kasturi Mandal
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

250

Study ID:

NCT05023980

Recruitment Status:

Recruiting

Sponsor:


Loxo Oncology, Inc.

How clear is this clinincal trial information?

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