A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

September 20, 2021

Primary Completion Date

April 30, 2026

Study Completion Date

January 31, 2027

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Pirtobrutinib

Oral

DRUG

Venetoclax

Oral

DRUG

Rituximab

Intravenous (IV)

Trial Locations (176)

1122

National Institute of Oncology, Budapest

1474

Akershus Universitetssykehus, Nordbyhagen

2200

Rigshospitalet, Copenhagen

3004

The Alfred Hospital, Melbourne

3065

St Vincent's Hospital, Melbourne

3199

Peninsula Private Hospital, Frankston

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

5000

Royal Adelaide Hospital, Adelaide

5530

CHU UCL Namur site Godinne, Yvoir

6000

Luzerner Kantonsspital, Lucerne

6009

Sir Charles Gairdner Hospital, Perth

6500

Ospedale Regionale Bellinzona e Valli, Bellinzona

7000

Royal Hobart Hospital, Hobart

7006

St-Olavs Hospital, Trondheim

7100

Groupe Jolimont, La Louvière

8035

Hospital Universitari Vall d'Hebron, Barcelona

8041

Hospital de la Santa Creu i Sant Pau, Barcelona

9000

Universitair Ziekenhuis Gent, Ghent

10002

National Taiwan University Hospital, Taipei

10029

The Mount Sinai Hospital, New York

10032

Columbia University Medical Center, New York

10034

Fakultni nemocnice Kralovske Vinohrady, Prague

10065

Memorial Sloan Kettering Cancer Center, New York

10126

A.O.U. Citta' della Salute e della Scienza di Torino, Torino

12100

Ospedale Santa Croce e Carle, Cuneo

12808

Vseobecna fakultni nemocnice v Praze, Prague

17176

Karolinska Universitetssjukhuset i Solna, Stockholm

18057

Unimedizin RostockZIM III -Haemtologie, Rostock

19111

Fox Chase Cancer Center, Philadelphia

20132

IRCCS Ospedale San Raffaele, Milan

20162

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

20817

American Oncology Partners of Maryland, PA, Bethesda

22031

Virginia Cancer Specialists, PC - Lee Highway, Fairfax

22100

Galilee Medical Center, Nahariya

22185

Skanes Universitetssjukhus, Hematoloaimottagningen, Lund

27710

Duke University Medical Center, Durham

27893

Regional Medical Oncology Center, Wilson

28031

Hospital Universitario Infanta Leonor, Madrid

28033

MD Anderson Cancer Center, Madrid

28040

Hospital Universitario Fundación Jiménez Díaz, Madrid

28100

Azienda Ospedale Maggiore Della Carita, Novara

28204

Levine Cancer Institute, Charlotte

Novant Cancer Institute Charlotte, Charlotte

28222

Hospital Puerta De Hierro, Majadahonda

28223

Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón

29600

Hospital Costa Del Sol, Marbella

32086

Cancer Specialists of North Florida -St Augustine, Saint Augustine

33011

Hospital Universitario Central de Asturias, Oviedo

33401

Florida Cancer Specialists East, West Palm Beach

34295

Hopital Saint Eloi, Montpellier

35033

Hôpital de Pontchaillou, Rennes

37044

CHRU De Tours, Tours

37203

Sarah Cannon Research Institute SCRI, Nashville

Tennessee Oncology PLLC, Nashville

40138

IRCCS - AOU di Bologna, Bologna

40519

Pratia Onkologia Katowice, Katowice

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen Del Rocio, Seville

41224

A.O.U. di Modena, Modena

41501

Pikeville Medical Center, Inc., Pikeville

43210

The James Cancer Hospital, Columbus

44093

CHU de Nantes - Hotel Dieu, Nantes

44106

University Hospitals Cleveland Medical Center, Cleveland

44124

AOU Arcispedale Sant'Anna, Cona

45007

Hospital Universitario de Toledo, Toledo

45147

Universtitätsklinikum Essen AöR, Essen

45242

Oncology Hematology Care Inc, Cincinnati

46026

Hospital Universitari i Politecnic La Fe, Valencia

47014

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

48106

St. Joseph Mercy Hospital, Ann Arbor

48109

University of Michigan, Ann Arbor

50134

Azienda Ospedaliera Universitaria Careggi, Florence

50309

Mission Cancer and Blood, Des Moines

50937

Uniklinik Köln, Kerpener

54511

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois, Morvan

62500

Fakultni nemocnice Brno, Brno

64132

Research Medical Center, Kansas City

67033

ICANS_Institut de Cancerologie Strasbourg Europe, Strasbourg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

72000

Centre Hospitalier du Mans, Le Mans

75010

Hopital Saint Louis, Paris

75246

Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas

75651

Hopital de la Pitie Salpetriere, Paris

76038

Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen, Rouen

77030

University of Texas MD Anderson Cancer Center, Houston

78240

USO - Texas Oncology - San Antonio, San Antonio

80804

München Klinik Schwabing, Koelner Platz 1

85054

Mayo Clinic Hospital, Phoenix

85224

Ironwood Physicians, Ironwood Cancer and Research Centers, Chandler

86021

Pole Regionalde Cancérologie(CHU de Poitiers), Politiers

88100

Azienda Ospedaliera Pugliese Ciaccio, Catanzaro

92111

Scripps Mercy Hospital, San Diego

92868

University of California Irvine Medical Center, Orange

93510

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii, Lodz

95403

Providence Medical Foundation, Santa Rosa

97080

Gemeinschaftspraxis Dres. Schöttker & Pretscher, z.Hd. Sophie Enz, Würzburg

97401

Oncology Associates of Bridgeport P.C., Eugene

98104

Swedish Cancer Institute; STE 1020, Seattle

98684

Northwest Cancer Specialists PC, Vancouver

100034

Peking University First Hospital, Beijing

100044

Peking University People's Hospital, Beijing

110004

Shengjing Hospital of China Medical University, Shenyang

169078

Singapore General Hospital, Singapore

200025

Shanghai Jiaotong University School of Medicine Ruijin Hospital, Shanghai

200336

Shanghai Tongren Hospital, Shanghai

210029

Jiangsu Province Hospital, Nanjing

214023

Wuxi People's Hospital, Wuxi

226000

Nantong Tumor Hospital, Nantong

230022

The First Affiliated Hospital of Anhui Medical University, Hefei

266555

The Affiliated Hospital of Qingdao University, Qingdao

300060

Tianjin Medical University Cancer Institute and Hospital, Tianjin

310003

First Affiliated Hosp of College of Med, Zhejiang University, Hangzhou

330029

Jiangxi Provincial Cancer Hospital, Nanchang

350014

Fujian Provincial Cancer Hospial, Fuzhou

400030

Chongqing Cancer Hospital, Chongqing

410008

The Second Xiangya Hospital of Central South University, Changsha

421001

The First Affiliated Hospital Of University Of South China, Hengyang

430022

Wuhan Union Hospital, Wuhan

430030

Wu Han Tongji Hospital, Wuhan

443003

Yichang Central People's Hospital, Yichang

450003

Henan Provincial People's Hospital, Zhengzhou

450008

Henan Cancer Hospital, Zhengzhou

510000

Cancer Center of Guangzhou Medical University, Guangzhou

528403

Zhongshan City People's Hospital, Zhongshan

530021

Guangxi Medical University Affiliated Tumor Hospital, Nanning

650034

The First People's Hospital of Yunnan Province, Kunming

3339419

Bnai Zion Medical Center, Haifa

4941492

Rabin Medical Center, Petah Tikva

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

7610001

Kaplan Medical Center, Rehovot

9101193

University of Fukui Hospital, Fukui

06902

Stamford Hospital, Stamford

33916-2233

Florida Cancer Specialists, Fort Myers

02215

Dana-Farber Cancer Institute, Boston

55905-0002

Mayo Clinic, Rochester

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

22908-0816

University of Virginia Health System, Charlottesville

23298-0070

Virginia Commonwealth University Massey Cancer Center, Richmond

98104-2092

Fred Hutchinson Cancer Research Center, Seattle

T2N 2T9

Foothills Medical Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

H3T 1E2

Jewish General Hospital, Montreal

M4N 3M5

Sunnybrook Research Institute, Toronto

V5Z 4E6

BC Cancer Vancouver, Vancouver

R3A 1M3

Cancer Care Manitoba, Winnipeg

010050

The Affiliated Hospital of Inner Mongolia Medical University, Hohhot

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

09131

Klinikum Chemnitz GmbH, Chemnitz

04103

Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Hämatologie, Leipzig

Unknown

Mater Misericordiae Hospital, Dublin

Instytut Hermatologii I Transfuzjologii, Warsaw

X91 ER8E

University Hospital Waterford, Waterford

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore, Roma

00161

Policlinico Umberto I - Haematology, Rome

113-8519

Tokyo Medical and Dental University Hospital, Bunkyō City

277 8577

National Cancer Center Hospital East, Chiba-Ken

409-3821

University of Yamanashi Hospital, Chūō

104-0045

National Cancer Center Hospital, Chūōku

135-8550

Japanese Foundation for Cancer Research, Kōtō City

602-8566

Kyoto Furitsu Medical University Hospital, Kyoto

783-8505

Kochi Medical School Hospital, Nankoku

700-8558

Okayama University Hospital, Okayama

534-0021

Osaka City General Hospital, Osaka

81-519

Szpitale Pomorskie Sp. z o. o., Gdynia

30-510

Pratia MCM Krakow, Krakow

20-081

Klinika Hematoonkologii i Transplantacji Szpiku,Samodzielny Publiczny Szpital Kliniczny Nr 1, Lublin

87-100

MICS Centrum Medyczne Torun, Torun

03080

Seoul National University Hospital, Seoul

06351

Samsung Medical Center, Seoul

08036

Hospital Clinic de Barcelona, Barcelona

B9 5SS

Birmingham Heartlands Hospital, Birmingham

LS9 7TF

St James's University Hospital, Leeds

LE1 5WW

Leicester Royal Infirmary, Leicester

SW3 6JJ

Royal Marsden Hospital, London

OX3 7LJ

Churchill Hospital, Oxford

PL6 8DH

Derriford Hospital, Plymouth

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Loxo Oncology, Inc.

INDUSTRY

NCT04965493 - A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) | Biotech Hunter | Biotech Hunter