Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

April 8, 2021

Primary Completion Date

January 31, 2027

Study Completion Date

April 30, 2028

Conditions
Lymphoma, Mantle-Cell
Interventions
DRUG

Pirtobrutinib

Oral

DRUG

Ibrutinib

Oral

DRUG

Acalabrutinib

Oral

DRUG

Zanubrutinib

Oral

Trial Locations (189)

114

Tri-Service General Hospital, Taipei City

704

National Cheng-Kung Uni. Hosp., Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

2025

Middlemore Clinical Trials, Auckland

2217

The St. George Hospital, Kogarah

3000

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven

4020

Ordensklinikum Linz GmbH Elisabethinen, Linz

4066

Icon Cancer Care - The Wesley Medical Centre, Auchenflower

5000

Odense Universitetshospital, Odense C

5020

Uniklinikum Salzburg, Salzburg

6000

Royal Perth Hospital, Perth

Kantonsspital Luzern, Lucerne

6009

Linear Clinical Research, Nedlands

7000

Royal Hobart Hospital, Hobart

8011

Christchurch Hospital, Addington

8035

Hospital Universitari Vall d'Hebron, Barcelona

8800

AZ Delta, Roeselare

9000

Universitair Ziekenhuis Gent, Ghent

10002

National Taiwan University Hospital, Taipei

10032

Columbia University Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

11217

Taipei Veterans General Hospital, Taipei

15100

Presidio Ospedaliero Civile Santi Antonio e Biagio, Alessandria

16132

IRCCS Ospedale Policlinico San Martino, Genova

20132

Ospedale San Raffaele, Milan

21100

Ospedale Di Circolo E Fondazione Macchi, Varese

21201

Greenebaum Comprehensive Cancer Center, Baltimore

21565

Gachon University Gil Medical Center, Namdong-gu

22031

USO-Virginia Cancer Specialists, PC, Fairfax

22903

University of Virginia Health System, Charlottesville

23538

Universitätsklinikum Schleswig-Holstein, Lübeck

28007

Hospital General Universitario Gregorio Marañon, Madrid

28031

Hospital Universitario Infanta Leonor, Madrid

28040

Hospital Universitario Fundación Jiménez Díaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28204

Levine Cancer Institute, Charlotte

28806

Messino Cancer Center, Asheville

29010

Hospital Universitario Virgen de la Victoria, Málaga

31008

Clinica Universidad de Navarra, Pamplona

32224

Mayo Clinic in Florida, Jacksonville

33076

Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux

33305

Chang Gung Memorial Hospital - Linkou, Taoyuan

33321

Oncology-Hematology Associates of West Broward, Tamarac

33401

Florida Cancer Specialists East, West Palm Beach

33604

Centre hospitalier universitaire de Haut Leveque, Pessac

35392

Universitätsklinikum Gießen und Marburg GmbH, Giessen

37044

CHRU De Tours, Tours

37203

Sarah Cannon Research Institute SCRI, Nashville

40138

IRCCS - AOU di Bologna, Bologna

40447

China Medical University Hospital, Taichung

40504

University of Kentucky Markey Cancer Center, Lexington

42003

Mercy Health-Paducah Medical Oncology and Hematology, Paducah

42123

Arcispedale Santa Maria Nuova, Reggio Emilia

44093

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu, Nantes

45219

Oncology Hematology Care Inc, Cincinnati

46010

Hospital Clínico Universitario de Valencia, Valencia

47014

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

48121

Ospedale Santa Maria delle Croci, Ravenna

48149

Universitätsklinikum Münster - Albert Schweitzer Campus, Münster

48201

Karmanos Cancer Institute, Detroit

49267

Kosin University Gospel Hospital, Busan

53226

Froedtert Memorial Lutheran Hospital, Milwaukee

54511

Chu De Nancy Hop D'Adultes De Brabois, Vandœuvre-lès-Nancy

55131

Universitätsmedizin Johannes Gutenberg Universität Mainz, Mainz

56068

InVO Institut für Versorgungsforschung in der Onkologie, Koblenz

59020

Hôpital Saint Vincent-de-Paul, Lille

61363

Chang Gung Memorial Hospital - Chiayi, Chiayi County

62500

Fakultni nemocnice Brno, Brno

63110

Washington University Medical School, St Louis

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70112

Tulane Cancer Center Office of Clinical Research, New Orleans

75090

Texas Oncology - Sherman, Sherman

75248

Institut Curie, Paris

75651

Hopital de la Pitie Salpetriere, Paris

75702

Texas Oncology - Tyler, Tyler

76022

Texas Oncology - Bedford, Bedford

76038

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

77030

University of Texas MD Anderson Cancer Center, Houston

77380

US Oncology, The Woodlands

78503

Texas Oncology - McAllen, McAllen

78705

Texas Oncology-Austin Midtown, Austin

80218

USO-Rocky Mountain Cancer Center, Denver

82000

Aarhus Universitetshospital, Aarhus Sygehus, Aarhus N

84112

Huntsman Cancer Institute, Salt Lake City

85013

Arizona Oncology Associates, P.C. - HOPE, Phoenix

85028

Irccs Crob, Potenza

86021

Pole Regionalde Cancérologie(CHU de Poitiers), Politiers

89075

Universitätsklinikum Ulm, Ulm

90095

UCLA Medical Center, Los Angeles

90100

Ospedale Vincenzo Cervello, Palermo

93510

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii, Lodz

97080

Klinikum der Universität München Großhadern, Würzburg

97401

Willamette Valley Cancer Institute & Research Ctr., Eugene

98109

Seattle Cancer Care Alliance, Seattle

99508

Alaska Oncology and Hematology, LLC, Anchorage

100020

Beijing ChaoYang Hospital, Beijing

100034

Peking University First Hospital, Beijing

Peking University People's Hospital, Beijing

100142

Beijing Cancer hospital, Beijing

100191

Peking University Third Hospital, Beijing

110004

Shengjing Hospital of China Medical University, Shenyang

125101

GUZ of Moscow City Clinical Hospital n.a. S.P. Botkin, Moscow

130000

Jilin Cancer Hospital, Changchun

191024

"Fed. State Budgetary Institution Russian Scientific & Research Institute of Hemat. & Transfusiology of Fed. Medico-Bio. Agency", Saint Petersburg

197022

State Medical University named after I.P. Pavlov, Saint Petersburg

200032

Fudan University Shanghai Cancer Center, Shanghai

215006

The First Affiliated Hospital of Soochow University, Suzhou

233004

Anhui Provincial Cancer Hospital, Hefei

300020

Blood Institute of the Chinese Academy of Medical science, Tianjin

300060

Tianjin Medical University Cancer Institute and Hospital, Tianjin

310022

Zhejiang Cancer Hospital, Hangzhou

323020

Lishui Central Hospital, Lishui

330006

The First Affiliated Hospital of Nanchang University, Nanchang

350014

Fujian Provincial Cancer Hospial, Fuzhou

400030

Chongqing Cancer Hospital, Chongqing

410013

Hunan Cancer Hospital, Changsha

430022

Wuhan Union Hospital, Wuhan

443003

Yichang Central People's Hospital, Yichang

450008

Henan Cancer Hospital, Zhengzhou

471003

The First Affiliated Hospital of Henan University of Science &Technology, Luoyang

510000

Cancer Center of Guangzhou Medical University, Guangzhou

510060

Sun Yat-sen University Cancer Center, Guangzhou

510515

Southern Medical University Nanfang Hospital, Guangzhou

610041

West China Hospital, Sichuan University, Chengdu

830002

Affiliated Tumor Hospital of Xinjiang Medical University, Ürümqi

3339419

Bnai Zion Medical Center, Haifa

5262100

Chaim Sheba Medical Center, Ramat Gan

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

9112001

Hadassah Medical Center, Jerusalem

02115

DFCI Lymphoma, Boston

55905-0002

Mayo Clinic, Rochester

27157-1045

Wake Forest University School of Medicine, Winston-Salem

53705-2254

University of Wisconsin Carbone Cancer Center, Madison

22061-080

Hospital São Lucas Copacabana, Rio de Janeiro

01321-001

Hospital Beneficência Portuguesa de São Paulo, São Paulo

60115-281

Centro de Oncologia e Hematologia do Ceará LTDA, Aldeota

74110-020

Hospital das Clínicas da UFGo - Goiânia, Goiânia

65060-645

Hospital Sao Domingos, São Luís

20230-130

Instituto Nacional de Câncer - INCA, Rio de Janeiro

13060-904

Centro de Pesquisa Clínica São Lucas, Campinas

01236-030

Instituto de Ensino e Pesquisas São Lucas - IEP Hemomed, Pacaembu

15090-000

Fundação Faculdade Regional de Medicina de São José do Rio Preto, Dept. CIP - Centro Integrado de Pesquisa, Rio Preto

09060-650

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André

01509-900

A. C. Camargo Cancer Center, São Paulo

80060 240

HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná, Curitiba- PR

01223-001

IPITEC, São Paulo

05403-000

Hospital da Clinicas da Faculdade de Medicina da USP, São Paulo

05652-900

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, São Paulo

Unknown

Hospital 9 De Julho, São Paulo

T6G 1Z2

Cross Cancer Institute, Edmonton

V5Z 4E6

BC Cancer Vancouver, Vancouver

R3A 1M3

Cancer Care Manitoba, Winnipeg

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

D-22081

OncoResearch Lerchenfeld GmbH, Hamburg

460-0001

Nagoya Medical Center, Nagoya

467-8602

Nagoya City University Hospital, Nagoya

060-8648

Hokkaido University Hospital, Sapporo

650-0047

Kobe City Medical Center General Hospital, Kobe

980-8574

Tohoku University Hospital, Sendai

589 8511

Kindai University Hospital, Osaka Sayama-shi

350-8550

Saitama Medical Center, Kawagoe

135-8550

Japanese Foundation for Cancer Research, Koto

720-0001

Chugoku Central Hospital, Hiroshima

860-8556

Kumamoto University Hospital, Kumamoto

602-8566

Kyoto Furitsu Medical University Hospital, Kyoto

700-8558

Okayama University Hospital, Okayama

4624 VT

Bravis Ziekenhuis, Bergen op Zoom

3015 GD

Erasmus Medisch Centrum, Rotterdam

2545 AA

Ziekenhuisapotheek HagaZiekenhuis, The Hague

20-090

Centrum Onkologii Ziemi Lubelskiej, Lublin

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

30-510

Pratia MCM Krakow, Krakow

60-185

AIDPORT Sp. z o.o., Skorzewo

50-367

Uniwersytecki Szpital Kliniczny Klinika, Wroclaw

1099-035

IPOFG - Lisboa, Lisbon

1400-038

Champalimaud Foundation, Lisbon

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

08908

Hospital Duran I Reynals, L'Hospitalet de Llobregat

07120

Hospital Universitario Son Espases, Palma de Mallorca

08036

Hospital Clinic de Barcelona, Barcelona

AB25 2ZN

Aberdeen Royal Infirmary, Aberdeen

PL6 8DH

Derriford Hospital, Plymouth

CB8 7XN

GenesisCare, Newmarket

G120YN

Beatson West of Scotland Cancer Centre, Glasgow

NG5 1PB

City Hospital, Nottingham University Hospitals, Nottingham

OX3 7LJ

Churchill Hospital, Oxford

SL4 3HD

GenesisCare, Windsor, Windsor

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Loxo Oncology, Inc.

INDUSTRY

NCT04662255 - Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) | Biotech Hunter | Biotech Hunter