Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

238

Participants

Timeline

Start Date

March 9, 2021

Primary Completion Date

August 29, 2023

Study Completion Date

May 31, 2027

Conditions
Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Interventions
DRUG

Pirtobrutinib

Oral Pirtobrutinib

DRUG

Idelalisib

Oral

DRUG

Bendamustine

IV

DRUG

Rituximab

IV

Trial Locations (232)

114

Tri-Service General Hospital, Taipei City

1090

Medizinische Universität Wien, Vienna

1097

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest

1340

Clinique Saint Pierre Ottignies, Ottignies

2010

St Vincent's Hospital, Darlinghurst

2145

Westmead Hospital, Wentworthville

2200

AZ St-Elisabeth, Herentals

2217

The St. George Hospital, Kogarah

2605

Canberra Hospital, Garran

3004

The Alfred Hospital, Melbourne

4020

Ordensklinikum Linz GmbH Elisabethinen, Linz

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4400

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Nyíregyháza

4800

CHR Verviers-Onco, Verviers

5020

Uniklinikum Salzburg, Salzburg

6000

Royal Perth Hospital, Perth

6500

Clinica di Ematologia IOSI, Ospedale Bellinzona e Valli, Ente Ospedaliero Cantonale, Bellinzona

7100

Groupe Jolimont, Haine-Saint-Paul

7624

University of Pecs 1st. Internalmedicin Clinic Dept, Pécs

8800

AZ Delta, Roeselare

9000

Universitair Ziekenhuis Gent, Ghent

10003

Hospital San Pedro de Alcántara, Cáceres

10021

Memorial Sloan Kettering Cancer Center, New York

10126

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

11590

Clinical Research Alliance, Inc., Westbury

12203

Charité Campus Virchow-Klinikum, Berlin

12808

Vseobecna fakultni nemocnice v Praze, Prague

14642

University of Rochester, Rochester

15100

Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo, Alessandria

15706

Complejo Hospitalario Universitario de Santiago de Compostel, Santiago de Compostela

16132

IRCCS Ospedale Policlinico San Martino, Genova

19713

Medical Oncology Hematology Consultants, PA, Newark

20132

IRCCS Ospedale San Raffaele, Milan

20155

Virginia Cancer Specialists, PC, Gainesville

20162

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

20900

ASST-Monza -U.O Ematologia Adulti, Monza (MB) -Settore E

21000

University Hospital Split, Split

21201

Greenebaum Comprehensive Cancer Center, Baltimore

21565

Gachon University Gil Hospital, Namdong-gu

23562

Lübecker Onkologische Schwerpunktpraxis, Lübeck

24014

Oncology and Hematology Associates of Southwest Virginia Inc, Roanoke

24105

Universitätsklinikum Schleswig-Holstein, Kiel

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo

25123

ASST Spedali Civili - Università degli Studi, Brescia

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

28007

Hospital General Universitario Gregorio Marañón, Madrid

28031

Hospital Universitario Infanta Leonor-INTERNAL MED, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28046

Hospital Universitario La Paz, Madrid

28223

Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón

29609

CHRU de Brest - Hôpital Morvan, Brest

29732

Carolina Blood and Cancer Care Associates, Rock Hill

30060

WellStar Health System, Marietta

30900

Chu Nimes/Institut De Cancerologie Du Gard, Nîmes

32256

Cancer Specialists of North Florida -St Augustine, Jacksonville

33076

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

33321

Oncology-Hematology Associates of West Broward, Tamarac

33342

Chang Gung Memorial Hospital - Linkou, Taoyuan, (r.o.c.)

33486

Boca Raton Regional Hospital, Boca Raton

34125

Azienda Sanitaria Universitaria Giuliano Isontina, Trieste

35100

Ege University Medical Faculty, Izmir

35330

Dokuz Eylul University Faculty of Medicine, Izmir

36100

AULSS8 Berica-Ospedale S.Bortolo, Vicenza

36526

Southern Cancer Center, P.C., Daphne

36604

Mitchell Cancer Institute -University of South Alabama, Mobile

37044

CHRU De Tours, Tours

37134

Ospedale Policlinico Giambattista Rossi, Borgo Roma, Verona

38039

Erciyes University Faculty of Medicine, Kayseri

38043

CHU De Grenoble Hopital Albert Michallon, Grenoble

39008

Hospital Universitario Marques De Valdecilla, Santander

40207

Norton Cancer Institute, Louisville

40447

China Medical University Hospital, Taichung

40519

Pratia Onkologia Katowice, Katowice

40563

University of Kentucky Markey Cancer Center, Lexington

41013

Hospital Universitario Virgen del Rocío, Seville

41124

A.O.U. di Modena, Modena

42003

Mercy Health-Paducah Medical Oncology and Hematology, Paducah

45004

Hospital Universitario de Toledo, Toledo

45236

Oncology Hematology Care Inc, Cincinnati

46250

Community Health Network, Indianapolis

47392

Inje Univ Busan Paik Hospital, Busan

47904

Arnett Cancer Center, Lafayette

48020

Ospedale Santa Maria delle Croci, Ravenna

48106

Saint Joseph Mercy Hospital, Ann Arbor

48236

Ascension St. John Hospital, Grosse Pointe Woods

49241

Pusan National University Hospital, Busan

50134

Azienda Ospedaliera Universitaria Careggi, Florence

50937

Uniklinik Köln, Kerpener

53705

University of Wisconsin Carbone Cancer Center, Madison

55102

Minnesota Oncology/Hematology PA, Saint Paul

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

59020

Hopital Saint Vincent De Paul, Lille

59102

St. Vincent Frontier Cancer Center, Billings

60612

Rush University Medical Center, Chicago

60714

Illinois Cancer Specialists-Niles, Niles

62500

Fakultni nemocnice Brno, Brno

64109

Centre Hospitalier de la Côte Basque, Bayonne

66046

Ch Perpignan, Perpignan

68506

Nebraska Hematology-Oncology, Lincoln

69120

Universitätsklinikum Heidelberg, Heidelberg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70112

Cancer Center Office of Clinical Research, New Orleans

70124

Irccs Istituto Tumori Giovanni Paolo Ii, Viale Orazio Flacco

72000

Centre Hospitalier du Mans, Le Mans

75230

Texas Oncology - Medical City Dallas, Dallas

75231

Texas Oncology - Dallas Presbyterian Hospital, Dallas

76038

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

76104

Texas Oncology Fort Worth, Fort Worth

The Center for Cancer and Blood Disorders, Fort Worth

78234

Brooke Army Medical Center, Fort Sam Houston

78240

Texas Oncology - San Antonio Medical Center, San Antonio

78503

Texas Oncology - McAllen, McAllen

78705

Texas Oncology Cancer Center, Austin

79106

Texas Oncology - Amarillo, Amarillo

80012

Rocky Mountain Cancer Center, Aurora

80804

München Klinik Schwabing, Koelner Platz 1

85000

CHD Vendee, La Roche-sur-Yon

85028

Irccs Crob, Rionero in Vulture

85304

Palo Verde Hematology Oncology, Glendale

85711

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

86021

Pole Regionalde Cancérologie(CHU de Poitiers), Politiers

88100

Azienda Ospedaliera Pugliese Ciaccio, Catanzaro

89081

Universitätsklinikum Ulm, Ulm

90027

California Research Institute, Los Angeles

92708

Orange Coast Memorial Medical Center, Fountain Valley

93510

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii, Lodz

95123

A.O.U. Policlinico G.Rodolico - S. Marco, Catania

97401

Willamette Valley Cancer Institute and Research Center, Eugene

98158

Ospedale Papardo, Messina

98405

Northwest Medical Specialties, PLLC, Tacoma

100034

Peking University First Hospital, Beijing

100053

Xuanwu Hospital Capital Medical University, Xicheng District

100191

Peking University Third Hospital, Beijing

100730

Beijing Hospital, Beijing

112201

Taipei Veterans General Hospital, Taipei

191024

"Federal State Budgetary Institution Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency", Saint Petersburg

197022

Academician I.P. Pavlov First St-Petersburg State Medical University, Saint Petersburg

200025

Shanghai Jiaotong University School of Medicine Ruijin Hospital, Shanghai

200032

Fudan University Shanghai Cancer Center, Shanghai

221006

The Affiliated Hospital of Xuzhou Medical College, Xuzhou

258499

Gleneagles Medical Centre, Singapore

300020

Blood Institute of the Chinese Academy of Medical science, Tianjin

310022

Zhejiang Cancer Hospital, Hangzhou

317000

Zhejiang Provincial Taizhou Hospital, Linhai

330006

The First Affiliated Hospital of Nanchang University, Nanchang

The Second Affiliated Hospital of Nanchang University, Nanchang

354057

Oncology Dispensary #2 of Krasnodar Region, Sochi

410013

Hunan Cancer Hospital, Changsha

450008

Henan Cancer Hospital, Zhengzhou

510000

Sun Yat-sen University Cancer Center, Guangzhou

510515

Southern Medical University Nanfang Hospital, Guangzhou

570100

Hainan Province People's Hospital, Haikou

644013

"Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary", Omsk

730050

Gansu Province Cancer Hospital, Lanzhou

830002

Affiliated Tumor Hospital of Xinjiang Medical University, Ürümqi

3436212

Carmel Hospital, Haifa

4244916

Laniado Medical Center, Netanya

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

8457108

Soroka Medical Center, Beersheba

08724

New Jersey Center for Cancer Research, Brick

NSW2170

Ingham Institute of Medical Research, Liverpool

B-9100

VITAZ, Sint-Niklaas

R3E 0V9

Cancer Care Manitoba, Winnipeg

B3H 1V7

Queen Elizabeth II Health Sciences Center, Halifax

L3Y 2P9

Southlake Regional Health Centre, Newmarket

M5G 1Z5

Princess Margaret Hospital (Ontario), Toronto

Unknown

Tianjin Medical University Cancer Institute and Hospital, Tianjin

Division of Hematology, Dept. of Internal Medicine, University Hospital Centre Zagreb, Zagreb

Mater Misericordiae Hospital, Dublin

Rabin Medical Center, Petah Tikva

Ankara University Medicine Hospital, Mamak

Istanbul University Istanbul Medicine Faculty, Faith

Singleton Hospital, Swansea

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

93 009

Hospital AVICENNE, Bobigny

D- 55131

Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik, Langenbeckstraße 1

D08 NHY1

St James's Hosptial, Dublin

DUBLIN 9

Beaumont Hospital, Dublin, Dublin

06132

Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich), Perugia

00168

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

05100

Azienda Ospedaliera Santa Maria Terni, Terni

4 - 73039

"Az. Osp. Card G Panico", Tricase

460-0001

Nagoya Medical Center, Nagoya

464-8681

Aichi Cancer Center Hospital, Nagoya

467-8602

Nagoya City University Hospital, Nagoya

503-8502

Ogaki Municipal Hospital, Ogaki-shi

060-8648

Hokkaido University Hospital, Sapporo

650-0047

Kobe City Medical Center General Hospital, Kobe

259-1143

Tokai University Hospital- Isehara Campus, Isehara

783-8505

Kochi Medical School Hospital, Nankoku

980-8574

Tohoku University Hospital, Sendai

983-8520

NHO Sendai Medical Center, Sendai

589 8511

Kindai University Hospital, Osaka Sayama-shi

350-8550

Saitama Medical Center, Kawagoe

135-8550

Japanese Foundation for Cancer Research, Koto

141-8625

NTT Medical Center Tokyo, Shinagawa-Ku

806 8501

JCHO Kyushu Hospital, Fukoka-ken

860-8556

Kumamoto University Hospital, Kumamoto

700-8558

Okayama University Hospital, Okayama

565-0871

Osaka University Hospital, Osaka

59-220

Wojewodzki Szpital Specjalistyczny, Iwaszkiewicza 5

20-081

Centrum Onkologii Ziemi Lubelskiej, Lublin

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

81-519

Szpitale Pomorskie Sp. z o. o., Gdynia

36-200

Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza, Brzozów

85-168

Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii, Bydgoszcz

30-510

Pratia MCM Krakow, Krakow

02-776

Instytut Hematologii i Transfuzjologii, Warsaw

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Warsaw

58-309

Oddzial Hematologiczny, Specjalistyczny Szpital im. dra Sokołowskiego w Wałbrzychu, Wałbrzych

50-367

Uniwersytecki Szpital Kliniczny Klinika, Wroclaw

06591

The Catholic University of Korea-Seoul St. Mary's Hospital, Seocho-Gu

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

08908

Hospital Duran I Reynals, L'Hospitalet de Llobregat

02006

Hospital General de Albacete, Albacete

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

01005

Hospital Universitario de Alava, Vitoria-Gasteiz

06560

Gazi University Faculty of Medicine, Ankara

AB25 2ZN

Aberdeen Royal Infirmary, Aberdeen

TR1 3LJ

The Royal Cornwall Hospital, Truro

PL6 8DH

Derriford Hospital, Plymouth

HU16 5JQ

Castle Hill Hospital, Cottingham

WC1E 6HX

University College London Hospitals, London

NR4 7UY

Norfolk and Norwich Hospital, Norwich

EH4 2XU

Western General Hospital, Edinburgh

SM2 5PT

Royal Marsden Hospital, Sutton

EH54 6PP

St Johns Hospital at Howden, Livingston

LS9 7TF

St James's University Hospital, Leeds

MK6 5LD

Milton Keynes University Hospital, Milton Keynes

CB8 7XN

GenesisCare Cambridge, Newmarket

Sponsors
All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Loxo Oncology, Inc.

INDUSTRY

NCT04666038 - Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) | Biotech Hunter | Biotech Hunter