To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)

PHASE3TerminatedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

May 24, 2021

Primary Completion Date

August 3, 2023

Study Completion Date

November 25, 2024

Conditions
MyelofibrosisPrimary MyelofibrosisPost Essential Thrombocythemia MyelofibrosisPost Polycythemia Vera Myelofibrosis
Interventions
DRUG

parsaclisib

parsaclisib will be administered QD orally

DRUG

ruxolitinib

ruxolitinib will be administered BID orally

DRUG

placebo

placebo will be administered QD orally

Trial Locations (177)

3010

Hospital General Unviersitario de Alicante, Alicante

10029

Mount Sinai School of Medicine, New York

10050

The Affiliated Hospital of Inner Mongolia Medical University, Hohhot

10065

Memorial Sloan Kettering Cancer Center, New York

10467

Montefiore Medical Center, The Bronx

10532

Westchester Medical Center Advanced Oncology and Infusion Center, Hawthorne

14263

Roswell Park Cancer Institute, Buffalo

16132

Universita Degli Studi Di Genova - Facolta Di Medicina E Chirurgia, Genova

18014

Hospital Universitario Virgen de Las Nieves, Granada

18057

Universitaetsmedizin Rostock, Rostock

20057

Georgetown University, Washington D.C.

20122

Fondazione Irccs Ca Granda Ospedale Maggiore, Milan

20132

Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele, Milan

21100

A.O. Universitaria Ospedale Di Circolo E Fondazione Macchi, Varese

21287

Johns Hopkins University, Baltimore

26426

Wonju Severance Christian Hospital, Wŏnju

27157

Wake Forest Baptist Medical Center, Winston-Salem

27710

Duke Cancer Center, Durham

28040

Fundacian Jimnez Diaz, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

30008

Hospital General Universitario Morales Meseguer, Murcia

30120

Hospital Universitario Virgen de La Arrixaca, El Palmar

30322

Emory University, Atlanta

30900

Chu Nimes, Nîmes

31999

Rambam Health Care Campus, Haifa

33100

Azienda Sanitaria Universitaria Friuli Centrale Asu Fc, Udine

34125

Klinikum Kassel Gmbh, Kassel

34214

Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi, Istanbul

34662

Baskent University Istanbul Hospital, Istanbul

35010

Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria

35033

Chu de Rennes - Hospital Pontchaillou, Rennes

35040

Ege University Hospital, Izmir

35340

Dokuz Eylul University, Izmir

37007

Hospital Clinico Universitario de Salamanca, Salamanca

37134

Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma), Verona

38700

Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon, La Tronche

39120

Universitatsklinikum Magdeburg A.O.R., Magdeburg

40138

Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or, Bologna

40536

University of Kentucky-Markey Cancer Center, Lexington

43210

Ohio State University, Columbus

44093

Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu, Nantes

46000

Hospital Universitari I Politecnic La Fe, Valencia

46017

Hospital Universitario Doctor Peset, Valencia

47014

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori, Meldola

48013

Hospital de Basurto, Bilbao

49100

Davidoff Cancer Center Rabin Medical Center, Petah Tikva

50000

The Second Hospital of Hebei Medical University, Shijiazhuang

55200

Ondokuz Mayis University Medicine Faculty, Samsun

57103

Avera Cancer Institute, Sioux Falls

59100

Centre Hospitalier de Roubaix, Roubaix

61122

Aormn Hospital Hematology and Bmt Center, Pesaro

64114

Midamerica Cancer Care, Kansas City

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

66205

University of Kansas Hospital Authority, Westwood

69495

Hospices Civils de Lyon Centre Hospitalier Lyon Sud, Pierre-Bénite

69710

Assuta Ramat Hahayal, Tel Aviv

70112

Tulane University, New Orleans

70300

Shamir Medical Center Formerly Assaf Harofeh Medical Center, BEER Yaaqov

71000

Affiliated Hospital of Hebei University, Baoding

74123

Azienda Ospedaliera San Giuseppe Moscati, Taranto

75010

Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris), Paris

76100

Kaplan Medical Center, Rehovot

77025

Kelsey Seybold Clinic, Houston

77030

Houston Methodist Hospital, Houston

77380

Renovatio Clinical, Spring

78157

Centre Hospitalier de Versailles - Hopital Andre Mignot, LE Chesnay-rocquencourt

80131

Universita Di Napoli Federico Ii, Napoli

84131

Aou San Giovanni Di Dio E Ruggi D'Aragona, Salerno

85054

Mayo Clinic Rochester, Phoenix

86021

Hospital de La Miletrie, Poitiers

87042

Chu Limoges - Hopital Dupuytren, Limoges

89133

Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria

90146

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo

91120

Hadassah Hebrew University Medical Center Ein Karem Hadassah, Jerusalem

92103

Scripps Clinic, San Diego

93401

Coastal Integrated Cancer Care-Cicc, San Luis Obispo

93720

CCARE, Fresno

94704

Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center, Berkeley

95123

Azienda Policlinico Vittorio Emanuele, Catania

97227

Kaiser Permanente-Northwest, Portland

97239

Oregon Health & Science University, Portland

98109

Seattle Cancer Care Alliance, Seattle

98201

Providence Regional Medical Center Everett, Everett

99508

Alaska Oncology and Hematology, Anchorage

100044

Peking University People'S Hospital (Pkuph) - Institute of Hematology, Beijing

100091

Peking University Third Hospital, Beijing

130021

The First Hospital of Jilin University, Changchun

150010

Harbin Institute of Hematology and Oncology, Harbin

200032

Zhongshan Hospital Fudan University, Shanghai

210029

Jiangsu Province Hospital, Nanjing

230001

Anhui Provincial Hospital, Hefei

250013

Jinan Central Hospital, Jinan

264000

Yantai Yuhuangding Hospital, Yantai

300052

Tianjin Medical University General Hospital, Tianjin

310003

The First Affiliated Hospital of Zhejiang University, Hangzhou

325000

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

330000

Jiangxi Provincial of People Hospital, Nanchang

330006

The First Affiliated Hospital of Nanchang University, Nanchang

350001

Fujian Medical University Union Hospital, Fuzhou

410008

Xiangya Hospital Central South University, Changsha

430022

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan

450003

Henan Provincial Peoples Hospital, Zhengzhou

510080

Guangdong Provincial of People Hospital, Guangzhou

510515

Nanfang Hospital, Guangzhou

518055

Shenzhen University Hospital, Shenzhen

730000

The First Hospital of Lanzhou University, Lanzhou

730030

Lanzhou University Second Hospital, Lanzhou

2591193

Tokai University Hospital, Isehara

5038502

Ogaki Municipal Hospital, Ōgaki

90027-6005

California Research Institute (Cri), Los Angeles

90095-3075

UCLA School of Medicine, Los Angeles

06904

Stamford Hospital-Medical Oncology Hematology, Stamford

02114

Massachusetts General Hospital, Boston

08724

New Jersey Hematology Oncology Associates Llc, Brick

07960

Morristown Medical Center-Atlantic Health System, Morristown

75246-2092

Texas Oncology-Baylor Sammons Cancer Center, Dallas

04020

Ordensklinikum Linz Gmbh Elisabethinen, Linz

03100

Universitaetsklinikum St. Poelten, Saint P�LTEN

01140

Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse, Vienna

Hanusch-Krankenhaus Wiener Gebietskrankenkasse, Vienna

08000

A.Z. St.-Jan A.V., Bruges

01000

Cliniques Universitaires Ucl Saint-Luc, Brussels

06000

Grand Hospital de Charleroi, Charleroi

03500

Jessa Ziekenhuis, Hasselt

08800

AZ DELTA, Roeselare

09000

Aalborg University Hospital, Aalborg

05000

Odense University Hospital, Odense

FI-00029

Helsinki University Central Hospital, Helsinki

06120

Universitatsklinikum Halle (Saale), Halle

00133

Universita Di Roma Tor Vergata, Roma

00161

Universita Di Roma, Roma

00168

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore, Roma

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore, Rome

260-8677

Chiba Cancer Center, Chiba

409-3898

University of Yamanashi Hospital, Chūō

812-8582

Kyushu University Hospital, Fukuoka

670-8540

Japanese Red Cross Society Himeji Hospital, Himeji-shi

573-1191

Kansai Medical University Hospital, Hirakata

890-8520

Kagoshima University Hospital, Kagoshima

807-8556

Hospital of the University of Occupation and Environmental Health, Kitakyushu-shi

650-0047

Kobe City Medical Center General Hospital, Kobe

862-8655

Kumamoto Shinto General Hospital, Kumamoto

889-1692

University of Miyazaki Hospital, Miyazaki

453-8511

Japanese Red Cross Nagoya Daini Hospital, Nagoya

545-8585

Osaka Metropolitan University Hospital, Osaka

343-8555

Dokkyo Medical University Saitama Medical Center, Saitama

003-0006

Hokuyukai Sapporo Hokuyu Hospital, Sapporo

980-8574

Tohoku University Hospital, Sendai

113-8431

Juntendo University Hospital, Tokyo

113-8603

Nippon Medical School Hospital, Tokyo

514-0001

Mie University Hospital, Tsu

221-0855

Yokohama Municipal Citizens Hospital, Yokohama

05021

Haukeland University Hospital, Bergen

01478

Akershus University Hospital, L�RENSKOG

80-214

Uniwersyteckie Centrum Kliniczne, Gdansk

40-027

Samodzielny Publiczny Szpital Kliniczny Im. Andrzeja Mielckiego, Katowice

41-519

Pratia Hematologia Katowice, Katowice

31-501

Sp Zoz Szpital Uniwersytecki, Krakow

20-081

Samodzielny Publiczny Szpital Kliniczny Nr 1, Lublin

02-776

Institute of Hematology and Transfusion Medicine, Warsaw

03080

Seoul National University Hospital, Seoul

03651

Samsung Medical Center, Seoul

06591

THE CATHOLIC UNIVERSITY OF KOREA SEOUL ST. MARY�S HOSPITAL, Seoul

08916

Ico Hospital Germans Trias I Pujol, Badalona

Ico Hospital Germans Trias I Pujol, Barcelona

08003

Hospital Del Mar, Barcelona

08035

Hospital General Universitario Vall D Hebron, Barcelona

08908

Ico-Hospital Duran I Reynals, Barcelona

Institut Catala Doncologia Ico - Hospital Duran I Reynals Location, Barcelona

01250

Baskent University Adana Hospital, Adana

06500

Gazi University Hospital Gazi University Faculty of Medicine, Ankara

PE21 9QS

United Lincolnshire Hospitals, Boston

GL1 3NN

Gloucestershire Royal Hospital, Gloucester

EC1A 7BE

Barts Health Nhs Trust - St Bartholomews Hospital, London

NW1 2BU

University College London Hospitals Nhs Foundation Trust, London

S5 7AT

Sheffield Teaching Hospitals Nhs Foundation Trust - Weston Park Hospital, Sheffield

ST4 6QG

University Hospital of North Midlands Nhs Trust, Stoke-on-Trent

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY