To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)

PHASE3TerminatedINTERVENTIONAL
Enrollment

177

Participants

Timeline

Start Date

May 26, 2021

Primary Completion Date

August 16, 2023

Study Completion Date

August 21, 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)

144

Ospedale Sant. Eugenio, Roma

3500

Jessa Ziekenhuis, Hasselt

6156

Ospedale S.Maria Della Misericordia, Perugia

8800

AZ Delta, Roeselare

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, Hawthorne

11111

Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi, Catania

15232

Hillman Cancer Center, Pittsburgh

16132

Irccs Azienda Ospedaliera Universitaria San Martino, Genova

17475

Universitaetsmedizin Greifswald, Greifswald

18057

Universitaetsmedizin Rostock, Rostock

20057

Georgetown University, Washington D.C.

20122

Fondazione Irccs Ca Granda Ospedale Maggiore, Milan

21100

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

24041

Hospital Universitario 12 de Octubre, Madrid

27710

Duke Cancer Center, Durham

28040

Fundacion Jimenez Diaz University Hospital, Madrid

28100

Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara, Novara

28721

Advent Health Hendersonville Park Ridge Hospital Hendersonville, Clyde

30008

Hospital General Universitario Morales Meseguer, Murcia

30120

Hospital Universitario Virgen de La Arrixaca, Murcia

30171

Spitalul Clinic Coltea - Clinica Hematologie, Bucharest

30322

Emory University, Atlanta

30900

Chu Nimes, Nîmes

30912

Augusta University - Medical College of Georgia, Augusta

31059

Institut Universitaire Du Cancer de Toulouse Oncopole, Toulouse

31999

Rambam Health Care Campus, Haifa

33100

Azienda Sanitaria Universitaria Friuli Centrale Asu Fc, Udine

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

35040

Ege University Hospital, Izmir

37007

Hospital Clinico Universitario de Salamanca, Salamanca

38120

Baptist Cancer Center, Memphis

38700

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

40138

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

41013

Hospital Universitario Virgen Del Rocio, Seville

43210

Oregon Health & Science University, Columbus

44093

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

44195

Cleveland Clinic, Cleveland

46000

Hospital Universitari I Politecnic La Fe, Valencia

46017

Hospital Universitario Doctor Peset, Valencia

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

49241

Pusan National University Yangsan Hospital, Busan

50009

Hospital Universitario Miguel Servet, Zaragoza

50134

University of Florence, Florence

53100

Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte, Siena

53127

Universitatsklinikum Bonn Aoer, Bonn

54500

Chu Vandoeuvre-Les-Nancy Hopital Brabois, Vandœuvre-lès-Nancy

55200

Ondokuz Mayis University Medicine Faculty, Samsun

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

64114

Midamerica Cancer Care, Kansas City

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

65124

Presidio Ospedaliero Pescara, Pescara

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

70124

Aou Policlinico Consorziale Di Bari, Bari

74123

Azienda Ospedaliera San Giuseppe Moscati, Taranto

75010

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

75012

Hospital Saint Antoine, Paris

75230

Texas Oncology - Medical City Dallas, Dallas

76100

Kaplan Medical Center, Rehovot

77005

Renovatio Clinical, Houston

77025

Kelsey Seybold Clinic, Houston

80131

Universita Di Napoli Federico Ii, Napoli

83100

Azienda Ospedaliera San Giuseppe Moscati, Avellino

83301

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

87042

Chu de Limoges, Limoges

CHU Limoges - Hopital Duputren, 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

92373

Emad Ibrahim Md Inc, Redlands

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

97239

Oregon Health & Science University, Portland

98201

Providence Regional Medical Center Everett, Everett

100044

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

100053

Xuanwu Hospital Capital Medical University, Beijing

100091

Peking University Third Hospital, Beijing

100191

Peking University Third Hospital, Beijing

110001

The First Hospital of China Medical University, Shenyang

130021

The First Hospital of Jilin University, Changchun

150010

Harbin Institute of Hematology and Oncology, Harbin

210029

Jiangsu Province Hospital, Nanjing

213003

The First Peoples Hospital of Changzhou, Changzhou

230022

University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital), Hefei

250013

Jinan Central Hospital, Jinan

264000

Yantai Yuhuangding Hospital, Yantai

266003

The Affiliated Hospital of Qingdao University, Qingdao

300052

Tianjin Medical University General Hospital, Tianjin

310003

The First Affiliated Hospital of Zhejiang University, Hangzhou

330000

Jiangxi Provincial of People Hospital, Nanchang

330006

The First Affiliated Hospital of Nanchang University, Nanchang

350001

Fujian Medical University Union Hospital, Fuzhou

430022

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

430030

Tongji Hospital Huazhong University of Science and Technology, Wuhan

450003

Henan Provincial Peoples Hospital, Zhengzhou

450008

Henan Cancer Hostipal, Zhengzhou

510080

Institute of Hematology and Hospital of Blood Diseases, Chinese Academy of Medical Sciences and Pek, Tianjin

510515

Nanfang Hospital, Guangzhou

518055

Shenzhen University Hospital, Shenzhen

540139

Spitalul Clinic Judetean de Urgenta Targu Mures, Târgu Gânguleşti

650101

The Second Affiliated Hospital of Kunming Medical University, Kunming

710004

The Second Affiliated Hospital of Xi an Jiaotong University, Xi'an

730000

The First Hospital of Lanzhou University, Lanzhou

730030

Lanzhou University Second Hospital, Lanzhou

2591193

Tokai University Hospital, Isehara

5038502

Ogaki Municipal Hospital, Ōgaki

7747629

Samson Assuta Ashdod University Hospital, Ashdod

90027-6005

California Research Institute (Cri), Los Angeles

06904

Stamford Hospital - Medical Oncology Hematology, Stamford

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, 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

75390-8565

University of Texas Southwestern Medical Center, Dallas

01140

Hanusch-Krankenhaus Wiener Gebietskrankenkasse, Vienna

08000

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

05530

Chu Ucl Namur University Hospital Mont-Godinne, Yvoir

FI-00029

Helsinki University Central Hospital, Helsinki

06120

Universitatsklinikum Halle (Saale), Halle

01088

Semmelweis Egyetem, Budapest

03300

Markhot Ferenc Korhaz, Eger

09024

Petz Aladar County Teaching Hospital, Győr

06156

Ospedale S.Maria Della Misericordia, Perugia

00161

Univ. Di Roma Facolta Di Armacia E Medicina, Roma

00168

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore, Roma

Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore, Rome

812-8582

Kyushu University Hospital, Fukuoka

670-8540

Japanese Red Cross Society Himeji Hospital, Himeji-shi

573-1191

Kansai Medical University Hospital, Hirakata

410-2211

Juntendo University Hospital, Izunokuni

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

113-8431

Juntendo University Hospital, Tokyo

113-8603

Nippon Medical School Hospital, Tokyo

409-3898

University of Yamanashi Hospital, Yamanashi

05021

Haukeland University Hospital, Bergen

01478

Akershus University Hospital, Lorenskog

40-040

Pratia Hematologia Katowice, Katowice

41-081

Pratia Hematologia Katowice, Katowice

31-501

Samodzielny Publiczny Zoz Szpital Uniwersytecki W Krakowie, 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

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea Seoul St. Mary?S Hospital, Seoul

03010

Hospital General Unviersitario de Alicante, Alicante

08916

Ico Hospital Germans Trias I Pujol, Badalona

08003

Hospital Del Mar, Barcelona

08035

Hospital General Universitario Vall D Hebron, Barcelona

08908

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

00404

China Medical University Hospital, Taichung

00704

National Cheng Kung University (Ncku) Hospital, Tainan City

01250

Baskent University Adana Hospital, Adana

06500

Gazi University Hospital Gazi University Faculty of Medicine, Ankara

AB15 6RE

Grampian Health Board, Aberdeen

PE21 9QS

United Lincolnshire Hospitals, Boston

GL1 3NN

Gloucestershire Royal Hospital, Gloucester

NW1 2BU

University College London Hospitals Nhs Foundation Trust, London

TS4 3BW

James Cook University Hospital, Middlesbrough

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Incyte Corporation

INDUSTRY