Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)

PHASE3CompletedINTERVENTIONAL
Enrollment

193

Participants

Timeline

Start Date

May 11, 2017

Primary Completion Date

March 27, 2020

Study Completion Date

July 12, 2021

Conditions
Chronic Graft Versus Host Disease
Interventions
DRUG

ibrutinib

Ibrutinib capsules administered orally daily

DRUG

Placebo

Placebo capsules administered orally daily

DRUG

Prednisone

Prednisone administered daily

Trial Locations (102)

1097

St. Laszlo Hospital /ID# 1140-1164, Budapest

2010

The Kinghorn Cancer Centre /ID# 1140-1165, Darlinghurst

2145

Westmead Hospital /ID# 1140-0848, Westmead

3052

Royal Children's Hospital/ID# 1140-1154, Parkville

Royal Melbourne Hospital (RMH) /ID# 1140-0633, Parkville

4020

Krankenhaus der Elisabethinen Linz /ID# 1140-0849, Linz

4029

Royal Brisbane and Women's Hospital /ID# 1140-0190, Herston

6000

Fiona Stanley Hospital /ID# 1140-0880, Perth

8036

Univ. Klinik for Innere Medizin, Klinische Abteilung for Hematologie, Graz /ID# 1140-0373, Graz

10000

UHC Zagreb /ID# 1140-1169, Zagreb

10002

National Taiwan Univ Hosp /ID# 1140-1184, Taipei City

10021

New York Presbyterian Hospital/Weill Cornell Med College /ID# 1140-0200, New York

Stony Brook University Medical Center /ID# 1140-0719, New York

10065

Weill Cornell Physicians - Hematologic Malignancies & Bone Marrow Transplant /ID# 1140-0019, New York

10124

University of Torino /ID# 1140-1268, Torino

10126

Centro Trapianti Cellule Staminali, Ospedale Infantile Regina Margherita /ID# 1140-1156, Turin

10467

Montefiore Medical Center - Moses Campus /ID# 1140-0120, The Bronx

15232

University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1140-0050, Pittsburgh

20010

Children's National Medical Center /ID# 1140-1122, Washington D.C.

20132

Ospedale San Raffaele IRCCS /ID# 1140-0523, Milan

21201

University of Maryland /ID# 1140-0205, Baltimore

24127

ASST Papa Giovanni XXIII /ID# 1140-1231, Bergamo

26506

West Virginia University /ID# 1140-1090, Morgantown

27516

University of North Carolina - Lineberger Comprehensive Cancer Center /ID# 1140-1133, Chapel Hill

29425

Medical University of South Carolina, MUSC /ID# 1140-0738, Charleston

30322

Emory University, Winship Cancer Institute /ID# 1140-0033, Atlanta

Emory University/Winship Cancer Institute /ID# 1140-1179, Atlanta

30625

Hannover Medical School /ID# 1140-1141, Hanover

32804

Florida Hospital Cancer Institute/Adventist Health System/Sunbelt, Inc /ID# 1140-1121, Orlando

33000

Groupe Hospitalier Pitie-Salpetriere /ID# 1140-0918, Paris

38043

CHU de GRENOBLE Alpes /ID# 1140-1058, Grenoble

40202

University of Louisville Hospital /ID# 1140-1131, Louisville

40447

China Medical University Hosp /ID# 1140-1199, Taichung

41013

Hospital Universitario Virgen del Rocio /ID# 1140-0863, Seville

41944

Kyungpook National Univ Hosp /ID# 1140-1153, Daegu

44093

CHU de Nantes /ID# 1140-0520, Nantes

44106

Univ Hosp Cleveland /ID# 1140-0941, Cleveland

46010

Hospital Clinico Universitario de Valencia /ID# 1140-1145, Valencia

48149

Universitatsklinikum Munster /ID# 1140-1195, Munster

48201

Barbara Ann Karmanos Cancer In /ID# 1140-0130, Detroit

54511

Hopital de Brabois /ID# 1140-0775, Vandœuvre-lès-Nancy

55455

University of Minnesota /ID# 1140-0807, Minneapolis

55905

Mayo Clinic, Rochester, MN /ID# 1140-0240, Rochester

59037

Centre Hospitalier Regional Universitaire de Lille /ID# 1140-0750, Lille

60126

A.O. Univ. Ospedali Riuniti /ID# 1140-0932, Ancona

60153

Loyola University /ID# 1140-0713, Maywood

60637

University of Chicago /ID# 1140-0126, Chicago

70376

Robert Bosch Hospital /ID# 1140-1160, Stuttgart

75010

Hopital Saint-Louis - Institut Hematologie Centre Hayem CHU /ID# 1140-0735, Paris

80010

UCHSC Anschultz Cancer Pavilion /ID# 1140-0068, Aurora

80054

CHU Amiens Groupe hospitalier Sud /ID# 1140-1205, Amiens

80337

Dr. Haunerschen Kinderspital /ID# 1140-1142, Munich

93053

University Hospital of Regensburg /ID# 1140-1446, Regensburg

94143

Ucsf /Id# 1140-0003, San Francisco

94304

LPCH Stanford /ID# 1140-1128, Palo Alto

94305

Stanford University/Stanford Cancer Center, Pasteur Drive /ID# 1140-0400, Stanford

98109

Fred Hutchinson Cancer Research Center /ID# 1140-0404, Seattle

100853

Chinese PLA General Hospital /ID# 1140-1198, Beijing

119228

National University Cancer Institute - National University Health System /ID# 1140-1155, Singapore

169608

Singapore General Hospital /ID# 1140-1162, Singapore

215006

The First Affiliated Hospital of Soochow University /ID# 1140-1208, Suzhou

510000

Nanfang Hospital /ID# 1140-1379, Guangzhou

85258-4547

Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 1140-1120, Scottsdale

33136-1096

Jackson Memorial Hospital, University of Miami /ID# 1140-0647, Miami

46202-5112

Indiana University Melvin and Bren Simon Cancer Center /ID# 1140-0010, Indianapolis

40508-2678

University of Kentucky /ID# 1140-1140, Lexington

02114

Massachusetts General Hospital Cancer Center /ID# 1140-0020, Boston

02115

Boston Childrens Hospital /ID# 1140-1615, Boston

02215

Dana-Farber Cancer Institute /ID# 1140-0349, Boston

07601

Hackensack University Medical Center/ John Theurer Cancer Center /ID# 1140-0343, Hackensack

08903

Rutgers Cancer Institute of NJ /ID# 1140-0803, New Brunswick

10032-1559

Columbia University Medical Center, MS-CHONY /ID# 1140-1124, New York

14642-0001

University of Rochester Cancer Center /ID# 1140-0127, Rochester

37232-5280

Vanderbilt University Medical Center Vanderbilt Ingram Cancer Center /ID# 1140-0024, Nashville

78229-3710

Methodist San Antonio /ID# 1140-1118, San Antonio

V5Z 1M9

University of British Columbia (UBC) - Vancouver General Hospital (VGH) /ID# 1140-1166, Vancouver

K1H 8L6

The Ottawa Hospital Regional Cancer Center /ID# 1140-0159, Ottawa

M5G 2M9

Princess Margaret Cancer Centre /ID# 1140-0043, Toronto

H3T 1C5

CHU Sainte-Justine /ID# 1140-1143, Montreal

01307

Universitaetsklinikum Dresden /ID# 1140-1367, Dresden

00165

IRCCS Ospedale Pediatrico Bambino Gesu /ID# 1140-1150, Rome

446-8602

Anjou Kousei Hospital /ID# 1140-1435, Anjo

730-8619

Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 1140-1437, Hiroshima

650-0047

Kobe City Medical Center General Hospital /ID# 1140-1438, Kobe

663-8501

Hyogo College of Medicine College Hospital /Id# 1140-1434, Nishinomiya-shi

305-8576

Duplicate_University of Tsukuba Hospital /ID# 1140-1445, Tsukuba

259-1193

Tokai University Hospital /ID# 1140-1444, Isehara-shi

710-8602

Duplicate_Kurashiki Central Hospital /ID# 1140-1442, Kurishiki-shi

700-8558

Okayama University Hospital /ID# 1140-1430, Okayama

594-1101

Osaka Women's and Children's Hospital /ID# 1140-1440, Izumi-Shi

545-8586

Osaka City University Hospital /ID# 1140-1157, Osaka

113-8677

Dup_Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 1140-1439, Bunkyo-ku

157-8535

National Center for Child Health and Development /ID# 1140-1443, Setagaya-ku

860-0008

Kumamoto Medical Center /ID# 1140-1431, Kumamoto

060-8648

Hokkaido University Hospital /ID# 1140-1436, Sapporo

03722

Yonsei University Health System, Severance Hospital /ID# 1140-0927, Seodaemun-gu

06351

Samsung Medical Center /ID# 1140-0925, Seoul

06591

Cath Univ Seoul St Mary's Hosp /ID# 1140-0928, Seoul

04401

SoonChunHyang University Seoul /ID# 1140-1163, Seoul

05505

Asan Medical Center /ID# 1140-0963, Seoul

08036

Hospital Clinic /ID# 1140-0533, Barcelona

08041

Hospital Santa Creu i Sant Pau /ID# 1140-0535, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Pharmacyclics LLC.

INDUSTRY