Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

November 19, 2018

Primary Completion Date

October 9, 2025

Study Completion Date

October 9, 2025

Conditions
Chronic Graft Versus Host Disease
Interventions
DRUG

Ibrutinib

Ibrutinib capsule, tablet, or suspension administered orally once daily

Trial Locations (48)

1090

St. Anna Kinderspital, Vienna

2031

Sydney Children's Hospital, Randwick

2145

Cancer Center for Children. The Children's Hospital at Westmead, Westmead

3052

The Royal Children's Hospital, Parkville

4101

Queensland Children's Hospital, South Brisbane

10065

Memorial Sloan Kettering Cancer Center, New York

10126

S.C. Farmacia Pediatrica - Presidio Ospedaliero Infantile Regina Margherita, Turin

13353

Charite-Universitaetsmedizin Berlin, Berlin

19104

The Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

20900

Fondazione MBBM-Clinica Pediatrica, Monza

21287

Johns Hopkins University, Baltimore

27100

U.O.C. Ematologia Oncoematologia Pediatrica, Pavia

28009

Hospital Infantil Universitario Nino Jesus, Madrid

28046

Hospital Universitario Universitario La Paz, Madrid

33701

Johns Hopkins All Children's Hospital, St. Petersburg

44093

CHU Nantes - Hopital Enfant Adolescent, Nantes

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

53226

Medical College of Wisconsin, Milwaukee

55454

University of Minnesota Masonic Children's Hospital, Minneapolis

60611

Ann & Robert H Lurie Children's Hospital of Chicago, Chicago

63110

Washington University, St Louis

75019

Hôpital Robert-Debré Ap-Hp, Paris

80045

Children's Hospital, Aurora

84113

Primary Children's Hospital, Salt Lake City

91010

City of Hope, Duarte

92123

Rady Children's Hospital, San Diego

94158

University of California, San Francisco

97239

Oregon Health and Science University, Portland

98109

Fred Hutchinson Cancer Research Center, Seattle

117997

"Federal State Budgetary Institution Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology", Moscow

197022

"Federal State Budgetary Educational Institution of Higher Professional Education LP.Pavlov First Saint Petersburg State Medical", Saint Petersburg

4920235

Schneider Children's Medical Center in Israel, Petah Tikva

5262100

The Edmond and Lily Safra Children's Hospital, Ramat Gan

9112001

Hadassah Medical Centre, Jerusalem

02215

Dana-Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

38105-2729

St. Jude Children's Research Hospital, Memphis

V6H 3V4

children's and Women's Health Centre of British Columbia, Vancouver

H3T1C5

CHU Sainte-Justine, Montreal

00165

Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica, Roma

3584 CS

Princess Maxima Center, Utrecht

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

Seoul Saint Mary's Hospital, Seoul

08035

Hospital Universitario Vall d'Hebron, Barcelona

WC1N 3JH

Safari Day Care, Great Ormond Street Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Pharmacyclics LLC.

INDUSTRY