Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)
NCT ID: NCT03790332
Last Updated: 2025-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
59 participants
INTERVENTIONAL
2018-11-19
2025-10-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1/2
Part A: Subjects ≥1 to \<12 years of age with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy, will receive oral ibrutinib once daily to determine Recommended Pediatric Equivalent Dose (RPED).
Part A Continuation: Subjects participating in Part A may continue receiving daily ibrutinib until the RPED is determined, at which time their dose may be adjusted to the RPED.
Part B: Subjects ≥1 to \<12 years of age( upper age limit is \< 22 years) with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy or with newly diagnosed moderate or severe cGVHD will be dosed at the RPED. Subjects ≥12 will be given 420mg orally ibrutinib once daily.
Ibrutinib
Ibrutinib capsule, tablet, or suspension administered orally once daily
Interventions
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Ibrutinib
Ibrutinib capsule, tablet, or suspension administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Part B: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy, or subjects with new onset moderate or severe cGVHD and in need of systemic immunosuppression
3. History of allogeneic stem cell transplantation
4. Age
* Part A: ≥1 to \<12 years of age at the time of enrollment
* Part B: ≥1 to \<22 years of age at the time of enrollment
5. Karnofsky or Lansky (subjects \<16 years of age) performance status ≥60
Key Eligibility:
Exclusion Criteria
2. Received an investigational agent within 28 days before enrollment.
3. Received donor lymphocyte infusion (DLI) within 56 days before enrollment
4. Progressive underlying malignant disease or active post-transplant lymphoproliferative disease
5. Any uncontrolled infection or active infection requiring ongoing systemic treatment
6. Known bleeding disorders
7. Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
1 Year
21 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Gauri Sunkersett
Role: STUDY_DIRECTOR
Pharmacyclics LLC.
Locations
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City of Hope
Duarte, California, United States
Rady Children's Hospital
San Diego, California, United States
University of California
San Francisco, California, United States
Children's Hospital
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
Washington University
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Cancer Center for Children. The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
The Royal Children's Hospital
Parkville, Victoria, Australia
Sydney Children's Hospital
Randwick, , Australia
St. Anna Kinderspital
Vienna, , Austria
children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
CHU Sainte-Justine
Montreal, Quebec, Canada
CHU Nantes - Hopital Enfant Adolescent
Nantes, , France
Hôpital Robert-Debré Ap-Hp
Paris, , France
Charite-Universitaetsmedizin Berlin
Berlin, , Germany
Hadassah Medical Centre
Jerusalem, , Israel
Schneider Children's Medical Center in Israel
Petah Tikva, , Israel
The Edmond and Lily Safra Children's Hospital
Ramat Gan, , Israel
U.O.C. Ematologia Oncoematologia Pediatrica
Pavia, PV, Italy
Fondazione MBBM-Clinica Pediatrica
Monza, , Italy
Dipartimento di Onco-Ematologia e Terapia Cellulare e Genica
Roma, , Italy
S.C. Farmacia Pediatrica - Presidio Ospedaliero Infantile Regina Margherita
Turin, , Italy
Princess Maxima Center
Utrecht, , Netherlands
Federal State Budgetary Institution "Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology
Moscow, , Russia
Federal State Budgetary Educational Institution of Higher Professional Education "LP.Pavlov First Saint Petersburg State Medical
Saint Petersburg, , Russia
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul Saint Mary's Hospital
Seoul, , South Korea
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Infantil Universitario Nino Jesus
Madrid, , Spain
Hospital Universitario Universitario La Paz
Madrid, , Spain
Safari Day Care, Great Ormond Street Hospital
London, Greater London, United Kingdom
Countries
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Other Identifiers
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2017-004558-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PCYC-1146-IM
Identifier Type: -
Identifier Source: org_study_id
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