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

Part of paid clinical trials in Duarte, California.

Sponsor
Pharmacyclics LLC.
Study ID
NCT03790332
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib capsule, tablet, or suspension administered orally once daily

Study Details

Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)

Key Dates

Start date
Nov 19, 2018
Status verified
May 2025
Primary completion
Oct 9, 2025
Completion
Oct 9, 2025

Study Design

Enrollment
59 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Part A- PK (measured by AUC) will be reported descriptively [ Time Frame: Approximately 24 months ]

Locations (20)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Rady Children's HospitalSan DiegoCalifornia92123-
University of CaliforniaSan FranciscoCalifornia94158-
Children's HospitalAuroraColorado80045-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701-
Ann & Robert H Lurie Children's Hospital of ChicagoChicagoIllinois60611-
Johns Hopkins UniversityBaltimoreMaryland21287-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of Minnesota Masonic Children's HospitalMinneapolisMinnesota55454-
Washington UniversitySt LouisMissouri63110-
Hackensack University Medical CenterHackensackNew Jersey07601-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Oregon Health and Science UniversityPortlandOregon97239-
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
St. Jude Children's Research HospitalMemphisTennessee38105-2729-
Primary Children's HospitalSalt Lake CityUtah84113-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CARady Children's Hospital· San Diego, CAUniversity of California· San Francisco, CAChildren's Hospital· Aurora, COChildren's National Medical Center· Washington D.C., DCJohns Hopkins All Children's Hospital· St. Petersburg, FL

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