TriangleNCT03790332 · CITED IN SOURCE DOCUMENTS
Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1, PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2025-10-21
Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Key Eligibility: Inclusion Criteria: 1. Part A: Subjects with moderate or severe cGVHD after failure of 1 or more lines of systemic therapy 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: 1. Presence of single organ genito-urinary involvement as the only manifestation of cGVHD 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)
- healthy Volunteers
- false
- maximum Age
- 21 Years
- minimum Age
- 1 Year
- sex
- ALL
- std Ages
- CHILD
- ADULT
Treatment arms and interventions
- arm Groups
- description
- 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.
- intervention Names
- Drug: Ibrutinib
- label
- Phase 1/2
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Phase 1/2
- description
- Ibrutinib capsule, tablet, or suspension administered orally once daily
- name
- Ibrutinib
- other Names
- IMBRUVICA®
- PCI-32765
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 59
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Part A- PK (measured by AUC) will be reported descriptively
- time Frame
- Approximately 24 months
- measure
- Part B- PK (measured by AUC) will be reported descriptively
- time Frame
- Approximately 7 years
- measure
- Number of patients with adverse events as a measure of safety and tolerability
- time Frame
- Approximately 7 years
- secondary Outcomes
- measure
- Part A- Number of patients with adverse events as a measure of safety and tolerability
- time Frame
- Approximately 24 months
- measure
- Part A- Pharmacodynamic effects as measured by in vitro BTK occupancy will be reported descriptively
- time Frame
- Approximately 24 months
- measure
- Part A continuation cohort and Part B-Response rate at 24 weeks
- time Frame
- Approximately 6 months after last subject in enrolled
- measure
- Part A continuation cohort and Part B- Duration of response (DOR)
- time Frame
- Up to 48 weeks
- measure
- Part A continuation cohort and Part B-Overall survival (OS)
- time Frame
- Approximately 5 years after last subject enrolled
- measure
- Part A continuation cohort and Part B-Late Effects Surveillance
- time Frame
- Up to 5 years post enrollment
- description
- Subjects will be monitored for growth and development
- measure
- Growth Parameter height in meters will be reported descriptively
- time Frame
- Up to 5 years post enrollment
- description
- Subjects will be monitored for growth and development
- measure
- Growth Parameter weight in kilograms will be reported descriptively.
- time Frame
- Up to 5 years post enrollment
- description
- Subjects will be monitored for immune reconstitution
- measure
- Available immune reconstitution laboratory parameters will be reported descriptively
- time Frame
- Up to 5 years post enrollment
- measure
- Late effects (Adverse events suspected to be related to treatment) will be quantified and reported descriptively
- time Frame
- Up to 5 years post enrollment
Full study description
- brief Summary
- Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)
Source references
Source notices and limitations
Discovery and provenance
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- edge id
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- clinical indication matching status
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- link basis
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- occurrences
- context exact
- cale overall summary score in 24% (10/42) of patients on at least 2 consecutive visits. iMAGINE The safety and efficacy of IMBRUVICA were evaluated in iMAGINE (NCT03790332), an open-label, multi-center, single-arm trial of IMBRUVICA for the treatment of pediatric and young adult patients age 1 year to less than 22 years with mode
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Preserved source evidence · Not medical advice