Chronic Graft Versus Host Disease (cGVHD)
Conditions
Brief summary
Part A: The primary endpoint is the PK (AUC) to determine the RPED of ibrutinib for use in pediatric subjects (age ≥ 1 to < 12 years) with cGVHD., Part B: The primary endpoint is the PK (AUC) and safety (treatment-emergent AEs and laboratory abnormalities) of ibrutinib in pediatric subjects (age ≥ 1 to < 22 years) with cGVHD.
Detailed description
Part A: The secondary endpoints are safety, including treatment-emergent AEs, laboratory abnormalities, and other safety endpoints; pharmacodynamics and for those subjects continuing therapy after dose escalation (Part A Continuation Cohort), secondary endpoints will be the same as outlined under Part B below. B/ Part B: The secondary endpoints include cGVHD response rate at 24 weeks; duration of response; overall survival rate; growth and development in pediatric subjects, Part B: The secondary endpoints include cGVHD response rate at 24 weeks; duration of response; overall survival rate; growth and development in pediatric subjects
Interventions
DRUGIbrutinib
DRUGTabletten
DRUGPrednison acis 50 mg
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: The primary endpoint is the PK (AUC) to determine the RPED of ibrutinib for use in pediatric subjects (age ≥ 1 to < 12 years) with cGVHD., Part B: The primary endpoint is the PK (AUC) and safety (treatment-emergent AEs and laboratory abnormalities) of ibrutinib in pediatric subjects (age ≥ 1 to < 22 years) with cGVHD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: The secondary endpoints are safety, including treatment-emergent AEs, laboratory abnormalities, and other safety endpoints; pharmacodynamics and for those subjects continuing therapy after dose escalation (Part A Continuation Cohort), secondary endpoints will be the same as outlined under Part B below. B/ Part B: The secondary endpoints include cGVHD response rate at 24 weeks; duration of response; overall survival rate; growth and development in pediatric subjects, Part B: The secondary endpoints include cGVHD response rate at 24 weeks; duration of response; overall survival rate; growth and development in pediatric subjects | — |
Countries
France, Germany, Italy, Netherlands, Spain
Outcome results
None listed