TriangleNCT02703272 · OUTCOME
Part 1: Relationship Between AUC and Body Size
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to Cycle 3 (each cycle of 28 days)
What was measured
The relationship between ibrutinib metrics of systemic exposure (AUC) with body size was assessed to determine the impact on AUC which were presented per dose groups (240 mg/m\^2, 329 mg/m\^2 and 440 mg/m\^2) and age groups (1-5, 6-11, 12-17 and \>18 years). The data could not be analyzed in tabular format for this outcome measure as they correspond to a flat regression line in nonlinear mixed effects modeling.
Analysis population: PK analysis set included participants in the ibrutinib group that received ibrutinib doses and had quantifiable plasma concentration of ibrutinib.
Groups in this outcome
Part 1: Ibrutinib+RICE
Participants received ibrutinib based on age group and body surface area (BSA) in combination with chemoimmunotherapy (CIT) (investigator choice of RICE \[rituximab, ifosfamide, carboplatin, etoposide, and dexamethasone\]). For both regimens, triple intrathecal therapy consisting of methotrexate, corticosteroid, and cytarabine will be administered for central nervous system (CNS) prophylaxis in age-appropriate dosing. Ibrutinib suspension or capsule was administered once daily starting Day 1 Cycle 1. The first 2 participants enrolled in each age group (1-5 years, 6-11 years, and 12-17 years) received Ibrutinib at a lower starting dose of 240 milligram per meter square (mg/m\^2) (not to exceed 420 mg per day) for the first cycle (older children \[6-17 years\] were enrolled first before enrolling younger children \[1-5 years\]), followed by dose escalation to 329 mg/m\^2 (not to exceed 560 mg per day) at the start of Cycle 2 based on the safety assessments. The RICE regimen was composed of rituximab 750 mg/m\^2, ifosfamide 9 grams per meter square (g/m\^2), carboplatin 635 mg/m\^2, etoposide 300 mg/m\^2, and dexamethasone 100 mg/m\^2. Study treatment continued for 3 cycles (each cycle of 28 or 21 days), unless the participants experienced unacceptable toxicity or disease progression.
Part 1: Ibrutinib+RVICI
Participants received ibrutinib based on age group and BSA in combination with CIT (investigator choice of RVICI \[rituximab, vincristine, ifosfamide, carboplatin, idarubicin, and dexamethasone\]). dexamethasone\]). For both regimens, triple intrathecal therapy consisting of methotrexate, corticosteroid, and cytarabine will be administered for central nervous system (CNS) prophylaxis in age-appropriate dosing. The first 2 participants enrolled in each age group (1-5 years, 6-11 years, and 12-17 years) received Ibrutinib at a lower starting dose of 240 mg/m2 (not to exceed 420 mg per day) for the first cycle (older children \[6-17 years\] were enrolled first before enrolling younger children \[1-5 years\]), followed by dose escalation to 329 mg/m2 (not to exceed 560 mg per day) at the start of Cycle 2 based on the safety assessments. The RVICI regimen was composed of rituximab 750 mg/m\^2, vincristine 1.6 mg/m\^2, ifosfamide 10 g/m\^2, carboplatin 800 mg/m\^2, idarubicin 20 mg/m\^2, and dexamethasone 100 mg/m\^2. Study treatment continued for 3 cycles (each cycle of 28 or 21 days), unless the participants experienced unacceptable toxicity or disease progression.
| Group | Source count |
|---|---|
| Part 1: Ibrutinib+RICE | 0 |
| Part 1: Ibrutinib+RVICI | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- The relationship between ibrutinib metrics of systemic exposure (AUC) with body size was assessed to determine the impact on AUC which were presented per dose groups (240 mg/m\^2, 329 mg/m\^2 and 440 mg/m\^2) and age groups (1-5, 6-11, 12-17 and \>18 years). The data could not be analyzed in tabular format for this outcome measure as they correspond to a flat regression line in nonlinear mixed effects modeling.
- groups
- description
- Participants received ibrutinib based on age group and body surface area (BSA) in combination with chemoimmunotherapy (CIT) (investigator choice of RICE \[rituximab, ifosfamide, carboplatin, etoposide, and dexamethasone\]). For both regimens, triple intrathecal therapy consisting of methotrexate, corticosteroid, and cytarabine will be administered for central nervous system (CNS) prophylaxis in age-appropriate dosing. Ibrutinib suspension or capsule was administered once daily starting Day 1 Cycle 1. The first 2 participants enrolled in each age group (1-5 years, 6-11 years, and 12-17 years) received Ibrutinib at a lower starting dose of 240 milligram per meter square (mg/m\^2) (not to exceed 420 mg per day) for the first cycle (older children \[6-17 years\] were enrolled first before enrolling younger children \[1-5 years\]), followed by dose escalation to 329 mg/m\^2 (not to exceed 560 mg per day) at the start of Cycle 2 based on the safety assessments. The RICE regimen was composed of rituximab 750 mg/m\^2, ifosfamide 9 grams per meter square (g/m\^2), carboplatin 635 mg/m\^2, etoposide 300 mg/m\^2, and dexamethasone 100 mg/m\^2. Study treatment continued for 3 cycles (each cycle of 28 or 21 days), unless the participants experienced unacceptable toxicity or disease progression.
- id
- OG000
- title
- Part 1: Ibrutinib+RICE
- description
- Participants received ibrutinib based on age group and BSA in combination with CIT (investigator choice of RVICI \[rituximab, vincristine, ifosfamide, carboplatin, idarubicin, and dexamethasone\]). dexamethasone\]). For both regimens, triple intrathecal therapy consisting of methotrexate, corticosteroid, and cytarabine will be administered for central nervous system (CNS) prophylaxis in age-appropriate dosing. The first 2 participants enrolled in each age group (1-5 years, 6-11 years, and 12-17 years) received Ibrutinib at a lower starting dose of 240 mg/m2 (not to exceed 420 mg per day) for the first cycle (older children \[6-17 years\] were enrolled first before enrolling younger children \[1-5 years\]), followed by dose escalation to 329 mg/m2 (not to exceed 560 mg per day) at the start of Cycle 2 based on the safety assessments. The RVICI regimen was composed of rituximab 750 mg/m\^2, vincristine 1.6 mg/m\^2, ifosfamide 10 g/m\^2, carboplatin 800 mg/m\^2, idarubicin 20 mg/m\^2, and dexamethasone 100 mg/m\^2. Study treatment continued for 3 cycles (each cycle of 28 or 21 days), unless the participants experienced unacceptable toxicity or disease progression.
- id
- OG001
- title
- Part 1: Ibrutinib+RVICI
- population Description
- PK analysis set included participants in the ibrutinib group that received ibrutinib doses and had quantifiable plasma concentration of ibrutinib.
- reporting Status
- POSTED
- time Frame
- Up to Cycle 3 (each cycle of 28 days)
- title
- Part 1: Relationship Between AUC and Body Size
- type
- PRIMARY
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Preserved source evidence · Not medical advice