NCT02435849 · OUTCOME
Pharmacokinetics (PK) Parameter: Cmax by qPCR in Peripheral Blood, by Day 28 Disease Response by IRC
Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients · Source last updated 2024-02-13
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- copies/ug
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- 60 months
What was measured
Cmax is the maximum (peak) observed in peripheral blood drug concentration after single dose administration reported by CR/CRi, no response (NR), Unknown and by All participants. D28 refers to the timepoint for definition of responder populations, whereas M60 is the actual timepoint for endpoint assessment. The reported Cmax is the summary of maximum level observed based on the data from each patient and based on all the data that's been collected for up to 60 months in a patient.
Analysis population: PAS: The PAS consisted of patients in the FAS who had at least one sample providing evaluable cellular kinetic data for tisagenlecleucel.
Groups in this outcome
Main Cohort: Single Dose of CTL019
Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).
Cohort 1: Single Dose of CTL019
Pediatric B-ALL patients who are very high risk at first relapse.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Cohort: Single Dose of CTL019 | 75 |
|---|
| Cohort 1: Single Dose of CTL019 | 1 |
|---|
Reported measurements
CR/CRi
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Cohort: Single Dose of CTL019 | 62 |
|---|
| Cohort 1: Single Dose of CTL019 | 1 |
|---|
Values in copies/ug · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 37200 | 154.2 | Not reported | Not reported | Not reported |
|---|
| Cohort 1: Single Dose of CTL019 | 2690 | NA | Not reported | Not reported | NA: Geo-CV could not be calculated for 1 participant. |
|---|
NR
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Cohort: Single Dose of CTL019 | 5 |
|---|
| Cohort 1: Single Dose of CTL019 | 0 |
|---|
Values in copies/ug · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 31700 | 87.4 | Not reported | Not reported | Not reported |
|---|
Unknown
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Cohort: Single Dose of CTL019 | 8 |
|---|
| Cohort 1: Single Dose of CTL019 | 0 |
|---|
Values in copies/ug · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 67700 | 132.5 | Not reported | Not reported | Not reported |
|---|
All Participants
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Cohort: Single Dose of CTL019 | 75 |
|---|
| Cohort 1: Single Dose of CTL019 | 1 |
|---|
Values in copies/ug · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 39200 | 148.8 | Not reported | Not reported | Not reported |
|---|
| Cohort 1: Single Dose of CTL019 | 2690 | NA | Not reported | Not reported | NA: Geo-CV could not be calculated for 1 participant. |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 154.2
- value
- 37200
- comment
- NA: Geo-CV could not be calculated for 1 participant.
- group Id
- OG001
- spread
- NA
- value
- 2690
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- CR/CRi
- categories
- measurements
- group Id
- OG000
- spread
- 87.4
- value
- 31700
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- NR
- categories
- measurements
- group Id
- OG000
- spread
- 132.5
- value
- 67700
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Unknown
- categories
- measurements
- group Id
- OG000
- spread
- 148.8
- value
- 39200
- comment
- NA: Geo-CV could not be calculated for 1 participant.
- group Id
- OG001
- spread
- NA
- value
- 2690
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- All Participants
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- Cmax is the maximum (peak) observed in peripheral blood drug concentration after single dose administration reported by CR/CRi, no response (NR), Unknown and by All participants. D28 refers to the timepoint for definition of responder populations, whereas M60 is the actual timepoint for endpoint assessment. The reported Cmax is the summary of maximum level observed based on the data from each patient and based on all the data that's been collected for up to 60 months in a patient.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).
- id
- OG000
- title
- Main Cohort: Single Dose of CTL019
- description
- Pediatric B-ALL patients who are very high risk at first relapse.
- id
- OG001
- title
- Cohort 1: Single Dose of CTL019
- param Type
- GEOMETRIC_MEAN
- population Description
- PAS: The PAS consisted of patients in the FAS who had at least one sample providing evaluable cellular kinetic data for tisagenlecleucel.
- reporting Status
- POSTED
- time Frame
- 60 months
- title
- Pharmacokinetics (PK) Parameter: Cmax by qPCR in Peripheral Blood, by Day 28 Disease Response by IRC
- type
- SECONDARY
- unit Of Measure
- copies/ug
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle