NCT02435849 · OUTCOME
Frequent Monitoring of Concentrations of Soluble Immune Factors in Blood (All Other Inflammatory Markers)
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
- fold-change from baseline
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Maximum post-baseline (approx. 60 months)
What was measured
Profile of soluble immune factors of key inflammatory markers and cytokine parameters in blood by maximum CRS grade that may be key to cytokine release syndrome (CRS).
Analysis population: Safety Set: The Safety set comprised all patients who received tisagenlecleucel infusion with evaluable data. This analysis included a subset of Safety set who had any data of the particular biomarker at the specific timepoint. Therefore, no participants in Cohort 1 had biomarker data at this time point, so no data was collected for Cohort 1.
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 | 21 |
|---|
| Cohort 1: Single Dose of CTL019 | 0 |
|---|
Reported measurements
Interferon gamma: Fold-change from BL Grade 4 CRS
Values in fold-change from baseline · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 2745.92 | 1186.3 | Not reported | Not reported | Not reported |
|---|
Interleukin 10: Fold-change from BL Grade 4 CRS
Values in fold-change from baseline · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 179.49 | 966.7 | Not reported | Not reported | Not reported |
|---|
Interleukin 12p70: Fold-change from BL Grade 4 CRS
Values in fold-change from baseline · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 93.50 | 261.0 | Not reported | Not reported | Not reported |
|---|
Interleukin 13: Fold-change from BL Grade 4 CRS
Values in fold-change from baseline · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 49.21 | 124.0 | Not reported | Not reported | Not reported |
|---|
Interleukin 1 beta: Fold-change from BL Grade 4 CRS
Values in fold-change from baseline · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 16.75 | 127.7 | Not reported | Not reported | Not reported |
|---|
Interleukin 2: Fold-change from BL Grade 4 CRS
Values in fold-change from baseline · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 337.86 | 161.1 | Not reported | Not reported | Not reported |
|---|
Interleukin 4: Fold-change from BL Grade 4 CRS
Values in fold-change from baseline · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 170.21 | 163.3 | Not reported | Not reported | Not reported |
|---|
Interleukin 6: Fold-change from BL Grade 4 CRS
Values in fold-change from baseline · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 1435.85 | 221.6 | Not reported | Not reported | Not reported |
|---|
Interleukin 8: Fold-change from BL Grade 4 CRS
Values in fold-change from baseline · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 139.40 | 246.9 | Not reported | Not reported | Not reported |
|---|
Tumor necrosis factor alpha: Fold-change from BL Grade 4 CRS
Values in fold-change from baseline · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Cohort: Single Dose of CTL019 | 27.13 | 223.7 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1186.3
- value
- 2745.92
- title
- Interferon gamma: Fold-change from BL Grade 4 CRS
- categories
- measurements
- group Id
- OG000
- spread
- 966.7
- value
- 179.49
- title
- Interleukin 10: Fold-change from BL Grade 4 CRS
- categories
- measurements
- group Id
- OG000
- spread
- 261.0
- value
- 93.50
- title
- Interleukin 12p70: Fold-change from BL Grade 4 CRS
- categories
- measurements
- group Id
- OG000
- spread
- 124.0
- value
- 49.21
- title
- Interleukin 13: Fold-change from BL Grade 4 CRS
- categories
- measurements
- group Id
- OG000
- spread
- 127.7
- value
- 16.75
- title
- Interleukin 1 beta: Fold-change from BL Grade 4 CRS
- categories
- measurements
- group Id
- OG000
- spread
- 161.1
- value
- 337.86
- title
- Interleukin 2: Fold-change from BL Grade 4 CRS
- categories
- measurements
- group Id
- OG000
- spread
- 163.3
- value
- 170.21
- title
- Interleukin 4: Fold-change from BL Grade 4 CRS
- categories
- measurements
- group Id
- OG000
- spread
- 221.6
- value
- 1435.85
- title
- Interleukin 6: Fold-change from BL Grade 4 CRS
- categories
- measurements
- group Id
- OG000
- spread
- 246.9
- value
- 139.40
- title
- Interleukin 8: Fold-change from BL Grade 4 CRS
- categories
- measurements
- group Id
- OG000
- spread
- 223.7
- value
- 27.13
- title
- Tumor necrosis factor alpha: Fold-change from BL Grade 4 CRS
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- Profile of soluble immune factors of key inflammatory markers and cytokine parameters in blood by maximum CRS grade that may be key to cytokine release syndrome (CRS).
- 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
- Safety Set: The Safety set comprised all patients who received tisagenlecleucel infusion with evaluable data. This analysis included a subset of Safety set who had any data of the particular biomarker at the specific timepoint. Therefore, no participants in Cohort 1 had biomarker data at this time point, so no data was collected for Cohort 1.
- reporting Status
- POSTED
- time Frame
- Maximum post-baseline (approx. 60 months)
- title
- Frequent Monitoring of Concentrations of Soluble Immune Factors in Blood (All Other Inflammatory Markers)
- type
- SECONDARY
- unit Of Measure
- fold-change from baseline
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Preserved source evidence · Not medical advice
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