TriangleNCT02601313 · OUTCOME
Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- ng/mL
- Interval / dispersion
- Full Range
- Time frame
- Baseline up to Week 4
What was measured
Peak was defined as the maximum post-baseline level of the cytokine.
Analysis population: Participants from the Safety Analysis Set were analyzed.
Groups in this outcome
Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
| Group | Source count |
|---|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 68 |
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 14 |
Reported measurements
Ferritin
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 1302.41 | Not reported | 0.80 | 25000 | Not reported |
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 1126.52 | Not reported | 557.97 | 6177.17 | Not reported |
IL-2 R alpha
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 18.72 | Not reported | 2.20 | 100.00 | Not reported |
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 23.95 | Not reported | 6.23 | 90.34 | Not reported |
ICAM-1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 1252.07 | Not reported | 230.12 | 60593.2467 | Not reported |
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 1033.85 | Not reported | 218.96 | 1678.80 | Not reported |
Perforin
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 18.71 | Not reported | 0.69 | 100.00 | Not reported |
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 13.84 | Not reported | 5.86 | 36.47 | Not reported |
VCAM-1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel | 1843.57 | Not reported | 503.80 | 156061.4308 | Not reported |
| Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel | 1829.69 | Not reported | 416.85 | 3239.41 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.80
- upper Limit
- 25000
- value
- 1302.41
- group Id
- OG001
- lower Limit
- 557.97
- upper Limit
- 6177.17
- value
- 1126.52
- title
- Ferritin
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.20
- upper Limit
- 100.00
- value
- 18.72
- group Id
- OG001
- lower Limit
- 6.23
- upper Limit
- 90.34
- value
- 23.95
- title
- IL-2 R alpha
- categories
- measurements
- group Id
- OG000
- lower Limit
- 230.12
- upper Limit
- 60593.2467
- value
- 1252.07
- group Id
- OG001
- lower Limit
- 218.96
- upper Limit
- 1678.80
- value
- 1033.85
- title
- ICAM-1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.69
- upper Limit
- 100.00
- value
- 18.71
- group Id
- OG001
- lower Limit
- 5.86
- upper Limit
- 36.47
- value
- 13.84
- title
- Perforin
- categories
- measurements
- group Id
- OG000
- lower Limit
- 503.80
- upper Limit
- 156061.4308
- value
- 1843.57
- group Id
- OG001
- lower Limit
- 416.85
- upper Limit
- 3239.41
- value
- 1829.69
- title
- VCAM-1
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- Peak was defined as the maximum post-baseline level of the cytokine.
- dispersion Type
- Full Range
- groups
- description
- Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
- id
- OG000
- title
- Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel
- description
- Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10\^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10\^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
- id
- OG001
- title
- Cohort 2: 0.5 x 10^6 Brexucabtagene Autoleucel
- param Type
- MEDIAN
- population Description
- Participants from the Safety Analysis Set were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline up to Week 4
- title
- Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice