NCT03105336 · OUTCOME
Levels of Serum C-Reactive Protein (CRP)
A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma · Source last updated 2025-12-23
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mg/L
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4
Analysis population: Participants in the Safety Analysis Set with available data were analyzed.
Groups in this outcome
Axicabtagene Ciloleucel (Follicular Lymphoma)
Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study:
* A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3).
* A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study:
* A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3).
* A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
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 |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 123 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 28 |
|---|
Reported measurements
Serum CRP on Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 122 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 28 |
|---|
Values in mg/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 22.36 | 40.60 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 19.87 | 28.62 | Not reported | Not reported | Not reported |
|---|
Serum CRP on Day 0
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 121 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 28 |
|---|
Values in mg/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 29.30 | 47.35 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 32.94 | 42.50 | Not reported | Not reported | Not reported |
|---|
Serum CRP on Day 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 106 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 27 |
|---|
Values in mg/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 72.50 | 91.76 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 66.73 | 92.82 | Not reported | Not reported | Not reported |
|---|
Serum CRP on Day 7
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 123 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 28 |
|---|
Values in mg/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 59.45 | 79.24 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 77.79 | 91.86 | Not reported | Not reported | Not reported |
|---|
Serum CRP on Week 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 113 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 26 |
|---|
Values in mg/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 9.07 | 19.70 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 13.59 | 42.20 | Not reported | Not reported | Not reported |
|---|
Serum CRP on Week 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 118 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 28 |
|---|
Values in mg/L · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 7.84 | 33.76 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 9.86 | 43.46 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 40.60
- value
- 22.36
- group Id
- OG001
- spread
- 28.62
- value
- 19.87
- denoms
- counts
- group Id
- OG000
- value
- 122
- group Id
- OG001
- value
- 28
- units
- Participants
- title
- Serum CRP on Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 47.35
- value
- 29.30
- group Id
- OG001
- spread
- 42.50
- value
- 32.94
- denoms
- counts
- group Id
- OG000
- value
- 121
- group Id
- OG001
- value
- 28
- units
- Participants
- title
- Serum CRP on Day 0
- categories
- measurements
- group Id
- OG000
- spread
- 91.76
- value
- 72.50
- group Id
- OG001
- spread
- 92.82
- value
- 66.73
- denoms
- counts
- group Id
- OG000
- value
- 106
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- Serum CRP on Day 3
- categories
- measurements
- group Id
- OG000
- spread
- 79.24
- value
- 59.45
- group Id
- OG001
- spread
- 91.86
- value
- 77.79
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 28
- units
- Participants
- title
- Serum CRP on Day 7
- categories
- measurements
- group Id
- OG000
- spread
- 19.70
- value
- 9.07
- group Id
- OG001
- spread
- 42.20
- value
- 13.59
- denoms
- counts
- group Id
- OG000
- value
- 113
- group Id
- OG001
- value
- 26
- units
- Participants
- title
- Serum CRP on Week 2
- categories
- measurements
- group Id
- OG000
- spread
- 33.76
- value
- 7.84
- group Id
- OG001
- spread
- 43.46
- value
- 9.86
- denoms
- counts
- group Id
- OG000
- value
- 118
- group Id
- OG001
- value
- 28
- units
- Participants
- title
- Serum CRP on Week 4
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 28
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with r/r B-cell iNHL subtype of FL received the following treatment during the study:
* A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3).
* A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
- id
- OG000
- title
- Axicabtagene Ciloleucel (Follicular Lymphoma)
- description
- Participants with r/r B-cell iNHL subtype of MZL received the following treatment during the study:
* A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3).
* A single IV infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.
- id
- OG001
- title
- Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
- param Type
- MEAN
- population Description
- Participants in the Safety Analysis Set with available data were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4
- title
- Levels of Serum C-Reactive Protein (CRP)
- type
- SECONDARY
- unit Of Measure
- mg/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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