NCT03105336 · OUTCOME
Levels of Anti-CD19 CAR T Cells in Blood
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
- cells/μL
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 7, Week 2, Week 4, Month 3, Month 6, Month 12, Month 18 and Month 24
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) | 124 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 28 |
|---|
Reported measurements
Day 7
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 124 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 28 |
|---|
Values in cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 101.49 | 220.01 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 120.07 | 394.91 | Not reported | Not reported | Not reported |
|---|
Week 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 112 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 26 |
|---|
Values in cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 41.45 | 63.65 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 90.76 | 128.63 | Not reported | Not reported | Not reported |
|---|
Week 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 117 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 27 |
|---|
Values in cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 7.52 | 19.85 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 14.03 | 23.43 | Not reported | Not reported | Not reported |
|---|
Month 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 114 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 24 |
|---|
Values in cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 0.78 | 1.91 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 0.52 | 0.51 | Not reported | Not reported | Not reported |
|---|
Month 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 106 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 24 |
|---|
Values in cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 3.49 | 28.89 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 0.68 | 1.90 | Not reported | Not reported | Not reported |
|---|
Month 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 86 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 15 |
|---|
Values in cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 1.00 | 5.65 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 0.23 | 0.43 | Not reported | Not reported | Not reported |
|---|
Month 18
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 66 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 17 |
|---|
Values in cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 0.47 | 1.51 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 0.42 | 0.77 | Not reported | Not reported | Not reported |
|---|
Month 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 65 |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 16 |
|---|
Values in cells/μL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | 0.36 | 0.84 | Not reported | Not reported | Not reported |
|---|
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | 0.88 | 2.09 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 220.01
- value
- 101.49
- group Id
- OG001
- spread
- 394.91
- value
- 120.07
- denoms
- counts
- group Id
- OG000
- value
- 124
- group Id
- OG001
- value
- 28
- units
- Participants
- title
- Day 7
- categories
- measurements
- group Id
- OG000
- spread
- 63.65
- value
- 41.45
- group Id
- OG001
- spread
- 128.63
- value
- 90.76
- denoms
- counts
- group Id
- OG000
- value
- 112
- group Id
- OG001
- value
- 26
- units
- Participants
- title
- Week 2
- categories
- measurements
- group Id
- OG000
- spread
- 19.85
- value
- 7.52
- group Id
- OG001
- spread
- 23.43
- value
- 14.03
- denoms
- counts
- group Id
- OG000
- value
- 117
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- Week 4
- categories
- measurements
- group Id
- OG000
- spread
- 1.91
- value
- 0.78
- group Id
- OG001
- spread
- 0.51
- value
- 0.52
- denoms
- counts
- group Id
- OG000
- value
- 114
- group Id
- OG001
- value
- 24
- units
- Participants
- title
- Month 3
- categories
- measurements
- group Id
- OG000
- spread
- 28.89
- value
- 3.49
- group Id
- OG001
- spread
- 1.90
- value
- 0.68
- denoms
- counts
- group Id
- OG000
- value
- 106
- group Id
- OG001
- value
- 24
- units
- Participants
- title
- Month 6
- categories
- measurements
- group Id
- OG000
- spread
- 5.65
- value
- 1.00
- group Id
- OG001
- spread
- 0.43
- value
- 0.23
- denoms
- counts
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Month 12
- categories
- measurements
- group Id
- OG000
- spread
- 1.51
- value
- 0.47
- group Id
- OG001
- spread
- 0.77
- value
- 0.42
- denoms
- counts
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 17
- units
- Participants
- title
- Month 18
- categories
- measurements
- group Id
- OG000
- spread
- 0.84
- value
- 0.36
- group Id
- OG001
- spread
- 2.09
- value
- 0.88
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 16
- units
- Participants
- title
- Month 24
- denoms
- counts
- group Id
- OG000
- value
- 124
- 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
- Day 7, Week 2, Week 4, Month 3, Month 6, Month 12, Month 18 and Month 24
- title
- Levels of Anti-CD19 CAR T Cells in Blood
- type
- SECONDARY
- unit Of Measure
- cells/μL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle