Follicular Lymphoma, Indolent Non-Hodgkin Lymphoma, Marginal Zone Lymphoma
Conditions
Brief summary
The goal of this study is to assess whether axicabtagene ciloleucel improves the clinical outcome in participants with relapsed or refractory indolent non-Hodgkin lymphoma (r/r) iNHL.
Detailed description
After completing at least 60 months (FL participants) or at least 24 months (MZL participants) of assessments in this study since the initial axicabtagene ciloleucel infusion and after agreement by the Sponsor, participants will transition to a long-term follow-up (LTFU) study, KT-US-982-5968 where they will complete the remainder of the 15 year follow-up assessments.
Interventions
Administered intravenously
Administered intravenously
Administered intravenously
Sponsors
Study design
Eligibility
Inclusion criteria
Key Inclusion Criteria: * Individual has follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has progressed after at least 2 lines of treatment with combination chemoimmunotherapy) (e.g. R-bendamustine, R-CHOP). * Individual has (measurable disease). * Individual has no known presence or history of central nervous system (CNS) involvement by lymphoma. * If individual is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, individual is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis. * Individual has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function * Individual is not pregnant or breastfeeding (female individuals only) and is willing to use birth control from the time of consent through 12 months following chimeric antigen receptor (CAR) T cell infusion (both male and female individuals). Key
Exclusion criteria
* Transformed FL or MZL * Small lymphocytic lymphoma * Histological Grade 3b FL * Individual will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant. * Individual has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect, tumor lysis syndrome, etc.) Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR): Percentage of Participants With Objective Response Per the Lugano Classification by Central Assessment | Up to 85.6 months | OR:CR (complete metabolic response (CMR)+complete radiological response (CRR))+PR (partial MR response (PMR) +partial RR(PRR)).CMR: score 1(no uptake above background)/2(uptake≤mediastinum)/3(uptake \>mediastinum but ≤liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions,CRR:target nodes/nodal masses regressed to ≤1.5 cm in longest transverse diameter of lesion (LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal; no new sites;bone marrow normal by morphology.PMR:score 4(uptake moderately\>liver)/5(uptake markedly\>liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment.PRR:≥50% decrease in sum of product of diameters up to 6 target nodes and extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed by\>50% in length beyond normal. Percentages were rounded-off. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR: Percentage of Participants With OR Per the Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy | Up to 85.6 months | OR was defined as percentage of participants with CR + PR per the Lugano Classification for participants with 3 or more lines of prior therapy. CR and PR are defined in OM#1. Percentages were rounded-off. |
| Percentage of Participants With CR Per Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy | Up to 85.6 months | CR is defined as OM#1. Percentages were rounded-off. |
| ORR: Percentage of Participants With OR Per the Lugano Classification by Investigator Assessment | Up to 85.6 months | OR was defined as percentage of participants with CR + PR per the Lugano Classification. CR and PR are defined in OM#1. Percentages were rounded-off. |
| Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | Up to 85.6 months | BOR was defined as percentage of participants with CR, PR, stable disease(SD), disease progression(PD), non-evaluable(NE), undefined/no disease or not done as best response to treatment by the Lugano Classification. CR and PR defined in OM#1. SD/no metabolic response(NMR):score 4(uptake moderately greater than (\>) liver) or 5(uptake markedly\>liver and/ or new lesions) with no significant change in fluorodeoxyglucose(FDG) uptake compared to baseline(screening), at interim time point or end of treatment; no new sites of disease should be observed. PD:score 4(uptake moderately\>liver) or 5(uptake markedly\>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. Not done:no assessment at time of analysis. Percentages were rounded off. |
| Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | Up to 85.6 months | BOR was defined as the percentage of participants with CR, PR, stable disease (SD), PD, NE (not evaluable) or not done as best response to treatment by the Lugano Classification. CR and PR are defined in OM#1. SD, PD and not done are defined in OM#6. Percentages were rounded off. |
| Duration of Response (DOR) by Central Assessment | Up to 85.6 months | DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. CR and PR are defined in OM#1. PD is defined in OM#6. Kaplan-Meier (KM) estimates were used for analysis. |
| DOR by Investigator Assessment | Up to 85.6 months | DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. Definitions for CR, PR are defined in OM#1. PD is defined in OM#6. KM estimates were used for analysis. |
| Progression-free Survival (PFS) Per Lugano Classification by Central Assessment | Up to 85.6 months | PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 6. KM estimates were used for analysis. |
| PFS Per Lugano Classification by Investigator Assessment | Up to 85.6 months | PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 6. KM estimates were used for analysis. |
| Percentage of Participants With CR Per the Lugano Classification by Central Assessment | Up to 85.6 months | CR is defined in outcome measure (OM)#1. Percentages were rounded-off. |
| Time to Next Therapy | Up to 85.6 months | Time from axicabtagene ciloleucel infusion date to the start of the subsequent new lymphoma therapy or death from any cause. KM estimates were used for analysis. |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Up to 85.6 months | TEAE was defined as any adverse event with onset on or after the start of treatment. Percentages were rounded-off. |
| Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Up to 85.6 months | Percentages were rounded-off. |
| Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Up to 85.6 months | Percentages were rounded-off. |
| Percentage of Participants With Antibodies Against Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells | Up to 85.6 months | — |
| Levels of Anti-CD19 CAR T Cells in Blood | Day 7, Week 2, Week 4, Month 3, Month 6, Month 12, Month 18 and Month 24 | — |
| Levels of Serum C-Reactive Protein (CRP) | Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4 | — |
| Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4 | Serum analytes: Serum Ferritin, Serum intercellular adhesion molecule-1 (ICAM-1), Serum interleukin-2 receptor (IL-2 R) alpha, Serum Perforin and Serum vascular cell adhesion molecule-1 (VCAM-1). |
| Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4 | Serum analytes: Serum CXCL10, Serum Granzyme B, Serum interferon (IFN)-gamma, Serum IL-1 receptor antagonist (RA), Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum tumor necrosis factor (TNF) Alpha. |
| Overall Survival (OS) | Up to 85.6 | OS was defined as the time from axicabtagene ciloleucel infusion to the date of death. KM estimates were used for analysis. |
Countries
France, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in the United States and France.
Pre-assignment details
189 participants were screened. A total of 159 participants were enrolled. However, one participant discontinued the study as the participant did not meet study condition eligibility criteria (was diagnosed with diffuse large B-cell lymphoma (DLBCL)). So, 158 participants were considered in the Full Analysis Set (FAS = all enrolled participants).
Participants by arm
| Arm | Count |
|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) Participants with relapsed or refractory (r/r) B-cell indolent non-Hodgkin lymphoma (iNHL) subtype of follicular lymphoma (FL) received the following treatment during the study:
* A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (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-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. | 124 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) Participants with r/r B-cell iNHL subtype of marginal zone lymphoma (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. | 28 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 40 | 8 |
| Overall Study | Investigator Decision | 3 | 0 |
| Overall Study | Lost to Follow-up | 13 | 2 |
| Overall Study | Reason Not Specified | 3 | 3 |
| Overall Study | Rollover to Longterm Follow-up Study Criteria | 61 | 15 |
| Overall Study | Subject Withdrawal of Consent from Further Follow-up | 7 | 3 |
Baseline characteristics
| Characteristic | Total | Axicabtagene Ciloleucel (Follicular Lymphoma) | Axicabtagene Ciloleucel (Marginal Zone Lymphoma) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 51 Participants | 38 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 101 Participants | 86 Participants | 15 Participants |
| Age, Continuous | 60.0 years STANDARD_DEVIATION 10 | 59 years STANDARD_DEVIATION 9.9 | 63 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 142 Participants | 118 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 6 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Other or More Than One Race | 4 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 140 Participants | 115 Participants | 25 Participants |
| Region of Enrollment France | 10 Participants | 10 Participants | 0 Participants |
| Region of Enrollment United States | 142 Participants | 114 Participants | 28 Participants |
| Sex: Female, Male Female | 66 Participants | 51 Participants | 15 Participants |
| Sex: Female, Male Male | 86 Participants | 73 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 36 / 127 | 8 / 31 | 5 / 14 | 0 / 2 |
| other Total, other adverse events | 123 / 124 | 28 / 28 | 13 / 14 | 2 / 2 |
| serious Total, serious adverse events | 65 / 124 | 19 / 28 | 5 / 14 | 1 / 2 |
Outcome results
Objective Response Rate (ORR): Percentage of Participants With Objective Response Per the Lugano Classification by Central Assessment
OR:CR (complete metabolic response (CMR)+complete radiological response (CRR))+PR (partial MR response (PMR) +partial RR(PRR)).CMR: score 1(no uptake above background)/2(uptake≤mediastinum)/3(uptake \>mediastinum but ≤liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions,CRR:target nodes/nodal masses regressed to ≤1.5 cm in longest transverse diameter of lesion (LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal; no new sites;bone marrow normal by morphology.PMR:score 4(uptake moderately\>liver)/5(uptake markedly\>liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment.PRR:≥50% decrease in sum of product of diameters up to 6 target nodes and extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed by\>50% in length beyond normal. Percentages were rounded-off.
Time frame: Up to 85.6 months
Population: Participants in the Full Analysis Set with available data were analyzed. Full Analysis Set consisted of all enrolled participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Objective Response Rate (ORR): Percentage of Participants With Objective Response Per the Lugano Classification by Central Assessment | 92 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Objective Response Rate (ORR): Percentage of Participants With Objective Response Per the Lugano Classification by Central Assessment | 69 percentage of participants |
DOR by Investigator Assessment
DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. Definitions for CR, PR are defined in OM#1. PD is defined in OM#6. KM estimates were used for analysis.
Time frame: Up to 85.6 months
Population: Participants with OR in Full Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | DOR by Investigator Assessment | 60.4 months |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | DOR by Investigator Assessment | NA months |
Duration of Response (DOR) by Central Assessment
DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. CR and PR are defined in OM#1. PD is defined in OM#6. Kaplan-Meier (KM) estimates were used for analysis.
Time frame: Up to 85.6 months
Population: Participants with OR in the Full Analysis Set with available data were analyzed
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Duration of Response (DOR) by Central Assessment | 38.6 months |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Duration of Response (DOR) by Central Assessment | NA months |
Levels of Anti-CD19 CAR T Cells in Blood
Time frame: Day 7, Week 2, Week 4, Month 3, Month 6, Month 12, Month 18 and Month 24
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Day 7 | 101.49 cells/μL | Standard Deviation 220.01 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Week 2 | 41.45 cells/μL | Standard Deviation 63.65 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Week 4 | 7.52 cells/μL | Standard Deviation 19.85 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Month 3 | 0.78 cells/μL | Standard Deviation 1.91 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Month 6 | 3.49 cells/μL | Standard Deviation 28.89 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Month 12 | 1.00 cells/μL | Standard Deviation 5.65 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Month 18 | 0.47 cells/μL | Standard Deviation 1.51 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Month 24 | 0.36 cells/μL | Standard Deviation 0.84 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Month 24 | 0.88 cells/μL | Standard Deviation 2.09 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Day 7 | 120.07 cells/μL | Standard Deviation 394.91 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Month 6 | 0.68 cells/μL | Standard Deviation 1.9 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Week 2 | 90.76 cells/μL | Standard Deviation 128.63 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Month 18 | 0.42 cells/μL | Standard Deviation 0.77 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Week 4 | 14.03 cells/μL | Standard Deviation 23.43 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Month 12 | 0.23 cells/μL | Standard Deviation 0.43 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Anti-CD19 CAR T Cells in Blood | Month 3 | 0.52 cells/μL | Standard Deviation 0.51 |
Levels of Serum C-Reactive Protein (CRP)
Time frame: Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum C-Reactive Protein (CRP) | Serum CRP on Day 3 | 72.50 mg/L | Standard Deviation 91.76 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum C-Reactive Protein (CRP) | Serum CRP on Week 2 | 9.07 mg/L | Standard Deviation 19.7 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum C-Reactive Protein (CRP) | Serum CRP on Day 0 | 29.30 mg/L | Standard Deviation 47.35 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum C-Reactive Protein (CRP) | Serum CRP on Week 4 | 7.84 mg/L | Standard Deviation 33.76 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum C-Reactive Protein (CRP) | Serum CRP on Day 7 | 59.45 mg/L | Standard Deviation 79.24 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum C-Reactive Protein (CRP) | Serum CRP on Baseline | 22.36 mg/L | Standard Deviation 40.6 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum C-Reactive Protein (CRP) | Serum CRP on Day 0 | 32.94 mg/L | Standard Deviation 42.5 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum C-Reactive Protein (CRP) | Serum CRP on Baseline | 19.87 mg/L | Standard Deviation 28.62 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum C-Reactive Protein (CRP) | Serum CRP on Day 3 | 66.73 mg/L | Standard Deviation 92.82 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum C-Reactive Protein (CRP) | Serum CRP on Day 7 | 77.79 mg/L | Standard Deviation 91.86 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum C-Reactive Protein (CRP) | Serum CRP on Week 2 | 13.59 mg/L | Standard Deviation 42.2 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum C-Reactive Protein (CRP) | Serum CRP on Week 4 | 9.86 mg/L | Standard Deviation 43.46 |
Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha
Serum analytes: Serum CXCL10, Serum Granzyme B, Serum interferon (IFN)-gamma, Serum IL-1 receptor antagonist (RA), Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum tumor necrosis factor (TNF) Alpha.
Time frame: Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-1 RA on Day 3 | 703.79 pg/mL | Standard Deviation 772.95 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-8 on Baseline | 13.59 pg/mL | Standard Deviation 15.09 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum Granzyme B on Week 4 | 3.14 pg/mL | Standard Deviation 5.15 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-8 on Day 0 | 21.12 pg/mL | Standard Deviation 33.53 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-1 RA on Day 7 | 1125.80 pg/mL | Standard Deviation 1316.88 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-8 on Week 4 | 20.36 pg/mL | Standard Deviation 68.72 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum CXCL10 on Week 4 | 623.87 pg/mL | Standard Deviation 535.45 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-10 on Baseline | 2.85 pg/mL | Standard Deviation 3.76 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-1 RA on Week 2 | 591.72 pg/mL | Standard Deviation 764.19 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-10 on Day 0 | 1.93 pg/mL | Standard Deviation 2.29 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IFN-gamma on Baseline | 9.25 pg/mL | Standard Deviation 7.17 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-10 on Day 3 | 9.34 pg/mL | Standard Deviation 17.6 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-2 on Day 3 | 8.01 pg/mL | Standard Deviation 13.08 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-10 on Day 7 | 15.01 pg/mL | Standard Deviation 34.55 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum CXCL10 on Day 7 | 841.62 pg/mL | Standard Deviation 572.8 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-10 on Week 2 | 2.06 pg/mL | Standard Deviation 4.64 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum CXCL10 on Baseline | 466.32 pg/mL | Standard Deviation 339 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-10 on Week 4 | 1.10 pg/mL | Standard Deviation 1.31 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-2 on Day 7 | 1.67 pg/mL | Standard Deviation 2.55 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-15 on Baseline | 2.70 pg/mL | Standard Deviation 2.69 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IFN-gamma on Day 0 | 11.20 pg/mL | Standard Deviation 16.17 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-15 on Day 0 | 31.06 pg/mL | Standard Deviation 13.55 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-2 on Week 2 | 0.95 pg/mL | Standard Deviation 0.48 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-15 on Week 4 | 4.98 pg/mL | Standard Deviation 3.52 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum Granzyme B on Baseline | 3.58 pg/mL | Standard Deviation 9.68 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum TNF Alpha on Baseline | 7.26 pg/mL | Standard Deviation 7.87 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-2 on Week 4 | 0.95 pg/mL | Standard Deviation 0.5 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum TNF Alpha on Day 0 | 3.32 pg/mL | Standard Deviation 2.62 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IFN-gamma on Day 3 | 157.13 pg/mL | Standard Deviation 326.44 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum TNF Alpha on Day 3 | 3.95 pg/mL | Standard Deviation 2.68 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-6 on Baseline | 2.71 pg/mL | Standard Deviation 2.9 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum TNF Alpha on Week 2 | 2.84 pg/mL | Standard Deviation 6.01 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum CXCL10 on Day 3 | 712.31 pg/mL | Standard Deviation 543.76 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum TNF Alpha on Week 4 | 2.36 pg/mL | Standard Deviation 1.65 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-6 on Day 0 | 2.42 pg/mL | Standard Deviation 2.27 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IFN-gamma on Day 7 | 139.82 pg/mL | Standard Deviation 359.84 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-6 on Day 3 | 59.30 pg/mL | Standard Deviation 185.89 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum Granzyme B on Day 7 | 76.29 pg/mL | Standard Deviation 494.66 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum Granzyme B on Week 2 | 2.73 pg/mL | Standard Deviation 5.67 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum Granzyme B on Day 0 | 2.95 pg/mL | Standard Deviation 7.86 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-1 RA on Day 0 | 677.50 pg/mL | Standard Deviation 743.22 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-6 on Week 2 | 20.01 pg/mL | Standard Deviation 92.15 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IFN-gamma on Week 2 | 25.98 pg/mL | Standard Deviation 48.82 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-1 RA on Week 4 | 653.88 pg/mL | Standard Deviation 1197.23 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-6 on Week 4 | 31.02 pg/mL | Standard Deviation 122.14 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-2 on Baseline | 1.03 pg/mL | Standard Deviation 0.53 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-2 on Day 0 | 1.20 pg/mL | Standard Deviation 1.22 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum CXCL10 on Week 2 | 474.45 pg/mL | Standard Deviation 371.95 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-6 on Day 7 | 67.49 pg/mL | Standard Deviation 197.95 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-7 on Baseline | 15.99 pg/mL | Standard Deviation 7.89 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IFN-gamma on Week 4 | 23.96 pg/mL | Standard Deviation 37.04 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-7 on Week 2 | 27.25 pg/mL | Standard Deviation 14.13 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-7 on Day 0 | 27.65 pg/mL | Standard Deviation 9.62 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-8 on Day 3 | 60.27 pg/mL | Standard Deviation 126.84 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum Granzyme B on Day 3 | 6.53 pg/mL | Standard Deviation 11.03 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-8 on Day 7 | 45.79 pg/mL | Standard Deviation 86.38 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-8 on Week 2 | 16.08 pg/mL | Standard Deviation 17.14 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-7 on Day 3 | 26.50 pg/mL | Standard Deviation 10.22 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-15 on Day 3 | 35.27 pg/mL | Standard Deviation 19.66 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-1 RA on Baseline | 584.66 pg/mL | Standard Deviation 400.47 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-15 on Day 7 | 18.73 pg/mL | Standard Deviation 9.77 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-7 on Day 7 | 23.42 pg/mL | Standard Deviation 11.28 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-15 on Week 2 | 10.30 pg/mL | Standard Deviation 5.9 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum CXCL10 on Day 0 | 499.16 pg/mL | Standard Deviation 334.85 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-7 on Week 4 | 18.45 pg/mL | Standard Deviation 8.92 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum TNF Alpha on Day 7 | 3.93 pg/mL | Standard Deviation 3.1 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-10 on Week 2 | 3.42 pg/mL | Standard Deviation 4.88 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum CXCL10 on Baseline | 634.56 pg/mL | Standard Deviation 539.17 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum CXCL10 on Day 3 | 962.96 pg/mL | Standard Deviation 611.23 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum CXCL10 on Day 7 | 1630.98 pg/mL | Standard Deviation 563.4 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum CXCL10 on Week 2 | 798.28 pg/mL | Standard Deviation 631.8 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum CXCL10 on Week 4 | 964.92 pg/mL | Standard Deviation 640.57 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum Granzyme B on Baseline | 121.49 pg/mL | Standard Deviation 623.76 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum Granzyme B on Day 0 | 46.36 pg/mL | Standard Deviation 234.23 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum Granzyme B on Day 7 | 52.87 pg/mL | Standard Deviation 68.63 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum Granzyme B on Week 4 | 17.00 pg/mL | Standard Deviation 39.9 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IFN-gamma on Baseline | 30.29 pg/mL | Standard Deviation 83.67 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IFN-gamma on Day 0 | 54.04 pg/mL | Standard Deviation 140.4 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IFN-gamma on Day 3 | 292.67 pg/mL | Standard Deviation 531.54 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IFN-gamma on Day 7 | 674.34 pg/mL | Standard Deviation 792.31 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IFN-gamma on Week 2 | 27.16 pg/mL | Standard Deviation 37.43 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IFN-gamma on Week 4 | 56.72 pg/mL | Standard Deviation 108.1 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-1 RA on Baseline | 627.95 pg/mL | Standard Deviation 467.39 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-1 RA on Day 3 | 848.20 pg/mL | Standard Deviation 757.98 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-1 RA on Day 7 | 2492.85 pg/mL | Standard Deviation 2895.93 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-2 on Baseline | 1.12 pg/mL | Standard Deviation 0.9 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-2 on Day 3 | 12.43 pg/mL | Standard Deviation 34.49 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-2 on Day 7 | 2.99 pg/mL | Standard Deviation 3.78 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-2 on Week 2 | 0.93 pg/mL | Standard Deviation 0.18 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-2 on Week 4 | 1.10 pg/mL | Standard Deviation 1.06 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-6 on Baseline | 5.08 pg/mL | Standard Deviation 8.11 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-6 on Day 0 | 4.14 pg/mL | Standard Deviation 5.39 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-6 on Day 3 | 103.93 pg/mL | Standard Deviation 281.61 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-6 on Week 2 | 33.00 pg/mL | Standard Deviation 66.24 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-6 on Week 4 | 58.84 pg/mL | Standard Deviation 169.85 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-7 on Baseline | 15.30 pg/mL | Standard Deviation 7.13 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-7 on Day 0 | 28.31 pg/mL | Standard Deviation 10.15 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-7 on Day 3 | 27.24 pg/mL | Standard Deviation 10.82 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-7 on Week 2 | 26.38 pg/mL | Standard Deviation 16.52 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-7 on Week 4 | 20.30 pg/mL | Standard Deviation 10.52 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-8 on Baseline | 13.71 pg/mL | Standard Deviation 9.11 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-8 on Day 7 | 37.47 pg/mL | Standard Deviation 30.74 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-8 on Week 4 | 18.90 pg/mL | Standard Deviation 13.8 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-10 on Baseline | 5.11 pg/mL | Standard Deviation 6.72 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-10 on Day 0 | 1.89 pg/mL | Standard Deviation 2.18 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-10 on Day 3 | 7.39 pg/mL | Standard Deviation 10.14 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-10 on Day 7 | 20.32 pg/mL | Standard Deviation 20.7 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-10 on Week 4 | 1.65 pg/mL | Standard Deviation 2.08 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-15 on Baseline | 2.59 pg/mL | Standard Deviation 1.42 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-15 on Day 0 | 33.89 pg/mL | Standard Deviation 16.32 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-15 on Week 4 | 7.41 pg/mL | Standard Deviation 5.21 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum TNF Alpha on Baseline | 6.73 pg/mL | Standard Deviation 7.86 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum TNF Alpha on Day 0 | 3.08 pg/mL | Standard Deviation 1.68 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum TNF Alpha on Day 7 | 5.97 pg/mL | Standard Deviation 4.09 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum TNF Alpha on Week 2 | 2.74 pg/mL | Standard Deviation 2.3 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum TNF Alpha on Week 4 | 3.03 pg/mL | Standard Deviation 2.13 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum CXCL10 on Day 0 | 763.99 pg/mL | Standard Deviation 569.42 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum Granzyme B on Day 3 | 74.28 pg/mL | Standard Deviation 348.53 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum Granzyme B on Week 2 | 27.21 pg/mL | Standard Deviation 102.65 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-1 RA on Day 0 | 960.41 pg/mL | Standard Deviation 1342.3 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-1 RA on Week 2 | 854.68 pg/mL | Standard Deviation 1693.69 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-1 RA on Week 4 | 1106.94 pg/mL | Standard Deviation 1935.55 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-2 on Day 0 | 1.16 pg/mL | Standard Deviation 1.09 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-6 on Day 7 | 206.75 pg/mL | Standard Deviation 282.31 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-7 on Day 7 | 23.28 pg/mL | Standard Deviation 11.69 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-8 on Day 0 | 42.71 pg/mL | Standard Deviation 129.39 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-8 on Day 3 | 80.86 pg/mL | Standard Deviation 154.41 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-8 on Week 2 | 41.41 pg/mL | Standard Deviation 117.98 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-15 on Day 3 | 43.43 pg/mL | Standard Deviation 37.4 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-15 on Day 7 | 25.22 pg/mL | Standard Deviation 15.38 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum IL-15 on Week 2 | 12.92 pg/mL | Standard Deviation 8.28 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum CXCL10, Serum Granzyme B, Serum IFN-gamma, Serum IL-1 RA, Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum TNF Alpha | Serum TNF Alpha on Day 3 | 4.90 pg/mL | Standard Deviation 4.59 |
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1
Serum analytes: Serum Ferritin, Serum intercellular adhesion molecule-1 (ICAM-1), Serum interleukin-2 receptor (IL-2 R) alpha, Serum Perforin and Serum vascular cell adhesion molecule-1 (VCAM-1).
Time frame: Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Perforin on Week 4 | 14.56 ng/L | Standard Deviation 11.92 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Ferritin on Day 0 | 503.99 ng/L | Standard Deviation 502.07 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Ferritin on Day 3 | 541.51 ng/L | Standard Deviation 457.18 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Ferritin on Day 7 | 779.75 ng/L | Standard Deviation 782.98 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Ferritin on Week 2 | 741.76 ng/L | Standard Deviation 787.7 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Ferritin on Week 4 | 528.83 ng/L | Standard Deviation 605.94 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum ICAM-1 on Baseline | 876.99 ng/L | Standard Deviation 833.8 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum ICAM-1 on Day 0 | 834.87 ng/L | Standard Deviation 854.35 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum ICAM-1 on Day 3 | 964.45 ng/L | Standard Deviation 904.79 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum ICAM-1 on Day 7 | 924.99 ng/L | Standard Deviation 846.56 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum ICAM-1 on Week 2 | 695.15 ng/L | Standard Deviation 605.03 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum ICAM-1 on Week 4 | 671.32 ng/L | Standard Deviation 656.46 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum IL-2 R alpha on Baseline | 8.52 ng/L | Standard Deviation 12.15 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum IL-2 R alpha on Day 0 | 8.39 ng/L | Standard Deviation 9.1 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum IL-2 R alpha on Day 3 | 9.96 ng/L | Standard Deviation 11.53 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum IL-2 R alpha on Day 7 | 14.42 ng/L | Standard Deviation 15.1 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum IL-2 R alpha on Week 2 | 7.16 ng/L | Standard Deviation 8.27 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum IL-2 R alpha on Week 4 | 3.39 ng/L | Standard Deviation 3.34 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Perforin on Day 0 | 2.56 ng/L | Standard Deviation 1.85 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Perforin on Day 3 | 3.87 ng/L | Standard Deviation 3.36 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Perforin on Day 7 | 8.49 ng/L | Standard Deviation 10.54 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Perforin on Week 2 | 8.06 ng/L | Standard Deviation 6.9 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Ferritin on Baseline | 330.54 ng/L | Standard Deviation 398.03 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum VCAM-1 on Baseline | 1499.37 ng/L | Standard Deviation 1637.98 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum VCAM-1 on Day 0 | 1182.41 ng/L | Standard Deviation 1166.58 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum VCAM-1 on Day 3 | 1213.84 ng/L | Standard Deviation 962.38 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum VCAM-1 on Day 7 | 1224.58 ng/L | Standard Deviation 1069.13 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum VCAM-1 on Week 2 | 891.64 ng/L | Standard Deviation 726.1 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum VCAM-1 on Week 4 | 981.67 ng/L | Standard Deviation 879.87 |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Perforin on Baseline | 13.26 ng/L | Standard Deviation 7.2 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum VCAM-1 on Day 3 | 1044.96 ng/L | Standard Deviation 870.11 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Ferritin on Baseline | 207.63 ng/L | Standard Deviation 218.42 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum IL-2 R alpha on Day 7 | 19.78 ng/L | Standard Deviation 20.82 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Ferritin on Day 0 | 398.49 ng/L | Standard Deviation 337.82 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Perforin on Week 4 | 12.32 ng/L | Standard Deviation 12.08 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Ferritin on Day 3 | 487.39 ng/L | Standard Deviation 414.9 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum IL-2 R alpha on Week 2 | 10.40 ng/L | Standard Deviation 12.26 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Ferritin on Day 7 | 1820.38 ng/L | Standard Deviation 4837.56 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum VCAM-1 on Week 2 | 977.88 ng/L | Standard Deviation 919.47 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Ferritin on Week 2 | 959.49 ng/L | Standard Deviation 1546.07 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum IL-2 R alpha on Week 4 | 4.02 ng/L | Standard Deviation 3.67 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Ferritin on Week 4 | 478.47 ng/L | Standard Deviation 459.54 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Perforin on Baseline | 13.58 ng/L | Standard Deviation 18.33 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum ICAM-1 on Baseline | 709.71 ng/L | Standard Deviation 430.14 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum VCAM-1 on Baseline | 1282.81 ng/L | Standard Deviation 1232.76 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum ICAM-1 on Day 0 | 642.60 ng/L | Standard Deviation 365.92 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Perforin on Day 0 | 3.30 ng/L | Standard Deviation 9.11 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum ICAM-1 on Day 3 | 792.47 ng/L | Standard Deviation 621.84 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum VCAM-1 on Day 7 | 1209.51 ng/L | Standard Deviation 780.31 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum ICAM-1 on Day 7 | 934.02 ng/L | Standard Deviation 618.96 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Perforin on Day 3 | 4.71 ng/L | Standard Deviation 13.53 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum ICAM-1 on Week 2 | 696.77 ng/L | Standard Deviation 438.71 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum VCAM-1 on Day 0 | 931.58 ng/L | Standard Deviation 709.94 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum ICAM-1 on Week 4 | 614.92 ng/L | Standard Deviation 487.67 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Perforin on Day 7 | 6.60 ng/L | Standard Deviation 7.99 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum IL-2 R alpha on Baseline | 5.62 ng/L | Standard Deviation 7.5 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum VCAM-1 on Week 4 | 930.89 ng/L | Standard Deviation 885.51 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum IL-2 R alpha on Day 0 | 4.91 ng/L | Standard Deviation 4.12 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum Perforin on Week 2 | 6.01 ng/L | Standard Deviation 6.77 |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1 | Serum IL-2 R alpha on Day 3 | 7.31 ng/L | Standard Deviation 5.68 |
ORR: Percentage of Participants With OR Per the Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy
OR was defined as percentage of participants with CR + PR per the Lugano Classification for participants with 3 or more lines of prior therapy. CR and PR are defined in OM#1. Percentages were rounded-off.
Time frame: Up to 85.6 months
Population: Participants with 3 or more lines of prior therapy in the Full Analysis Set with available data were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | ORR: Percentage of Participants With OR Per the Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy | 91 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | ORR: Percentage of Participants With OR Per the Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy | 75 percentage of participants |
ORR: Percentage of Participants With OR Per the Lugano Classification by Investigator Assessment
OR was defined as percentage of participants with CR + PR per the Lugano Classification. CR and PR are defined in OM#1. Percentages were rounded-off.
Time frame: Up to 85.6 months
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | ORR: Percentage of Participants With OR Per the Lugano Classification by Investigator Assessment | 94 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | ORR: Percentage of Participants With OR Per the Lugano Classification by Investigator Assessment | 77 percentage of participants |
Overall Survival (OS)
OS was defined as the time from axicabtagene ciloleucel infusion to the date of death. KM estimates were used for analysis.
Time frame: Up to 85.6
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Overall Survival (OS) | NA months |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Overall Survival (OS) | NA months |
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
TEAE was defined as any adverse event with onset on or after the start of treatment. Percentages were rounded-off.
Time frame: Up to 85.6 months
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 99 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | 100 percentage of participants |
Percentage of Participants With Antibodies Against Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells
Time frame: Up to 85.6 months
Population: Participants from the Safety Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Antibodies Against Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells | 0 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Antibodies Against Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells | 0 percentage of participants |
Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment
BOR was defined as percentage of participants with CR, PR, stable disease(SD), disease progression(PD), non-evaluable(NE), undefined/no disease or not done as best response to treatment by the Lugano Classification. CR and PR defined in OM#1. SD/no metabolic response(NMR):score 4(uptake moderately greater than (\>) liver) or 5(uptake markedly\>liver and/ or new lesions) with no significant change in fluorodeoxyglucose(FDG) uptake compared to baseline(screening), at interim time point or end of treatment; no new sites of disease should be observed. PD:score 4(uptake moderately\>liver) or 5(uptake markedly\>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. Not done:no assessment at time of analysis. Percentages were rounded off.
Time frame: Up to 85.6 months
Population: Participants in the Full Analysis Set with available data were analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | SD | 4 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | Non-evaluable | 0 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | PR | 14 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | Undefined/ No Disease | 1 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | PD | 0 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | Not Done | 3 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | CR | 78 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | Not Done | 17 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | CR | 52 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | PR | 17 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | SD | 0 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | PD | 3 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | Non-evaluable | 0 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment | Undefined/ No Disease | 10 percentage of participants |
Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment
BOR was defined as the percentage of participants with CR, PR, stable disease (SD), PD, NE (not evaluable) or not done as best response to treatment by the Lugano Classification. CR and PR are defined in OM#1. SD, PD and not done are defined in OM#6. Percentages were rounded off.
Time frame: Up to 85.6 months
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | PD | 2 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | PR | 15 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | NE | 0 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | SD | 2 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | Not Done | 3 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | CR | 79 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | Not Done | 10 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | PR | 13 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | SD | 10 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | PD | 3 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | NE | 0 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment | CR | 65 percentage of participants |
Percentage of Participants With CR Per Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy
CR is defined as OM#1. Percentages were rounded-off.
Time frame: Up to 85.6 months
Population: Participants with 3 or more lines of prior therapy in the Full Analysis Set with available data were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With CR Per Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy | 79 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With CR Per Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy | 60 percentage of participants |
Percentage of Participants With CR Per the Lugano Classification by Central Assessment
CR is defined in outcome measure (OM)#1. Percentages were rounded-off.
Time frame: Up to 85.6 months
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With CR Per the Lugano Classification by Central Assessment | 78 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With CR Per the Lugano Classification by Central Assessment | 52 percentage of participants |
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
Percentages were rounded-off.
Time frame: Up to 85.6 months
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Platelets (10^9/L) | 35 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Phosphate (mmol/L) | 23 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Calcium (mmol/L) | 10 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Potassium (mmol/L) | 4 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Neutrophils (10^9/L) | 92 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Sodium (mmol/L) | 9 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Glucose (mmol/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Hemoglobin (mmol/L) | 33 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Albumin (g/L) | 2 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Leukocytes (10^9/L) | 94 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Magnesium (mmol/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Lymphocytes (10^9/L) | 99 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Magnesium (mmol/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Neutrophils (10^9/L) | 96 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Platelets (10^9/L) | 32 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Albumin (g/L) | 4 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Calcium (mmol/L) | 7 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Glucose (mmol/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Lymphocytes (10^9/L) | 100 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Phosphate (mmol/L) | 39 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Potassium (mmol/L) | 7 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Sodium (mmol/L) | 18 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Hemoglobin (mmol/L) | 39 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Decrease in Leukocytes (10^9/L) | 93 percentage of participants |
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
Percentages were rounded-off.
Time frame: Up to 85.6 months
Population: Participants in the Safety Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Sodium (mmol/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Calcium (mmol/L) | 1 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Alanine Aminotransferase (U/L) | 6 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Creatinine (umol/L) | 1 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Leukocytes (10^9/L) | 1 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Direct Bilirubin (umol/L) | 2 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Alkaline Phosphatase (U/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Glucose (mmol/L) | 9 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Hemoglobin (mmol/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Magnesium (mmol/L) | 3 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Aspartate Aminotransferase (U/L) | 4 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Potassium (mmol/L) | 1 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Lymphocytes (10^9/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Urate (mmol/L) | 13 percentage of participants |
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Bilirubin (umol/L) | 4 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Urate (mmol/L) | 25 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Hemoglobin (mmol/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Leukocytes (10^9/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Lymphocytes (10^9/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Alanine Aminotransferase (U/L) | 21 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Alkaline Phosphatase (U/L) | 4 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Aspartate Aminotransferase (U/L) | 11 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Bilirubin (umol/L) | 11 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Calcium (mmol/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Creatinine (umol/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Direct Bilirubin (umol/L) | 11 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Glucose (mmol/L) | 21 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Magnesium (mmol/L) | 4 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Sodium (mmol/L) | 0 percentage of participants |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher | Grade 3 or Higher Increase in Potassium (mmol/L) | 0 percentage of participants |
PFS Per Lugano Classification by Investigator Assessment
PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 6. KM estimates were used for analysis.
Time frame: Up to 85.6 months
Population: Participants in Full Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | PFS Per Lugano Classification by Investigator Assessment | 58.2 months |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | PFS Per Lugano Classification by Investigator Assessment | NA months |
Progression-free Survival (PFS) Per Lugano Classification by Central Assessment
PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 6. KM estimates were used for analysis.
Time frame: Up to 85.6 months
Population: Participants in the Full Analysis Set with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Progression-free Survival (PFS) Per Lugano Classification by Central Assessment | 40.2 months |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Progression-free Survival (PFS) Per Lugano Classification by Central Assessment | 18.3 months |
Time to Next Therapy
Time from axicabtagene ciloleucel infusion date to the start of the subsequent new lymphoma therapy or death from any cause. KM estimates were used for analysis.
Time frame: Up to 85.6 months
Population: Participants in the Full Analysis Set were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axicabtagene Ciloleucel (Follicular Lymphoma) | Time to Next Therapy | NA months |
| Axicabtagene Ciloleucel (Marginal Zone Lymphoma) | Time to Next Therapy | NA months |