Trial Outcomes & Findings for Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma (NCT NCT04002401)

Last Updated: 2024-02-20

Results Overview

CR rate is defined as the incidence of a CR per the IWG Lugano Classification as determined by study investigators. CR rate: percentage of participants with CR \[complete metabolic response (CMR); complete radiological response (CRR)\]. CMR: positron emission tomography (PET) 5-point scale (5-PS) scores of 1 (no uptake above background), 2 (uptake ≤ mediastinum), 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass); no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow (BM). 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; and bone marrow normal by morphology. 95% confidence interval (CI) was calculated by Clopper-Pearson method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

First infusion date up to maximum duration of 32.7 months

Results posted on

2024-02-20

Participant Flow

Participants were enrolled at study sites in the United States.

36 participants were screened.

Participant milestones

Participant milestones
Measure	Axicabtagene Ciloleucel and Rituximab Combination Participants received rituximab 375 mg/m\^2 intravenously (IV) once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-cluster of differentiate 19 (CD19) chimeric antigen receptor (CAR) T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Overall Study STARTED	27
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Axicabtagene Ciloleucel and Rituximab Combination Participants received rituximab 375 mg/m\^2 intravenously (IV) once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-cluster of differentiate 19 (CD19) chimeric antigen receptor (CAR) T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Overall Study Rolled Over to Long-term Follow-up Study	13
Overall Study Death	10
Overall Study Subject Withdrawal of Consent From Further Follow-up	2
Overall Study Enrolled but Never Treated	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=26 Participants Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants
Age, Categorical >=65 years	12 Participants n=93 Participants
Age, Continuous	60 years STANDARD_DEVIATION 12.6 • n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Race/Ethnicity, Customized Race · White	19 Participants n=93 Participants
Race/Ethnicity, Customized Race · Other or More Than One Race	4 Participants n=93 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=93 Participants
Region of Enrollment United States	26 Participants n=93 Participants

PRIMARY outcome

Timeframe: First infusion date up to maximum duration of 32.7 months

Population: Modified intent-to-treat (mITT) analysis set included all enrolled participants who were treated with the target dose of axicabtagene ciloleucel and at least 1 dose of rituximab after axicabtagene ciloleucel infusion.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=26 Participants Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators	73 percentage of participants Interval 52.0 to 88.0

SECONDARY outcome

Timeframe: First infusion date up to maximum duration of 27 months

Population: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.

An AE is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a relationship with study treatment or worsening of a pre-existing medical condition. TEAEs are any AEs with onset on or after axicabtagene ciloleucel infusion or worsening of a pre-existing medical condition that occurs on or after axicabtagene ciloleucel infusion.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=26 Participants Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)	100 percentage of participants

SECONDARY outcome

Timeframe: First infusion date up to maximum duration of 27 months

Population: Participants in the safety analysis set were analyzed.

Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory parameters with only non-zero values are presented.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=26 Participants Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Bilirubin	8 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Alanine Aminotransferase	12 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Aspartate Aminotransferase	12 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Calcium	8 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Direct Bilirubin	15 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Glucose	19 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Magnesium	8 percentage of participants
Percentage of Participants Who Experienced Laboratory Toxicity Grade Shifts to Grade 3 or Higher Resulting From Increased Parameter Value Urate	8 percentage of participants

SECONDARY outcome

Timeframe: First infusion date up to maximum duration of 32.7 months

Population: Participants in the mITT analysis set were analyzed.

ORR: percentage of participants with CR \[CMR;CRR\] or PR \[partial metabolic response (PMR); partial radiologic response (PRR)\].CMR: PET 5PS scores of 1 (no uptake above background, 2 (uptake ≤ mediastinum), 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass; no new lesions; no evidence of FDG-avid disease in BM. CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in LDi;no extralymphatic sites of disease;absent NMLs;organ enlargement regress to normal;no new sites;bone marrow morphology normal. PMR: scores 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 (EOT). PRR: ≥ 50% decrease in sum of the product of perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absent/normal, regressed, but no increase of NMLs; spleen regressed by \> 50% in length beyond normal; no new sites.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=26 Participants Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Objective Response Rate (ORR) Per the IWG Lugano Classification as Determined by Study Investigators	88 percentage of participants Interval 70.0 to 98.0

SECONDARY outcome

Timeframe: From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (up to approximately 32.7 months)

Population: Participants in the mITT analysis set with an objective response (CR+PR) were analyzed.

DOR is defined only for participants who experience an objective response and is the time from the first objective response to disease progression \[progressive metabolic disease (PMD); progressive radiologic disease (PRD)\] or death from any cause. Objective response is defined in outcome measure (OM) 4. PMD: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with increased uptake compared with baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi \>1.5 cm; ≥ 50% increase from cross product of LDi and perpendicular diameter (PPD); increase in LDi or shortest axis perpendicular to the LDi (SDi) of 0.5 cm for lesions ≤1.5 cm and 1 cm for lesions \>2 cm; spleen increased by \>50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. Kaplan-Meier (KM) estimate of median was reported.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=23 Participants Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Duration of Response (DOR) Per the IWG Lugano Classification as Determined by Study Investigators	26.0 months Interval 2.6 to The upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of events.

SECONDARY outcome

Timeframe: First infusion date up to disease progression or death regardless of cause (up to approximately 32.7 months)

Population: Participants in the mITT analysis set were analyzed.

PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression (PMD; PRD) or death from any cause. PMD: scores 4 (uptake moderately \> liver), 5 (uptake markedly \> liver, new lesions) with increased uptake compared with baseline; new FDG-avid foci consistent with lymphoma rather than another etiology; new or recurrent FDG-avid foci in bone marrow. PRD: LDi \>1.5 cm; ≥ 50% increase from cross product of LDi and PPD; increase in LDi or SDi of 0.5 cm for lesions ≤1.5 cm and 1 cm for lesions \>2 cm; spleen increased by \>50% in length beyond normal; new or recurrent splenomegaly, bone marrow involvement; new lesions; progression of pre-existing lesions. KM estimate of median was reported.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=26 Participants Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Progression-Free Survival (PFS) Per the IWG Lugano Classification as Determined by Study Investigators	23.6 months Interval 3.4 to The upper limit of 95% CI was not estimable due to insufficient number of events.

SECONDARY outcome

Timeframe: First infusion date up to death regardless of cause (up to approximately 32.7 months)

Population: Participants in the mITT analysis set were analyzed.

OS is defined as the time from axicabtagene ciloleucel infusion to the date of death from any cause. KM estimate of median was reported.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=26 Participants Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Overall Survival (OS)	NA months Interval 25.8 to KM median and upper limit of 95% CI were not reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24

Population: Participants in the safety analysis set were analyzed.

Peak was defined as the maximum number of CAR T cells in blood measured after infusion.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=26 Participants Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Peak Level of Anti-CD19 CAR T Cells in Blood	40.33 cells per microliter (cells/µL) Interval 1.15 to 304.36

SECONDARY outcome

Timeframe: Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24

Population: Participants in the safety analysis set with available data were analyzed.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=26 Participants Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Level of Anti-CD19 CAR T Cells in Blood by Visit Baseline (Day 0)	0.00 cells/µL Interval 0.0 to 0.0
Level of Anti-CD19 CAR T Cells in Blood by Visit Day 7 Post-infusion	18.11 cells/µL Interval 1.15 to 304.36
Level of Anti-CD19 CAR T Cells in Blood by Visit Day 14 Post-infusion	12.74 cells/µL Interval 0.05 to 172.54
Level of Anti-CD19 CAR T Cells in Blood by Visit Day 21 Post-infusion	4.66 cells/µL Interval 0.02 to 43.26
Level of Anti-CD19 CAR T Cells in Blood by Visit Day 28 Post-infusion	1.66 cells/µL Interval 0.03 to 17.14
Level of Anti-CD19 CAR T Cells in Blood by Visit Day 49 Post-infusion	0.99 cells/µL Interval 0.01 to 26.49
Level of Anti-CD19 CAR T Cells in Blood by Visit Day 105 Post-infusion	0.32 cells/µL Interval 0.0 to 1.23
Level of Anti-CD19 CAR T Cells in Blood by Visit Day 180 Post-infusion	0.09 cells/µL Interval 0.0 to 1.34
Level of Anti-CD19 CAR T Cells in Blood by Visit Month 9 Post-infusion	0.06 cells/µL Interval 0.0 to 1.01
Level of Anti-CD19 CAR T Cells in Blood by Visit Month 12 Post-infusion	0.0054 cells/µL Interval 0.0 to 0.91
Level of Anti-CD19 CAR T Cells in Blood by Visit Month 15 Post-infusion	0.0027 cells/µL Interval 0.0 to 0.47
Level of Anti-CD19 CAR T Cells in Blood by Visit Month 18 Post-infusion	0.00 cells/µL Interval 0.0 to 0.36
Level of Anti-CD19 CAR T Cells in Blood by Visit Month 24 Post-infusion	0.00 cells/µL Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline (Day 0), post-infusion on Days 7, 14, 21, and 28

Population: Participants in the safety analysis set were analyzed.

AUC0-28 is defined as the area under curve in a plot of number of CAR T cells against scheduled visit from Day 0 to Day 28.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=26 Participants Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Area Under the Curve of CAR T Cells From Day 0 to Day 28 (AUC0-28)	376.83 cells/μL*days Interval 14.93 to 3430.5

SECONDARY outcome

Timeframe: Baseline (Day 0), post-infusion on Days 7, 14, 21, 28, 49, 105, 180, Months 9, 12, 15, 18, and 24

Population: Participants in the safety analysis set were analyzed.

Time to peak was defined as the number of days from the date of the axicabtagene ciloleucel infusion to the date of peak level defined as the maximum number of CAR T cells in blood measured after infusion.

Outcome measures

Outcome measures
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=26 Participants Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Time to Peak Level of Anti-CD19 CAR T Cells in Blood	8 days Interval 8.0 to 21.0

Adverse Events

Axicabtagene Ciloleucel and Rituximab Combination

Serious events: 14 serious events

Other events: 26 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=26 participants at risk Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Infections and infestations Pneumonia	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Infections and infestations Sepsis	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Metabolism and nutrition disorders Decreased appetite	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Metabolism and nutrition disorders Hypokalaemia	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Blood and lymphatic system disorders Anaemia	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Blood and lymphatic system disorders Febrile neutropenia	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
General disorders Chills	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
General disorders Pyrexia	11.5% 3/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Infections and infestations Covid-19 pneumonia	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Metabolism and nutrition disorders Hyponatraemia	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	23.1% 6/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Nervous system disorders Aphasia	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Nervous system disorders Dizziness	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Nervous system disorders Headache	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Nervous system disorders Somnolence	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Nervous system disorders Syncope	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Nervous system disorders Tremor	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Psychiatric disorders Agitation	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Psychiatric disorders Confusional state	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Psychiatric disorders Depression	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Vascular disorders Embolism	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Vascular disorders Hypotension	3.8% 1/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.

Other adverse events

Other adverse events
Measure	Axicabtagene Ciloleucel and Rituximab Combination n=26 participants at risk Participants received rituximab 375 mg/m\^2 IV once on Day -5 along with conditioning chemotherapy (fludarabine 30 mg/m\^2 over 30 minutes and cyclophosphamide 500 mg/m\^2 over 60 minutes) administered IV once on Days -5 to -3, followed by axicabtagene ciloleucel 2 x 10\^6 anti-CD19 CAR T cells/kg administered IV once on Day 0 and additional rituximab 375 mg/m\^2 of 5 doses, administered IV once every 28 days starting from Day 21 up to Day 133.
Blood and lymphatic system disorders Anaemia	50.0% 13/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Blood and lymphatic system disorders Neutropenia	19.2% 5/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Blood and lymphatic system disorders Pancytopenia	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Blood and lymphatic system disorders Thrombocytopenia	15.4% 4/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Cardiac disorders Sinus tachycardia	15.4% 4/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Cardiac disorders Tachycardia	30.8% 8/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Eye disorders Eye pain	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Gastrointestinal disorders Abdominal pain	11.5% 3/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Gastrointestinal disorders Constipation	26.9% 7/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Gastrointestinal disorders Diarrhoea	30.8% 8/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Gastrointestinal disorders Dysphagia	15.4% 4/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Gastrointestinal disorders Nausea	61.5% 16/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Gastrointestinal disorders Vomiting	11.5% 3/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
General disorders Asthenia	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
General disorders Chills	15.4% 4/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
General disorders Fatigue	38.5% 10/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
General disorders Gait disturbance	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
General disorders Malaise	11.5% 3/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
General disorders Oedema peripheral	19.2% 5/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
General disorders Pain	11.5% 3/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
General disorders Pyrexia	88.5% 23/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Immune system disorders Hypogammaglobulinaemia	19.2% 5/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Infections and infestations Covid-19	11.5% 3/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Infections and infestations Oral candidiasis	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Infections and infestations Urinary tract infection	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Investigations Alanine aminotransferase increased	15.4% 4/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Investigations Aspartate aminotransferase increased	11.5% 3/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Investigations Blood creatinine increased	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Investigations Lymphocyte count decreased	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Investigations Neutrophil count decreased	65.4% 17/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Investigations Platelet count decreased	23.1% 6/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Investigations White blood cell count decreased	23.1% 6/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Metabolism and nutrition disorders Decreased appetite	38.5% 10/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Metabolism and nutrition disorders Hyperglycaemia	11.5% 3/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Metabolism and nutrition disorders Hypokalaemia	30.8% 8/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Metabolism and nutrition disorders Hypomagnesaemia	15.4% 4/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Metabolism and nutrition disorders Hyponatraemia	19.2% 5/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Metabolism and nutrition disorders Hypophosphataemia	26.9% 7/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Musculoskeletal and connective tissue disorders Arthralgia	11.5% 3/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Musculoskeletal and connective tissue disorders Back pain	26.9% 7/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Musculoskeletal and connective tissue disorders Muscular weakness	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Musculoskeletal and connective tissue disorders Myalgia	11.5% 3/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Nervous system disorders Aphasia	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Nervous system disorders Dizziness	23.1% 6/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Nervous system disorders Encephalopathy	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Nervous system disorders Headache	46.2% 12/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Nervous system disorders Peripheral sensory neuropathy	11.5% 3/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Nervous system disorders Somnolence	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Nervous system disorders Tremor	23.1% 6/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Psychiatric disorders Agitation	19.2% 5/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Psychiatric disorders Confusional state	34.6% 9/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Psychiatric disorders Insomnia	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Renal and urinary disorders Dysuria	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Respiratory, thoracic and mediastinal disorders Cough	19.2% 5/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.4% 4/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Respiratory, thoracic and mediastinal disorders Hypoxia	11.5% 3/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Respiratory, thoracic and mediastinal disorders Tachypnoea	19.2% 5/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Skin and subcutaneous tissue disorders Hyperhidrosis	7.7% 2/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Vascular disorders Hypertension	11.5% 3/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.
Vascular disorders Hypotension	57.7% 15/26 • All-cause mortality: Enrollment up to last follow up visit (maximum duration of 37.9 months); Adverse events: First infusion date up to maximum duration of 27 months All-cause mortality: All enrolled analysis set included all the enrolled participants. Adverse events: Safety analysis set included all participants treated with any dose of axicabtagene ciloleucel.

Additional Information

Medical Information

Kite, A Gilead Company

Phone: 844-454-5483 (1-844-454-KITE)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER