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CompletedNCT03105336ZUMA-5Updated Dec 23, 2025Results posted

A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

A Phase 2 interventional study of Axicabtagene ciloleucel and Cyclophosphamide in Follicular Lymphoma, Marginal Zone Lymphoma and Indolent Non-Hodgkin Lymphoma, sponsored by Kite, A Gilead Company. Completed at 19 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by Kite, A Gilead Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
159
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Indolent Non-Hodgkin Lymphoma
03

In context

Lymphoma, Follicular

931 studies on the registry are indexed under Lymphoma, Follicular; 237 are open to participants now.

This study's enrollment of 159 is above the median of 48 across 797 interventional studies indexed under Lymphoma, Follicular.

Browse Lymphoma, Follicular studies →

Lead sponsor

Kite, A Gilead Company is the lead sponsor of 36 studies on the registry; 7 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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/Exclusion criteria may apply.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
159 participants (actual)

Study arms

  • Experimental
    Axicabtagene Ciloleucel (Follicular Lymphoma)

    Participants with relapsed or refractory (r/r) B-cell indolent non-Hodgkin lymphoma (iNHL) subtype of follicular lymphoma (FL) will receive the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day for 3 days (Day -5 to Day -3). * A single 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.

    Biological: Axicabtagene ciloleucel · Drug: Cyclophosphamide · Drug: Fludarabine

  • Experimental
    Axicabtagene Ciloleucel (Marginal Zone Lymphoma)

    Participants with r/r B-cell iNHL subtype of marginal zone lymphoma (MZL) will receive the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine 30 mg/m\^2/day and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). * A single infusion at a target dose of 2×10\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.

    Biological: Axicabtagene ciloleucel · Drug: Cyclophosphamide · Drug: Fludarabine

Interventions

  • BiologicalAxicabtagene ciloleucel

    Administered intravenously

    Also known as: Axi-cel, Yescarta®

  • DrugCyclophosphamide

    Administered intravenously

  • DrugFludarabine

    Administered intravenously

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. Percentage of Participants With Antibodies Against Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells

    Time frame: Up to 85.6 months

  17. 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

  18. Levels of Serum C-Reactive Protein (CRP)

    Time frame: Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4

  19. 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

  20. 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

07

Results

Posted Dec 23, 2025

Participant flow

Participants were enrolled at study sites in the United States and France.

Participant flow — Overall Study
MilestoneAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Started12731
Completed00
Not completed12731
Withdrew: Rollover to longterm follow-up study criteria6115
Withdrew: Death408
Withdrew: Lost to follow-up132
Withdrew: Subject withdrawal of consent from further follow-up73
Withdrew: Reason not specified33
Withdrew: Investigator decision30

Outcome measures

PrimaryObjective 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
Reported as:
Number · percentage of participants
Objective Response Rate (ORR): Percentage of Participants With Objective Response Per the Lugano Classification by Central Assessment
percentage of participantsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Objective Response Rate (ORR): Percentage of Participants With Objective Response Per the Lugano Classification by Central Assessment92 (86 to 96)69 (49 to 85)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With CR Per the Lugano Classification by Central Assessment
percentage of participantsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Percentage of Participants With CR Per the Lugano Classification by Central Assessment78 (70 to 85)52 (33 to 71)
SecondaryORR: 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
Reported as:
Number · percentage of participants
ORR: Percentage of Participants With OR Per the Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy
percentage of participantsAxicabtagene Ciloleucel (Follicular Lymphoma)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 Therapy91 (83 to 96)75 (51 to 91)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With CR Per Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy
percentage of participantsAxicabtagene Ciloleucel (Follicular Lymphoma)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 Therapy79 (68 to 87)60 (36 to 81)
SecondaryORR: 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
Reported as:
Number · percentage of participants
ORR: Percentage of Participants With OR Per the Lugano Classification by Investigator Assessment
percentage of participantsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
ORR: Percentage of Participants With OR Per the Lugano Classification by Investigator Assessment94 (88 to 97)77 (59 to 90)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment
percentage of participantsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
CR78 (70 to 85)52 (33 to 71)
PR14 (9 to 21)17 (6 to 36)
SD4 (1 to 9)0 (0 to 12)
PD0 (0 to 3)3 (0 to 18)
Non-evaluable0 (0 to 3)0 (0 to 12)
Undefined/ No Disease1 (0 to 4)10 (2 to 27)
Not Done3 (1 to 8)17 (6 to 36)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment
percentage of participantsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
CR79 (71 to 85)65 (45 to 81)
PR15 (9 to 22)13 (4 to 30)
SD2 (0 to 6)10 (2 to 26)
PD2 (0 to 6)3 (0 to 17)
NE0 (0 to 3)0 (0 to 11)
Not Done3 (1 to 8)10 (2 to 26)
SecondaryDuration 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
Reported as:
Median · months
Duration of Response (DOR) by Central Assessment
monthsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Duration of Response (DOR) by Central Assessment38.6 (NA to NA)NA (8.2 to NA)
SecondaryDOR 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
Reported as:
Median · months
DOR by Investigator Assessment
monthsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
DOR by Investigator Assessment60.4 (36.6 to NA)NA (13.9 to NA)
SecondaryProgression-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
Reported as:
Median · months
Progression-free Survival (PFS) Per Lugano Classification by Central Assessment
monthsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Progression-free Survival (PFS) Per Lugano Classification by Central Assessment40.2 (28.9 to NA)18.3 (12.1 to NA)
SecondaryPFS 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
Reported as:
Median · months
PFS Per Lugano Classification by Investigator Assessment
monthsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
PFS Per Lugano Classification by Investigator Assessment58.2 (30.9 to NA)NA (12.4 to NA)
SecondaryOverall 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
Reported as:
Median · months
Overall Survival (OS)
monthsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Overall Survival (OS)NA (NA to NA)NA (NA to NA)
SecondaryTime 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
Reported as:
Median · months
Time to Next Therapy
monthsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Time to Next TherapyNA (37.8 to NA)NA (12.1 to NA)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
percentage of participantsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)99100
SecondaryPercentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher

Percentages were rounded-off.

Time frame:
Up to 85.6 months
Reported as:
Number · percentage of participants
Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher
percentage of participantsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Grade 3 or Higher Increase in Hemoglobin (mmol/L)00
Grade 3 or Higher Increase in Leukocytes (10^9/L)10
Grade 3 or Higher Increase in Lymphocytes (10^9/L)00
Grade 3 or Higher Increase in Alanine Aminotransferase (U/L)621
Grade 3 or Higher Increase in Alkaline Phosphatase (U/L)04
Grade 3 or Higher Increase in Aspartate Aminotransferase (U/L)411
Grade 3 or Higher Increase in Bilirubin (umol/L)411
Grade 3 or Higher Increase in Calcium (mmol/L)10
Grade 3 or Higher Increase in Creatinine (umol/L)10
Grade 3 or Higher Increase in Direct Bilirubin (umol/L)211
Grade 3 or Higher Increase in Glucose (mmol/L)921
Grade 3 or Higher Increase in Magnesium (mmol/L)34
Grade 3 or Higher Increase in Potassium (mmol/L)10
Grade 3 or Higher Increase in Sodium (mmol/L)00
Grade 3 or Higher Increase in Urate (mmol/L)1325
SecondaryPercentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher

Percentages were rounded-off.

Time frame:
Up to 85.6 months
Reported as:
Number · percentage of participants
Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher
percentage of participantsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Grade 3 or Higher Decrease in Hemoglobin (mmol/L)3339
Grade 3 or Higher Decrease in Leukocytes (10^9/L)9493
Grade 3 or Higher Decrease in Lymphocytes (10^9/L)99100
Grade 3 or Higher Decrease in Neutrophils (10^9/L)9296
Grade 3 or Higher Decrease in Platelets (10^9/L)3532
Grade 3 or Higher Decrease in Albumin (g/L)24
Grade 3 or Higher Decrease in Calcium (mmol/L)107
Grade 3 or Higher Decrease in Glucose (mmol/L)00
Grade 3 or Higher Decrease in Magnesium (mmol/L)00
Grade 3 or Higher Decrease in Phosphate (mmol/L)2339
Grade 3 or Higher Decrease in Potassium (mmol/L)47
Grade 3 or Higher Decrease in Sodium (mmol/L)918
SecondaryPercentage of Participants With Antibodies Against Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells
Time frame:
Up to 85.6 months
Reported as:
Number · percentage of participants
Percentage of Participants With Antibodies Against Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells
percentage of participantsAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Percentage of Participants With Antibodies Against Anti-CD19 Chimeric Antigen Receptor (CAR) T Cells00
SecondaryLevels 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
Reported as:
Mean · cells/μL
Levels of Anti-CD19 CAR T Cells in Blood
cells/μLAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Day 7101.49 ± 220.01120.07 ± 394.91
Week 241.45 ± 63.6590.76 ± 128.63
Week 47.52 ± 19.8514.03 ± 23.43
Month 30.78 ± 1.910.52 ± 0.51
Month 63.49 ± 28.890.68 ± 1.90
Month 121.00 ± 5.650.23 ± 0.43
Month 180.47 ± 1.510.42 ± 0.77
Month 240.36 ± 0.840.88 ± 2.09
SecondaryLevels of Serum C-Reactive Protein (CRP)
Time frame:
Baseline (at enrollment), predose: Day 0, postdose: Day 3, Day 7, Week 2, Week 4
Reported as:
Mean · mg/L
Levels of Serum C-Reactive Protein (CRP)
mg/LAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Serum CRP on Baseline22.36 ± 40.6019.87 ± 28.62
Serum CRP on Day 029.30 ± 47.3532.94 ± 42.50
Serum CRP on Day 372.50 ± 91.7666.73 ± 92.82
Serum CRP on Day 759.45 ± 79.2477.79 ± 91.86
Serum CRP on Week 29.07 ± 19.7013.59 ± 42.20
Serum CRP on Week 47.84 ± 33.769.86 ± 43.46
SecondaryLevels 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
Reported as:
Mean · ng/L
Levels of Serum Ferritin, Serum ICAM-1, Serum IL-2 R Alpha, Serum Perforin and Serum VCAM-1
ng/LAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Serum Ferritin on Baseline330.54 ± 398.03207.63 ± 218.42
Serum Ferritin on Day 0503.99 ± 502.07398.49 ± 337.82
Serum Ferritin on Day 3541.51 ± 457.18487.39 ± 414.90
Serum Ferritin on Day 7779.75 ± 782.981820.38 ± 4837.56
Serum Ferritin on Week 2741.76 ± 787.70959.49 ± 1546.07
Serum Ferritin on Week 4528.83 ± 605.94478.47 ± 459.54
Serum ICAM-1 on Baseline876.99 ± 833.80709.71 ± 430.14
Serum ICAM-1 on Day 0834.87 ± 854.35642.60 ± 365.92
Serum ICAM-1 on Day 3964.45 ± 904.79792.47 ± 621.84
Serum ICAM-1 on Day 7924.99 ± 846.56934.02 ± 618.96
Serum ICAM-1 on Week 2695.15 ± 605.03696.77 ± 438.71
Serum ICAM-1 on Week 4671.32 ± 656.46614.92 ± 487.67
Serum IL-2 R alpha on Baseline8.52 ± 12.155.62 ± 7.50
Serum IL-2 R alpha on Day 08.39 ± 9.104.91 ± 4.12
Serum IL-2 R alpha on Day 39.96 ± 11.537.31 ± 5.68
Serum IL-2 R alpha on Day 714.42 ± 15.1019.78 ± 20.82
Serum IL-2 R alpha on Week 27.16 ± 8.2710.40 ± 12.26
Serum IL-2 R alpha on Week 43.39 ± 3.344.02 ± 3.67
Serum Perforin on Baseline13.26 ± 7.2013.58 ± 18.33
Serum Perforin on Day 02.56 ± 1.853.30 ± 9.11
Serum Perforin on Day 33.87 ± 3.364.71 ± 13.53
Serum Perforin on Day 78.49 ± 10.546.60 ± 7.99
Serum Perforin on Week 28.06 ± 6.906.01 ± 6.77
Serum Perforin on Week 414.56 ± 11.9212.32 ± 12.08
Serum VCAM-1 on Baseline1499.37 ± 1637.981282.81 ± 1232.76
Serum VCAM-1 on Day 01182.41 ± 1166.58931.58 ± 709.94
Serum VCAM-1 on Day 31213.84 ± 962.381044.96 ± 870.11
Serum VCAM-1 on Day 71224.58 ± 1069.131209.51 ± 780.31
Serum VCAM-1 on Week 2891.64 ± 726.10977.88 ± 919.47
Serum VCAM-1 on Week 4981.67 ± 879.87930.89 ± 885.51
SecondaryLevels 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
Reported as:
Mean · pg/mL
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
pg/mLAxicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)
Serum CXCL10 on Baseline466.32 ± 339.00634.56 ± 539.17
Serum CXCL10 on Day 0499.16 ± 334.85763.99 ± 569.42
Serum CXCL10 on Day 3712.31 ± 543.76962.96 ± 611.23
Serum CXCL10 on Day 7841.62 ± 572.801630.98 ± 563.40
Serum CXCL10 on Week 2474.45 ± 371.95798.28 ± 631.80
Serum CXCL10 on Week 4623.87 ± 535.45964.92 ± 640.57
Serum Granzyme B on Baseline3.58 ± 9.68121.49 ± 623.76
Serum Granzyme B on Day 02.95 ± 7.8646.36 ± 234.23
Serum Granzyme B on Day 36.53 ± 11.0374.28 ± 348.53
Serum Granzyme B on Day 776.29 ± 494.6652.87 ± 68.63
Serum Granzyme B on Week 22.73 ± 5.6727.21 ± 102.65
Serum Granzyme B on Week 43.14 ± 5.1517.00 ± 39.90
Serum IFN-gamma on Baseline9.25 ± 7.1730.29 ± 83.67
Serum IFN-gamma on Day 011.20 ± 16.1754.04 ± 140.40
Serum IFN-gamma on Day 3157.13 ± 326.44292.67 ± 531.54
Serum IFN-gamma on Day 7139.82 ± 359.84674.34 ± 792.31
Serum IFN-gamma on Week 225.98 ± 48.8227.16 ± 37.43
Serum IFN-gamma on Week 423.96 ± 37.0456.72 ± 108.10
Serum IL-1 RA on Baseline584.66 ± 400.47627.95 ± 467.39
Serum IL-1 RA on Day 0677.50 ± 743.22960.41 ± 1342.30
Serum IL-1 RA on Day 3703.79 ± 772.95848.20 ± 757.98
Serum IL-1 RA on Day 71125.80 ± 1316.882492.85 ± 2895.93
Serum IL-1 RA on Week 2591.72 ± 764.19854.68 ± 1693.69
Serum IL-1 RA on Week 4653.88 ± 1197.231106.94 ± 1935.55
Serum IL-2 on Baseline1.03 ± 0.531.12 ± 0.90
Serum IL-2 on Day 01.20 ± 1.221.16 ± 1.09
Serum IL-2 on Day 38.01 ± 13.0812.43 ± 34.49
Serum IL-2 on Day 71.67 ± 2.552.99 ± 3.78
Serum IL-2 on Week 20.95 ± 0.480.93 ± 0.18
Serum IL-2 on Week 40.95 ± 0.501.10 ± 1.06
Serum IL-6 on Baseline2.71 ± 2.905.08 ± 8.11
Serum IL-6 on Day 02.42 ± 2.274.14 ± 5.39
Serum IL-6 on Day 359.30 ± 185.89103.93 ± 281.61
Serum IL-6 on Day 767.49 ± 197.95206.75 ± 282.31
Serum IL-6 on Week 220.01 ± 92.1533.00 ± 66.24
Serum IL-6 on Week 431.02 ± 122.1458.84 ± 169.85
Serum IL-7 on Baseline15.99 ± 7.8915.30 ± 7.13
Serum IL-7 on Day 027.65 ± 9.6228.31 ± 10.15
Serum IL-7 on Day 326.50 ± 10.2227.24 ± 10.82
Serum IL-7 on Day 723.42 ± 11.2823.28 ± 11.69
Serum IL-7 on Week 227.25 ± 14.1326.38 ± 16.52
Serum IL-7 on Week 418.45 ± 8.9220.30 ± 10.52
Serum IL-8 on Baseline13.59 ± 15.0913.71 ± 9.11
Serum IL-8 on Day 021.12 ± 33.5342.71 ± 129.39
Serum IL-8 on Day 360.27 ± 126.8480.86 ± 154.41
Serum IL-8 on Day 745.79 ± 86.3837.47 ± 30.74
Serum IL-8 on Week 216.08 ± 17.1441.41 ± 117.98
Serum IL-8 on Week 420.36 ± 68.7218.90 ± 13.80
Serum IL-10 on Baseline2.85 ± 3.765.11 ± 6.72
Serum IL-10 on Day 01.93 ± 2.291.89 ± 2.18
Serum IL-10 on Day 39.34 ± 17.607.39 ± 10.14
Serum IL-10 on Day 715.01 ± 34.5520.32 ± 20.70
Serum IL-10 on Week 22.06 ± 4.643.42 ± 4.88
Serum IL-10 on Week 41.10 ± 1.311.65 ± 2.08
Serum IL-15 on Baseline2.70 ± 2.692.59 ± 1.42
Serum IL-15 on Day 031.06 ± 13.5533.89 ± 16.32
Serum IL-15 on Day 335.27 ± 19.6643.43 ± 37.40
Serum IL-15 on Day 718.73 ± 9.7725.22 ± 15.38
Serum IL-15 on Week 210.30 ± 5.9012.92 ± 8.28
Serum IL-15 on Week 44.98 ± 3.527.41 ± 5.21
Serum TNF Alpha on Baseline7.26 ± 7.876.73 ± 7.86
Serum TNF Alpha on Day 03.32 ± 2.623.08 ± 1.68
Serum TNF Alpha on Day 33.95 ± 2.684.90 ± 4.59
Serum TNF Alpha on Day 73.93 ± 3.105.97 ± 4.09
Serum TNF Alpha on Week 22.84 ± 6.012.74 ± 2.30
Serum TNF Alpha on Week 42.36 ± 1.653.03 ± 2.13

Adverse events

Collected over Up to 85.6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Axicabtagene Ciloleucel: Follicular Lymphoma36/127 (28.3%)65/124 (52.4%)123/124 (99.2%)
Axicabtagene Ciloleucel: Marginal Zone Lymphoma8/31 (25.8%)19/28 (67.9%)28/28 (100%)
Axicabtagene Ciloleucel: Retreatment (FL)5/14 (35.7%)5/14 (35.7%)13/14 (92.9%)
Axicabtagene Ciloleucel: Retreatment (MZL)0/2 (0%)1/2 (50%)2/2 (100%)
Most frequent serious events
Showing 10 of 117
Most frequent serious events
EventAxicabtagene Ciloleucel: Follicular LymphomaAxicabtagene Ciloleucel: Marginal Zone LymphomaAxicabtagene Ciloleucel: Retreatment (FL)Axicabtagene Ciloleucel: Retreatment (MZL)
Urinary tract infectionInfections and infestations3/1240/280/141/2
PyrexiaGeneral disorders16/1246/280/140/2
Febrile neutropeniaBlood and lymphatic system disorders2/1243/280/140/2
PneumoniaInfections and infestations10/1243/280/140/2
EncephalopathyNervous system disorders8/1243/280/140/2
SomnolenceNervous system disorders2/1243/280/140/2
HypotensionVascular disorders2/1243/280/140/2
Atrial fibrillationCardiac disorders0/1242/280/140/2
Parainfluenzae virus infectionInfections and infestations0/1240/281/140/2
Progressive multifocal leukoencephalopathyInfections and infestations0/1240/281/140/2
Most frequent other events
Showing 10 of 112
Most frequent other events
EventAxicabtagene Ciloleucel: Follicular LymphomaAxicabtagene Ciloleucel: Marginal Zone LymphomaAxicabtagene Ciloleucel: Retreatment (FL)Axicabtagene Ciloleucel: Retreatment (MZL)
Sinus tachycardiaCardiac disorders41/1248/283/142/2
ConstipationGastrointestinal disorders35/1247/281/142/2
NauseaGastrointestinal disorders45/12417/285/142/2
FatigueGeneral disorders50/12415/283/142/2
PyrexiaGeneral disorders99/12424/288/142/2
HeadacheNervous system disorders55/12412/285/142/2
HypotensionVascular disorders59/12415/283/141/2
AnaemiaBlood and lymphatic system disorders46/12414/282/141/2
Oedema peripheralGeneral disorders10/1244/281/141/2
PainGeneral disorders17/1243/280/141/2

Baseline characteristics

The Safety Analysis Set was defined as all participants treated with any dose of study drug.

Age, Categorical
Age, Categorical(Participants)Axicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)Total
<=18 years000
Between 18 and 65 years8615101
>=65 years381351
Age, Continuous
Age, Continuous(years)Axicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)Total
Mean59 ± 9.963 ± 9.660.0 ± 10.0
Sex: Female, Male
Sex: Female, Male(Participants)Axicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)Total
Female511566
Male731386
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Axicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)Total
Hispanic or Latino639
Not Hispanic or Latino11824142
Unknown or Not Reported011
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Axicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)Total
Race — White11525140
Race — Black or African American426
Race — Other or More Than One Race314
Race — Asian202
Region of Enrollment
Region of Enrollment(Participants)Axicabtagene Ciloleucel (Follicular Lymphoma)Axicabtagene Ciloleucel (Marginal Zone Lymphoma)Total
United States11428142
France10010
08

Study locations

19 sites
  • Banner MD Anderson Cancer Center
    Gilbert, Arizona 85234, United States
  • USC Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • University of California Los Angeles
    Los Angeles, California 90095, United States
  • Georgetown Lombardi Comprehensive Cancer Center
    Washington D.C., District of Columbia 20007, United States
  • University of Miami Hospital and Clinics
    Miami, Florida 33136, United States
  • H Lee Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Hackensack University Medical Center - John Theurer Cancer Center
    Hackensack, New Jersey 07601, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • University of Rochester Medical Center (URMC)
    Rochester, New York 14642, United States
  • Ohio State University Medical Center
    Cleveland, Ohio 44106, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • UPMC Hillman Cancer Center
    Pittsburgh, Pennsylvania 15232, United States
  • Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109, United States
  • Centre Hospitalier Régional Universitaire de Lille
    Lille, 59037, France
  • Centre Hospitalier Lyon Sud
    Pierre-Bénite, 69495, France
09

References and documents

Publications

  • Jacobson CA, Chavez JC, Sehgal AR, et al. Interim analysis of ZUMA-5: A phase II study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL). Conference Proceedings of the American Society of Clinical Oncology 2020
  • Jacobson CA, Chavez JC, Sehgal AR, et al. Interim analysis of ZUMA-5: A phase II study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL) [Abstract]. Conference Proceedings of the Society of Hematologic Oncology 2020.
  • Jacobson CA, Chavez JC, Sehgal AR, et al. Interim analysis of ZUMA-5: A phase II study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL) [Abstract]. Clinical Lymphoma, Myeloma and Leukemia 2020;20 (1 Suppl):S278.
  • Jacobson C, Chavez JC, Sehgal AR, et al. Primary analysis of Zuma-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL). Blood 2020;136 (1 Suppl):40-41.
  • Chavez JC, Jacobson CA, Sehgal AR, et al. Retreatment with axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory indolent non-Hodgkin lymphoma in ZUMA-5. Blood 2020;136 (1 Suppl):34.
  • Jacobson CA, Chavez JC, Sehgal AR, William BM, Munoz J, Salles G, Munshi PN, Casulo C, Maloney DG, de Vos S, Reshef R, Leslie LA, Yakoub-Agha I, Oluwole OO, Fung HCH, Rosenblatt J, Rossi JM, Goyal L, Plaks V, Yang Y, Vezan R, Avanzi MP, Neelapu SS. Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022 Jan;23(1):91-103. doi: 10.1016/S1470-2045(21)00591-X. Epub 2021 Dec 8. PubMed 34895487 ↗
  • Chavez JC, Jacobson CA, Sehgal A, et al. Updated outcomes with axicabtagene ciloleucel (axi-cel) retreatment (reTx) in patients (pts) with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5. J Clin Oncol 2021;39 (15 suppl):7548.
  • Chavez JC, Jacobson CA, Sehgal AR, et al. Retreatment with axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (r/r) indolent non-hodgkin lymphoma (iNHL) in ZUMA-5 [Oral abstract]. Transplantation and Cellular Therapy 2021;27 (Issue 3, Supplement):S43, ISSN 2666-6367
  • Chavez JC, Jacobson CA, Sehgal AR, et al. Retreatment with axicabtagene ciloleucel in patients with relapsed/refractory indolent non-hodgkin lymphoma in ZUMA-5 [Oral abstract]. British Journal of Heamatology 2021;193. Abstract BSH2021-PO-149.
  • Chavez JC, Jacobson CA, Sehgal AR, et al. Updated outcomes with axicabtagene ciloleucel (axi-cel) retreatment in patients with relapsed/refractory indolent non-Hodgkin lymphoma in ZUMA-5 [Abstract]. European Hematology Association (EHA) 2021:325549.
  • Ghione P, Patel A, Bobillo S, et al. A comparison of clinical outcomes from Zuma-5 (axicabtagene ciloleucel) and the international scholar-5 external control cohort in relapsed/refractory follicular lymphoma (R/R/FL) [Abstract]. European Hematology Association (EHA) Virtual; 2021 09-17 June.
  • Ghione P, Palomba ML, Ghesquieres H, Bobillo S, Patel AR, Nahas M, Kanters S, Deighton K, Hatswell A, Ma L, Limbrick-Oldfield EH, Snider JT, Wade SW, Riberio MT, Radford J, Beygi S, Gribben J. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023 Mar 1;108(3):822-832. doi: 10.3324/haematol.2022.281421. PubMed 36263843 ↗
  • Jacobson CA, Chavez JC, Sehgal A, et al. Outcomes in ZUMA-5 with axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) who had the high-risk feature of progression within 24 months from initiation of first anti-CD20-containing chemoimmunotherapy (POD24). J Clin Oncol 2021a;39 (15 Suppl):7515
  • Jacobson CA, Chavez JC, Sehgal AR, et al. Outcomes in Zuma-5 with axicabtagene ciloleucel in patients with relapsed/refractory indolent non-Hodgkin lymphoma who had the high-risk feature of early progression after first chemoimmunotherapy [Abstract]. European Hematology Association (EHA) Virtual; 2021b 09-17 June.
  • Jacobson CA, Chavez JC, Sehgal AR, et al. Primary analysis of ZUMA-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL) [Oral abstract 69]. Transplantation and Cellular Therapy 2021; 27 (Issue 3, Supplement): S67-S68, ISSN 2666-6367
  • Jacobson CA, Chavez JC, Sehgal AR, et al. Primary analysis of ZUMA-5: A phase 2 study of axicabtagene ciloleucel in patients with relapsed/refractory indolent non-hodgkin lymphoma [Oral abstract]. British Journal of Heamatology 2021, BSH2021-OR-036.
  • Neelapu SS, Chavez JC, Sehgal AR, et al. Long-term follow-up analysis of ZUMA-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL) [Abstract 93]. Blood 2021;138 (1 Suppl)
  • Plaks V, Chou J, Goyal L, et al. Axicabtagene ciloleucel (axi-cel) product attributes and immune biomarkers associated with clinical outcomes in patients (pts) with relapsed/refractory R/R) indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5 [Abstract CT036]. Cancer Res 2021;81 (13 Suppl).
  • Kanters S, Ball G, Kahl B, Wiesinger A, Limbrick-Oldfield EH, Sudhindra A, Snider JT, Patel AR. Clinical outcomes in patients relapsed/refractory after >/=2 prior lines of therapy for follicular lymphoma: a systematic literature review and meta-analysis. BMC Cancer. 2023 Jan 23;23(1):74. doi: 10.1186/s12885-023-10546-6. PubMed 36690960 ↗
  • Palomba ML, Ghione P, Patel AR, et al. A comparison of clinical outcomes from updated ZUMA-5 (axicabtagene ciloleucel) and the international scholar-5 external control cohort in relapsed/refractory follicular lymphoma (R/R FL) [Abstract PB1571]. Blood 2021;138 (1 Suppl):3543.
  • Neelapu SS, Chavez JC, Sehgal AR, et al. Long-term follow-up analysis of Zuma-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL) [Abstract 75]. Transplantation and Cellular Therapy 2022;28 (Issue 3, Supplement):S64-S65, ISSN 2666-6367.
  • Neelapu SS, Chavez JC, Sehgal AR, et al. Long-term analysis of ZUMA-5 phase 2 study of axicabtagene ciloleucel in patients with indolent non-Hodgkin lymphoma [Oral presentation O3-5]. 2022 Japanese Society of Medical Oncology - 19th Scientific Meeting
  • Hatswell AJ, Deighton K, Snider JT, Brookhart MA, Faghmous I, Patel AR. Approaches to Selecting "Time Zero" in External Control Arms with Multiple Potential Entry Points: A Simulation Study of 8 Approaches. Med Decis Making. 2022 Oct;42(7):893-905. doi: 10.1177/0272989X221096070. Epub 2022 May 6. PubMed 35514320 ↗
  • Ghione P, Palomba ML, Patel AR, Bobillo S, Deighton K, Jacobson CA, Nahas M, Hatswell AJ, Jung AS, Kanters S, Snider JT, Neelapu SS, Ribeiro MT, Brookhart MA, Ghesquieres H, Radford J, Gribben JG. Comparative effectiveness of ZUMA-5 (axi-cel) vs SCHOLAR-5 external control in relapsed/refractory follicular lymphoma. Blood. 2022 Aug 25;140(8):851-860. doi: 10.1182/blood.2021014375. PubMed 35679476 ↗
  • Neelapu SS, Chavez JC, Sehgal AR, et al. 3-Year follow-up analysis of ZUMA-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL). Blood 2022;140 (1 Suppl):10380-10383.
  • Oluwole OO, Ray MD, Rosettie KL, Ball G, Jacob J, Bilir SP, Patel AR, Jacobson CA. Cost-Effectiveness of Axicabtagene Ciloleucel for Adult Patients With Relapsed or Refractory Follicular Lymphoma in the United States. Value Health. 2024 Aug;27(8):1030-1038. doi: 10.1016/j.jval.2024.04.003. Epub 2024 Apr 17. PubMed 38641058 ↗
  • Ghione P, Palomba ML, Ray MD, et al. A 3-year follow-up comparison of clinical outcomes from Zuma-5 (axicabtagene ciloleucel) and the international Scholar-5 external control cohort in relapsed/refractory follicular lymphoma (R/R FL). Blood 2022;140 (1 Suppl):4676-4677.
  • Neelapu SS, Chavez JC, Sehgal AR, et al. 3-Year follow-up analysis of Zuma-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients (pts) with relapsed/refractory (r/r) indolent non-Hodgkin lymphoma (iNHL) [Abstract 500]. Transplantation and Cellular Therapy 2023;29 (Issue 2, Supplement):S374, ISSN 2666-6367
  • Palomba ML, Ghione P, Patel AR, Nahas M, Beygi S, Hatswell AJ, Kanters S, Limbrick-Oldfield EH, Wade SW, Ray MD, Owen J, Neelapu SS, Gribben J, Radford J, Bobillo S. A 24-month updated analysis of the comparative effectiveness of ZUMA-5 (axi-cel) vs. SCHOLAR-5 external control in relapsed/refractory follicular lymphoma. Expert Rev Anticancer Ther. 2023 Feb;23(2):199-206. doi: 10.1080/14737140.2023.2171994. Epub 2023 Feb 10. PubMed 36723678 ↗
  • Patel AR, Limbrick-Oldfield EH, Kanters S, et al., The prognostic value of progressing within 24 months of frontline chemoimmunotherapy (POD24) in relapsed/refractory (R/R) follicular lymphoma (FL)-a SCHOLAR-5 analysis. Hematological Oncology 2023;41:376-377.
  • Ray MD, Kanters S, Beygi S, et al. Matching-adjusted indirect comparison of axicabtagene ciloleucel versus mosunetuzumab in relapsed/refractory follicular lymphoma patients after 2 prior systemic treatments. Hematological Oncology 2023;41:522-523
  • Neelapu SS, Chavez JC, Sehgal AR, et al. Axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory indolent non-Hodgkin lymphoma: 4-year follow-up from the phase 2 ZUMA-5 trial. Blood 2023;142 (1 Suppl):4868.
  • Bachy E, Neelapu SS, Chavez JC, et al. A retrospective intra-patient analysis from ZUMA-5: Axicabtagene ciloleucel (axi-cel) compared with prior standard-of-care therapy in patients with relapsed/refractory follicular lymphoma. Blood 2023;142 (1 Suppl):4865.
  • Gribben JG, Ghione P, Palomba ML, et al. An updated comparison of clinical outcomes from 4-year follow-up of Zuma-5 (axicabtagene ciloleucel) and the international Scholar-5 external control cohort in relapsed/refractory follicular lymphoma. Blood 2023;142 (1 Suppl):4869.
  • Eklund O, Hedlöf Kanje V, Doble B, et al. EE536 Cost-effectiveness of axicabtagene ciloleucel (axi-cel) vs standard of care for adult patients with relapsed or refractory follicular lymphoma as 4TH or later line treatment in Sweden. Value in Health 2023;26 (Issue 12, Supplement):S155, ISSN 1098-3015.
  • Ghione P, Palomba ML, Ray MD, Limbrick-Oldfield EH, Owen J, Kanters S, Bobillo S, Ribiero MT, Jacobson CA, Neelapu SS, Ghesquieres H, Nahas M, Beygi S, Patel AR, Gribben JG. A Comparison of 3-Year Follow-up of ZUMA-5 (Axicabtagene Ciloleucel) With SCHOLAR-5 in Relapsed/Refractory Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2024 May;24(5):e191-e195.e6. doi: 10.1016/j.clml.2024.01.011. Epub 2024 Jan 24. PubMed 38365528 ↗
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Study documents

  • Study protocol · Jan 29, 2024
  • Statistical analysis plan · Aug 3, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment

Supporting information: Study protocol, Sap

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03105336
Lead sponsor
Kite, A Gilead Company
Responsible party
Sponsor
First posted
Apr 7, 2017
Start date
Jun 6, 2017
Primary completion
Dec 20, 2024
Completion
Dec 20, 2024
Results posted
Dec 23, 2025
Last update
Dec 23, 2025

Study contacts

Kite Study Director
study director · Kite, A Gilead Company

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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