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Completed

NCT Number: NCT03105336

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

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.

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Key information

Conditions

Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Indolent Non-hodgkin Lymphoma Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Marginal Zone Lymphoma Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Régional Universitaire de Lille, Lille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Axicabtagene Ciloleucel

Biological

Administered intravenously

Other names: Axi-cel, Yescarta®

Cyclophosphamide

Drug

Administered intravenously

Fludarabine

Drug

Administered intravenously

Primary outcomes

  1. Objective Response Rate (ORR): Percentage of Participants With Objective Response Per the Lugano Classification by Central Assessment

    Time frame: Up to 85.6 months

    OR:CR (complete metabolic response (CMR)+complete radiological response (CRR))+PR (partial MR response (PMR) +partial RR(PRR)).CMR: score 1(no uptake above background)/2(uptake≤mediastinum)/3(uptake >mediastinum but ≤liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions,CRR:target nodes/nodal masses regressed to ≤1.5 cm in longest transverse diameter of lesion (LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal; no new sites;bone marrow normal by morphology.PMR:score 4(uptake moderately>liver)/5(uptake markedly>liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment.PRR:≥50% decrease in sum of product of diameters up to 6 target nodes and extra-nodal sites;absent/normal,regressed,but no increase of NMLs;spleen regressed by>50% in length beyond normal. Percentages were rounded-off.

Secondary outcomes

  1. Percentage of Participants With CR Per the Lugano Classification by Central Assessment

    Time frame: Up to 85.6 months

    CR is defined in outcome measure (OM)#1. Percentages were rounded-off.

  2. ORR: Percentage of Participants With OR Per the Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy

    Time frame: Up to 85.6 months

    OR was defined as percentage of participants with CR + PR per the Lugano Classification for participants with 3 or more lines of prior therapy. CR and PR are defined in OM#1. Percentages were rounded-off.

  3. Percentage of Participants With CR Per Lugano Classification by Central Assessment Among Participants With 3 or More Lines of Prior Therapy

    Time frame: Up to 85.6 months

    CR is defined as OM#1. Percentages were rounded-off.

  4. ORR: Percentage of Participants With OR Per the Lugano Classification by Investigator Assessment

    Time frame: Up to 85.6 months

    OR was defined as percentage of participants with CR + PR per the Lugano Classification. CR and PR are defined in OM#1. Percentages were rounded-off.

  5. Percentage of Participants With Best Overall Response (BOR) Per the Lugano Classification by Central Assessment

    Time frame: Up to 85.6 months

    BOR was defined as percentage of participants with CR, PR, stable disease(SD), disease progression(PD), non-evaluable(NE), undefined/no disease or not done as best response to treatment by the Lugano Classification. CR and PR defined in OM#1. SD/no metabolic response(NMR):score 4(uptake moderately greater than (>) liver) or 5(uptake markedly>liver and/ or new lesions) with no significant change in fluorodeoxyglucose(FDG) uptake compared to baseline(screening), at interim time point or end of treatment; no new sites of disease should be observed. PD:score 4(uptake moderately>liver) or 5(uptake markedly>liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. Not done:no assessment at time of analysis. Percentages were rounded off.

  6. Percentage of Participants With BOR Per the Lugano Classification by Investigator Assessment

    Time frame: Up to 85.6 months

    BOR was defined as the percentage of participants with CR, PR, stable disease (SD), PD, NE (not evaluable) or not done as best response to treatment by the Lugano Classification. CR and PR are defined in OM#1. SD, PD and not done are defined in OM#6. Percentages were rounded off.

  7. Duration of Response (DOR) by Central Assessment

    Time frame: Up to 85.6 months

    DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. CR and PR are defined in OM#1. PD is defined in OM#6.

    Kaplan-Meier (KM) estimates were used for analysis.

  8. DOR by Investigator Assessment

    Time frame: Up to 85.6 months

    DOR was defined only for participants who experienced an OR (CR and PR) and was the time from the first objective response to disease progression or disease-related death, whichever came first. Definitions for CR, PR are defined in OM#1. PD is defined in OM#6.

    KM estimates were used for analysis.

  9. Progression-free Survival (PFS) Per Lugano Classification by Central Assessment

    Time frame: Up to 85.6 months

    PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 6. KM estimates were used for analysis.

  10. PFS Per Lugano Classification by Investigator Assessment

    Time frame: Up to 85.6 months

    PFS was defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per Lugano classification or death from any cause. PD is defined in OM 6. KM estimates were used for analysis.

  11. Overall Survival (OS)

    Time frame: Up to 85.6

    OS was defined as the time from axicabtagene ciloleucel infusion to the date of death. KM estimates were used for analysis.

  12. Time to Next Therapy

    Time frame: Up to 85.6 months

    Time from axicabtagene ciloleucel infusion date to the start of the subsequent new lymphoma therapy or death from any cause. KM estimates were used for analysis.

  13. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to 85.6 months

    TEAE was defined as any adverse event with onset on or after the start of treatment. Percentages were rounded-off.

  14. Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher

    Time frame: Up to 85.6 months

    Percentages were rounded-off.

  15. Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher

    Time frame: Up to 85.6 months

    Percentages were rounded-off.

  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

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

    Serum analytes: Serum Ferritin, Serum intercellular adhesion molecule-1 (ICAM-1), Serum interleukin-2 receptor (IL-2 R) alpha, Serum Perforin and Serum vascular cell adhesion molecule-1 (VCAM-1).

  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

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

    Serum analytes: Serum CXCL10, Serum Granzyme B, Serum interferon (IFN)-gamma, Serum IL-1 receptor antagonist (RA), Serum IL-2, Serum IL-6, Serum IL-7, Serum IL-8, Serum IL-10, Serum IL-15, Serum tumor necrosis factor (TNF) Alpha.

Sponsors and collaborators

Lead sponsor

Kite, A Gilead Company

Industry

Registry information

Official study title

A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)

Acronym: ZUMA-5

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Apr 7, 2017
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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