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Completed

NCT Number: NCT05459571

Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma

The goal of this clinical study is to learn more about the study drug, axicabtagene ciloleucel, in participants with relapsed or refractory large B-cell lymphoma (LBCL) in the outpatient setting.

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Key information

Conditions

Relapsed or Refractory Large B-cell Lymphoma Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte, California, United States

Loading trial locations.

About this study

Participants who complete at minimum 24 months follow up will be transitioned to a separate long-term follow-up study (study KT-US-982-5968) to 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:

  • Histologically confirmed large B-cell lymphoma (LBCL), including the following types defined by World Health Organization (WHO) 2016 classification, by local pathology laboratory assessment, are eligible as defined below:
  • Diffuse large B-cell lymphoma (DLBCL) not otherwise specified.
  • High-grade B-cell lymphoma (HGBL) with or without MYC and BCL2 and/or BCL6 rearrangement.
  • DLBCL associated with chronic inflammation; Epstein-Barr virus (EBV) + DLBCL.
  • Primary mediastinal (thymic) LBCL.
  • Primary cutaneous DLBCL, leg type.
  • Transformation of follicular lymphoma to DLBCL will also be included.
  • Relapsed or refractory disease after 1 or more lines of therapy.
  • Individuals must have received adequate prior therapy including:
  • Anti-CD20 monoclonal antibody AND
  • An anthracycline-containing chemotherapy regimen.
  • At least 1 measurable lesion according to the Lugano Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Individual agrees to outpatient treatment setting and to adhere to the prespecified clinical monitoring requirements.

Key Exclusion Criteria:

  • History of autologous or allogeneic stem cell transplant.
  • Prior cluster of differentiation (CD)19 targeted therapy.
  • Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor.
  • Individuals with detectable cerebrospinal fluid malignant cells, brain metastases, or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma. DLBCL epidural involvement should be considered as positive CNS disease.
  • In the investigator's judgment, the individual is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Axicabtagene Ciloleucel

Biological

Administered intravenously

Other names: Yescarta®

Cyclophosphamide

Drug

Administered intravenously

Fludarabine

Drug

Administered intravenously

Dexamethasone

Drug

Administered orally or intravenously

Primary outcomes

  1. Percentage and Severity of Participants with Treatment-emergent Cytokine Release Syndrome (CRS) and Neurologic Events

    Time frame: Up to 24 months

Secondary outcomes

  1. Time to Onset of CRS and Neurologic Events Following Axicabtagene Ciloleucel Administration

    Time frame: First infusion date of axicabtagene ciloleucel up to 24 months

  2. Duration of CRS and Neurologic Events Following Axicabtagene Ciloleucel Administration

    Time frame: First infusion date of axicabtagene ciloleucel up to 24 months

  3. Rates of Hospitalization After Axicabtagene Ciloleucel Infusion as Measured by Proportion of Hospitalized Participants Within 72 hours

    Time frame: First infusion date of axicabtagene ciloleucel up to 72 hours

  4. Rates of Hospitalization After Axicabtagene Ciloleucel Infusion as Measured by Proportion of Hospitalized Participants 3 Days After Infusion Date

    Time frame: First infusion date of axicabtagene ciloleucel up to 3 days

  5. Rates of Hospitalization After Axicabtagene Ciloleucel Infusion as Measured by Proportion of Hospitalized Participants Within 7 days

    Time frame: First infusion date of axicabtagene ciloleucel up to 7 days

  6. Rates of Hospitalization After Axicabtagene Ciloleucel Infusion as Measured by Proportion of Hospitalized Participants Within 14 days

    Time frame: First infusion date of axicabtagene ciloleucel up to 14 days

  7. Rates of Hospitalization After Axicabtagene ciloleucel Infusion as Measured by Proportion of Hospitalized Participants Within 30 days

    Time frame: First infusion date of axicabtagene ciloleucel up to 30 days

  8. Duration of Initial Hospitalization After Axicabtagene Ciloleucel Infusion

    Time frame: First infusion date of axicabtagene ciloleucel up to 24 months

  9. Proportion of Intensive Care Unit (ICU) Admitted Participants

    Time frame: Up to 24 months

  10. Duration of ICU Admission During First Hospitalization After Axicabtagene Ciloleucel Infusion

    Time frame: Up to 24 months

  11. Percentage of Participants Experiencing Treatment- Emergent Adverse Events

    Time frame: First infusion date of axicabtagene ciloleucel up to 24 months

  12. Percentage of Participants Experiencing Treatment- Emergent Serious Adverse Events

    Time frame: First infusion date of axicabtagene ciloleucel up to 24 months

  13. Change in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L) From Baseline to Month 6

    Time frame: Baseline, 6 Months

    The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant's health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.

  14. Objective Response Rate (ORR) as Assessed by Investigator Assessment

    Time frame: Up to 24 months

    ORR is defined as the incidence of either a complete response or a partial response by the revised international working group (IWG) response criteria for malignant lymphoma.

  15. Complete Response (CR) Rate as Assessed by Investigator Assessment

    Time frame: Up to 24 months

    CR rate is defined as the incident of complete response.

  16. Duration of response (DOR) as Assessed by Investigator Assessment

    Time frame: Up to 24 months

    DOR is defined as the time from first objective response to disease progression per the revised IWG response criteria for malignant lymphoma or death from any cause.

  17. Progression-free Survival (PFS) as Assessed by Investigator Assessment

    Time frame: Up to 24 months

    PFS is defined as the time from the axicabtagene ciloleucel infusion date to the date of disease progression per the revised IWG response criteria for malignant lymphoma or death from any cause.

  18. Event Free Survival (EFS) as Assessed by Investigator Assessment

    Time frame: Up to 24 months

    EFS is defined as the time from infusion to the earliest date of disease progression per the revised IWG response criteria for malignant lymphoma, commencement of new anti-lymphoma therapy, or death from any cause.

  19. Overall Survival (OS)

    Time frame: Up to 24 months

    OS is defined as the time from axicabtagene ciloleucel infusion to the date of death.

  20. Peak Serum Levels of Homeostatic/Proliferative Cytokines: Interleukin (IL)-2, IL-7, and IL-15

    Time frame: Up to 24 months

  21. Peak Serum Levels of Inflammatory and Immune Modulating Cytokines: IFN-γ, IL-1, IL-6, IL- 13, IL-17, IL-1, IL-1RA, Granulocyte-macrophage Colony Stimulating Factor (GM-CSF), Tumor Necrosis Factor-Alpha (TNF-α), and IL-12p40/p70

    Time frame: Up to 24 months

    IFN-γ=Interferon-Gamma, IL-1RA=IL-1 Receptor Antagonist

  22. Peak Serum Levels of Immune Effector Molecules: Granzyme A, Granzyme B, and Perforin

    Time frame: Up to 24 months

  23. Peak Serum Levels of the Acute Phase Response Proteins: C-Reactive Protein (CRP), Serum Amyloid A (SAA), Soluble IL-2 Receptor Alpha (sIL-1Ra), Ferritin

    Time frame: Up to 24 months

  24. Peak Serum Levels of Chemokines: IL-8, C-X-C Motif Chemokine Ligand-10 (CXCL-10), and Monocyte Chemotactic Protein-1 (MCP-1)

    Time frame: Up to 24 months

  25. Blood Levels of Axicabtagene Ciloleucel Chimeric Antigen Receptor (CAR) T-cells Over Time

    Time frame: Up to 24 months

Sponsors and collaborators

Lead sponsor

Kite, A Gilead Company

Industry

Registry information

Official study title

A Phase 2 Open-Label, Multicenter Study Evaluating The Safety And Efficacy of Axicabtagene Ciloleucel Concomitant With Prophylactic Steroids In Subjects With Relapsed Or Refractory Large B-Cell Lymphoma In The Outpatient Setting

Acronym: ZUMA-24

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2022
Registry last updated
Feb 2, 2026

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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