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NCT Number: NCT05371093

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Relapsed/Refractory Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hopital Henri Mondor, Créteil, France

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About this study

Five years after the last study participant is randomized, participants who have received axicabtagene ciloleucel will transition 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 follicular lymphoma (FL) (Grade 1, 2, or 3a)
  • Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy
  • Clinical indication for treatment.
  • At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
  • Adequate renal, hepatic, pulmonary, and cardiac function

Key Exclusion Criteria:

  • Presence of large B cell lymphoma or transformed FL
  • Small lymphocytic lymphoma
  • Lymphoplasmacytic lymphoma
  • Full-thickness involvement of the gastric wall by lymphoma
  • FL Grade 3b
  • Prior CD19-targeted therapy
  • Prior CAR therapy or other genetically modified T-cell therapy
  • Uncontrolled fungal, bacterial, viral, or other infection
  • Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus
  • History or presence of a clincially significant central nervous system (CNS) disorder.
  • History of autoimmune disease
  • Known history or CNS lymphoma involvement
  • Cardiac lymphoma involvement
  • History of clinically significant cardiac disease 6 months before randomization
  • Neuropathy greater than grade 2
  • Females who are pregnant or breastfeeding
  • Individuals of both genders who are not willing to practice birth control
  • Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardial catheter, or Ommaya reservoirs). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.

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

Treatment and study plan

Axicabtagene Ciloleucel

Biological

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

Other names: Yescarta®, axi-cel

Cyclophosphamide

Drug

Administered intravenously

Fludarabine

Drug

Administered intravenously

Lenalidomide

Drug

Administered orally

Rituximab

Drug

Administered intravenously

Doxorubicin

Drug

Administered intravenously

Vincristine

Drug

Administered intravenously

Prednisone

Drug

Administered orally

Bendamustine

Drug

Administered intravenously

Primary outcomes

  1. Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification

    Time frame: Up to 5 years

    PFS is defined as the time from randomization to disease progression or death due to any cause.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 5 years

    OS is defined as the time from randomization to death from any cause.

  2. Complete Response (CR) Rate as Assessed by Blinded Central Assessment per Lugano Classification

    Time frame: Up to 5 years

    CR rate is defined as the proportion of participants with best overall response of CR during the study prior to any subsequent off-protocol anti-follicular lymphoma (FL) therapy.

  3. Objective Response Rate (ORR) as Assessed by Blinded Central Assessment per Lugano Classification

    Time frame: Up to 5 years

    Objective response rate is defined as the proportion of participants with best overall response of either a complete response or a partial response during the study prior to any subsequent off-protocol anti-FL therapy.

  4. Duration of Response (DOR) as Assessed by Blinded Central Assessment per Lugano Classification

    Time frame: Up to 5 years

    DOR is defined as the time from first objective response to disease progression or death from any cause.

  5. Duration of CR as Assessed by Blinded Central Assessment per Lugano Classification

    Time frame: Up to 5 years

    Duration of CR is defined as the time from first CR to disease progression or death from any cause.

  6. Event Free Survival (EFS) as Assessed by Blinded Central Assessment per Lugano Classification

    Time frame: Up to 5 years

    EFS is defined as the time from randomization to the earliest date of disease progression, the initiation of subsequent off-protocol anti-FL therapy, or death from any cause.

  7. Time to Next Treatment (TTNT)

    Time frame: Up to 5 years

    TTNT is defined as the time from randomization to the start of subsequent off-protocol anti-lymphoma therapy or death from any cause.

  8. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Time frame: Randomization up to 5 years plus 30 days

  9. Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values

    Time frame: Randomization up to 5 years plus 30 days

  10. Percentage of Participants with Replication-competent Retrovirus in Blood Over time

    Time frame: Up to 5 years

  11. Change From Baseline in the Global Health Status Quality of Life Scale of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30)

    Time frame: Baseline, up to 5 years

    The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.

  12. Change From Baseline in the Physical Functioning Domain of the EORTC QLQ-C30

    Time frame: Baseline, up to 5 years

    The EORTC-QLQ-C30) is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.

  13. Change From Baseline in the Global Health Status Quality of Life Scale of the Low Grade Non-Hodgkin Lymphoma-20 (NHL-LG20)

    Time frame: Baseline, up to 5 years

    The NHL-LG20 is is a 20-item supplement questionnaire that was specifically developed to assess HRQoL in participants with low-grade non-Hodgkin lymphomas (such as follicular lymphoma). The NHL-LG20 includes multi-item scales of symptom burden, physical condition/fatigue, worries/fears on health and functioning, and emotional impact; and is administered in conjunction with the EORTC QLQ-C30. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales and for the global health status or global HRQoL scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.

  14. Change From Baseline in the Physical Functioning Domain of the NHL-LG20

    Time frame: Baseline, up to 5 years

    The NHL-LG20 is is a 20-item supplement questionnaire that was specifically developed to assess HRQoL in participants with low-grade non-Hodgkin lymphomas (such as follicular lymphoma). The NHL-LG20 includes multi-item scales of symptom burden, physical condition/fatigue, worries/fears on health and functioning, and emotional impact; and is administered in conjunction with the EORTC QLQ-C30. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales and for the global health status or global HRQoL scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.

  15. Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L)

    Time frame: Baseline, up to 5 years

    The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS). 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.

  16. Changes From Baseline in the Visual Analog Scale (VAS) Scores

    Time frame: Baseline, up to 5 years

    The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). Higher scores indicate better health.

Sponsors and collaborators

Lead sponsor

Kite, A Gilead Company

Industry

Registry information

Official study title

A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma

Acronym: ZUMA-22

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
May 12, 2022
Registry last updated
Oct 15, 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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