The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.
Five years after randomization, 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Administered intravenously
Administered intravenously
Event-free Survival (EFS) by Blinded Central Assessment
EFS, is defined as the time from randomization to the earliest occurrence of death due to any cause, disease progression/relapse, initiation of any non-protocol specified subsequent new lymphoma therapy for the treatment of residual disease or Biopsy-proven residual disease at the Month 6 disease assessment or later, regardless of whether subsequent new lymphoma therapy is initiated or not.
Time frame: Up to 5 years
Progression-free Survival (PFS) by Blinded Central Assessment
PFS is defined as the time from randomization to disease progression or death due to any cause.
Time frame: Up to 5 years
Overall Survival
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to 5 years
PFS by Investigator Assessment
PFS is defined as the time from randomization to disease progression or death due to any cause.
Time frame: Up to 5 years
Complete Response (CR) Rate by Blinded Central Assessment
CR rate is defined as the proportion of participants who have achieved CR per Lugano classification after treatment completion and prior to subsequent new off protocol anti-lymphoma therapy.
Time frame: Up to 5 years
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths
Time frame: First dose date up to 5 years plus 30 days
Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
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Administered intravenously
Administered intravenously
Administered intravenously
Administered intravenously
Administered orally
University of Alabama Hospital
Birmingham, Alabama, United States
RECRUITINGBanner MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGMayo Clinic
Phoenix, Arizona, United States
RECRUITINGUC San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGUniversity of California Los Angeles (UCLA)
Los Angeles, California, United States
RECRUITINGStanford Cancer Institute
Palo Alto, California, United States
RECRUITINGColorado Blood Cancer Institute
Denver, Colorado, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGGeorgia Cancer Center at Augusta University
Augusta, Georgia, United States
RECRUITINGNorthwestern Memorial Hospital
Chicago, Illinois, United States
RECRUITING...and 80 more locations
Time frame: First dose date up to 5 years plus 30 days
Change From Baseline in the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30) Score
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, six (6) symptom single-item 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.
Time frame: Baseline, Month 18
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Non-Hodgkin Lymphoma High Grade Module (EORTC QLQ-NHL-HG29) Score
The EORTC QLQ-NHL-HG29 is a 29-item patient-reported assessment measuring patients' high-grade NHL-specific symptoms and functioning. The 29 items assess symptom burden due to disease and/or treatment, fatigue/physical condition, neuropathy, emotional impacts, and worries/fears health and functioning. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.
Time frame: Baseline, Month 18
Change From Baseline in the European Quality of Life Five Dimensions Five Levels Questionnaire (EQ-5D-5L) Score
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.
Time frame: Baseline, Month 18