The goal of this clinical study is to compare the study drug KITE-753 versus axicabtagene ciloleucel (axi-cel) in adult participants with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) after one prior line of therapy. The primary objective of this study is to evaluate the efficacy of KITE-753 versus axicabtagene ciloleucel.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
550
A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
Administered intravenously
Administered intravenously
City of Hope Arizona
Goodyear, Arizona, United States
RECRUITINGCity of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
RECRUITINGStanford University
Stanford, California, United States
RECRUITINGColorado Blood Cancer Institute
Denver, Colorado, United States
RECRUITINGYale University School of Medicine
New Haven, Connecticut, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGSoutheastern Regional Medical Center, Inc. dba City of Hope Atlanta
Newnan, Georgia, United States
RECRUITINGCity of Hope - Chicago
Zion, Illinois, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITING...and 9 more locations
Proportion of Participants in Complete Response (CR) at Month 6
Participants who would be in CR at Month 6 postinfusion of KITE-753 or axi-cel and prior to subsequent anti-lymphoma therapy. This will be assessed by the Lugano Classification by the blinded central assessment.
Time frame: Month 6
Event-free survival (EFS)
EFS is defined as the time from randomization to the earliest occurrence of the following EFS events: a) Death due to any cause, b) Disease progression/relapse per blinded central assessment, and c) Initiation of any non-protocol specified subsequent anti-lymphoma therapy for the treatment of residual disease (including stable disease and partial response as per International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma).
Time frame: Up to 36 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have achieved either CR or partial response (PR) by the Lugano Classification as determined by blinded central assessment after treatment completion and prior to subsequent anti-lymphoma therapy.
Time frame: Up to 36 months
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to disease progression per the Lugano Classification as determined by blinded central assessment or death from any cause.
Time frame: Up to 36 months
Duration of Response (DOR)
DOR is defined as the time from first objective response (CR or PR) prior to subsequent anti-lymphoma therapy to disease progression or death from any cause.
Time frame: Up to 36 months
Duration of Complete Response (DOCR)
DOCR is defined as the time from first CR prior to subsequent anti-lymphoma therapy to disease progression or death from any cause.
Time frame: Up to 36 months
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause.
Time frame: Up to 36 months
Percentage of Participants Experiencing Adverse Events (AEs)
Time frame: First dose date up to 36 months, plus 30 days
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: First dose date up to 36 months, plus 30 days
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Cancer-30 (EORTC-QLQ-C30)
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) single item symptoms 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 high level of symptoms.
Time frame: Baseline, up to 36 months
Changes From Baseline in the 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
The EQ-5D-5L is a standard measure of health-related quality of life. The tool consists of the EQ-5D-5L descriptive part and the EQ visual analogue scale (VAS). The descriptive part comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each of these 5 dimensions has 5 levels (no problem, slight problems, moderate problems, severe problems, and extreme problems). Results for each of the 5 dimensions are combined into a 5-digit number to describe the participant's health state. The EQ-VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine." Higher scores of EQ VAS indicate better health.
Time frame: Baseline, up to 36 months
Changes From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score
The EQ-VAS records the participant's self-rated health on a vertical VAS, where the end points were labeled "the best health you can imagine" and "the worst health you can imagine." The EQ-VAS could be used as a quantitative measure of a health outcome that reflected the participant's own judgment. The EQ-VAS recorded the participant's self-rated health on a vertical VAS, with a score numbered from 0 to 100, where '100 meant the best health you can imagine' and '0 meant the worst health you can imagine".
Time frame: Baseline, up to 36 months
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ)-Non-Hodgkin's lymphoma (NHL)-Non-Hodgkin Lymphoma High Grade Module 29 (HG29)
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, up to 36 months
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