The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
231
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Administered intravenously
Administered intravenously
Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification
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)
OS is defined as the time from randomization to death from any cause.
Time frame: Up to 5 years
Complete Response (CR) Rate as Assessed by Blinded Central Assessment per Lugano Classification
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.
Time frame: Up to 5 years
Objective Response Rate (ORR) as Assessed by Blinded Central Assessment per Lugano Classification
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.
Time frame: Up to 5 years
Duration of Response (DOR) as Assessed by Blinded Central Assessment per Lugano Classification
DOR is defined as the time from first objective response to disease progression or death from any cause.
Time frame: Up to 5 years
Duration of CR as Assessed by Blinded Central Assessment per Lugano Classification
Duration of CR is defined as the time from first CR to disease progression or death from any cause.
Time frame: Up to 5 years
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Administered orally
Administered intravenously
Administered intravenously
Administered intravenously
Administered orally
Administered intravenously
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
Stanford Health Care
Stanford, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
The University of Kansas Hospital
Westwood, Kansas, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Novant Health Cancer Institute Hematology - Charlotte
Charlotte, North Carolina, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
TriStar Centennial Medical Center - Cell Processing
Nashville, Tennessee, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
...and 42 more locations
Event Free Survival (EFS) as Assessed by Blinded Central Assessment per Lugano Classification
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.
Time frame: Up to 5 years
Time to Next Treatment (TTNT)
TTNT is defined as the time from randomization to the start of subsequent off-protocol anti-lymphoma therapy or death from any cause.
Time frame: Up to 5 years
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Randomization up to 5 years plus 30 days
Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
Time frame: Randomization up to 5 years plus 30 days
Percentage of Participants with Replication-competent Retrovirus in Blood Over time
Time frame: Up to 5 years
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)
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.
Time frame: Baseline, up to 5 years
Change From Baseline in the Physical Functioning Domain of the 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, 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, up to 5 years
Change From Baseline in the Global Health Status Quality of Life Scale of the Low Grade Non-Hodgkin Lymphoma-20 (NHL-LG20)
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.
Time frame: Baseline, up to 5 years
Change From Baseline in the Physical Functioning Domain of the NHL-LG20
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.
Time frame: Baseline, up to 5 years
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L)
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, up to 5 years
Changes From Baseline in the Visual Analog Scale (VAS) Scores
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.
Time frame: Baseline, up to 5 years