NCT03391466 · CITED IN SOURCE DOCUMENTS

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2025-12-01

The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Event Free Survival (EFS) Per Blinded Central Assessment

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outcome · POSTED

Objective Response Rate (ORR) Per Blinded Central Assessment

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Duration of Response (DOR) Per Blinded Central Assessments

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outcome · POSTED

Modified Event Free Survival (mEFS) Per Blinded Central Assessment

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outcome · POSTED

EFS Per Investigator Disease Assessments

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outcome · POSTED

Progression-Free Survival (PFS) Per Investigator Disease Assessments

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outcome · POSTED

Modified Event Free Survival (mEFS) Per Investigator Assessment

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outcome · POSTED

Change From Baseline in Global Health Status Scores

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outcome · POSTED

Change From Baseline in EORTC QLQ-C30 Physical Functioning Score

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outcome · POSTED

Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score

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outcome · POSTED

Change From Baseline in EQ-5D-5L VAS Scale Score

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outcome · POSTED

Number of Participants With Post-dose Anti-Axicabtagene Ciloleucel Antibodies

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outcome · POSTED

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

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outcome · POSTED

Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher

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outcome · POSTED

Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Key Inclusion Criteria: * Histologically proven large B-cell lymphoma (BCL) including the following types defined by World Health Organization (WHO) 2016. * Diffuse large B-cell lymphoma (DLBCL) not otherwise specified activated B-cell/ germinal center B-cell (ABC/GCB). * High-grade B-cell lymphoma (HGBL) with or without myelocytomatosis oncogene (MYC) and BCL 2 and/or BCL 6 rearrangement. * DLBCL arising from follicular lymphoma (FL). * T-cell/histiocyte rich large B-cell lymphoma. * DLBCL associated with chronic inflammation. * Primary cutaneous DLBCL, leg type. * Epstein-Barr virus (EBV) + DLBCL. * Relapsed or refractory disease after first-line chemoimmunotherapy. * Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. * Progressive disease (PD) as best response to first-line therapy. * Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP). * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 12 months of therapy. * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse ≤ 12 months of first-line therapy. * Individuals must have received adequate first-line therapy including at a minimum: * Anti-Cluster of Differentiation 20 antigen (CD20) monoclonal antibody unless investigator determines that tumor is CD20 negative, and * An anthracycline containing chemotherapy regimen. * No known history or suspicion of central nervous system involvement by lymphoma. * Eastern cooperative oncology group (ECOG) performance status of 0 or 1. * Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) ≥ 1000/μl * Platelet ≥ 75,000/μl * Absolute lymphocyte count ≥ 100/μl * Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: * Creatinine clearance (Cockcroft Gault) ≥ 60 mL/min. * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN). * Total bilirubin ≤ 1.5 mg/dl * Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings. * No clinically significant pleural effusion. * Baseline oxygen saturation \> 92% on room air. Key Exclusion Criteria: * History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years. * Received more than one line of therapy for DLBCL. * History of autologous or allogeneic stem cell transplant. * Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management. * Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or anti-hepatitis C virus (HCV) positive. If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing. * Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases. * History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement. * Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted. * History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment. * History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment. * History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years. * History of anti-Cluster of Differentiation 19 (CD19) or chimeric antigen receptor (CAR)-T therapy or history of prior randomization in ZUMA-7. Note: Other protocol defined Inclusion/Exclusion criteria may apply
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants will receive cyclophosphamide 500 mg/m\^2/day intravenously (IV) and fludarabine 30 mg/m\^2/day IV conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-cluster of differentiation antigen (CD) 19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. Participants who will achieve a partial response or complete response and subsequently experience disease progression may have an option to receive a second course of conditioning chemotherapy and axicabtagene ciloleucel.
intervention Names
Biological: Axicabtagene Ciloleucel
Drug: Cyclophosphamide
Drug: Fludarabine
label
Axicabtagene Ciloleucel Treatment
type
EXPERIMENTAL
description
Participants will receive 2 or 3, 21-day cycles of second-line chemotherapy: * R-ICE:rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours continuous infusion (CI) on Day 2+mesna, carboplatin area under the curve (AUC)5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP:rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP:rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin area under the curve (AUC)=5; or * R-DHAP:rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Responders will receive high-dose therapy and autologous stem cell transplant.
intervention Names
Drug: Platinum-containing Salvage Chemotherapy
label
Standard of Care Therapy
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Axicabtagene Ciloleucel Treatment
description
Administered intravenously
name
Axicabtagene Ciloleucel
other Names
KTE-C19
axi-cel
Yescarta ®
type
BIOLOGICAL
arm Group Labels
Standard of Care Therapy
description
Platinum-containing salvage chemotherapy (Rituximab-ifosfamide, carboplatin, etoposide (R-ICE), Rituximab-dexamethasone, cytarabine, cisplatin,oxaliplatin (R-DHAP), Rituximab-etoposide, methylprednisolone, cisplatin, cytarabine (R-ESHAP), or Rituximab-gemcitabine, dexamethasone, cisplatin/carboplatin (R-GDP) as selected by treating investigator).
name
Platinum-containing Salvage Chemotherapy
type
DRUG
arm Group Labels
Axicabtagene Ciloleucel Treatment
description
Administered intravenously
name
Cyclophosphamide
type
DRUG
arm Group Labels
Axicabtagene Ciloleucel Treatment
description
Administered intravenously
name
Fludarabine
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 359
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
EFS:Time from randomization to disease progression (PD), best response of stable disease (SD) up to Day 150, start of new anti-lymphoma therapy including stem cell transplant, or death from any cause. PD=Score 4 (uptake moderately \> liver) or 5 (uptake markedly \> liver and/or new lesions) with increased uptake from baseline; New fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology or in bone marrow; Individual node/lesion abnormal with longest diameter \> 1.5 cm, ≥ 50% increase from nadir; Splenic length increase \> 50% of prior increase beyond baseline or ≥ 2 cm increase if no prior splenomegaly; New/recurrent splenomegaly, progression of non-measurable lesions, new lesion, or new/recurrent bone marrow involvement. KM estimates was used for analysis.
measure
Event Free Survival (EFS) Per Blinded Central Assessment
time Frame
From randomization date up to a median follow-up: 24.9 months

secondary Outcomes

description
ORR: Percentage of participants with CR (Complete Metabolic Response (CMR);Complete Radiologic Response (CRR)) or PR (partial metabolic response (PMR); partial radiologic response (PRR)).CMR: Positron emission tomography (PET) 5-point scale scores: 1-No uptake above background; 2-Uptake ≤mediastinum; 3-Uptake \>mediastinum but ≤liver, with/without residual mass; no new lesions, no FDG-avid disease in bone marrow. CRR: Target nodes/nodal masses regressed ≤1.5 cm in longest diameter, no extralymphatic sites, no non-measured lesions, normal organ size, no new sites, normal bone marrow morphology. PMR: Scores 4 (uptake moderately \>liver), 5 (uptake markedly \>liver, new lesions) with reduced uptake from baseline and residual mass, no new lesions. Responding at interim/residual disease at end of treatment. PRR: ≥50% decrease in sum of diameters of up to 6 target measurable lesions, no increase in non-measured lesions, spleen length decreased \>50% if previously enlarged, no new lesion sites.
measure
Objective Response Rate (ORR) Per Blinded Central Assessment
time Frame
From randomization date up to a median follow-up: 24.9 months
description
Overall survival is defined as the time from randomization to death from any cause. Kaplan-Meier (KM) estimates were used for analysis.
measure
Overall Survival (OS)
time Frame
Up to 74.9 months
description
DOR was defined only for participants who experience an objective response after axicabtagene ciloleucel infusion and was the time from the first objective response per Lugano classification to disease progression or death from any cause. Objective response was defined in outcome measure 2 and disease progression was defined in outcome measure 1. KM estimates were used for analysis.
measure
Duration of Response (DOR) Per Blinded Central Assessments
time Frame
From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (Up to 37.8 months)
description
Modified event free survival is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis.
measure
Modified Event Free Survival (mEFS) Per Blinded Central Assessment
time Frame
From randomization date up to a median follow-up: 24.9 months
description
EFS was defined as the time from randomization to the earliest date of disease progression per the Lugano Classification, best response of stable disease (SD) up to and including Day 150, commencement of new lymphoma therapy, or death from any cause. Disease progression is defined in outcome measure 1.
measure
EFS Per Investigator Disease Assessments
time Frame
From randomization date up to a median follow-up: 47.2 months
description
PFS is defined as the time from the randomization date to the date of disease progression per Lugano classification or death from any cause. Disease progression is defined in outcome measure 1. KM estimates were used for analysis.
measure
Progression-Free Survival (PFS) Per Investigator Disease Assessments
time Frame
From randomization date up to a median follow-up: 47.2 months
description
mEFS is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis.
measure
Modified Event Free Survival (mEFS) Per Investigator Assessment
time Frame
From randomization date up to a median follow-up: 47.2 months
description
Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scores were transformed to 0-100. Higher scores for Global Health Status indicated better HRQoL.
measure
Change From Baseline in Global Health Status Scores
time Frame
Baseline, Days 50, 100, and 150; Months 9, 12, 15, 18, 21 and 24
description
The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were transformed to a scale from 0 to 100, where a high score indicated better QoL. A positive change from baseline indicates better QoL.
measure
Change From Baseline in EORTC QLQ-C30 Physical Functioning Score
time Frame
Baseline, Days 50, 100, 150, Months 9, 12, 15, 18, 21 and 24
description
The Euro-QOL (EQ) Five Dimensions (5D) Five Levels (5L), EQ-5D-5L questionnaire was a generic measure of health status that provided a simple descriptive profile and a single index value. The EQ-5D-5L comprised 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health stated using a visual analog scale (VAS). The total score for EQ-5D-5L index was presented on a range from 0 to 1 where higher scores indicated better outcome. A positive change from Baseline indicates improvement.
measure
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score
time Frame
Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24
description
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"). The value 100 indicates improvement.
measure
Change From Baseline in EQ-5D-5L VAS Scale Score
time Frame
Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24
measure
Number of Participants With Post-dose Anti-Axicabtagene Ciloleucel Antibodies
time Frame
Up to 74.9 months

Full study description

brief Summary: The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
detailed Description: After completing the treatment period, all participants will be followed in the post-treatment follow-up period for up to 5 years. Thereafter, participants who received at least one dose of axicabtagene ciloleucel as protocol therapy will transition to a separate long term follow up (LTFU) study and complete the remainder of the 15-year follow-up assessments within KT-US-982-5968 (NCT05041309).

Source references

references

citation
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