Trial · NCT03391466

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

NCT03391466, Phase 3, Completed, Kite, A Gilead Company; results first posted 2024-03-07

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma. Trials, record NCT03391466. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03391466

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
NCT number: NCT03391466
Status: Completed
Phases: Phase 3
Enrollment: 359 participants, actual
Lead sponsor: Kite, A Gilead Company
Conditions: Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Interventions: Axicabtagene Ciloleucel, Platinum-containing Salvage Chemotherapy, Cyclophosphamide, Fludarabine
First posted: 2018-01-05
Last updated: 2025-12-01
Other registries' IDs: eudract:2017-002261-22
Results first posted: 2024-03-07

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Event Free Survival (EFS) Per Blinded Central Assessment	From randomization date up to a median follow-up: 24.9 months	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.
Secondary	Objective Response Rate (ORR) Per Blinded Central Assessment	From randomization date up to a median follow-up: 24.9 months	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.
Secondary	Overall Survival (OS)	Up to 74.9 months	Overall survival is defined as the time from randomization to death from any cause. Kaplan-Meier (KM) estimates were used for analysis.
Secondary	Duration of Response (DOR) Per Blinded Central Assessments	From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (Up to 37.8 months)	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.
Secondary	Modified Event Free Survival (mEFS) Per Blinded Central Assessment	From randomization date up to a median follow-up: 24.9 months	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.
Secondary	EFS Per Investigator Disease Assessments	From randomization date up to a median follow-up: 47.2 months	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.
Secondary	Progression-Free Survival (PFS) Per Investigator Disease Assessments	From randomization date up to a median follow-up: 47.2 months	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.
Secondary	Modified Event Free Survival (mEFS) Per Investigator Assessment	From randomization date up to a median follow-up: 47.2 months	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.
Secondary	Change From Baseline in Global Health Status Scores	Baseline, Days 50, 100, and 150; Months 9, 12, 15, 18, 21 and 24	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.
Secondary	Change From Baseline in EORTC QLQ-C30 Physical Functioning Score	Baseline, Days 50, 100, 150, Months 9, 12, 15, 18, 21 and 24	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.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event Free Survival (EFS) Per Blinded Central Assessment	From randomization date up to a median follow-up: 24.9 months	Participants in Full Analysis Set were analyzed.	months	MEDIAN
SECONDARY	Objective Response Rate (ORR) Per Blinded Central Assessment	From randomization date up to a median follow-up: 24.9 months	Participants in the Full Analysis Set were analyzed.	percentage of participants	NUMBER
SECONDARY	Overall Survival (OS)	Up to 74.9 months	Participants in the Full Analysis Set were analyzed.	months	MEDIAN
SECONDARY	Duration of Response (DOR) Per Blinded Central Assessments	From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (Up to 37.8 months)	Participants in the Full Analysis Set with objective response were analyzed. Participants not meeting the criteria by the analysis data cut-off date were censored at their last evaluable disease assessment date prior to the data cut-off date or new lymphoma therapy start date (including stem cell transplant in the axicabtagene ciloleucel arm or retreatment of axicabtagene ciloleucel), whichever was earlier.	months	MEDIAN
SECONDARY	Modified Event Free Survival (mEFS) Per Blinded Central Assessment	From randomization date up to a median follow-up: 24.9 months	Participants in the Full Analysis Set were analyzed.	months	MEDIAN
SECONDARY	EFS Per Investigator Disease Assessments	From randomization date up to a median follow-up: 47.2 months	Participants in the Full Analysis Set were analyzed.	months	MEDIAN
SECONDARY	Progression-Free Survival (PFS) Per Investigator Disease Assessments	From randomization date up to a median follow-up: 47.2 months	Participants in the Full Analysis Set were analyzed.	months	MEDIAN
SECONDARY	Modified Event Free Survival (mEFS) Per Investigator Assessment	From randomization date up to a median follow-up: 47.2 months	Participants in the Full Analysis Set were analyzed.	months	MEDIAN
SECONDARY	Change From Baseline in Global Health Status Scores	Baseline, Days 50, 100, and 150; Months 9, 12, 15, 18, 21 and 24	Participants in Quality of Life (QoL) Analysis Set with data available at given timepoint were analyzed. The QoL Analysis Set was defined as the subset of participants in the Full Analysis Set who have a baseline and Day 150 post-randomization QoL assessment.	Score on scale	MEAN
SECONDARY	Change From Baseline in EORTC QLQ-C30 Physical Functioning Score	Baseline, Days 50, 100, 150, Months 9, 12, 15, 18, 21 and 24	Participants in QoL analysis set with data available at given timepoint were analyzed.	Score on scale	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group149

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Event Free Survival (EFS) Per Blinded Central Assessment	Axicabtagene Ciloleucel	8.3	95% Confidence Interval 4.5 to 15.8	months
Event Free Survival (EFS) Per Blinded Central Assessment	Standard of Care Therapy	2.0	95% Confidence Interval 1.6 to 2.8	months
Objective Response Rate (ORR) Per Blinded Central Assessment	Axicabtagene Ciloleucel	83	95% Confidence Interval 77.1 to 88.5	percentage of participants
Objective Response Rate (ORR) Per Blinded Central Assessment	Standard of Care Therapy	50	95% Confidence Interval 42.7 to 57.8	percentage of participants
Overall Survival (OS)	Axicabtagene Ciloleucel	NA	95% Confidence Interval 28.3 to NA	months
Overall Survival (OS)	Standard of Care Therapy	35.1	95% Confidence Interval 18.5 to NA	months
Duration of Response (DOR) Per Blinded Central Assessments	Axicabtagene Ciloleucel	26.9	95% Confidence Interval 13.6 to NA	months
Duration of Response (DOR) Per Blinded Central Assessments	Standard of Care Therapy	8.9	95% Confidence Interval 5.7 to NA	months
Modified Event Free Survival (mEFS) Per Blinded Central Assessment	Axicabtagene Ciloleucel	10.3	95% Confidence Interval 5.0 to 21.5	months
Modified Event Free Survival (mEFS) Per Blinded Central Assessment	Standard of Care Therapy	2.0	95% Confidence Interval 1.6 to 2.8	months

1 to 10 of 149Source ClinicalTrials.gov

See all 149 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Axicabtagene Ciloleucel	180
Overall Study	STARTED	Standard of Care Therapy	179
Overall Study	COMPLETED	Axicabtagene Ciloleucel	2
Overall Study	COMPLETED	Standard of Care Therapy	67
Overall Study	NOT COMPLETED	Axicabtagene Ciloleucel	178
Overall Study	NOT COMPLETED	Standard of Care Therapy	112

Source ClinicalTrials.gov

Adverse events783

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Axicabtagene Ciloleucel Treatment	71	170
other	Anaemia	Blood and lymphatic system disorders	Standard of Care Therapy	90	168
other	Anaemia	Blood and lymphatic system disorders	Retreatment Axicabtagene Ciloleucel	4	10
other	Febrile neutropenia	Blood and lymphatic system disorders	Axicabtagene Ciloleucel Treatment	0	170
other	Febrile neutropenia	Blood and lymphatic system disorders	Standard of Care Therapy	24	168
other	Febrile neutropenia	Blood and lymphatic system disorders	Retreatment Axicabtagene Ciloleucel	0	10
other	Leukopenia	Blood and lymphatic system disorders	Axicabtagene Ciloleucel Treatment	9	170
other	Leukopenia	Blood and lymphatic system disorders	Standard of Care Therapy	6	168
other	Leukopenia	Blood and lymphatic system disorders	Retreatment Axicabtagene Ciloleucel	0	10
other	Neutropenia	Blood and lymphatic system disorders	Axicabtagene Ciloleucel Treatment	75	170

1 to 10 of 783Source ClinicalTrials.gov

See all 783 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Axicabtagene Ciloleucel Treatment	81	180
Total, all-cause mortality	Standard of Care Therapy	101	179
Total, all-cause mortality	Retreatment Axicabtagene Ciloleucel	3	10
Total, other adverse events	Axicabtagene Ciloleucel Treatment	170	170
Total, other adverse events	Standard of Care Therapy	166	168
Total, other adverse events	Retreatment Axicabtagene Ciloleucel	10	10
Total, serious adverse events	Axicabtagene Ciloleucel Treatment	96	170
Total, serious adverse events	Standard of Care Therapy	78	168
Total, serious adverse events	Retreatment Axicabtagene Ciloleucel	2	10

Source ClinicalTrials.gov

Papers20

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25113753	BACKGROUND	PubMed
26980727	BACKGROUND	PubMed
33288485	DERIVED	PubMed
34515338	DERIVED	PubMed
34891224	BACKGROUND	PubMed
34922648	DERIVED	PubMed
35114155	DERIVED	PubMed
35839452	BACKGROUND	PubMed
36646322	BACKGROUND	PubMed
36999993	BACKGROUND	PubMed

1 to 10 of 20

See all 20 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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