AzTrials
AzTrials

Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Phase 3ZUMA-7NCT03391466

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

A Phase 3 study testing Axicabtagene Ciloleucel, Platinum-containing Salvage Chemotherapy and Cyclophosphamide in people with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL), run by Kite, A Gilead Company at 72 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Axicabtagene Ciloleucel, Platinum-containing Salvage Chemotherapy and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
359 participants
Where
72 sitesin 14 countries
Study dates
25 Jan 2018to 25 Nov 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 30Show fewer
  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

72 sites in 14 countries.

72 sites in 14 countries

United States30 sites

  • University of Maryland, Greenbaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60612

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinincs

    Iowa City, Iowa, 52242

  • The University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Henry-Joyce Cancer Center

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15213

  • Mayo Clinic, Patient Location

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of Utah, Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • UCLA

    Santa Monica, California, 90404

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Washington University School of Medicine

    St Louis, Missouri, 63130

  • Stanford Cancer Institute

    Stanford, California, 94305

  • Moffitt Cancer Center

    Tampa, Florida, 12902

Other trials in United States

Canada8 sites

  • QEII Health Sciences Centre

    Halifax, B3H 2Y9

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1

  • Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont

    Montreal, H1T 2M4

  • The Ottawa Hospital - General Campus

    Ottawa, K1H 8L6

  • CHU de Quebec-Universite Laval, Hopital de L'Enfante-Jesus

    Québec, G1J 1Z4

  • Uninversity Health Network - Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

  • Vancouver General Hospital

    Vancouver, British Columbia

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Germany5 sites

  • Universitäts-klinikum Dresden

    Dresden, 01307

  • Universitatsmedizin Gottingen

    Göttingen, 37075

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitäts-klinikum Würzburg

    Würzburg, 97080

Other trials in Germany

Spain5 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Institut Catala d'Oncologia

    Barcelona, 08908

  • Hospital Universitario La Paz

    Madrid, 28046

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Hospital Universitario de Salamanca

    Salamanca, 37007

Other trials in Spain

United Kingdom5 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2GW

  • Barts Health NHS Trust

    London, EC1A 7BE

  • University College London Hospitals NHS Foundation Trust

    London, NW3 2QG

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

Other trials in United Kingdom

France4 sites

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037

  • Hopital Saint-Louis

    Paris, 75010

  • Centre Hospitalier Lyon-Sud - Service d'Hematologie clinique

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033

Other trials in France

Netherlands4 sites

  • Academic Medical Center

    Amsterdam, 1105 AZ

  • University Medical Center Groningen

    Groningen, 9700 RB

  • Erasmus Medical Center

    Rotterdam, 3011PL

  • University Medical Center Utrecht

    Utrecht

Other trials in Netherlands

Austria2 sites

  • Universitatsklinikum Graz, Division of Hematology

    Graz, 6020

  • Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie

    Innsbruck, 6020

Other trials in Austria

Belgium2 sites

  • Cliniques Universiaires Saint-Luc

    Brussels

  • UZ Gasthuisberg

    Leuven

Other trials in Belgium

Italy2 sites

  • Instituto di Ematologia "L. e A. Seragnoli" - Dipartimento di Medicina Specialistica Diagnostica e Sperimentale

    Bologna, 40138

  • IRCCS Ospedale San Raffaele di Milano

    Milan, 20132

Other trials in Italy

Switzerland2 sites

  • IOSI, OSpedale Regionale Bellinzona e Valli

    Bellinzona, 6500

  • University Hospital Zurich

    Zurich, 8091

Other trials in Switzerland

Australia1 site

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000

Other trials in Australia

Israel1 site

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Sweden1 site

  • Uppsala Akademiska Sjukhus

    Uppsala, 75185

Other trials in Sweden

About this study

Official title: A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)

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).

Read the 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).

Being tested
Axicabtagene Ciloleucel, Platinum-containing Salvage Chemotherapy, Cyclophosphamide, Fludarabine
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axicabtagene CiloleucelBiological

    Also called KTE-C19, axi-cel, Yescarta ®

    Administered intravenously

  • Platinum-containing Salvage ChemotherapyDrug

    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).

  • CyclophosphamideDrug

    Administered intravenously

  • FludarabineDrug

    Administered intravenously

Study groups in NCT03391466
Study groupRoleWhat they receive
Axicabtagene Ciloleucel TreatmentExperimentalParticipants 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.
Receives: Biological: Axicabtagene Ciloleucel; Drug: Cyclophosphamide; Drug: Fludarabine
Standard of Care TherapyActive comparatorParticipants 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.
Receives: Drug: Platinum-containing Salvage Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free Survival (EFS) Per Blinded Central Assessment

    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.

    Measured: From randomization date up to a median follow-up: 24.9 months

Secondary outcomes (15)

  1. Objective Response Rate (ORR) Per Blinded Central Assessment

    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.

    Measured: From randomization date up to a median follow-up: 24.9 months

  2. Overall Survival (OS)

    Overall survival is defined as the time from randomization to death from any cause. Kaplan-Meier (KM) estimates were used for analysis.

    Measured: Up to 74.9 months

  3. Duration of Response (DOR) Per Blinded Central Assessments

    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.

    Measured: From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (Up to 37.8 months)

  4. Modified Event Free Survival (mEFS) Per Blinded Central Assessment

    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.

    Measured: From randomization date up to a median follow-up: 24.9 months

  5. EFS Per Investigator Disease Assessments

    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.

    Measured: From randomization date up to a median follow-up: 47.2 months

  6. Progression-Free Survival (PFS) Per Investigator Disease Assessments

    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.

    Measured: From randomization date up to a median follow-up: 47.2 months

  7. Modified Event Free Survival (mEFS) Per Investigator Assessment

    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.

    Measured: From randomization date up to a median follow-up: 47.2 months

  8. Change From Baseline in Global Health Status Scores

    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.

    Measured: Baseline, Days 50, 100, and 150; Months 9, 12, 15, 18, 21 and 24

  9. Change From Baseline in EORTC QLQ-C30 Physical Functioning Score

    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.

    Measured: Baseline, Days 50, 100, 150, Months 9, 12, 15, 18, 21 and 24

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

    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.

    Measured: Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24

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

    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.

    Measured: Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24

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

    Measured: Up to 74.9 months

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

    A TEAE was defined as any AE that begins on or after the first dose of study treatment (axicabtagene ciloleucel infusion or SOC), excluding bridging therapy.

    Measured: From first dose up to 61.8 months

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

    Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off.

    Measured: From first dose up to 61.8 months

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

    Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off.

    Measured: From first dose up to 61.8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2018
  2. Study start25 Jan 2018
  3. Primary completion18 Mar 2021
  4. Study completion25 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
359 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03391466
Sponsor's protocol ID
KTE-C19-107
Other IDs
2017-002261-22, 2017
Acronym
ZUMA-7
Status last verified
Nov 2025
First submitted
21 Dec 2017
Last updated
1 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment

Publications

  • Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.

    PubMed 25113753

  • Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15.

    PubMed 26980727

  • Elsawy M, Chavez JC, Avivi I, Larouche JF, Wannesson L, Cwynarski K, Osman K, Davison K, Rudzki JD, Dahiya S, Dorritie K, Jaglowski S, Radford J, Morschhauser F, Cunningham D, Martin Garcia-Sancho A, Tzachanis D, Ulrickson ML, Karmali R, Kekre N, Thieblemont C, Enblad G, Dreger P, Malladi R, Joshi N, Wang WJ, Solem CT, Snider JT, Cheng P, To C, Kersten MJ. Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma. Blood. 2022 Nov 24;140(21):2248-2260. doi: 10.1182/blood.2022015478.

    PubMed 35839452

  • Kersten MJ, Qiao Y, Shah R, Solem C, Snider JT, To C, Cheng P, Spooner C, Perales MA. Quality-Adjusted Time without Symptoms or Toxicity: Analysis of Axicabtagene Ciloleucel versus Standard of Care in Patients with Relapsed/Refractory Large B Cell Lymphoma. Transplant Cell Ther. 2023 May;29(5):335.e1-335.e8. doi: 10.1016/j.jtct.2023.01.008. Epub 2023 Jan 14.

    PubMed 36646322

  • Locke FL, Miklos DB, Jacobson CA, Perales MA, Kersten MJ, Oluwole OO, Ghobadi A, Rapoport AP, McGuirk J, Pagel JM, Munoz J, Farooq U, van Meerten T, Reagan PM, Sureda A, Flinn IW, Vandenberghe P, Song KW, Dickinson M, Minnema MC, Riedell PA, Leslie LA, Chaganti S, Yang Y, Filosto S, Shah J, Schupp M, To C, Cheng P, Gordon LI, Westin JR; All ZUMA-7 Investigators and Contributing Kite Members. Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma. N Engl J Med. 2022 Feb 17;386(7):640-654. doi: 10.1056/NEJMoa2116133. Epub 2021 Dec 11.

    PubMed 34891224

  • Westin JR, Locke FL, Dickinson M, Ghobadi A, Elsawy M, van Meerten T, Miklos DB, Ulrickson ML, Perales MA, Farooq U, Wannesson L, Leslie L, Kersten MJ, Jacobson CA, Pagel JM, Wulf G, Johnston P, Rapoport AP, Du L, Vardhanabhuti S, Filosto S, Shah J, Snider JT, Cheng P, To C, Oluwole OO, Sureda A. Safety and Efficacy of Axicabtagene Ciloleucel versus Standard of Care in Patients 65 Years of Age or Older with Relapsed/Refractory Large B-Cell Lymphoma. Clin Cancer Res. 2023 May 15;29(10):1894-1905. doi: 10.1158/1078-0432.CCR-22-3136.

    PubMed 36999993

  • Westin JR, Oluwole OO, Kersten MJ, Miklos DB, Perales MA, Ghobadi A, Rapoport AP, Sureda A, Jacobson CA, Farooq U, van Meerten T, Ulrickson M, Elsawy M, Leslie LA, Chaganti S, Dickinson M, Dorritie K, Reagan PM, McGuirk J, Song KW, Riedell PA, Minnema MC, Yang Y, Vardhanabhuti S, Filosto S, Cheng P, Shahani SA, Schupp M, To C, Locke FL; ZUMA-7 Investigators; Kite Members. Survival with Axicabtagene Ciloleucel in Large B-Cell Lymphoma. N Engl J Med. 2023 Jul 13;389(2):148-157. doi: 10.1056/NEJMoa2301665. Epub 2023 Jun 5.

    PubMed 37272527

  • Filosto S, Vardhanabhuti S, Canales M, Poiré X, Lekakis LJ, de Vos S, et al. Product attributes of axicabtagene ciloleucel (axi-cel) that associate differentially with efficacy and toxicity in second-line large B-cell lymphoma. Cancer Res. 2022;82(12_Supplement):CT004.

  • Ghobadi A, Munoz J, Westin J, Locke FL, Miklos DB, Rapoport AP, et al. Outcomes of Subsequent Anti-Lymphoma Therapies in Patients (Pts) with Large B-Cell Lymphoma (LBCL) Treated with Axicabtagene Ciloleucel (Axi-Cel) or Standard of Care (SOC) in the Second-Line (2L) ZUMA-7 Study. Blood. 2022;140(Supplement 1):1595-1597.

  • Locke FL, Oluwole OO, Kuruvilla J, Thieblemont C, Morschhauser F, Salles G, et al. Association of Metabolic Tumor Volume (MTV) and Clinical Outcomes in Second-Line (2L) Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Following Axicabtagene Ciloleucel (Axi-Cel) Versus Standard-of-Care (SOC) Therapy in ZUMA-7. Blood. 2022;140(Supplement 1):638-640.

  • Chartier M, Filosto S, Peyret T, Chiney M, Milletti F, Budka J, Ndi A, Dong J, Vardhanabhuti S, Mao D, Duffull S, Dodds M, Shen R. Investigating the Influence of Covariates on Axicabtagene Ciloleucel (axi-cel) Kinetics in Patients with Non-Hodgkin's Lymphoma. Clin Pharmacokinet. 2024 Sep;63(9):1283-1299. doi: 10.1007/s40262-024-01413-z. Epub 2024 Sep 6.

    PubMed 39240498

  • Filosto S, Vardhanabhuti S, Canales MA, Poire X, Lekakis LJ, de Vos S, Portell CA, Wang Z, To C, Schupp M, Poddar S, Trinh T, Warren CM, Aguilar EG, Budka J, Cheng P, Chou J, Bot A, Shen RR, Westin JR. Product Attributes of CAR T-cell Therapy Differentially Associate with Efficacy and Toxicity in Second-line Large B-cell Lymphoma (ZUMA-7). Blood Cancer Discov. 2024 Jan 8;5(1):21-33. doi: 10.1158/2643-3230.BCD-23-0112.

    PubMed 37983485

  • Ghobadi A, Munoz J, Westin JR, Locke FL, Miklos DB, Rapoport AP, Perales MA, Reagan PM, McGuirk J, Jacobson CA, Kersten MJ, Avivi I, Peng A, Schupp M, To C, Oluwole OO. Outcomes of subsequent antilymphoma therapies after second-line axicabtagene ciloleucel or standard of care in ZUMA-7. Blood Adv. 2024 Jun 11;8(11):2982-2990. doi: 10.1182/bloodadvances.2023011532.

    PubMed 38315832

  • Locke FL, Chou J, Vardhanabhuti S, Perbost R, Dreger P, Hill BT, et al. Association of pretreatment (preTx) tumor characteristics and clinical outcomes following second-line (2L) axicabtagene ciloleucel (axi-cel) versus standard of care (SOC) in patients (pts) with relapsed/refractory (R/R) large B-cell lymphoma (LBCL). J Clin Oncol.2022;40(16_suppl):7565

  • Locke FL, Filosto S, Chou J, Vardhanabhuti S, Perbost R, Dreger P, Hill BT, Lee C, Zinzani PL, Kroger N, Lopez-Guillermo A, Greinix H, Zhang W, Tiwari G, Budka J, Marincola FM, To C, Mattie M, Schupp M, Cheng P, Bot A, Shen R, Bedognetti D, Miao H, Galon J. Impact of tumor microenvironment on efficacy of anti-CD19 CAR T cell therapy or chemotherapy and transplant in large B cell lymphoma. Nat Med. 2024 Feb;30(2):507-518. doi: 10.1038/s41591-023-02754-1. Epub 2024 Jan 17.

    PubMed 38233586

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Axicabtagene Ciloleucel, Platinum-containing Salvage Chemotherapy and Cyclophosphamide in people with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL), run by Kite, A Gilead Company at 72 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Canada, Germany, Spain, United Kingdom and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival (EFS) Per Blinded Central Assessment (time frame: From randomization date up to a median follow-up: 24.9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03391466, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in