LAST UPDATED
December 01, 2025
Clinicaltrials.gov ID
EudraCT ID
OVERVIEW
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) (ZUMA-7)
PROTOCOL 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).
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Gender
N/A
Date
January 2018 - March 2021
Study Type
Interventional
Study Phase
Phase 3
Product
Axicabtagene Ciloleucel, Platinum-containing Salvage Chemotherapy, Cyclophosphamide, Fludarabine
Eligibility information
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.
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
Locations
Locations (72)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
University of Iowa Hospitals and Clinincs
Iowa City, Iowa, United States, 52242
The University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
University of Maryland, Greenbaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Mayo Clinic, Patient Location
Rochester, Minnesota, United States, 55905
Washington University School of Medicine
St Louis, Missouri, United States, 63130
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
University of Rochester Medical Center
Rochester, New York, United States, 14642
James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Universitatsklinikum Graz, Division of Hematology
Graz, Austria, 6020
Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie
Innsbruck, Austria, 6020
Uninversity Health Network - Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont
Montreal, Canada, H1T 2M4
CHU de Quebec-Universite Laval, Hopital de L'Enfante-Jesus
Québec, Canada, G1J 1Z4
Centre Hospitalier Lyon-Sud - Service d'Hematologie clinique
Pierre-Bénite, France, 69495
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, France, 35033
Instituto di Ematologia "L. e A. Seragnoli" - Dipartimento di Medicina Specialistica Diagnostica e Sperimentale
Bologna, Italy, 40138
IOSI, OSpedale Regionale Bellinzona e Valli
Bellinzona, Switzerland, 6500
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2GW
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW3 2QG
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
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