LAST UPDATED
December 23, 2025
Clinicaltrials.gov ID
EudraCT ID
CTSID
OVERVIEW
A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL) (ZUMA-5)
PROTOCOL SUMMARY
The goal of this study is to assess whether axicabtagene ciloleucel improves the clinical outcome in participants with relapsed or refractory indolent non-Hodgkin lymphoma (r/r) iNHL.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Follicular Lymphoma, Marginal Zone Lymphoma, Indolent Non-Hodgkin Lymphoma
Gender
N/A
Date
June 2017 - December 2024
Study Type
Interventional
Study Phase
Phase 2
Product
Axicabtagene ciloleucel, Cyclophosphamide, Fludarabine
Eligibility information
Inclusion criteria
- Individual has follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has progressed after at least 2 lines of treatment with combination chemoimmunotherapy) (e.g. R-bendamustine, R-CHOP).
- Individual has (measurable disease).
- Individual has no known presence or history of central nervous system (CNS) involvement by lymphoma.
- If individual is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, individual is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis.
- Individual has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function
- Individual is not pregnant or breastfeeding (female individuals only) and is willing to use birth control from the time of consent through 12 months following chimeric antigen receptor (CAR) T cell infusion (both male and female individuals).
Exclusion criteria
- Transformed FL or MZL
- Small lymphocytic lymphoma
- Histological Grade 3b FL
- Individual will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.
- Individual has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect, tumor lysis syndrome, etc.)
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (19)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
University of California Los Angeles
Los Angeles, California, United States, 90095
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester Medical Center (URMC)
Rochester, New York, United States, 14642
Ohio State University Medical Center
Cleveland, Ohio, United States, 44106
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Centre Hospitalier Régional Universitaire de Lille
Lille, France, 59037
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