Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma
NCT ID: NCT05459571
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2022-08-09
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Axicabtagene Ciloleucel
Participant will receive lymphodepleting chemotherapy (cyclophosphamide 500 mg/m\^2/day and fludarabine 30 mg/m\^2/day) over 3 days (Days -5, -4, and -3) followed by prophylactic corticosteroid treatment with 10 mg dexamethasone on Day 0 (prior to axicabtagene ciloleucel), Day 1, and Day 2.
Participant will receive axicabtagene ciloleucel consisting of a single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells on Day 0 (following dexamethasone 10 mg) at a target dose of 2 x 10\^6 cells/kg.
Axicabtagene Ciloleucel
Administered intravenously
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Dexamethasone
Administered orally or intravenously
Interventions
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Axicabtagene Ciloleucel
Administered intravenously
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Dexamethasone
Administered orally or intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diffuse large B-cell lymphoma (DLBCL) not otherwise specified.
* High-grade B-cell lymphoma (HGBL) with or without MYC and BCL2 and/or BCL6 rearrangement.
* DLBCL associated with chronic inflammation; Epstein-Barr virus (EBV) + DLBCL.
* Primary mediastinal (thymic) LBCL.
* Primary cutaneous DLBCL, leg type.
* Transformation of follicular lymphoma to DLBCL will also be included.
* Relapsed or refractory disease after 1 or more lines of therapy.
* Individuals must have received adequate prior therapy including:
* Anti-CD20 monoclonal antibody AND
* An anthracycline-containing chemotherapy regimen.
* At least 1 measurable lesion according to the Lugano Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Individual agrees to outpatient treatment setting and to adhere to the prespecified clinical monitoring requirements.
Exclusion Criteria
* Prior cluster of differentiation (CD)19 targeted therapy.
* Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.
* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor.
* Individuals with detectable cerebrospinal fluid malignant cells, brain metastases, or with a history of central nervous system (CNS) lymphoma or primary CNS lymphoma. DLBCL epidural involvement should be considered as positive CNS disease.
* In the investigator's judgment, the individual is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
18 Years
ALL
No
Sponsors
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Kite, A Gilead Company
INDUSTRY
Responsible Party
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Principal Investigators
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Kite Study Director
Role: STUDY_DIRECTOR
Kite, A Gilead Company
Locations
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City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
UCLA
Los Angeles, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States
Prisma Health - Upstate
Greenville, South Carolina, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States
Intermountain Healthcare
Murray, Utah, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Leslie LA, Baird JH, Flinn IW, Tees M, Hoda D, Deol A, Young P, McClune B, Varadarajan I, Essell J, Fanning S, Simmons G, Clark W, Rapoport AP, Rodriguez TE, Winters JN, Davis M, Miao HM, Ray M, Fang X, Kim JJ, Oluwole OO. Outpatient axicabtagene ciloleucel for relapsed/refractory large B-cell lymphoma: ZUMA-24 primary analysis. Am J Cancer Res. 2025 Aug 15;15(8):3417-3433. doi: 10.62347/GJNN1023. eCollection 2025.
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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KT-US-482-0137
Identifier Type: -
Identifier Source: org_study_id
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