OVERVIEW
A Phase 2 Open-Label, Multicenter Study Evaluating The Safety And Efficacy of Axicabtagene Ciloleucel Concomitant With Prophylactic Steroids In Subjects With Relapsed Or Refractory Large B-Cell Lymphoma In The Outpatient Setting (ZUMA-24)
PROTOCOL SUMMARY
The goal of this clinical study is to learn more about the study drug, axicabtagene ciloleucel, in participants with relapsed or refractory large B-cell lymphoma (LBCL) in the outpatient setting.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Relapsed or Refractory Large B-cell Lymphoma
Gender
N/A
Date
August 2022 - November 2025
Study Type
Interventional
Study Phase
Phase 2
Product
Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Dexamethasone
Eligibility information
Inclusion criteria
- Histologically confirmed large B-cell lymphoma (LBCL), including the following types defined by World Health Organization (WHO) 2016 classification, by local pathology laboratory assessment, are eligible as defined below:
- 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
- History of autologous or allogeneic stem cell transplant.
- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (16)
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91010
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, United States, 45242
Prisma Health - Upstate
Greenville, South Carolina, United States, 29615
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States, 78229
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
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