Study Details

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)

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Relapsed or Refractory Large B-cell Lymphoma

Gender

N/A

Date

August 2022 - September 2024

Study Type

INTERVENTIONAL

Study Phase

PHASE2

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

UCLA

Los Angeles, California, United States, 90025

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

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States, 37232

Methodist Healthcare System of San Antonio

San Antonio, Texas, United States, 78229

Intermountain Healthcare

Murray, Utah, United States, 84107

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States, 84112

University of Virginia Health System

Charlottesville, Virginia, United States, 22908

Virginia Oncology Associates

Norfolk, Virginia, United States, 23502

Virginia Commonwealth University

Richmond, Virginia, United States, 23219

Study of Axicabtagene Ciloleucel Given With Steroids In Participants With Relapsed Or Refractory Large B-Cell Lymphoma (ZUMA-24)