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COMPLETEDPHASE2

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

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

NCT05459571•Kite, A Gilead Company

View on ClinicalTrials.gov

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.

Detailed Description

Participants who complete at minimum 24 months follow up will be transitioned to a separate long-term follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+4 more criteria

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.

Locations (16)

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

Key Dates

Start Date

August 9, 2022

Primary Completion Date

November 24, 2025

Completion Date

November 24, 2025

Last Updated

February 2, 2026

Enrollment

ACTUAL participants

Conditions

Relapsed or Refractory Large B-cell Lymphoma

Interventions

Axicabtagene Ciloleucel

BIOLOGICAL

Cyclophosphamide

DRUG

Fludarabine

DRUG

Dexamethasone

DRUG

Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy

NCT07479797

Relapsed or Refractory Large B-cell Lymphoma (r/r LBCL)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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