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Clinical Trials in the UK / NCT05605899
Active, not recruiting Phase 3

Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma

NCT05605899 · tracked via the Priya Life Science UK tracker
Sponsor
Kite, A Gilead Company
Phase
Phase 3
Started
2023-02-10
Last updated
2026-04-15

Condition(s) studied

High-risk Large B-cell Lymphoma (LBCL)

Investigational drug(s) / intervention(s)

Axicabtagene CiloleucelCyclophosphamideFludarabineEtoposideRituximabDoxorubicinVincristinePrednisone

Axicabtagene Ciloleucel: A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

Cyclophosphamide: Administered intravenously

Fludarabine: Administered intravenously

Etoposide: Administered intravenously

Rituximab: Administered intravenously

Doxorubicin: Administered intravenously

Vincristine: Administered intravenously

Prednisone: Administered orally

Study summary

The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * Histologically confirmed large B cell lymphoma (LBCL) based on 2016 World Health Organization (WHO) classification by local pathology lab assessment, including of the following: * Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) * High-grade B-cell lymphoma (HGBL) * Note: Transformed DLBCL from follicular lymphoma or from marginal zone lymphoma is eligible if no prior treatment with anthracycline-containing regimen. * High-risk disease defined as an International Prognostic Index (IPI) score of 4 or 5 at initial diagnosis. * Have received only 1 cycle of rituximab plus chemotherapy (R-chemotherapy). * Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function. * Females of childbearing potential must have a negative serum or urine pregnancy test. Key Exclusion Criteria: * The following WHO 2016 subcategories by local assessment: * T-cell/histiocyte-rich LBCL * Primary DLBCL of the central nervous system (CNS) * Primary mediastinal (thymic) LBCL * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma * Burkitt lymphoma * History of Richter's transformation of chronic lymphocytic leukemia * Presence of detectable cerebrospinal fluid (CSF)-malignant cells, brain metastases, or a history of CNS involvement of lymphoma. * Presence of cardiac lymphoma involvement. * Any prior treatment for LBCL other than the 1 cycle of R-chemotherapy. * History of severe immediate hypersensitivity reaction to any of the agents used in this study. * Presence of CNS disorder. History of stroke, transient ischemic attack, or posterior reversible encephalopathy syndrome (PRES) within 12 months prior to enrollment. * History of acute or chronic active hepatitis B or C infection. * Positive for human immunodeficiency virus (HIV) unless taking appropriate anti-HIV medications, with an undetectable viral load by PCR and with a cluster of differentiation 4 (CD4) count \> 200 cells/uL. * Medical conditions or residual toxicities from prior therapies likely to interfere with assessment of safety or efficacy of study treatment. Please refer to protocol for further details. * History of clinically significant cardiac disease within 12 months before enrollment. * History of any medical condition requiring maintenance systemic immunosuppression/systemic disease modifying agents within the last 2 years. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (85)

FacilityCityRegionStatus
University of Alabama Hospital Birmingham Alabama
Banner MD Anderson Cancer Center Gilbert Arizona
Mayo Clinic Phoenix Arizona
UC San Diego Moores Cancer Center La Jolla California
University of California Los Angeles (UCLA) Los Angeles California
Colorado Blood Cancer Institute Denver Colorado
Moffitt Cancer Center Tampa Florida
Georgia Cancer Center at Augusta University Augusta Georgia
Northwestern Memorial Hospital Chicago Illinois
University of Chicago Medical Center Chicago Illinois
University of Iowa Iowa City Iowa
The University of Kansas Hospital Westwood Kansas
Norton Cancer Institute, St. Matthews Campus Shelbyville Kentucky
Ochsner Clinic Foundation New Orleans Louisiana
University of MD Greenebaum Comprehensive Cancer Center Baltimore Maryland
Dana-Farber Cancer Institute Boston Massachusetts
University of Michigan Ann Arbor Michigan
Mayo Clinic Cancer Center Outpatient Pharmacy Rochester Minnesota
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey
Roswell Park Cancer Institute Buffalo New York
Weill Cornell Medical College - NewYork Presbyterian Hospital New York New York
Columbia University Medical Center New York New York
University of Rochester Medical Center Rochester New York
Montefiore Medical Center The Bronx New York
Novant Health Cancer Institute- Hematology Charlotte North Carolina
Prisma Health Cancer Institute Greenville South Carolina
Tennessee Oncology, PLLC Nashville Tennessee
Henry-Joyce Cancer Center Nashville Tennessee
University of Texas Southwestern Medical Center Dallas Texas
The University of Texas, MD Anderson Cancer Center Houston Texas
Intermountain LDS Hospital/Blood and Marrow Transplant/ Acute Leukemia Program Salt Lake City Utah
Virginia Commonwealth University Richmond Virginia
Royal Prince Alfred Hospital Camperdown New South Wales
Royal Brisbane and Women's Hospital South Brisbane Queensland
Peter MacCallum Cancer Center Melbourne Victoria
Medizinische Universität Innsbruck Innsbruck Austria
Zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU Salzburg Austria
Universitätsklinikum St. Pölten Sankt Pölten Austria
Medizinische Universität Wien (AKH Wien, Medical University Vienna and General Hospital Vienna) Vienna Austria
Jewish General Hospital Montreal Canada

+ 45 more sites — see the full list on the official registry below.

On this site

📄 Yescarta (axicabtagene ciloleucel) drug profile → 📄 Rituxan (rituximab) drug profile → 📄 Deltasone (prednisone) drug profile →

More Kite, A Gilead Company trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05605899 on ClinicalTrials.gov ↗ ← All trials in the UK