Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel Versus Standard of Care Therapy as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-23)

Details

Five years after the last study participant is randomized, participants who have received axicabtagene ciloleucel will transition to a separate long-term follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Keywords

High-risk Large B-cell Lymphoma (LBCL), Lymphoma, B-Cell Lymphoma, Prednisone, Cyclophosphamide, Rituximab, Doxorubicin, Fludarabine, Etoposide, Vincristine, Axicabtagene ciloleucel

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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
  • 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 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.

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • University of California Los Angeles (UCLA) accepting new patients
    Los Angeles California 90025 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kite, A Gilead Company
Links
Gilead Clinical Trials Website
ID
NCT05605899
Phase
Phase 3 Lymphoma Research Study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated