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

Description

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.

Conditions

High-risk Large B-cell Lymphoma (LBCL)

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
High-risk Large B-cell Lymphoma (LBCL)
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Hospital, Birmingham, Alabama, United States, 35233

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Phoenix

Mayo Clinic, Phoenix, Arizona, United States, 85054

La Jolla

UC San Diego Moores Cancer Center, La Jolla, California, United States, 92093

Los Angeles

University of California Los Angeles (UCLA), Los Angeles, California, United States, 90095

Palo Alto

Stanford Cancer Institute, Palo Alto, California, United States, 94305

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Augusta

Georgia Cancer Center at Augusta University, Augusta, Georgia, United States, 30912

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kite, A Gilead Company,

Kite Study Director, STUDY_DIRECTOR, Kite, A Gilead Company

Study Record Dates

2031-03