RECRUITING

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

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Conditions

High-risk Large B-cell Lymphoma (LBCL)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2023-02-10
Study Completion:2031-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05605899

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically confirmed large B cell lymphoma (LBCL) based on 2016 World Health Organization (WHO) classification by local pathology lab assessment, including of the following:
  2. * Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)
  3. * High-grade B-cell lymphoma (HGBL)
  4. * Note: Transformed DLBCL from follicular lymphoma or from marginal zone lymphoma is eligible if no prior treatment with anthracycline-containing regimen.
  5. * High-risk disease defined as an International Prognostic Index (IPI) score of 4 or 5 at initial diagnosis.
  6. * Have received only 1 cycle of rituximab plus chemotherapy (R-chemotherapy).
  7. * Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.
  8. * Females of childbearing potential must have a negative serum or urine pregnancy test.
  1. * The following WHO 2016 subcategories by local assessment:
  2. * T-cell/histiocyte-rich LBCL
  3. * Primary DLBCL of the central nervous system (CNS)
  4. * Primary mediastinal (thymic) LBCL
  5. * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma
  6. * Burkitt lymphoma
  7. * History of Richter's transformation of chronic lymphocytic leukemia
  8. * Presence of detectable cerebrospinal fluid (CSF)-malignant cells, brain metastases, or a history of CNS involvement of lymphoma.
  9. * Presence of cardiac lymphoma involvement.
  10. * Any prior treatment for LBCL other than the 1 cycle of R-chemotherapy.
  11. * History of severe immediate hypersensitivity reaction to any of the agents used in this study.
  12. * Presence of CNS disorder. History of stroke, transient ischemic attack, or posterior reversible encephalopathy syndrome (PRES) within 12 months prior to enrollment.
  13. * History of acute or chronic active hepatitis B or C infection.
  14. * 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.
  15. * 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.
  16. * History of clinically significant cardiac disease within 12 months before enrollment.
  17. * History of any medical condition requiring maintenance systemic immunosuppression/systemic disease modifying agents within the last 2 years.

Contacts and Locations

Study Contact

Medical Information
CONTACT
844-454-5483(1-844-454-KITE)
medinfo@kitepharma.com

Principal Investigator

Kite Study Director
STUDY_DIRECTOR
Kite, A Gilead Company

Study Locations (Sites)

University of Alabama Hospital
Birmingham, Alabama, 35233
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
United States
Mayo Clinic
Phoenix, Arizona, 85054
United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
United States
Stanford Cancer Institute
Palo Alto, California, 94305
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60612
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
University of Iowa
Iowa City, Iowa, 52242
United States
The University of Kansas Hospital
Westwood, Kansas, 66205
United States
Norton Cancer Institute, St. Matthews Campus
Shelbyville, Kentucky, 40065
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
University of MD Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Mayo Clinic Cancer Center Outpatient Pharmacy
Rochester, Minnesota, 55902
United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Roswell Park Cancer Institute
Buffalo, New York, 14203
United States
Weill Cornell Medical College - NewYork Presbyterian Hospital
New York, New York, 10021
United States
Columbia University Medical Center
New York, New York, 10032
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Novant Health Cancer Institute- Hematology
Charlotte, North Carolina, 28204
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Prisma Health Cancer Institute
Greenville, South Carolina, 29615
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
United States
Henry-Joyce Cancer Center
Nashville, Tennessee, 37232
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
United States
Intermountain LDS Hospital/Blood and Marrow Transplant/ Acute Leukemia Program
Salt Lake City, Utah, 84143
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Kite, A Gilead Company

  • Kite Study Director, STUDY_DIRECTOR, Kite, A Gilead Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-10
Study Completion Date2031-03

Study Record Updates

Study Start Date2023-02-10
Study Completion Date2031-03

Terms related to this study

Additional Relevant MeSH Terms

  • High-risk Large B-cell Lymphoma (LBCL)