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

Launched by KITE, A GILEAD COMPANY · Oct 31, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called axicabtagene ciloleucel for patients with high-risk large B-cell lymphoma (LBCL), a type of cancer that affects the lymphatic system. The goal is to see if this new treatment works better than the standard care currently used for these patients, particularly those who have just started treatment and have a high chance of complications. The study is open to individuals aged 65 and older who have been diagnosed with certain types of LBCL and have only received one round of a specific chemotherapy combined with a drug called rituximab.

Participants in the trial will receive either the new treatment or the standard care and will be closely monitored for their health and how well the treatment is working. To be eligible, individuals should not have had any prior treatments for LBCL, should meet certain health criteria, and must not have specific types of lymphoma or other medical conditions that could complicate treatment. This study is currently recruiting participants, and it represents an important step in exploring potentially more effective options for treating high-risk LBCL.

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Eligibility criteria

• 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.