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.
Description
Five years after randomization, 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.
Eligibility
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.