Non Hodgkin Lymphoma Clinical Trial
Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
The goal of this study is to find out if the experimental product, axi-cel, is safe and effective in treating your lymphoma, compared to standard of care (SOC) therapy), which includes either R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone) or DA-EPOCH-R (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab).
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.
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:
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
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 10 Locations for this study
Palo Alto California, 94305, United States
Denver Colorado, 80218, United States
Boston Massachusetts, 02215, United States
New York New York, 10032, United States
Sioux Falls South Dakota, 57105, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Camperdown New South Wales, 2050, Australia
Melbourne Victoria, 3000, Australia
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.