This clinical trial is for men and women who have high-risk large B-cell lymphoma (LBCL) and standard therapies available to treat their disease have limited effectiveness.
   
The purpose of this study is to find out if an experimental product called axicabtagene ciloleucel (axi-cel) is safe and effective in treating lymphoma, compared to standard of care (SOC) therapy (chemotherapy), 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).

“Experimental” means that axicabtagene ciloleucel (axi-cel) is not approved by the U.S. Food and Drug Administration (FDA). The standard of care chemotherapy regimens are approved by the FDA.   

The treatment a participant receives in this study will be randomly assigned (like tossing a coin). Participants have a 50% chance of receiving axi-cel and a 50% chance of receiving standard of care (SOC) therapy.
   
Axi-cel is manufactured using a participant’s own blood cells. Those assigned to the experimental treatment group will undergo a procedure called leukapheresis. This is a procedure where blood is taken from the participant and passed through a machine that separates out the white blood cells, including T cells (T cells are a type of white blood cell that helps to fight infection and cancer), and returns the remainder of the blood back into the participant’s circulation. The T cells that are collected will then be sent to a manufacturing facility to be genetically modified in order to make the experimental treatment axi-cel. The modified T cells (axi-cel) are then sent back to the study doctor. In preparation for receiving the genetically modified T cells (axi-cel), participants will receive lymphodepletion chemotherapy, have a few rest days, and then receive axi-cel through an intravenous (IV) infusion. The hope is that these genetically modified T cells can then target and kill tumor cells.
   
Participants in the standard of care (SOC) treatment group will receive either R-CHOP or DA-EPOCH-R for a total of 6 cycles of treatment (including 1 cycle of treatment received prior to study enrollment). Participants in this group may also receive 2 additional cycles of rituximab as a single agent if suggested by the study doctor.
   
The duration of the study in both treatment arms will vary depending on the screening requirements and response to treatment. Participants in both treatment arms will be followed for approximately 5 years after randomization. If participants are randomized into the experimental treatment arm, after the month 60 visit, they will transition to a separate Kite Long-term Follow-up (LTFU) study, KT-US-982-5968, in which they will be followed for up to approximately 10 more years. If participants are randomized into the SOC arm, they will not transition to the LTFU study. Visits will occur more frequently in the beginning of the study, but then become less frequent as years go on.