Study on Radiation Therapy Before CD19 CAR-T Cell Treatment for High-Risk Large B-Cell Lymphoma

Inclusion Criteria

• Diagnosed with diffuse large B-cell lymphoma (DLBCL) and planning to receive treatment at Moffitt Cancer Center.
• Able to understand and willing to sign a consent form to participate in the study.
• Eligible for CAR T-cell therapy (axicabtagene ciloleucel) for LBCL and related types as per standard care guidelines.
• Have a performance status score of 0 to 2, indicating good overall health.
• Have at least one large tumor (5 cm or bigger) that can be targeted with radiation.
• Able to receive radiation therapy to all visible cancer sites.
• No signs of cancer in the central nervous system.
• Have adequate bone marrow and organ function as per study guidelines.
• Agree to use effective birth control methods during the study to prevent pregnancy.
• Men must take precautions to avoid fathering a child during the study.
• Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective birth control.
• Women who are not of childbearing potential (surgically sterile or postmenopausal for 12 months) are eligible.

Exclusion Criteria

• Currently receiving or have recently received another investigational treatment within 4 weeks before the study.
• Have had previous CAR T-cell therapy.
• Unable to safely receive radiation therapy to all cancer sites.
• Have significant heart disease or unstable heart conditions.
• Have uncontrolled or untreated infections.
• Known HIV positive status.
• Active or chronic hepatitis B infection unless viral load is undetectable with treatment.
• History of hepatitis C infection unless cleared with treatment.
• Require ongoing use of steroids or immunosuppressant medications.
• Any condition that may interfere with participation or pose a risk to the patient.
• Unlikely to complete all study visits or procedures.
• Women who are pregnant or breastfeeding. Women who are surgically sterile or postmenopausal for 12 months are not considered of childbearing potential.