Study Comparing Axicabtagene Ciloleucel to Standard Treatment for Relapsed or Hard-to-Treat Follicular Lymphoma

Inclusion Criteria

• Diagnosed with follicular lymphoma (FL) of Grade 1, 2, or 3a.
• The lymphoma has returned or not responded after initial treatment and is considered high-risk if it relapsed or progressed within 24 months of the first treatment, or has not responded after at least two previous treatments.
• There is a need for treatment based on medical evaluation.
• At least one tumor that can be measured using standard medical criteria.
• Sufficient kidney, liver, lung, and heart function.

Exclusion Criteria

• Presence of large B cell lymphoma or transformed follicular lymphoma.
• Diagnosed with small lymphocytic lymphoma or lymphoplasmacytic lymphoma.
• Lymphoma affecting the full thickness of the stomach wall.
• Follicular lymphoma of Grade 3b.
• Previous treatment targeting CD19 or with CAR-T or other genetically modified T-cell therapies.
• Uncontrolled infections, including fungal, bacterial, or viral.
• Active infection with HIV, hepatitis B, or hepatitis C.
• History or current significant central nervous system disorders.
• History of autoimmune diseases.
• Known involvement of the central nervous system or heart by lymphoma.
• Significant heart disease within six months before joining the study.
• Severe nerve damage (neuropathy) greater than grade 2.
• Women who are pregnant or breastfeeding.
• Individuals not willing to use birth control.
• Presence of any indwelling medical lines or drains, except for specific types of central venous access catheters.