A Phase 3 Randomized, Open-Label, Multicenter StudyEvaluating the Efficacy of Axicabtagene Ciloleucel VersusStandard of Care Therapy in Subjects withRelapsed/Refractory Follicular Lymphoma
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You are being invited to take part in a research study that includes studying an experimental treatment named axicabtagene ciloleucel, referred to as “axi-cel”. The experimental treatment would involve removing some of your immune cells, genetically engineering those cells to identify cancer, receiving additional therapy while you wait for those cells to be released, and then infusing those cells back and assessing the effect on your cancer cells. The purpose of this main study is to determine if the experimental treatment, axi-cel, is safe and effective in treating your relapsed or refractory follicular lymphoma, compared to standard of care therapy. What treatment you receive will be randomly assigned (like tossing a coin), and you will have a 50% chance to receive axi- cel. You and your Study Doctor will know if you are receiving axi-cel or standard of care therapy. If you are randomized into the experimental treatment group, you will have one course of axi-cel treatment. Standard of care therapy may include Rituximab/Bendamustine (BR), Rituximab/Cyclophosphamide/Doxorubicin/Vincristine/Prednisone (R-CHOP) or Rituximab/Lenalidomide (R2) as selected by your Study Doctor.
Are you Eligible? (Inclusion Criteria)
- Age 18 years or older
- Diagnosed with Relapsed/Refractory Follicular Lymphoma
- Clinical indication for treatment
- No known history or suspicion of central nervous system (CNS) lymphoma involvement