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Lymphoma (Diffuse Large B Cell): A Study Evaluating the Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL) (ZUMA-7)

Research Question:
Is the experimental treatment, axi-cel, safety and effective in treating your lymphoma, compared to standard of care therapy, which includes platinum-based combination therapy with rituximab, followed by high dose therapy and autologus stem cell transplant (ASCT)?

Basic Study Information

If you decide to participate in this study, you will be randomized or assigned to one of two study groups based on your previous response to therapy and the International Prognostic Index score, a tool used to predict the likely course of your disease. The Experimental Treatment Group will undergo collection of white blood cells by a process called leukapheresis in order to manufacture your T cells into axi-cel, three days of conditioning chemotherapy, and a single infusion of axi-cel. If your Study Doctor believes the current status of your disease is rapidly progressing, you may receive steroid therapy while axi-cel is being manufactured. The Standard of Care (SOC) Treatment Group will receive standard of care therapies including two or three cycles of second-line platinum-based combination chemotherapy regimens with rituximab; R-ICE (Rituximab, Ifosfamide, Carboplatin, Etoposide), R-DHAP (Rituximab, Dexamethasone, High-dose Cytarabine, Platinum) R-ESHAP (Rituximab, Etoposide, Methylprednisolone, Cytarabine, Cisplatin) or R-GDP (Rituximab, Gemcitabine, Dexamethasone, Platinum), as selected by your Study Doctor. If your cancer responds to the chemotherapy treatment, you will also receive high dose therapy and ASCT per your Study Doctor.

Location: Cancer Center
Study Web URL:
Study Reference #: IBMT17130

Lead Researcher (Principal Investigator)

Lead Researcher:  Patrick Reagan

Study Contact Information

Study Coordinator: Andrew Bui
Phone: (585) 276-4405

Additional Study Details

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