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)
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
Purpose:Location: Cancer Center
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.
Study Web URL: https://clinicaltrials.gov/ct2/show/NCT03391466?term=kte-c19-107&rank=1
Study Reference #: IBMT17130
Lead Researcher (Principal Investigator)
Lead Researcher: Patrick Reagan
Study Contact InformationStudy Coordinator: Andrew Bui
Phone: (585) 276-4405
Additional Study Details
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