Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

Inclusion Criteria

• •Histologically proven large B-cell lymphoma (BCL) including the following types defined by World Health Organization (WHO) 2016.
• •* Diffuse large B-cell lymphoma (DLBCL) not otherwise specified activated B-cell/ germinal center B-cell (ABC/GCB).
• •* High-grade B-cell lymphoma (HGBL) with or without myelocytomatosis oncogene (MYC) and BCL 2 and/or BCL 6 rearrangement.
• •* DLBCL arising from follicular lymphoma (FL).
• •* T-cell/histiocyte rich large B-cell lymphoma.
• •* DLBCL associated with chronic inflammation.
• •* Primary cutaneous DLBCL, leg type.
• •* Epstein-Barr virus (EBV) + DLBCL.
• •Relapsed or refractory disease after first-line chemoimmunotherapy.
• •* Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded.
• •* Progressive disease (PD) as best response to first-line therapy.
• •* Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP).
• •* Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 12 months of therapy.
• •* Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse ≤ 12 months of first-line therapy.
• •Individuals must have received adequate first-line therapy including at a minimum:
• •* Anti-Cluster of Differentiation 20 antigen (CD20) monoclonal antibody unless investigator determines that tumor is CD20 negative, and
• •* An anthracycline containing chemotherapy regimen.
• •No known history or suspicion of central nervous system involvement by lymphoma.
• •Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
• •Adequate bone marrow function as evidenced by:
• •* Absolute neutrophil count (ANC) ≥ 1000/μl
• •* Platelet ≥ 75,000/μl
• •* Absolute lymphocyte count ≥ 100/μl
• •Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:
• •* Creatinine clearance (Cockcroft Gault) ≥ 60 mL/min.
• •* Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN).
• •* Total bilirubin ≤ 1.5 mg/dl
• •* Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings.
• •* No clinically significant pleural effusion.
• •* Baseline oxygen saturation \> 92% on room air.