Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation

Exclusion Criteria

• •Patients who received more than one prior line of systemic therapy
• •Prior CD19 targeted therapy
• •Patients with cardiac atrial or cardiac ventricular lymphoma involvement
• •Requirement for urgent therapy due to tumor mass effects, such as bowel obstruction or blood vessel compression
• •Patient with clinically significant pleural effusion
• •History of another primary malignancy that has not been in remission for at least 2 years (except for nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast))
• •Patients with detectable Central Nervous System (CNS) lymphoma
• •History or presence of non-malignant CNS disorder, such as seizure disorder requiring anti-convulsive therapy, cerebellar disease, or any autoimmune disease with CNS involvement disease
• •Active hepatitis B or hepatitis C infection, positive serology of human immunodeficiency virus (HIV) and syphilis at the time of screening
• •Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or axi-cel administration
• •History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
• •History of autoimmune disease requiring systemic immunosuppression and/or systemic disease modifying agents within the last year
• •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computed tomography (CT) scan at screening.
• •History of severe immediate hypersensitivity reaction to tocilizumab or any of the agents used in this study
• •History of severe immediate hypersensitivity reaction attributed to aminoglycosides, cyclophosphamide and fludarabine
• •Treatment with a live, attenuated vaccine within 6 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the course of the study
• •Women of childbearing potential who are pregnant or breastfeeding (from the time of consent during treatment and for at least 6 months after conditioning chemotherapy dosing or axicabtagene ciloleucel dosing, whichever is later)
• •In the investigator's judgment, the patient is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
• •Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness