study to evaluate the efficacy and safety of axicabtagene ciloleucel as first-line therapy in participants with high-risk large b-cell lymphoma

Conditions: B-cell Lymphoma

Summary: the primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in participants with high-risk large b-cell lymphoma. after the end of kte-c19-112 (zuma-12), participants who received an infusion of axicabtagene ciloleucel will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, kt-us-982-5968.


Eligibility criteria:
key inclusion criteria: * histologically confirmed large b-cell lymphoma * high-grade large b-cell lymphoma * individuals must have a positive interim positron emission tomography (pet) (deauville pet score of 4 or 5) after 2 cycles (pet2+) of chemoimmunotherapy * no evidence, suspicion and/or history of central nervous system (cns) involvement of lymphoma * eastern cooperative oncology group (ecog) performance status of 0 or 1 * absolute neutrophil count ≥ 1000/μl * platelet count ≥ 75,000/μl * absolute lymphocyte count ≥ 100/μl * adequate renal, hepatic, pulmonary, and cardiac function defined as: * creatinine clearance (as estimated by cockcroft gault) ≥ 60 ml/min * serum alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 2.5 upper limit of normal (uln) * total bilirubin ≤1.5 mg/dl, except in individuals with gilbert's syndrome * 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 key exclusion criteria: * history of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years * history of richter's transformation of chronic lymphocytic leukemia or primary mediastinal b-cell lymphoma * history of autologous or allogeneic stem cell transplant * prior cd19-targeted therapy * prior chimeric antigen receptor therapy or other genetically modified t-cell therapy * presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring iv antimicrobials for management * history of human immunodeficiency virus (hiv) infection or acute or chronic active hepatitis b or c infection * presence of any indwelling line or drain dedicated central venous access catheters, such as a port-a-cath or hickman catheter, are permitted * individuals with detectable cerebrospinal fluid malignant cells, brain metastases, or active cns lymphoma * history or presence of cns disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with cns involvement * history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment * history of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years * history of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment note: other protocol defined inclusion/exclusion criteria may apply.