Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kite, A Gilead Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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:
* 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
You may not be if
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
Clareo Health | Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma
