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Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma

The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in participants with high-risk large B-cell lymphoma.
Not Available
Phase II
Adults
Not Available
Not Available
Oluwole, Olalekan
International
Vanderbilt University
05-08-2019
Treatment
VICCBMT18146
NCT03761056

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Histologically confirmed large B-cell lymphoma

High-grade large B-cell lymphoma

Individuals must have a positive interim positron emission tomography (PET) per Cheson, 2014 (Deauville PET score of 4 or 5) after 2 cycles (PET2+) of chemoimmunotherapy

No evidence, suspicion and/or history of CNS involvement of lymphoma

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Absolute neutrophil count ? 1000/?L

Platelet count ? 75,000/?L

Absolute lymphocyte count ? 100/?L

Adequate renal, hepatic, pulmonary, and cardiac function defined as:

Creatinine clearance (as estimated by Cockcroft Gault) ? 60 mL/min

Serum alanine aminotransferase (ALT/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 ECHO, and no clinically significant ECG findings

No clinically significant pleural effusion

Baseline oxygen saturation > 92% on room air



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 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

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