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

Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:January 29, 2019
End Date:January 2035
Contact:Medical Information

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A Phase 2 Multicenter Study Evaluating the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Subjects With High-Risk Large B-Cell Lymphoma (ZUMA-12)

The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in
participants with high-risk large B-cell lymphoma.

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) per
Cheson, 2014 (Deauville PET score of 4 or 5) after 2 cycles (PET2+) of

- 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/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/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

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 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

- 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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