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Efficacy of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Subjects With Relapsed / Refractory Diffuse Large B Cell Lymphoma

The purpose of this study is to evaluate whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed / refractory diffuse large B-cell lymphoma (DLBCL).
Phase III
Chemotherapy - cytotoxic, Mol. targeted/Immunotherapy/Biologics
Axicabtagene Ciloleucel, Carboplatin, Cisplatin, Cyclophosphamide (CPM), Cytarabine (ARA-C), Dexamethasone, Etoposide, Fludarabine (Fludara), Gemcitabine, High Dose Cytarabine (HD ARAC), Ifosfamide, Methylprednisolone, Rituximab (Rituxan)
Oluwole, Olalekan
Vanderbilt University


18 Years
Inclusion Criteria:

Histologically proven large B-cell lymphoma including the following types defined by WHO 2016 (Swerdlow et al, 2016)

DLBCL not otherwise specified (ABC/GCB)

HGBL with or without MYC and BCL2 and/or BCL6 rearrangement

DLBCL arising from FL

T-cell/histiocyte rich large B-cell lymphoma

DLBCL associated with chronic inflammation

Primary cutaneous DLBCL, leg type

Epstein-Barr virus (EBV) + DLBCL

Relapsed or refractory disease after first-line chemoimmunotherapy

Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded.

Progressive disease (PD) as best response to first-line therapy

Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP)

Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ? 12 months of therapy

Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse ? 12 months of first-line therapy

Individuals must have received adequate first-line therapy including at a minimum:

Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and

An anthracycline containing chemotherapy regimen

No known history or suspicion of central nervous system involvement by lymphoma

Eastern cooperative oncology group (ECOG) performance status of 0 or 1

Adequate bone marrow function as evidenced by:

Absolute neutrophil count (ANC) ? 1000/uL

Platelet ? 75,000/uL

Absolute lymphocyte count ? 100/uL

Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:

Creatinine clearance (Cockcroft Gault) ? 60 mL/min

Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ? 2.5 Upper limit of normal (ULN)

Total bilirubin ? 1.5 mg/dl

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

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

Received more than one line of therapy for DLBCL

History of autologous or allogeneic stem cell transplant

Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.

Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.

Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.

History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement

Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.

History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment

History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment

History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years

History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7

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