ZUMA-7: This phase III trial is comparing the effectiveness of a biological therapy (Axicabtagene Ciloleucel) and standard of care chemotherapy in Diffuse Large B-Cell Lymphoma patients who have got worse or not responded to prior treatmentA Phase 3, Randomized, Open-Label Study Evaluating Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma

Inclusion

• 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