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

• Status: Active, not recruiting
• Trial end date: 2035-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kite, A Gilead Company
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

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 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/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 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

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