Relapsed/refractory follicular lymphoma
Conditions
Interventions
Subjects in the axicabtagene ciloleucel treatment arm will receive a single infusion of axicabtagene ciloleucel.
Subjects in the SOCT arm will receive the investigators choice of either rituximab plus
Sponsors
Mari Ikuta
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a) 2. Relapsed/refractory disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after > =2 prior systemic lines of therapy 3. Clinical indication for treatment. 4. At least 1 measurable lesion per the Lugano Classification {Cheson 2014} 5. Adequate renal, hepatic, pulmonary, and cardiac function
Exclusion criteria
Exclusion criteria: - Presence of large B cell lymphoma or transformed FL - Small lymphocytic lymphoma - Lymphoplasmacytic lymphoma - Full-thickness involvement of the gastric wall by lymphoma - FL Grade 3b - Prior CD19-targeted therapy - Prior CAR therapy or other genetically modified T-cell therapy - Uncontrolled fungal, bacterial, viral, or other infection - Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus - History or presence of a clincially significant central nervous system (CNS) disorder. - History of autoimmune disease - Known history or CNS lymphoma involvement - Cardiac lymphoma involvement - History of clinically significant cardiac disease 6 months before randomization - Neuropathy Grade 1 or 2 - Females who are pregnant or breastfeeding - Individuals of both genders who are not willing to practice birth control - Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardial catheter, or Ommaya reservoirs). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall survival (OS) - Complete response (CR) rate per Lugano Classification {Cheson 2014} as determined per a blinded central assessment - Objective response rate (CR + partial response per Lugano Classification {Cheson 2014}) as determined per a blinded central assessment - Duration of response - Duration of CR - Event free survival - Time to next treatment - Incidence of adverse events (AEs) and clinically significant changes in safety laboratory values - Incidence of replication competent retrovirus (RCR) detection in blood over time - Change from baseline in the Global Health Status Quality of Life scale and the physical functioning domain of the European Organisation for Research and Treatment of Cancer-30 and Low Grade Non-Hodgkin Lymphoma-20 - Change from baseline in the EuroQoL 5-Dimension 5-Level index and visual analogue scale | — |
Countries
France, Germany, Italy, Japan, Spain, United Kingdom, United States
Contacts
Public ContactClinical Operations
Gilead Sciences, K.K.
Outcome results
None listed