Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kite, A Gilead Company
Five years after the last study participant is randomized, participants who have received axicabtagene ciloleucel will transition to a separate Long-term Follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
Relapsed/refractory (R/r) 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
Clinical indication for treatment.
At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
Adequate renal, hepatic, pulmonary, and cardiac function
You may not be if
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 greater than grade 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.
Clareo Health | Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
