Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel,
works in participants with relapsed/refractory follicular lymphoma
works in participants with relapsed/refractory follicular lymphoma
Lymphoma
Phase III
Adults
Chemotherapy - cytotoxic
Mol. targeted/Immunotherapy/Biologics
Axicabtagene Ciloleucel
Bendamustine
Cyclophosphamide
Doxorubicin
Lenalidomide
Prednisone
Rituximab (Rituxan)
Vincristine
Oluwole, Olalekan
International
Vanderbilt University
04-14-2023
Treatment
VICCCTT2266
NCT05371093
Eligibility
18 Years
BOTH
NO
Inclusion Criteria:
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
Exclusion Criteria:
Transformed FL
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 central nervous system (CNS) disorder.
History of autoimmune disease
Known history or CNS lymphoma involvement
Cardiac lymphoma involvement
History of clinically significant cardiac disease within 6 months of randomization
Neuropathy greater than Grade 1
Females who are pregnant or breastfeeding
Individuals of both genders who are not willing to practice birth control
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
Exclusion Criteria:
Transformed FL
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 central nervous system (CNS) disorder.
History of autoimmune disease
Known history or CNS lymphoma involvement
Cardiac lymphoma involvement
History of clinically significant cardiac disease within 6 months of randomization
Neuropathy greater than Grade 1
Females who are pregnant or breastfeeding
Individuals of both genders who are not willing to practice birth control
