Non Hodgkin Lymphoma Clinical Trial
Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
Summary
The primary objective of this study is to determine if axicabtagene ciloleucel is superior to standard of care therapy (SOCT), as measured by progression-free survival (PFS) in participants with relapsed/refractory follicular lymphoma.
Full Description
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.
Eligibility Criteria
Key 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
Key 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 39 Locations for this study
Duarte California, 91010, United States
Orange California, 92868, United States
Stanford California, 94305, United States
Denver Colorado, 80218, United States
Washington District of Columbia, 20007, United States
Westwood Kansas, 66205, United States
Lexington Kentucky, 40536, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02215, United States
Hackensack New Jersey, 07601, United States
New York New York, 10032, United States
Pittsburgh Pennsylvania, 15232, United States
Greenville South Carolina, 29615, United States
Sioux Falls South Dakota, 57105, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Richmond Virginia, 23298, United States
Créteil , 94010, France
Dijon , 21079, France
Lille cedex , 59037, France
Montpellier , 34295, France
Paris , 75013, France
Pierre Benite , 69495, France
Rouen , 76038, France
Bergamo , 24128, Italy
Milano , 20100, Italy
Milano , 20132, Italy
Reggio Emilia , 42123, Italy
Rozzano , 20089, Italy
Barcelona , 08036, Spain
Barcelona , 08908, Spain
Barcelona , 8035, Spain
Madrid , 28009, Spain
Madrid , 28041, Spain
Valencia , 46010, Spain
Birmingham , B15 2, United Kingdom
London , NW3 2, United Kingdom
Sutton , SM2 5, United Kingdom
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