Clinical Trial 21621

• Overview

  Study Title:

  A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma

  Summary:

  The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

  Objective:

  Primary Objective: The primary objective of this study is to determine if axicabtagene ciloleucel is superior to SOCT, as measured by PFS per a blinded independent radiologic review committee (hereafter referred to as blinded central assessment) in subjects with r/r FL. Secondary Objectives: The secondary objective of this study is to further characterize the efficacy and safety profile and patient reported outcomes associated with axicabtagene ciloleucel compared with SOCT. Exploratory Objectives: - To characterize the pharmacokinetic profile of axicabtagene ciloleucel in subjects with r/r FL (including those with high-risk disease), as measured by anti-CD19 CAR T-cell expansion and persistence in blood - To characterize the levels of serum/plasma analytes (including cytokines) as well as minimal residual disease (MRD) over time - To evaluate impact of disease and treatment on work productivity and activity

• Treatments

  Therapies:

  Cell Therapy; Chemotherapy (NOS); Therapy (NOS)

  Medications:

  Adriamycin (doxorubicin); Axicabtagene Ciloleucel (Yescarta); Bendamustine (); CC-5013 (Lenalidomide); Lenalidomide (Revlimid); Rituxan (rituximab); Vincristine (); cyclophosphamide (); cytoxan (cyclophosphamide); doxorubicin (); fludarabine (Fludarabine phosphate); prednisone (); rituximab ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Age 18 or older
  • 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 greater than or equal to 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
  • Other criteria apply

• Exclusion Criteria

  Exclusion Criteria:
  • Transformed Follicular Lymphoma (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 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
  • Other criteria apply

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