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

ENROLLING
Protocol # :
22-271
Conditions
Relapsed/Refractory Follicular Lymphoma
Phase
III
Disease Sites
Non-Hodgkin's Lymphoma
Principal Investigator
Jacobson, Caron, A

Trial Description

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

Eligibility Requirements

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 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

22-271