Vanderbilt Clinical Trials

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

Purpose

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

Condition

Relapsed/Refractory Follicular Lymphoma

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: 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

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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Axicabtagene Ciloleucel	Participants will receive cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV lymphodepleting chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells will be administered.	Biological: Axicabtagene Ciloleucel A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells Other names: Yescarta® axi-cel Drug: Cyclophosphamide Administered intravenously Drug: Fludarabine Administered intravenously
Active Comparator Standard of Care Therapy	Participants will receive the investigator's choice of one of the following therapies/dosing schedules: - Rituximab plus lenalidomide (R^2) for 12 cycles (28-day cycle) - Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m^2 on Day 1, Day 8, Day 15, and Day 22 - Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1 - Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21 - Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle) - rituximab 375 mg/m^2 on Day 1 - cyclophosphamide 750 mg/m^2 on Day 1 - doxorubicin 50 mg/m^2 on Day 1 - vincristine 1.4 mg/m^2 (maximum 2 mg) on Day 1 - prednisone 40 mg/m^2 on Day 1 through Day 5 - Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle) - rituximab 375 mg/m^2 on Day 1 - bendamustine 90 mg/m^2 on Day 1 and Day 2	Drug: Cyclophosphamide Administered intravenously Drug: Lenalidomide Administered orally Drug: Rituximab Administered intravenously Drug: Doxorubicin Administered intravenously Drug: Vincristine Administered intravenously Drug: Prednisone Administered orally Drug: Bendamustine Administered intravenously

Recruiting Locations

Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232

More Details

Status: Recruiting
Sponsor: Kite, A Gilead Company

Study Contact

Medical Information
844-454-5483(1-844-454-KITE)
medinfo@kitepharma.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.