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. |
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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 |
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Recruiting Locations
Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Kite, A Gilead Company
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.