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. |
|
|
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 |
|
Recruiting Locations
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California 91010
Duarte, California 91010
Stanford Health Care
Stanford, California 94305
Stanford, California 94305
Moffitt Cancer Center
Tampa, Florida 33612
Tampa, Florida 33612
The University of Kansas Hospital
Westwood, Kansas 66205
Westwood, Kansas 66205
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Novant Health Cancer Institute Hematology - Charlotte
Charlotte, North Carolina 28204
Charlotte, North Carolina 28204
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
TriStar Centennial Medical Center - Cell Processing
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Henry-Joyce Cancer Clinic
Nashville, Tennessee 37232
Nashville, Tennessee 37232
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Virginia Commonwealth University
Richmond, Virginia 23298
Richmond, Virginia 23298
More Details
- NCT ID
- NCT05371093
- 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.