Clinical Trial 21621
- Cancer Type: Malignant Hematology
- Study Type: Treatment
- NCT#: NCT05371093
- Phase: Phase III
- Principal Investigator: Gaballa, Sameh
- 813-745-6100
- Or 1-800-679-0775
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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
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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 ()
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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
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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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