Clinical Trial 22080
- Cancer Type: Malignant Hematology
- Study Type: Treatment
- NCT#: NCT05605899
- Phase: Phase III
- Principal Investigator: Chavez, Julio
- 813-745-6100
- Or 1-800-679-0775
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Overview
Study Title:
An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphoma
Summary:
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.
Objective:
Primary Objective: To compare the efficacy of axicabtagene versus SOCT, as measured by EFS Key Secondary Objective: To compare the efficacy of axicabtagene ciloleucel versus SOCT, as measured by PFS and OS Secondary Objectives: To compare the efficacy of axicabtagene ciloleucel versus SOCT, as measured by PFS and CR rate To compare the safety of axicabtagene ciloleucel versus SOCT To compare quality of life (QOL) of axicabtagene ciloleucel versus SOCT Exploratory Objectives: To compare objective response rate (ORR), duration of response (DOR), duration of CR, and progression free survival on next line therapy (PFS2) To evaluate impact of disease and treatment on work productivity and activity To evaluate the pharmacokinetics /pharmacodynamics of axicabtagene ciloleucel
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Treatments
Therapies:
Cell Therapy; Chemotherapy (NOS)
Medications:
Adriamycin (doxorubicin); Axicabtagene Ciloleucel (Yescarta); Etoposide (); Rituxan (rituximab); Vincristine (); cyclophosphamide (); cytoxan (cyclophosphamide); doxorubicin (); fludarabine (Fludarabine phosphate); prednisone (); rituximab ()
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Inclusion Criteria
- Inclusion Criteria:
- Histologically confirmed large B cell lymphoma (LBCL) based on 2016 World Health Organization (WHO) classification by local pathology lab assessment, including of the following:
- Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)
- High-grade B-cell lymphoma (HGBL) Note: Transformed DLBCL from follicular lymphoma or from marginal zone lymphoma is eligible if no prior treatment with anthracycline-containing regimen.
- High-risk disease defined as an International Prognostic Index (IPI) score of 4 or 5 at initial diagnosis.
- Have received only 1 cycle of rituximab plus chemotherapy (R-chemotherapy).
- Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.
- Females of childbearing potential must have a negative serum or urine pregnancy test.
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Exclusion Criteria
- Exclusion Criteria:
- Presence of detectable cerebrospinal fluid (CSF)-malignant cells, brain metastases, or a history of CNS involvement of lymphoma.
- Presence of cardiac lymphoma involvement.
- Any prior treatment for LBCL other than the 1 cycle of R-chemotherapy.
- History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- Presence of CNS disorder. History of stroke, transient ischemic attack, or posterior reversible encephalopathy syndrome (PRES) within 12 months prior to enrollment.
- History of acute or chronic active hepatitis B or C infection.
- Positive for human immunodeficiency virus (HIV) unless taking appropriate anti-HIV medications, with an undetectable viral load by PCR and with a cluster of differentiation 4 (CD4) count > 200 cells/uL.
- Medical conditions likely to interfere with assessment of safety or efficacy of study treatment. Please refer to protocol for further details.
- History of clinically significant cardiac disease within 12 months before enrollment.
- History of any medical condition requiring maintenance systemic immunosuppression/systemic disease modifying agents within the last 2 years.
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