Clinical Trial 22080

• 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

• 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 ()

• 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.

• 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.

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.