Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
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.
Lymphoma
Phase III
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
Axicabtagene Ciloleucel,
Cyclophosphamide,
Doxorubicin,
Etoposide,
Fludarabine,
Leukapheresis,
Prednisone,
Rituximab (Rituxan),
Vincristine
Jallouk, Andrew
International
Vanderbilt University
01-16-2024
Eligibility
18 Years and older
ALL
false
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)
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.
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.
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).
Have received only 1 cycle of rituximab plus chemotherapy (R-chemotherapy).
Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.
Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.
Females of childbearing potential must have a negative serum or urine pregnancy test.
Females of childbearing potential must have a negative serum or urine pregnancy test.
Exclusion Criteria:
The following WHO 2016 subcategories by local assessment: * T-cell/histiocyte-rich LBCL * Primary DLBCL of the central nervous system (CNS) * Primary mediastinal (thymic) LBCL * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma * Burkitt lymphoma * History of Richter's transformation of chronic lymphocytic leukemia
The following WHO 2016 subcategories by local assessment: * T-cell/histiocyte-rich LBCL * Primary DLBCL of the central nervous system (CNS) * Primary mediastinal (thymic) LBCL * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma * Burkitt lymphoma * History of Richter's transformation of chronic lymphocytic leukemia
Presence of detectable cerebrospinal fluid (CSF)-malignant cells, brain metastases, or a history of CNS involvement of lymphoma.
Presence of detectable cerebrospinal fluid (CSF)-malignant cells, brain metastases, or a history of CNS involvement of lymphoma.
Presence of cardiac lymphoma involvement.
Presence of cardiac lymphoma involvement.
Any prior treatment for LBCL other than the 1 cycle of R-chemotherapy.
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.
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.
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.
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.
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 or residual toxicities from prior therapies likely to interfere with assessment of safety or efficacy of study treatment. Please refer to protocol for further details.
Medical conditions or residual toxicities from prior therapies 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 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.
History of any medical condition requiring maintenance systemic immunosuppression/systemic disease modifying agents within the last 2 years.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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)
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.
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.
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).
Have received only 1 cycle of rituximab plus chemotherapy (R-chemotherapy).
Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.
Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.
Females of childbearing potential must have a negative serum or urine pregnancy test.
Females of childbearing potential must have a negative serum or urine pregnancy test.
Exclusion Criteria:
The following WHO 2016 subcategories by local assessment: * T-cell/histiocyte-rich LBCL * Primary DLBCL of the central nervous system (CNS) * Primary mediastinal (thymic) LBCL * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma * Burkitt lymphoma * History of Richter's transformation of chronic lymphocytic leukemia
The following WHO 2016 subcategories by local assessment: * T-cell/histiocyte-rich LBCL * Primary DLBCL of the central nervous system (CNS) * Primary mediastinal (thymic) LBCL * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma * Burkitt lymphoma * History of Richter's transformation of chronic lymphocytic leukemia
Presence of detectable cerebrospinal fluid (CSF)-malignant cells, brain metastases, or a history of CNS involvement of lymphoma.
Presence of detectable cerebrospinal fluid (CSF)-malignant cells, brain metastases, or a history of CNS involvement of lymphoma.
Presence of cardiac lymphoma involvement.
Presence of cardiac lymphoma involvement.
Any prior treatment for LBCL other than the 1 cycle of R-chemotherapy.
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.
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.
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.
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.
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 or residual toxicities from prior therapies likely to interfere with assessment of safety or efficacy of study treatment. Please refer to protocol for further details.
Medical conditions or residual toxicities from prior therapies 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 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.
History of any medical condition requiring maintenance systemic immunosuppression/systemic disease modifying agents within the last 2 years.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
