Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in High-Risk Large B-Cell Lymphoma

Overview

About this study

The purpose of this study is to compare the effectiveness of axicabtagene ciloleucel versus standard of care therapy (SOCT), as measured by eventfree survival (EFS). Additionally, to compare the effectiveness of axicabtagene ciloleucel versus SOCT, as measured by progression-free survival (PFS) and overall survival (OS).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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:

- 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

- 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/3/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yi Lin, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Mankato, Minn.

Mayo Clinic principal investigator

Amrit Singh, M.B.B.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

La Crosse, Wis.

Mayo Clinic principal investigator

Scott Okuno, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Eau Claire, Wis.

Mayo Clinic principal investigator

Eyad Al-Hattab, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Javier Munoz, M.D., M.B.A.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Albert Lea, Minn.

Mayo Clinic principal investigator

Mina Hanna, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available