Non Hodgkin Lymphoma Clinical Trial

Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma

Summary

The goal of this study is to find out if the experimental product, axi-cel, is safe and effective in treating your lymphoma, compared to standard of care (SOC) therapy), which includes either R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone) or DA-EPOCH-R (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab).

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Full Description

Five years after the last study participant is randomized, participants who have received axicabtagene ciloleucel will transition to a separate long-term follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

View Eligibility Criteria

Eligibility Criteria

Key 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.

Key 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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT05605899

Recruitment Status:

Recruiting

Sponsor:

Kite, A Gilead Company

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There are 10 Locations for this study

See Locations Near You

Stanford Cancer Institute
Palo Alto California, 94305, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Columbia University Medical Center
New York New York, 10032, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
The University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States
Royal Prince Alfred Hospital
Camperdown New South Wales, 2050, Australia
Peter MacCallum Cancer Center
Melbourne Victoria, 3000, Australia

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT05605899

Recruitment Status:

Recruiting

Sponsor:


Kite, A Gilead Company

How clear is this clinincal trial information?

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