Non Hodgkin Lymphoma Clinical Trial

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

Summary

The primary objective of this study is to determine if axicabtagene ciloleucel is superior to standard of care therapy (SOCT), as measured by progression-free survival (PFS) in participants with relapsed/refractory follicular lymphoma.

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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 follicular lymphoma (FL) (Grade 1, 2, or 3a)
Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy
Clinical indication for treatment.
At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
Adequate renal, hepatic, pulmonary, and cardiac function

Exclusion Criteria:

Transformed FL
FL Grade 3b
Prior CD19-targeted therapy
Prior CAR therapy or other genetically modified T-cell therapy
Uncontrolled fungal, bacterial, viral, or other infection
Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus
History or presence of a central nervous system (CNS) disorder.
History of autoimmune disease
Known history or CNS lymphoma involvement
Cardiac lymphoma involvement
History of clinically significant cardiac disease within 6 months of randomization
Neuropathy greater than Grade 1
Females who are pregnant or breastfeeding
Individuals of both genders who are not willing to practice birth control

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

230

Study ID:

NCT05371093

Recruitment Status:

Recruiting

Sponsor:

Kite, A Gilead Company

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There are 7 Locations for this study

See Locations Near You

Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Columbia University Irving Medical Center
New York New York, 10032, United States
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
TriStar Centennial Medical Center - Cell Processing
Nashville Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

230

Study ID:

NCT05371093

Recruitment Status:

Recruiting

Sponsor:


Kite, A Gilead Company

How clear is this clinincal trial information?

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