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A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma
Trial Status: complete
The goal of this study is to assess whether axicabtagene ciloleucel improves the clinical
outcome in participants with relapsed or refractory indolent non-Hodgkin lymphoma (r/r)
iNHL.
Inclusion Criteria
Individual has follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has progressed after at least 2 lines of treatment with combination chemoimmunotherapy) (e.g. R-bendamustine, R-CHOP).
Individual has (measurable disease).
Individual has no known presence or history of central nervous system (CNS) involvement by lymphoma.
If individual is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, individual is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis.
Individual has Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function
Individual is not pregnant or breastfeeding (female individuals only) and is willing to use birth control from the time of consent through 12 months following chimeric antigen receptor (CAR) T cell infusion (both male and female individuals). Key
Exclusion Criteria
Transformed FL or MZL
Small lymphocytic lymphoma
Histological Grade 3b FL
Individual will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.
Individual has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect, tumor lysis syndrome, etc.) Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03105336.
Locations matching your search criteria
United States
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
After completing at least 60 months (FL participants) or at least 24 months (MZL
participants) of assessments in this study since the initial axicabtagene ciloleucel
infusion and after agreement by the Sponsor, participants will transition to a long-term
follow-up (LTFU) study, KT-US-982-5968 where they will complete the remainder of the 15