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NCT03105336CompletedPhase 2

A Study of Axicabtagene Ciloleucel in Participants With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma

A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)

Source: ClinicalTrials.gov · Last updated 23 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
159 (actual)
First submitted
3 Apr 2017
Start date
6 Jun 2017
Primary completion date
20 Dec 2024
Lead sponsor
Kite, A Gilead Company
NCT number
NCT03105336
EU CT number
2023-505169-10-00
EudraCT number
2017-001912-13

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 159
  • From 6 Jun 2017 to the primary completion date, 20 Dec 2024
  • 19 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Individual will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.

Other illness

  • 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.

Other

  • Transformed FL or MZL
  • Small lymphocytic lymphoma
  • Histological Grade 3b FL

Who the study is looking for

  • 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).

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceCompleted
Hospices Civils de Lyon
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Pierre-BéniteFranceCompleted
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Ohio State University Medical Center
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ClevelandUnited StatesUnknown status
Banner MD Anderson Cancer Center
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GilbertUnited StatesUnknown status
Hackensack University Medical Center - John Theurer Cancer Center
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HackensackUnited StatesUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesUnknown status
University of California, Los Angeles
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Los AngelesUnited StatesUnknown status
University of Miami Hospital and Clinics
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MiamiUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
Sarah Cannon Research Institute
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NashvilleUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
Fox Chase Cancer Center
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PhiladelphiaUnited StatesUnknown status
UPMC Hillman Cancer Center
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PittsburghUnited StatesUnknown status
University of Rochester Medical Center (URMC)
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RochesterUnited StatesUnknown status
Fred Hutchinson Cancer Research Center
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SeattleUnited StatesUnknown status
H Lee Moffitt Cancer Center
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TampaUnited StatesUnknown status
Georgetown Lombardi Comprehensive Cancer Center
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.