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
- Diseases
- Follicular lymphoma, Hodgkin lymphoma
- 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
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Completed |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Ohio State University Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Banner MD Anderson Cancer Center Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Hackensack University Medical Center - John Theurer Cancer Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Miami Hospital and Clinics Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| University of Rochester Medical Center (URMC) Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Fred Hutchinson Cancer Research Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| H Lee Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Georgetown Lombardi Comprehensive Cancer Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.