Relapsed/Refractory Follicular LymphomaPhase 3ZUMA-22NCT05371093
Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
A Phase 3 study testing Axicabtagene Ciloleucel, Cyclophosphamide and Fludarabine in people with Relapsed/Refractory Follicular Lymphoma, run by Kite, A Gilead Company at 52 sites in 7 countries.
Trial summary
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Follicular Lymphoma
- What is being tested?
- Axicabtagene Ciloleucel, Cyclophosphamide and Fludarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 52 sitesin 7 countries
- Study dates
- 22 Sep 2022to Oct 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of large B cell lymphoma or transformed FL
- Small lymphocytic lymphoma
- Lymphoplasmacytic lymphoma
- Full-thickness involvement of the gastric wall by lymphoma
- FL Grade 3b
- Prior CD19-targeted therapy
Show all 19Show fewer
- 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 clincially significant central nervous system (CNS) disorder.
- History of autoimmune disease
- Known history or CNS lymphoma involvement
- Cardiac lymphoma involvement
- History of clinically significant cardiac disease 6 months before randomization
- Neuropathy greater than grade 2
- Females who are pregnant or breastfeeding
- Individuals of both genders who are not willing to practice birth control
- Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardial catheter, or Ommaya reservoirs). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
52 sites in 7 countries.
52 sites in 7 countries
United States12 sites
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Novant Health Cancer Institute Hematology - Charlotte
Charlotte, North Carolina, 28204
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
TriStar Centennial Medical Center - Cell Processing
Nashville, Tennessee, 37203
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
Virginia Commonwealth University
Richmond, Virginia, 23298
Stanford Health Care
Stanford, California, 94305
Moffitt Cancer Center
Tampa, Florida, 33612
The University of Kansas Hospital
Westwood, Kansas, 66205
France11 sites
Hopital Henri Mondor
Créteil, 94010
CHU de Dijon
Dijon, 21079
Hôpital Claude Huriez-CHU de Lille
Lille, 59037
Institut Paoli-Calmettes
Marseille, 13273
Hopital Saint Eloi
Montpellier, 34295
Hopital Pitie-Salpetriere
Paris, 75013
CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie
Pessac, 33604
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
CHU de Poitiers
Poitiers, 86021
Hopital Pontchaillou - CHU Rennes
Rennes, 35033
Centre Henri Becquerel
Rouen, 76038
Spain8 sites
Hospital Universitari Vall d'Hebrón
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet)
Barcelona, 08908
Hospital General Universitario Gregorio Maranon
Madrid, 28009
Hospital 12 de Octubre
Madrid, 28041
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Clínico Universitario de Valencia
Valencia, 46010
United Kingdom8 sites
University Hospital Birmingham NHS Foundation Trust
Birmingham, B15 2GW
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 2QQ
University College London Hospitals NHS Foundation Trust
London, NW2 2QG
King's College Hospital NHS Foundation Trust
London, SE5 9RS
The Christie NHS Foundation Trust
Manchester, M20 4BX
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE
The University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
Italy6 sites
ASST Papa Giovanni XXIII
Bergamo, 24128
Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna, 40138
Fondazione IRCCS - Istituto Nazionale Tumori
Milan, 20100
Ospedale San Raffaele
Milan, 20132
Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
Istituto Clinico Humanitas-IRCCS
Rozzano, 20089
Japan5 sites
Hyogo Medical University Hospital
Hyōgo, 663-8501
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566,
Tohoku University Hospital
Miyagi, 980-8574
Okayama University Hospital
Okayama, 700-8558
Osaka University Hospital
Osaka, 565-0871
Germany2 sites
Universitatsmedizin Gottingen
Göttingen, 37075
Universitatsklinikum Koln Klinik I fur Innere Medizin
Würzburg, 97080
About this study
Official title: A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
Read the detailed 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.
- Conditions
- Relapsed/Refractory Follicular Lymphoma
- Being tested
- Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axicabtagene CiloleucelBiological
Also called Yescarta®, axi-cel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
CyclophosphamideDrug
Administered intravenously
FludarabineDrug
Administered intravenously
LenalidomideDrug
Administered orally
RituximabDrug
Administered intravenously
DoxorubicinDrug
Administered intravenously
VincristineDrug
Administered intravenously
PrednisoneDrug
Administered orally
BendamustineDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Axicabtagene Ciloleucel | Experimental | Participants will receive cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV lymphodepleting chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells will be administered. Receives: Biological: Axicabtagene Ciloleucel; Drug: Cyclophosphamide; Drug: Fludarabine |
| Standard of Care Therapy | Active comparator | Participants will receive the investigator's choice of one of the following therapies/dosing schedules:
* Rituximab plus lenalidomide (R^2) for 12 cycles (28-day cycle)
* Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m^2 on Day 1, Day 8, Day 15, and Day 22
* Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1
* Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21
* Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle)
* rituximab 375 mg/m^2 on Day 1
* cyclophosphamide 750 mg/m^2 on Day 1
* doxorubicin 50 mg/m^2 on Day 1
* vincristine 1.4 mg/m^2 (maximum 2 mg) on Day 1
* prednisone 40 mg/m^2 on Day 1 through Day 5
* Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle)
* rituximab 375 mg/m^2 on Day 1
* bendamustine 90 mg/m^2 on Day 1 and Day 2 Receives: Drug: Cyclophosphamide; Drug: Lenalidomide; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification
PFS is defined as the time from randomization to disease progression or death due to any cause.
Measured: Up to 5 years
Secondary outcomes (16)
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Measured: Up to 5 years
Complete Response (CR) Rate as Assessed by Blinded Central Assessment per Lugano Classification
CR rate is defined as the proportion of participants with best overall response of CR during the study prior to any subsequent off-protocol anti-follicular lymphoma (FL) therapy.
Measured: Up to 5 years
Objective Response Rate (ORR) as Assessed by Blinded Central Assessment per Lugano Classification
Objective response rate is defined as the proportion of participants with best overall response of either a complete response or a partial response during the study prior to any subsequent off-protocol anti-FL therapy.
Measured: Up to 5 years
Duration of Response (DOR) as Assessed by Blinded Central Assessment per Lugano Classification
DOR is defined as the time from first objective response to disease progression or death from any cause.
Measured: Up to 5 years
Duration of CR as Assessed by Blinded Central Assessment per Lugano Classification
Duration of CR is defined as the time from first CR to disease progression or death from any cause.
Measured: Up to 5 years
Event Free Survival (EFS) as Assessed by Blinded Central Assessment per Lugano Classification
EFS is defined as the time from randomization to the earliest date of disease progression, the initiation of subsequent off-protocol anti-FL therapy, or death from any cause.
Measured: Up to 5 years
Time to Next Treatment (TTNT)
TTNT is defined as the time from randomization to the start of subsequent off-protocol anti-lymphoma therapy or death from any cause.
Measured: Up to 5 years
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Measured: Randomization up to 5 years plus 30 days
Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
Measured: Randomization up to 5 years plus 30 days
Percentage of Participants with Replication-competent Retrovirus in Blood Over time
Measured: Up to 5 years
Change From Baseline in the Global Health Status Quality of Life Scale of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30)
The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.
Measured: Baseline, up to 5 years
Change From Baseline in the Physical Functioning Domain of the EORTC QLQ-C30
The EORTC-QLQ-C30) is a multi-item questionnaire measuring the following content five (5) multi-item functional scales, three (3) multi-item symptom scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL) each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a higher level of symptoms.
Measured: Baseline, up to 5 years
Change From Baseline in the Global Health Status Quality of Life Scale of the Low Grade Non-Hodgkin Lymphoma-20 (NHL-LG20)
The NHL-LG20 is is a 20-item supplement questionnaire that was specifically developed to assess HRQoL in participants with low-grade non-Hodgkin lymphomas (such as follicular lymphoma). The NHL-LG20 includes multi-item scales of symptom burden, physical condition/fatigue, worries/fears on health and functioning, and emotional impact; and is administered in conjunction with the EORTC QLQ-C30. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales and for the global health status or global HRQoL scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.
Measured: Baseline, up to 5 years
Change From Baseline in the Physical Functioning Domain of the NHL-LG20
The NHL-LG20 is is a 20-item supplement questionnaire that was specifically developed to assess HRQoL in participants with low-grade non-Hodgkin lymphomas (such as follicular lymphoma). The NHL-LG20 includes multi-item scales of symptom burden, physical condition/fatigue, worries/fears on health and functioning, and emotional impact; and is administered in conjunction with the EORTC QLQ-C30. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales and for the global health status or global HRQoL scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.
Measured: Baseline, up to 5 years
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L)
The EQ-5D-5L questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS). Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Measured: Baseline, up to 5 years
Changes From Baseline in the Visual Analog Scale (VAS) Scores
The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). Higher scores indicate better health.
Measured: Baseline, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start22 Sep 2022
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Kite, A Gilead CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kite, A Gilead Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kite Study Director, Study director, Kite, A Gilead Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371093
- Sponsor's protocol ID
- KT-US-473-0133
- Other IDs
- 2021-003260-28, 2024-511594-30
- Acronym
- ZUMA-22
- Status last verified
- Oct 2025
- First submitted
- 9 May 2022
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT05371093
- Acronym / sponsor ID
- ZUMA-22 / KT-US-473-0133
- Conditions
- Relapsed/Refractory Follicular Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Kite, A Gilead CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axicabtagene Ciloleucel | Experimental | Biological: Axicabtagene Ciloleucel, Drug: Cyclophosphamide, Drug: FludarabineParticipants will receive cyclophosphamide 500 mg/m^2/day intravenously (IV) and fludarabine 30 mg/m^2/day IV lymphodepleting chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10^8 anti-CD19 CAR T cells will be administered. |
| Standard of Care Therapy | Active comparator | Drug: Cyclophosphamide, Drug: Lenalidomide, Drug: Rituximab, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: BendamustineParticipants will receive the investigator's choice of one of the following therapies/dosing schedules: * Rituximab plus lenalidomide (R^2) for 12 cycles (28-day cycle) * Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m^2 on Day 1, Day 8, Day 15, and Day 22 * Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1 * Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21 * Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle) * rituximab 375 mg/m^2 on Day 1 * cyclophosphamide 750 mg/m^2 on Day 1 * doxorubicin 50 mg/m^2 on Day 1 * vincristine 1.4 mg/m^2 (maximum 2 mg) on Day 1 * prednisone 40 mg/m^2 on Day 1 through Day 5 * Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle) * rituximab 375 mg/m^2 on Day 1 * bendamustine 90 mg/m^2 on Day 1 and Day 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- Presence of large B cell lymphoma or transformed FL
- Small lymphocytic lymphoma
- Lymphoplasmacytic lymphoma
- Full-thickness involvement of the gastric wall by lymphoma
- FL Grade 3b
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axicabtagene CiloleucelAlso: Yescarta®, axi-celA single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells | Biological | Axicabtagene Ciloleucel |
| CyclophosphamideAdministered intravenously | Drug | Axicabtagene Ciloleucel, Standard of Care Therapy |
| FludarabineAdministered intravenously | Drug | Axicabtagene Ciloleucel |
| LenalidomideAdministered orally | Drug | Standard of Care Therapy |
| RituximabAdministered intravenously | Drug | Standard of Care Therapy |
| DoxorubicinAdministered intravenously | Drug | Standard of Care Therapy |
| VincristineAdministered intravenously | Drug | Standard of Care Therapy |
| PrednisoneAdministered orally | Drug | Standard of Care Therapy |
| BendamustineAdministered intravenously | Drug | Standard of Care Therapy |
Primary outcome
Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification
Time frame: Up to 5 years
PFS is defined as the time from randomization to disease progression or death due to any cause.
16 secondary outcomes
Overall Survival (OS)
Time frame: Up to 5 years
Complete Response (CR) Rate as Assessed by Blinded Central Assessment per Lugano Classification
Time frame: Up to 5 years
Objective Response Rate (ORR) as Assessed by Blinded Central Assessment per Lugano Classification
Time frame: Up to 5 years
Duration of Response (DOR) as Assessed by Blinded Central Assessment per Lugano Classification
Time frame: Up to 5 years
Duration of CR as Assessed by Blinded Central Assessment per Lugano Classification
Time frame: Up to 5 years
Event Free Survival (EFS) as Assessed by Blinded Central Assessment per Lugano Classification
Time frame: Up to 5 years
Time to Next Treatment (TTNT)
Time frame: Up to 5 years
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Randomization up to 5 years plus 30 days
Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
Time frame: Randomization up to 5 years plus 30 days
Percentage of Participants with Replication-competent Retrovirus in Blood Over time
Time frame: Up to 5 years
Change From Baseline in the Global Health Status Quality of Life Scale of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30)
Time frame: Baseline, up to 5 years
Change From Baseline in the Physical Functioning Domain of the EORTC QLQ-C30
Time frame: Baseline, up to 5 years
Change From Baseline in the Global Health Status Quality of Life Scale of the Low Grade Non-Hodgkin Lymphoma-20 (NHL-LG20)
Time frame: Baseline, up to 5 years
Change From Baseline in the Physical Functioning Domain of the NHL-LG20
Time frame: Baseline, up to 5 years
Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L)
Time frame: Baseline, up to 5 years
Changes From Baseline in the Visual Analog Scale (VAS) Scores
Time frame: Baseline, up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kite Study Director study director
Kite, A Gilead Company
52 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Axicabtagene Ciloleucel, Cyclophosphamide and Fludarabine in people with Relapsed/Refractory Follicular Lymphoma, run by Kite, A Gilead Company at 52 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, France, Spain, United Kingdom, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.