DIFFUSE LARGE B-CELL LYMPHOMAPhase 2LATE-R-GEL-23NCT07254754
Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma
A Phase 2 study testing Axicabtagene Ciloleucel in people with DIFFUSE LARGE B-CELL LYMPHOMA, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 15 sites in Spain.
Trial summary
Single-arm, open-label, multicenter, phase II trial aiming to include approximately 45 patients over 24 months. Patients will receive axicabtagene ciloleucel infusion and will be followed up to 5 years. The total duration of the study is therefore of 7 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DIFFUSE LARGE B-CELL LYMPHOMA
- What is being tested?
- Axicabtagene Ciloleucel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 15 sitesSpain
- Study dates
- 20 Nov 2024to 31 Dec 2031
- Phase
- Phase 2
- 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
- Signed written Informed Consent Form
- Age > 18 years
- Patient who understands and speaks one of the country official languages
- Histologically proven relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL) of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL) and follicular lymphoma Grade 3B per WHO 2016 classification. Indolent B-NHL who transformed into aggressive B-NHL and were previously treated with R-CHOP-like after transformation are eligible. Primary mediastinal B-cell lymphoma are not eligible.
- Positron-emission tomography (PET)-positive disease
- Patients must have received adequate first-line therapy including at a minimum:
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- An anti-CD20 monoclonal antibody (rituximab or obinutuzumab), and
- CHOP or CHOP-like chemotherapy Note: CHOP-like chemotherapy corresponds to ACVBP, EPOCH, or COPADEM. Dose-reduced CHOP (i.e., miniCHOP) is excluded except for dose-reductions of vincristine due to peripheral neuropathy. Patients who have received additional drugs in combination with CHOP or CHOP-like regimen are eligible.
- Relapsed disease after first line chemo immunotherapy (full dose of R-CHOP or R-CHOP-like regimen), documented by PET-scan and biopsy:
- Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapse after 12 months and up to 5 years from end of first-line therapy.
- Patients must meet CAR-T-eligible criteria as defined by:
- Patient deemed eligible for CAR T-cells therapy by the CAR-T physician
- AND all the following criteria:
- ECOG performance status of 0, 1 or 2
- Adequate vascular access for leukapheresis procedure (either peripheral or central venous line)
- Absolute neutrophil count (ANC) ≥ 1 x 109/L
- Platelets ≥ 75 x 109/L
- Absolute lymphocyte count ≥ 0.1 x 109/L
- Creatinine clearance (CrCl) as estimated by Cockcroft Gault or MDRD ≥ 40 mL/min
- Serum alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5xULN
- Total bilirubin <1.5 mg/dL, except in patients with Gilbert's syndrome
- Cardiac ejection fraction ≥ 45%
- Baseline oxygen saturation ≥ 92% on room air
- Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 12 months are not considered to be of childbearing potential).
Who cannot join
- Patients who received more than one prior line of systemic therapy
- Early relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapse before 12 months from end of first-line therapy.
- Refractory disease defined as:
- Progressive disease (PD) during first-line therapy
- Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP)
- Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease
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- Patients who received first line of R-CHOP or obinutuzumab-CHOP for an indolent B-NHL who relapse as transformed aggressive B-NHL after a year from the end of first-line therapy are NOT eligible.
- Prior CD19 targeted therapy
- Patients with cardiac atrial or cardiac ventricular lymphoma involvement
- Requirement for urgent therapy due to tumor mass effects, such as bowel obstruction or blood vessel compression
- Patient with clinically significant pleural effusion
- History of another primary malignancy that has not been in remission for at least 3 years (except for nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast)). A maintenance treatment is not allowed.
- Patients with detectable Central Nervous System (CNS) lymphoma. Patients with a history of CNS lymphoma but no active CNS disease (after systematic MRI and lumbar puncture) at the time of enrolment will be eligible.
- Presence of CNS disorder such as dementia, autoimmune disease with CNS involvement, cerebral edema with confirmed structural defects by appropriate imaging, or seizure disorders requiring active anticonvulsive medication. History of stroke, transient ischemic attack, or posterior reversible encephalopathy syndrome (PRES) within 12 months prior to enrolment.
- Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters, such as a Port-a-Cath or Hickman catheter, are permitted.
- History of acute or chronic active hepatitis B or C infection (seropositivity). If there is a positive history of treated hepatitis B or hepatitis C (negative HBsAg and positive Anti-HBc/ positive anti-HCV), the viral load HBV DNA/ HCV RNA) must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing
- Positive for human immunodeficiency virus (HIV) unless taking appropriate anti-HIV medications, with an undetectable viral load by PCR and with a CD4 count > 200 cells/uL.
- Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antimicrobials or other treatment at the time of leukapheresis or axicabtagene ciloleucel administration
- History of any one of the following cardiovascular conditions within the past 12 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
- Presence of primary immunodeficiency
- History of any medical condition including but not limited to autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression and/or systemic disease modifying agents within the last year. Endocrine conditions that require maintenance with physiologic dose steroids are allowed.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computed tomography (CT) scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is allowed.
- History of severe immediate hypersensitivity reaction to tocilizumab or any of the agents used in this study
- History of severe, immediate hypersensitivity reaction attributed to aminoglycosides, cyclophosphamide or fludarabine
- Treatment with a live, attenuated vaccine within 6 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study
- Women of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of lymphodepletion chemotherapy on the fetus or infant.
- Patients of either sex who are not willing to practice birth control from the time of consent during treatment and for at least 12 months after conditioning chemotherapy dosing or axicabtagene ciloleucel dosing, whichever is later
- In the investigator's judgment, the patient is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
- Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ana María Méndez contact
15 sites in 1 country
Spain15 sites, 15 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña, 15008
Sandra García Doval, +34 981176668, sandragarciadoval@gmail.com
Almudena Pérez Rodriguez, +34 981176668, almudena.perez.rodriguez@sergas.es
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, 08035
Alicia Nogueroles Olivares, + 34 93 274 61 00 ext. Ext. 4976/ 26, alicianogueroles@vhio.net
Julia Sedó, + 34 93 274 61 00 ext. Ext. 4976/2697, jsedo@vhio.net
- Recruiting
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, 08036
Veronica Martil, +34 913303000, MARTIL@recerca.clinic.cat
Cecilia Vilas, CVILAS@recerca.clinic.cat
- Recruiting
Institut Català d'oncologia de L'Hospitalet
L'Hospitalet de Llobregat, Catalonia, 08908
Lydia Guillem, +34 932607750, lguillem@idibell.cat
Mariona Guillamet, +34 932607750, mguillamet@idibell.cat
- Recruiting
Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, 35019
Elizabeth Alfonso Bermejo, +34 928450767, ealfonso@fciisc.es
Julia Wiedermann, +34 928450767, jmwiedermann@fciisc.es
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Soraya Oviedo, +34 914269658, soraya.oviedo.hgugm@gmail.com
Ana García, +34 914269658, ana.garcia.hgugm@gmail.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Alba Gutiérrez de la Peña, +34 917792809, albagu12oct@gmail.com
Paula Garcés, +34 917792809, paulagarcesh12oct@gmail.com
- Recruiting
Hospital General Universitario Morales Meseguer
Murcia, Murcia, 30008
José Navarro Fernández, +34 968363969, josenafer79@gmail.com
Josefa Gálvez Martínez, +34 968363969, josegalvez100@gmail.com
- Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 7120
Mª Teresa Ros Matheu, +34 871206268, maria.ros@ssib.es
Silvia Roig Juan, +34 871206268, silvia.roig@ssib.es
- Recruiting
Clínica Universidad de Navarra
Pamplona, Navarre, 31008
Andoni Urrutia, +34 948 296 666 ext. Ext. 2703, aurrutia@unav.es
Sara Morales Espinosa, +34 948 296 666 ext. Ext. 2768, smoralesesp@unav.es
- Recruiting
Hospital Universitario de Salamanca
Salamanca, Castille and León, 37007
Andrea Torices, +34 923291100 ext. 56078, atorices.ibsal@saludcastillayleon.es
Manuel Delgado, +34 923291100 ext. 56022, mdelgadocri@saludcastillayleon.es
- Recruiting
Hospital Universitario Donostia
San Sebastián, Gipuzkoa
Nerea Castroagudín Romero, +34 943006046, NEREA.CASTROAGUDINROMERO@bio-gipuzkoa.eus
María Aurora Barbero Martínez, +34 943006046, MARIAAURORA.BARBEROMARTINEZ@bio-gipuzkoa.eus
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Alba del Río Manzano, +34 942204078, amanzano@idival.org
Pilar González Echezarreta, +34 942204078, mpilar.gonzaleze@scsalud.es
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
Rocío Jiménez, +34 955013277, rociojimenezalvarez@gmail.com
Estefanía Menéndez Pedregal, +34 955013277, estefania.menpe@gmail.com
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010
María Mercedes Bou Moreno, +34 96 197 3500 ext. Ext. 436697, mbou@incliva.es
Carmen Hurtado Fontelles, +34 96 197 3500 ext. Ext. 436697, carmenhurtadoincliva@gmail.com
About this study
Official title: LATE-R Trial. A Phase II, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma
Single-arm, open-label, multicenter, phase II trial aiming to include approximately 45 patients over 24 months. Patients will receive axicabtagene ciloleucel infusion and will be followed up to 5 years.
The total duration of the study is therefore of 7 years.
Read the detailed description
Axicabtagene Ciloleucel , an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, demonstrated a high rate of durable responses with a manageable safety profile, in patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more previous therapies. Recently, axicabtagene ciloleucel as demonstrated superior efficacy compared to standard of care (SOC) in 2nd line LBCL patients considered eligible for autologous stem-cell transplantation (ASCT) with primary refractory disease or early relapse (ZUMA-7). In this study, after a median follow-up of 24.9 months, the median event-free survival was 8.3 months in the axicabtagene ciloleucel group and 2.0 months in the standard-care group, and the 24-month event-free survival was 41% and 16%, respectively (hazard ratio, [HR] for event or death, 0.40; 95% confidence interval, 0.31 to 0.51; p<0.001). Some response occurred in 83% of the patients in the axicabtagene ciloleucel group and in 50% of those in the SOC group (with a complete response [CR] in 65% and 32% of the patients, respectively). These data led to the approval of axicabtagene ciloleucel by the American and European regulatory agencies, for patients with LBCL refractory to first-line or relapsing within the first year after completion of induction immunochemotherapy.
More recently, the open-label phase 2 ALYCANTE trial assessed the safety and efficacy of axicabtagene ciloleucel as second-line therapy in patients with primary refractory or early relapsed aggressive B-cell lymphoma who were not deemed candidates for ASCT. Treatment with axicabtagene ciloleucel resulted in high response rates (best overall response 92.5%, best CR = 80.0%) and durable remissions (median PFS, 11 months, median overall survival [OS], not reached), with an acceptable safety profile in this population of patients considered unfit for ASCT.
The above-mentioned trials included only patients who were primary refractory or had relapsed within a year of completing first-line treatment. However, no data are available on the efficacy of axicabtagene ciloleucel in second line for patients relapsing more than one year after completion of induction. Although it is generally assumed that the outcome of these patients is better than that of patients showing early failure, still the outcome is not optimal at all, with at least half of the patients dying from the lymphoma in the next months. The current proposal is aimed at studying a possible role of axicabtagene ciloleucel in this subset of cases.
- Conditions
- DIFFUSE LARGE B-CELL LYMPHOMA
- Being tested
- Axicabtagene Ciloleucel
- Keywords
- lymphoma, axicabtagene, geltamo, DIFFUSE LARGE B-CELL LYMPHOMA, DLBCL, RELAPSE
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axicabtagene CiloleucelDrug
Treatment consists of a single dose for infusion containing a dispersion for infusion of CAR-positive viable T cells in one infusion bag. The target dose is 2 × 106 CAR-positive viable T cells per kg of body weight (within a range of 1 × 106 - 2 × 106 cells/kg), with a maximum of 2 × 108 CAR-positive viable T cells for patients 100 kg and above.
| Study group | Role | What they receive |
|---|---|---|
| Axicabtagene ciloleucel | Experimental | Treatment consists of a single dose for infusion containing a dispersion for infusion of CAR-positive viable T cells in one infusion bag. The target dose is 2 × 106 CAR-positive viable T cells per kg of body weight (within a range of 1 × 10E6 - 2 × 10E6 cells/kg), with a maximum of 2 × 10E8 CAR-positive viable T cells for patients 100 kg and above. Receives: Drug: Axicabtagene Ciloleucel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response month 3
The Complete Metabolic Response, defined as negative findings on a PET/CT scan at month 3 after receiving axicabtagene ciloleucel infusion at day 0. The negativity of PET/CT findings will be assessed according to Lugano Classification and Deauville criteria
Measured: Month 3
Secondary outcomes (14)
Response month 3 central
The Complete Metabolic Response defined as negative findings on a PET/CT scan at month3 after receving axicabtagene ciloleucel infusion as assessed by central imaging review of PET/CT
Measured: Month 3
Overall response rate
The Overall response rate (ORR) defined as the percentage of patients who achieved partial metabolic response (PMR) or complete metabolic response (CMR) according to the Lugano Classification criteria at month 3 determined by both central and investigator assessments.
Measured: Month 3
Best objective response
Best objective response rate defined as the percentage of CMR + PMR determined by the investigator assessment among all patients between month 1 and month 12 from axicabtagene ciloleucel infusion
Measured: 1 year
Best complete response rate
Best Complete Response rate defined as the percentage of CMR determined by the investigator assessment among all patients between month 1 and month 12 from axicabtagene ciloleucel infusion
Measured: 1 year
Overall survival
The overall survival, defined as the time from inclusion to death from any cause. Alive patients will be censored at their last follow-up date.
Measured: Up to 5 years
Progression free survival
The Progresison Free Survival, defined as the time from axicabtagene ciloleucel infusion to the first observation of documented disease progression/relapse (based on investigator disease assessment (INV)) or death due to any cause. If a patient has not progressed or died, PFS will be censored at the time of last visit with adequate assessment
Measured: Up to 5 years
Event Free Survival
Event-free survival (EFS), defined as the time between leukapheresis and to any event preventing axicabtagene ciloleucel infusion if axicabtagene ciloleucel is never infused, or death, disease progression, or instauration of a new lymphoma therapy for lymphoma progression after axicabtagene ciloleucel infusion. Patients without documented event at the time of analysis will be censored at the time of last visit with adequate assessment.
Measured: Up to 5 years
Duration of Response
The Duration of Response (DOR), defined as the time from attainment of PMR or CMR to the date of first documented disease progression/relapse (based on investigator disease assessment) or death from any cause
Measured: Up to 5 years
Duration of Complete Response
Duration of complete response (DoCR), defined as the time from achievement CMR to the date of first documented disease progression/relapse (based on investigator disease assessment) or death from any cause.
Measured: Up to 5 years
Adverse events
Type, frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to 4 weeks
AESIs
Incidence, severity and treatment of adverse events of special interest: Cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), prolonged cytopenia and infections, hypogammaglobulinemia and emergent secondary malignancies.
Measured: Up to 5 years
Quality of Life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 is a 30-item questionnaire measuring cancer patients' physical, emotional, and social functioning. Scores range from 0 to 100. Range: 0 (worst) to 100 (best). Higher scores indicate better quality of life for functional scales and worse symptoms for symptom scales.
Measured: Up yo 1 year
Quality of Life assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
The EQ-5D-5L evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It includes a visual analog scale (VAS) from 0 to 100. Range: 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate better health status.
Measured: Up to 1 year
Quality of Life assessed using the EORTC Quality of Life Questionnaire for High-Grade Non-Hodgkin Lymphoma (QLQ-NHL-HG29)
The QLQ-NHL-HG29 is a disease-specific module assessing symptoms and functioning in patients with high-grade non-Hodgkin lymphoma. Scores range from 0 to 100. Range: 0 to 100. Higher scores indicate worse symptoms or problems.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start20 Nov 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DIFFUSE LARGE B-CELL LYMPHOMAStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Sponsor type
- University, hospital or other
- Collaborators
- Kite, A Gilead Company, Evidenze CRO
- Responsible party
- Sponsor
- Investigators
- Mariana Bastos-Oreiro, Principal investigator, Hospital General Universitario Gregorio MarañonAlejandro Martín García-Sancho, Principal investigator, Hospital Universitario SalamancaArmando López-Guillermo, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254754
- Sponsor's protocol ID
- LATE-R-GEL-23
- Acronym
- LATE-R-GEL-23
- Status last verified
- Nov 2025
- First submitted
- 4 Jul 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in hematology diseases. All individual data collected during the trial will be available. Data shared will be coded, with no PHI included. Study protocol, statistical analysis plan, informed consent form and clinical study report will be also available. Information will be available beginning 6 months after final publication with no end date established. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 6 months after article publication. Access to trial IPD can be requested by qualified researchers and will be provided following review and approval of a research and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact to GELTAMO though the web page: https://www.geltamo.com/contacto
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LATE-R Trial. A Phase II, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07254754
- Acronym / sponsor ID
- LATE-R-GEL-23 / LATE-R-GEL-23
- Conditions
- DIFFUSE LARGE B-CELL LYMPHOMA
- Keywords
- lymphoma, axicabtagene, geltamo, DIFFUSE LARGE B-CELL LYMPHOMA, DLBCL, RELAPSE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Collaborators
- Kite, A Gilead Company, Evidenze CRO
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 28 Nov 2025 (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.
Single-arm, open-label, multicenter, phase II trial aiming to include approximately 45 patients over 24 months. Patients will receive axicabtagene ciloleucel infusion and will be followed up to 5 years.
The total duration of the study is therefore of 7 years.
Detailed description
Axicabtagene Ciloleucel , an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, demonstrated a high rate of durable responses with a manageable safety profile, in patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more previous therapies. Recently, axicabtagene ciloleucel as demonstrated superior efficacy compared to standard of care (SOC) in 2nd line LBCL patients considered eligible for autologous stem-cell transplantation (ASCT) with primary refractory disease or early relapse (ZUMA-7). In this study, after a median follow-up of 24.9 months, the median event-free survival was 8.3 months in the axicabtagene ciloleucel group and 2.0 months in the standard-care group, and the 24-month event-free survival was 41% and 16%, respectively (hazard ratio, [HR] for event or death, 0.40; 95% confidence interval, 0.31 to 0.51; p<0.001). Some response occurred in 83% of the patients in the axicabtagene ciloleucel group and in 50% of those in the SOC group (with a complete response [CR] in 65% and 32% of the patients, respectively). These data led to the approval of axicabtagene ciloleucel by the American and European regulatory agencies, for patients with LBCL refractory to first-line or relapsing within the first year after completion of induction immunochemotherapy.
More recently, the open-label phase 2 ALYCANTE trial assessed the safety and efficacy of axicabtagene ciloleucel as second-line therapy in patients with primary refractory or early relapsed aggressive B-cell lymphoma who were not deemed candidates for ASCT. Treatment with axicabtagene ciloleucel resulted in high response rates (best overall response 92.5%, best CR = 80.0%) and durable remissions (median PFS, 11 months, median overall survival [OS], not reached), with an acceptable safety profile in this population of patients considered unfit for ASCT.
The above-mentioned trials included only patients who were primary refractory or had relapsed within a year of completing first-line treatment. However, no data are available on the efficacy of axicabtagene ciloleucel in second line for patients relapsing more than one year after completion of induction. Although it is generally assumed that the outcome of these patients is better than that of patients showing early failure, still the outcome is not optimal at all, with at least half of the patients dying from the lymphoma in the next months. The current proposal is aimed at studying a possible role of axicabtagene ciloleucel in this subset of cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axicabtagene ciloleucel | Experimental | Drug: Axicabtagene CiloleucelTreatment consists of a single dose for infusion containing a dispersion for infusion of CAR-positive viable T cells in one infusion bag. The target dose is 2 × 106 CAR-positive viable T cells per kg of body weight (within a range of 1 × 10E6 - 2 × 10E6 cells/kg), with a maximum of 2 × 10E8 CAR-positive viable T cells for patients 100 kg and above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Signed written Informed Consent Form
- Age > 18 years
- Patient who understands and speaks one of the country official languages
- Histologically proven relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL) of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL) and follicular lymphoma Grade 3B per WHO 2016 classification. Indolent B-NHL who transformed into aggressive B-NHL and were previously treated with R-CHOP-like after transformation are eligible. Primary mediastinal B-cell lymphoma are not eligible.
- Positron-emission tomography (PET)-positive disease
Key exclusion criteria (29 listed)
- Patients who received more than one prior line of systemic therapy
- Early relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapse before 12 months from end of first-line therapy.
- Refractory disease defined as:
- Patients who received first line of R-CHOP or obinutuzumab-CHOP for an indolent B-NHL who relapse as transformed aggressive B-NHL after a year from the end of first-line therapy are NOT eligible.
- Prior CD19 targeted therapy
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 CiloleucelTreatment consists of a single dose for infusion containing a dispersion for infusion of CAR-positive viable T cells in one infusion bag. The target dose is 2 × 106 CAR-positive viable T cells per kg of body weight (within a range of 1 × 106 - 2 × 106 cells/kg), with a maximum of 2 × 108 CAR-positive viable T cells for patients 100 kg and above. | Drug | Axicabtagene ciloleucel |
Primary outcome
Response month 3
Time frame: Month 3
The Complete Metabolic Response, defined as negative findings on a PET/CT scan at month 3 after receiving axicabtagene ciloleucel infusion at day 0. The negativity of PET/CT findings will be assessed according to Lugano Classification and Deauville criteria
14 secondary outcomes
Response month 3 central
Time frame: Month 3
Overall response rate
Time frame: Month 3
Best objective response
Time frame: 1 year
Best complete response rate
Time frame: 1 year
Overall survival
Time frame: Up to 5 years
Progression free survival
Time frame: Up to 5 years
Event Free Survival
Time frame: Up to 5 years
Duration of Response
Time frame: Up to 5 years
Duration of Complete Response
Time frame: Up to 5 years
Adverse events
Time frame: Up to 4 weeks
AESIs
Time frame: Up to 5 years
Quality of Life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Time frame: Up yo 1 year
Quality of Life assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Time frame: Up to 1 year
Quality of Life assessed using the EORTC Quality of Life Questionnaire for High-Grade Non-Hodgkin Lymphoma (QLQ-NHL-HG29)
Time frame: Up to 1 year
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 28 Nov 2025.
- GELTAMO web pageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in hematology diseases. All individual data collected during the trial will be available. Data shared will be coded, with no PHI included. Study protocol, statistical analysis plan, informed consent form and clinical study report will be also available. Information will be available beginning 6 months after final publication with no end date established. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 6 months after article publication. Access to trial IPD can be requested by qualified researchers and will be provided following review and approval of a research and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact to GELTAMO though the web page: https://www.geltamo.com/contacto
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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.
Ana María Méndez contact
Mariana Bastos-Oreiro principal investigator
Hospital General Universitario Gregorio Marañon
Alejandro Martín García-Sancho principal investigator
Hospital Universitario Salamanca
Armando López-Guillermo principal investigator
Hospital Clinic of Barcelona
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Axicabtagene Ciloleucel in people with DIFFUSE LARGE B-CELL LYMPHOMA, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 15 sites in Spain.
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 24 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Auxi Moreno (+34 683636850, amoreno@geltamo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response month 3 (time frame: Month 3). 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 28 Nov 2025.