Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma
NCT ID: NCT07254754
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2024-11-20
2031-12-31
Brief Summary
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The total duration of the study is therefore of 7 years.
Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Axicabtagene ciloleucel
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.
Axicabtagene Ciloleucel
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.
Interventions
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Axicabtagene Ciloleucel
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.
Eligibility Criteria
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Inclusion Criteria
2. Age \> 18 years
3. Patient who understands and speaks one of the country official languages
4. 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.
5. Positron-emission tomography (PET)-positive disease
6. Patients must have received adequate first-line therapy including at a minimum:
* 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.
7. 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.
8. 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
9. 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).
Exclusion Criteria
2. 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.
3. 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
4. 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.
5. Prior CD19 targeted therapy
6. Patients with cardiac atrial or cardiac ventricular lymphoma involvement
7. Requirement for urgent therapy due to tumor mass effects, such as bowel obstruction or blood vessel compression
8. Patient with clinically significant pleural effusion
9. 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.
10. 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.
11. 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.
12. 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.
13. 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
14. 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.
15. Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antimicrobials or other treatment at the time of leukapheresis or axicabtagene ciloleucel administration
16. 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
17. Presence of primary immunodeficiency
18. 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.
19. 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.
20. History of severe immediate hypersensitivity reaction to tocilizumab or any of the agents used in this study
21. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides, cyclophosphamide or fludarabine
22. 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
23. Women of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of lymphodepletion chemotherapy on the fetus or infant.
24. 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
25. 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
26. Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.
18 Years
ALL
No
Sponsors
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Kite, A Gilead Company
INDUSTRY
Evidenze Health España (CRO)
UNKNOWN
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
OTHER
Responsible Party
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Principal Investigators
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Mariana Bastos-Oreiro
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario Gregorio Marañón
Alejandro Martín García-Sancho
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Salamanca
Armando López-Guillermo
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Institut Català d'oncologia de L'Hospitalet
L'Hospitalet de Llobregat, Catalonia, Spain
Hospital Universitario Donostia
San Sebastián, Gipuzkoa, Spain
Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital General Universitario Morales Meseguer
Murcia, Murcia, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Countries
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Central Contacts
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Facility Contacts
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Sandra García Doval
Role: primary
Almudena Pérez Rodriguez
Role: backup
Mª Teresa Ros Matheu
Role: primary
Silvia Roig Juan
Role: backup
Alba del Río Manzano
Role: primary
Pilar González Echezarreta
Role: backup
Andrea Torices
Role: primary
Manuel Delgado
Role: backup
Alicia Nogueroles Olivares
Role: primary
Julia Sedó
Role: backup
Veronica Martil
Role: primary
Cecilia Vilas
Role: backup
Lydia Guillem
Role: primary
Mariona Guillamet
Role: backup
Nerea Castroagudín Romero
Role: primary
María Aurora Barbero Martínez
Role: backup
Elizabeth Alfonso Bermejo
Role: primary
Julia Wiedermann
Role: backup
Soraya Oviedo
Role: primary
Ana García
Role: backup
Alba Gutiérrez de la Peña
Role: primary
Paula Garcés
Role: backup
José Navarro Fernández
Role: primary
Josefa Gálvez Martínez
Role: backup
Andoni Urrutia
Role: primary
Sara Morales Espinosa
Role: backup
Rocío Jiménez
Role: primary
Estefanía Menéndez Pedregal
Role: backup
María Mercedes Bou Moreno
Role: primary
Carmen Hurtado Fontelles
Role: backup
Related Links
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GELTAMO web page
Other Identifiers
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LATE-R-GEL-23
Identifier Type: -
Identifier Source: org_study_id