Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B Lymphoma Ineligible to Autologous Stem Cell Transplantation

NCT04531046 | Active Not Recruiting Phase 2

• 1 other identifier: ALYCANTE
• Study Type: interventional
• Target: 62
• Locations: 2 countries
• Sites: 16

Brief Summary

This is a phase 2, open-label, multicenter study evaluating axicabtagene ciloleucel (axi-cel) as a 2nd line therapy in patients with Relapsed/Refractory aggressive B-NHL who are ineligible to receive Autologous Stem Cell Transplantation but eligible to receive CAR T-cell therapy.

Conditions

B-Cell Lymphoma Refractory; B-cell Lymphoma Recurrent

Outcome Measures

Primary Outcomes (1)

• Complete Metabolic Response (CMR) - determined by investigator

  CMR from axi-cel infusion (without additional anticancer therapy) based on investigator disease assessment according to PET-scan (using the Lugano Response Criteria)

  3 months from axi-cel infusion

Secondary Outcomes (19)

• Complete Metabolic Response (CMR) - determined by central imaging review

  3 months from axi-cel infusion

• Best objective response

  between Day 14 and Month 12

• Number of Serious Adverse Events (SAE)

  at 30 days after axi-cel infusion

• Event-free survival (EFS) based on investigator disease assessment

  at 3 months

• Event-free survival (EFS) based on investigator disease assessment

  at 6 months

Study Arms (1)

axicabtagene ciloleucel

EXPERIMENTAL

Single infusion administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg

Drug: axicabtagene ciloleucel

Interventions

axicabtagene ciloleucel DRUG

Patient-specific (autologous) product cryopreserved in cryostorage bag

Also known as: axi-cel

axicabtagene ciloleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who understands and speaks one of the country official languages and signed Informed Consent Form
• 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), follicular lymphoma Grade 3B per World Health Organization (WHO) 2016 classification and Primary mediastinal Bcell lymphomas. Indolent B-NHL who transformed into aggressive B-NHL and were previously treated with Rituximab-Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone (R-CHOP) are eligible.
• Tumoral tissue (at diagnosis or relapse) available for central pathology review, exploratory endpoints and ancillary studies
• Positron-emission tomography (PET)-positive disease
• Patients must have received adequate first-line therapy including at a minimum: an anti-CD20 monoclonal antibody (rituximab or obinutuzumab), and Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone (CHOP) or CHOP-like chemotherapy
• Relapsed or refractory disease after first-line chemoimmunotherapy (full dose of R-CHOP or R-CHOP-like regimen), documented by PET-scan
• At least 2 weeks must have elapsed since any prior systemic cancer therapy at the time the patient provides consent
• Patients must be autologous stem cell transplantation (ASCT)-ineligible
• Patients must be CAR-T-eligible
• 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)

You may not qualify if:

• Patients who received more than one prior line of systemic therapy
• Patients who are intolerant to first-line therapy or who received suboptimal first-line therapy, including dose-reduced R-CHOP ("R-miniCHOP"), and those who discontinued prematurely first-line therapy due to toxicity 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 2 years (except for nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast))
• Patients with detectable Central Nervous System (CNS) lymphoma
• History or presence of non-malignant CNS disorder, such as seizure disorder requiring anti-convulsive therapy, cerebellar disease, or any autoimmune disease with CNS involvement disease
• Active hepatitis B or hepatitis C infection, positive serology of human immunodeficiency virus (HIV) and syphilis at the time of screening
• Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or axi-cel administration
• History of any one of the following cardiovascular conditions within the past 6 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
• History of autoimmune disease requiring systemic immunosuppression and/or systemic disease modifying agents within the last year
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computed tomography (CT) scan at screening.
• History of severe immediate hypersensitivity reaction to tocilizumab or any of the agents used in this study

Sponsors & Collaborators

• The Lymphoma Academic Research Organisation: lead

Study Sites (16)

CH Liège

Liège, 4000, Belgium

Location

CHU de Bordeaux - Hôpital Haut Lévêque

Bordeaux, France

Location

CHU Clermont Ferrand - Hôpital Estaing

Clermont-Ferrand, France

Location

APHP - Hôpital Henri Mondor

Créteil, France

Location

CHU de Dijon - Hôpital le Bocage

Dijon, 21000, France

Location

Hôpital Claude Huriez

Lille, 59037, France

Location

Hôpital Saint Eloi

Montpellier, 34295, France

Location

CHU de Nantes - Hôtel Dieu

Nantes, 44093, France

Location

APHP - Hôpital Saint Louis

Paris, 75475, France

Location

Hopital La Pitié Salpétriere

Paris, France

Location

Hôpital Saint Antoine

Paris, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU de Rennes - Hôpital de Pontchaillou

Rennes, 35003, France

Location

IUCT Oncopole

Toulouse, France

Location

CHU Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Institut de Cancérologie Gustave Roussy

Villejuif, France

Location

Related Publications (2)

• Charton E, Anota A, Bachy E, Cartron G, Gros FX, Morschhauser F, Oberic L, Gastinne T, Feugier P, Dulery R, Thieblemont C, Joris M, Jardin F, Choquet S, Casasnovas O, Brisou G, Cheminant M, Bay JO, Llamas Gutierrez F, Portugues C, Itti E, Palard-Novello X, Blanc-Durand P, Al Tabaa Y, Bailly C, Laurent C, Lemonnier F, Houot R. Health-related quality of life after second-line axi-cel in transplant-ineligible patients with large B-cell lymphoma. Blood Adv. 2026 Mar 10;10(5):1773-1782. doi: 10.1182/bloodadvances.2025018057.

  PMID: 41512176 DERIVED

• Houot R, Bachy E, Cartron G, Gros FX, Morschhauser F, Oberic L, Gastinne T, Feugier P, Dulery R, Thieblemont C, Joris M, Jardin F, Choquet S, Casasnovas O, Brisou G, Cheminant M, Bay JO, Gutierrez FL, Menard C, Tarte K, Delfau MH, Portugues C, Itti E, Palard-Novello X, Blanc-Durand P, Al Tabaa Y, Bailly C, Laurent C, Lemonnier F. Axicabtagene ciloleucel as second-line therapy in large B cell lymphoma ineligible for autologous stem cell transplantation: a phase 2 trial. Nat Med. 2023 Oct;29(10):2593-2601. doi: 10.1038/s41591-023-02572-5. Epub 2023 Sep 14.

  PMID: 37710005 DERIVED

MeSH Terms

Interventions

axicabtagene ciloleucel

Study Officials

• Roch Houot, PhD

  Rennes University Hospital, Rennes, France

  PRINCIPAL INVESTIGATOR

• François Lemonnier, PhD

  Henri Mondor Hospital, Créteil, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open-label, multicenter study

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: March 10, 2021
• Primary Completion: April 19, 2022
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (15); BE (1)