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B-Cell Lymphoma RefractoryPhase 2NCT04531046

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

A Phase 2 study testing axicabtagene ciloleucel in people with B-Cell Lymphoma Refractory and B-cell Lymphoma Recurrent, run by The Lymphoma Academic Research Organisation at 16 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
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
62 participants
Where
16 sitesin 2 countries
Study dates
10 Mar 2021to Jun 2026
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

  • 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
Show all 10Show fewer
  • 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)

Who cannot join

  • 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
Show all 20Show fewer
  • 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
  • History of severe immediate hypersensitivity reaction attributed to aminoglycosides, cyclophosphamide and 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 course of the study
  • Women of childbearing potential who are pregnant or breastfeeding (from the time of consent during treatment and for at least 6 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

16 sites in 2 countries.

16 sites in 2 countries

France15 sites

  • CHU de Bordeaux - Hôpital Haut Lévêque

    Bordeaux

  • CHU Clermont Ferrand - Hôpital Estaing

    Clermont-Ferrand

  • APHP - Hôpital Henri Mondor

    Créteil

  • CHU de Dijon - Hôpital le Bocage

    Dijon, 21000

  • Hôpital Claude Huriez

    Lille, 59037

  • Hôpital Saint Eloi

    Montpellier, 34295

  • CHU de Nantes - Hôtel Dieu

    Nantes, 44093

  • APHP - Hôpital Saint Louis

    Paris, 75475

  • Hopital La Pitié Salpétriere

    Paris

  • Hôpital Saint Antoine

    Paris

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Rennes - Hôpital de Pontchaillou

    Rennes, 35003

  • IUCT Oncopole

    Toulouse

  • CHU Brabois

    Vandœuvre-lès-Nancy, 54511

  • Institut de Cancérologie Gustave Roussy

    Villejuif

Other trials in France

Belgium1 site

  • CH Liège

    Liège, 4000

Other trials in Belgium

About this study

Official title: Phase 2, Open-Label Study Evaluating Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B-Non Hodgkin Lymphoma (B-NHL) Who Are Ineligible to Autologous Stem Cell Transplantation

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.

Read the detailed description

Axicabtagene ciloleucel (axi-cel) is a chimeric antigen receptor (CAR) T-cell therapy directed against CD19 which has been approved for the treatment of relapse/refractory diffuse large B-cell lymphoma DLBCL and primary mediastinal large B-cell lymphoma (PMBCL) after 2 or more lines of systemic therapy.

But administrating CAR T-cells earlier in the therapeutic strategy may be beneficial to patients.

Axi-cel will improve the outcome of patients with DLBCL who are refractory or relapse early (i.e. within 1 year from end of treatment) after first-line therapy and who are not eligible for Autologous Stem Cell Transplantation (ASCT).

Transplant-ineligible patients will include those who are deemed ineligible for high-dose chemotherapy and Hematopoietic Stem Cell Transplantation (HSCT) due to age, comorbidity, or prior ASCT.

The primary endpoint will be complete metabolic response (CMR) at 3 months after Axi-cel infusion.

Being tested
axicabtagene ciloleucel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • axicabtagene ciloleucelDrug

    Also called axi-cel

    Patient-specific (autologous) product cryopreserved in cryostorage bag

Study groups in NCT04531046
Study groupRoleWhat they receive
axicabtagene ciloleucelExperimentalSingle infusion administered intravenously at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg
Receives: Drug: axicabtagene ciloleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 months from axi-cel infusion

Secondary outcomes (19)

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

    CMR from axi-cel infusion (without additional anticancer therapy) determined by central imaging review (using the Lugano Response Criteria)

    Measured: 3 months from axi-cel infusion

  2. Best objective response

    Percentage of CMR and Partial MR determined by investigator disease assessment

    Measured: between Day 14 and Month 12

  3. Number of Serious Adverse Events (SAE)

    Measured: at 30 days after axi-cel infusion

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

    Measured: at 3 months

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

    Measured: at 6 months

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

    Measured: at 12 months

  7. Event-free survival (EFS) based on central imaging review

    Measured: at 3 months

  8. Event-free survival (EFS) based on central imaging review

    Measured: at 6 months

  9. Event-free survival (EFS) based on central imaging review

    Measured: at 12 months

  10. Modified EFS (mEFS) based on investigator assessment

    Measured: at 6 months

  11. Modified EFS (mEFS) based on investigator assessment

    Measured: at 12 months

  12. Modified EFS (mEFS) based on central imaging review

    Measured: at 6 months

  13. Modified EFS (mEFS) based on central imaging review

    Measured: at 12 months

  14. Best objective response

    Measured: at 2 years

  15. Best objective response

    Measured: at 3 years

  16. Duration of response (DOR)

    Measured: at 2 years

  17. Duration of response (DOR)

    Measured: at 3 years

  18. Overall survival (OS) from leukaphaeresis and Axi-cel infusion

    Measured: at 2 years

  19. Overall survival (OS) from leukaphaeresis and Axi-cel infusion

    Measured: at 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2020
  2. Study start10 Mar 2021
  3. Primary completion19 Apr 2022
  4. Study completionJun 2026 (estimated)

Resources

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
Model description
open-label, multicenter study
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04531046
Sponsor's protocol ID
ALYCANTE
Status last verified
Mar 2026
First submitted
25 Aug 2020
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41512176

  • 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.

    PubMed 37710005

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing axicabtagene ciloleucel in people with B-Cell Lymphoma Refractory and B-cell Lymphoma Recurrent, run by The Lymphoma Academic Research Organisation at 16 sites in 2 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 10 inclusion and 20 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France, Belgium. 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?

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?

Complete Metabolic Response (CMR) - determined by investigator (time frame: 3 months from axi-cel infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04531046, which also lists 2 linked publications.

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 27 Mar 2026.

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