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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Patient-specific (autologous) product cryopreserved in cryostorage bag
CH Liège
Liège, Belgium
CHU de Bordeaux - Hôpital Haut Lévêque
Bordeaux, France
CHU Clermont Ferrand - Hôpital Estaing
Clermont-Ferrand, France
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)
Time frame: 3 months from axi-cel infusion
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)
Time frame: 3 months from axi-cel infusion
Best objective response
Percentage of CMR and Partial MR determined by investigator disease assessment
Time frame: between Day 14 and Month 12
Number of Serious Adverse Events (SAE)
Time frame: at 30 days after axi-cel infusion
Event-free survival (EFS) based on investigator disease assessment
Time frame: at 3 months
Event-free survival (EFS) based on investigator disease assessment
Time frame: at 6 months
Event-free survival (EFS) based on investigator disease assessment
Time frame: at 12 months
Event-free survival (EFS) based on central imaging review
Time frame: at 3 months
Event-free survival (EFS) based on central imaging review
Time frame: at 6 months
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APHP - Hôpital Henri Mondor
Créteil, France
CHU de Dijon - Hôpital le Bocage
Dijon, France
Hôpital Claude Huriez
Lille, France
Hôpital Saint Eloi
Montpellier, France
CHU de Nantes - Hôtel Dieu
Nantes, France
APHP - Hôpital Saint Louis
Paris, France
Hopital La Pitié Salpétriere
Paris, France
...and 6 more locations
Event-free survival (EFS) based on central imaging review
Time frame: at 12 months
Modified EFS (mEFS) based on investigator assessment
Time frame: at 6 months
Modified EFS (mEFS) based on investigator assessment
Time frame: at 12 months
Modified EFS (mEFS) based on central imaging review
Time frame: at 6 months
Modified EFS (mEFS) based on central imaging review
Time frame: at 12 months
Best objective response
Time frame: at 2 years
Best objective response
Time frame: at 3 years
Duration of response (DOR)
Time frame: at 2 years
Duration of response (DOR)
Time frame: at 3 years
Overall survival (OS) from leukaphaeresis and Axi-cel infusion
Time frame: at 2 years
Overall survival (OS) from leukaphaeresis and Axi-cel infusion
Time frame: at 3 years