This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first. Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study. The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion. The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
golcadomide 0.3 mg weekly from D+5 post CAR T-cells administration until D+166
Hopital Henri Mondor
Créteil, France
RECRUITINGChu Dijon Bourgogne
Dijon, France
RECRUITINGChu de Grenoble
La Tronche, France
RECRUITINGChru de Lille
Lille, France
RECRUITINGInstitut Paoli Calmettes
Marseille, France
RECRUITINGChu de Montpellier
Montpellier, France
RECRUITINGChu de Nantes
Nantes, France
RECRUITINGHopital Saint-Louis
Paris, France
RECRUITINGChu de Bordeaux
Pessac, France
RECRUITINGChu Pontchaillou
Rennes, France
RECRUITING...and 3 more locations
Complete metabolic response rate (CMR rate)
efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion
Time frame: 3 months
Objective response rate (ORR)
incidence of either a complete (CMR) or a partial (PMR) metabolic response per the Lugano Classification (Cheson 2014) as determined by study investigators
Time frame: at 1 month, 3 months, 6 months, 1 year and 2 years, from CAR-T infusion
Objective response rate (ORR)
determined by imaging central review
Time frame: at 1 month and 3 months
Complete response rate (CRR)
percentage of complete response determined by investigator assessment classification
Time frame: at 1 Month, 6 Months, 1 year, and 2 years
Duration of response (DR)
time from attainment of PMR or CMR to the date of first documented disease progression/relapse (based on investigator disease assessment (INV)) or death from any cause
Time frame: 2 years
Event-free survival (EFS)
the time between CAR T-cells injection and death, disease progression, or start of subsequent new anti-lymphoma therapy including Stem Cell Transplant (SCT)
Time frame: 2 years
Progression-free survival (PFS)
time from CAR T-cells injection to the first observation of documented disease progression/relapse (based on investigator disease assessment (INV)) or death
Time frame: 2 years
Time To Next anti-Lymphoma Treatment (TTNLT)
from the date of CAR T-cells injection to the date of first documented administration of any new anti-lymphoma treatment
Time frame: 2 years
Overall survival (OS)
from date of CAR T-cells injection to the date of death
Time frame: 2 years
Incidence of Adverse Events and Serious Adverse events
Time frame: 2 years
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