Etude : REGENERON /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme / Nom
Situation thérapeutique
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme / Nom : REGENERON

Situation thérapeutique : Induction

Traitement : Thérapie ciblée

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 15/01/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude en ouvert visant à évaluer l'activité antitumorale et la sécurité d'emploi du REGN1979, un Ac bispécifique anti-CD20 x anti-CD3, chez des patients atteints de lymphome folliculaire en rechute ou réfractaire

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C82 - Lymphome folliculaire

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C85 - Lymphome non hodgkinien, de types autres et non précisés
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups:
- In patients with follicular lymphoma (FL) grade 1-3a *1,2
- In patients with diffuse large B-cell lymphoma (DLBCL) *1,2
- In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy.
- In patients with marginal zone lymphoma (MZL) *1
- In patients with other B-NHL subtypes *1

Phase : II

Stade : NA

Rechute, Réfractaire
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : ATTENTION LISTE NON EXHAUSTIVE
- For the FL grade 1-3a cohort only:
-> Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).
-> Disease-specific cohorts that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
- DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
- MCL after BTK inhibitor therapy cohort: Patients with MCL who have relapsed after or are refractory to a BTK inhibitor as defined in the protocol
- MZL cohort: Patients with MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
- Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
- Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
- Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI))
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow, hepatic, and renal function as defined in the protocol

Critères de non-inclusion : ATTENTION LISTE NON EXHAUSTIVE
- Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
- Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter.
- History of allogeneic stem cell transplantation
- Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy
- Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
- History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded
- Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent.
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or other uncontrolled infection as defined in the protocol
- Known hypersensitivity to both allopurinol and rasburicase
- Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03888105
Promoteur :
Regeneron Pharmaceuticals
Type de sponsor : Industriel
-
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Institut d'Hématologie Bas-Normand (IHBN) - Avenue de la Cote de Nacre - 14000 CAEN

Investigateur :
Gandhi Laurent DAMAJ

TEC / ARC / IDE :
Emmanuel GIRARD
girard-e@chu-caen.fr

Statut de l'essai : OUVERT

MAJ : 25/11/2020