Etude : TIRHOL / BGB-A317-210



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Acronyme / Nom
Situation thérapeutique
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme / Nom : TIRHOL / BGB-A317-210

Situation thérapeutique : Induction

Traitement : Immunothérapie

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 15/01/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Étude multicentrique de phase 2, en ouvert, évaluant le tislélizumab (BGB-A317) chez des patients atteints de lymphome de Hodgkin classique en rechute ou réfractaire

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C81 - Lymphome de Hodgkin
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The primary objective of the study is to evaluate the efficacy of tislelizumab in participants with relapsed/refractory classical Hodgkin lymphoma, as measured by the overall response rate per the Lugano Classification, and as determined by the investigator.

Experimental: Cohort 1: Tislelizumab Monotherapy Post HSCT
Participants with relapsed or refractory Classical Hodgkin Lymphoma (cHL) who have failed to achieve a response or progressed after autologous hematopoietic stem cell transplantation (HSCT) and failed to achieve a response or progressed after brentuximab vedotin

Experimental: Cohort 2: Tislelizumab Monotherapy Post Chemotherapy
Participants with relapsed or refractory cHL who have received at least 2 prior systemic chemotherapy regimens, and are not candidates for autologous or allogeneic HSCT due to disease refractory to salvage chemotherapy (did not achieve a Partial Response (PR) or Complete Response (CR)) and failed to achieve a response or progressed after brentuximab vedotin

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 : - Histologically confirmed diagnosis of relapsed or refractory cHL
- Relapsed cHL (disease progression after PR or CR to the most recent therapy) or refractory cHL (failure to achieve PR or CR to most recent therapy). Participants will be allocated to one of two cohorts based on the following criteria:
-> i) Cohort 1: Relapsed or refractory to prior autologous hematopoietic stem cell transplant (HSCT) and brentuximab vedotin
-> ii) Cohort 2: Relapsed or refractory to salvage chemotherapy, including brentuximab vedotin, and has not received prior autologous or allogeneic HSCT
* Is not a candidate for autologous or allogeneic HSCT due to disease refractory to salvage chemotherapy (did not achieve a PR or CR)
* Has received at least 2 prior systemic chemotherapy regimens for cHL and failed to achieve a response or progressed after brentuximab vedotin
- Measurable disease defined as ≥ 1 2-[18F] fluoro-2-deoxy-D-glucose (FDG)-avid nodal lesion that is > 1.5 cm in the longest diameter, or ≥ 1 FDG-avid extra-nodal lesion (eg, hepatic nodules) that is > 1 cm in the longest diameter
- Eastern Cancer Oncology Group (ECOG) performance status of 0 or 1

Critères de non-inclusion : - Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma
- Prior allogeneic hematopoietic stem cell transplantation
- Prior therapy targeting PD-1 or PD-L1, anti-PD-L2, or anti CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) agent
- Active autoimmune disease or history of autoimmune disease that may relapse
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04318080
Promoteur :
BeiGene
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 :
Caroline SEREE
seree-c@chu-caen.fr

Statut de l'essai : OUVERT

MAJ : 11/12/2020