Etude : ELARA / CTL019E2202



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : ELARA

Nom : CTL019E2202

Traitement : Greffe

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 14/02/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients With Refractory or Relapsed Follicular Lymphoma

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C82 - Lymphome folliculaire
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.


Study arm:
Experimental: CTL019: tisagenlecleucel single infusion


Main objective of the trial :
Evaluate the efficacy of tisagenlecleucel therapy as measured by CRR determined by IRC

Secondary objectives of the trial:
- Evaluate the efficacy of tisagenlecleucel as measured by additional efficacy measures, including ORR, DOR, PFS and OS
- Evaluate safety of tisagenlecleucel
- Characterize the in vivo cellular kinetics (levels, expansion, persistence) of tisagenlecleucel transduced cells into target tissues (blood, bone marrow, and other tissues if available) and CD3+ tisagenlecleucel cells in peripheral blood, summarized by clinical response
- Characterize the incidence and prevalence of tisagenlecleucel immunogenicity (humoral and cellular)
- Characterize the impact of pre-existing and treatment induced immunogenicity (cellular and humoral) on cellular kinetics, efficacy and safety
- Describe the effect of tisagenlecleucel therapy on Patient reported outcomes (PRO)

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 : - Written informed consent prior to any screening procedures
- ≥18 years of age at the time of ICF signature
- FL (Grade 1, 2, 3A) confirmed histologically by central pathology review before tisagenlecleucel infusion.
- FL meeting one of the following criteria:
* Refractory to a second line or later line of systemic therapy (including anti-CD20 antibodies and alkylating agents) or relapsed within 6 months after completion of a second line or later line of systemic therapy
* Relapsed during anti-CD20 antibody maintenance (following at least two lines of therapies as above) or within 6 months after maintenance completion
* Relapsed after autologous HSCT
- Radiographically measurable disease at screening defined as:
- At least one nodal lesion greater than 20 mm in the long axis, regardless of the length of the short axis AND/OR
- Extranodal lesions (outside lymph node or nodal mass, including liver and spleen) greater than 10 mm in long AND short axis

Critères de non-inclusion : - Evidence of histologic transformation
- Follicular Lymphoma Grade 3B
- Prior anti-CD19 therapy
- Prior gene therapy
- Prior adoptive T cell therapy
- Prior allogeneic hematopoietic stem cell transplant
- Active CNS involvement by malignancy
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03568461
Promoteur :
Novartis Pharmaceuticals
Type de sponsor : Industriel
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Ibrahim YAKOUB-AGHA

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Statut de l'essai : CLOS

MAJ : 14/02/2020