Etude ELORA : Etude de phase 2 évaluant l'efficacité et la tolérance de tisagenlecleucel (CTL019) chez des patients ayant une lymphome folliculaire réfractaire ou récidivant.

Résumé

A venir

Population cible

• Type de cancer : traitement symptomatique
• Sexe : hommes et femmes
• Age : Entre 18 ans et 85 ans.

Références de l'essai

• N°RECF : RECF3919
• EudraCT/ID-RCB : 2017-004385-94
• Liens d'intérêt : http://clinicaltrials.gov/show/NCT03568461

Caractéristiques de l'essai

• Type de l'essai : traitement symptomatique
• Essai avec tirage au sort : Oui
• Essai avec placebo : Non
• Phase : 2
• Etendue d'investigation : multicentrique - Monde

Détails plus scientifiques

Titre officiel de l’essai : 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

Résumé à destination des professionnels : A venir

Objectif(s) principal(aux) : Evaluate the efficacy of tisagenlecleucel therapy as measured by CRR determined by IRC

Objectifs secondaires :

• 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)

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: oRefractory 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 oRelapsed during anti-CD20 antibody maintenance (following at least two lines of therapies as above) or within 6 months after maintenance completion oRelapsed 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

Critère(s) d’évaluation principal(aux) : Complete response rate (CRR) [ Time Frame: 2 years ] CRR based on Lugano classification response criteria