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.

Updated on

Cancer type(s) :

  • Relapsed follicular lymphoma

Specialty(ies) :

  • Pharmacologie - Recherche de Transfert

Sex :

hommes et femmes

Age category :

Entre 18 ans et 85 ans.

Sponsor :

Novartis Pharma

Trial status :

clos aux inclusions

Trial progress :

Ouverture prévue le : -
Ouverture effective le : 12/11/2018
Fin d'inclusion prévue le : 25/02/2025
Fin d'inclusion effective le : 24/11/2020
Dernière inclusion le : -
Nombre d'inclusions prévues:
France: -
Tous pays: 113
Nombre d'inclusions faites :
France: -
Tous pays: 98
Nombre de centre prévus :
France: 2
Tous pays: 30

Summary

A venir

Target population

  • Type of cancer : Relapsed follicular lymphoma
  • Sex : hommes et femmes
  • Age : Entre 18 ans et 85 ans.

Trial references

  • RECF No. : RECF3919
  • EudraCT/ID-RCB : 2017-004385-94
  • Interest links : http://clinicaltrials.gov/show/NCT03568461

Trial characteristics

  • Type of trial : traitement symptomatique
  • Randomized trial : Oui
  • Placebo-controlled trial : Non
  • Phase : 2
  • Scope of investigation : multicentrique - Monde

More scientific details

Official trial title : 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

Summary for professionals : A venir

Primary objective(s) : Evaluate the efficacy of tisagenlecleucel therapy as measured by CRR determined by IRC

Secondary objectives :

  • 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)

Inclusion criteria :

  • 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

Exclusion criteria :

  • 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

Primary evaluation criteria : Complete response rate (CRR) [ Time Frame: 2 years ] CRR based on Lugano classification response criteria