SBI-0145-304_TERZO (SECURA BIO)

Étude de phase III, multicentrique, en ouvert, randomisée et contrôlée, évaluant le duvélisib par rapport à la gemcitabine ou à la bendamustine selon le choix de l’investigateur chez des patients atteints d’un lymphome T ganglionnaire de phénotype T helper folliculaire (TFH) en rechute/réfractaire (TERZO)

HomeClinical trialsLymphoïdeLT (Lymphomes et leucémies à cellules T)RechuteSBI-0145-304_TERZO (SECURA BIO)

Objectif

To evaluate the Independent Review Committee (IRC)-determined progression-free survival (PFS) benefit of duvelisib monotherapy as compared to investigator’s choice of gemcitabine or bendamustin

Principaux critères d’inclusion

  • Relapsed or refractory to at least 1 prior systemic, cytotoxic therapy for T cell lymphoma
  • Measurable disease
  • Slides, including positive staining for at least 2 TFH-related antigens (CD279/PD1, CD10, BCL6, CXCL13, ICOS, SAP, and CCR5), should be submitted for central pathology review
  • PS 0-2

Principaux critères d’exclusion

  • Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
  • Cutaneous-only disease
Sector
Lymphoïde
Indication
LT (Lymphomes et leucémies à cellules T)
Treatment line
Rechute
Investigating doctor
Portrait de collaborateur du CHU Lyon Sud
Pr Emmanuel BACHY
Clinical Research Associate
Samuel MOULLE
Are you interested in this trial?

Send your application or questions to the following email address.

Clinical trial.gov link