Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Titre officiel

A Modular Phase II, Open-Label, Multicentre Study to Assess the Efficacy and Safety of Capivasertib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL)


This study is an open-label, multicentre Phase II study of capivasertib administered orally in participants with Relapsed or Refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).

Description de l'essai

Primary Outcome:

  • Proportion of participants with objective response
Secondary Outcome:
  • Duration of response (DoR)
  • Progression-free survival
  • Overall survival (OS)
  • Change from baseline in health-related quality of life as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
  • Proportion of participants reporting symptomatic adverse events (AEs) and overall side effect burden at each time point as measured by Patient Global Impression of Treatment Tolerability (PGI-TT)
  • Change in National Cancer Institute patient-reported outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) symptoms
  • Time to first subsequent therapy or death (TFST)
  • Time to objective response (TTR)
  • Number of participants with AEs and Serious adverse events
  • Observed lowest drug concentration reached before the next dose is administered (Ctrough) of capivasertib
  • Plasma concentration of capivasertib post-dose
The study protocol follows a modular design. The study will investigate the safety and efficacy of capivasertib monotherapy in participants with R/R Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL).

Voir cet essai sur

Intéressé(e) par cet essai?

Imprimez cette page et apportez-la chez votre médecin pour discuter de votre admissibilité à cet essai et des options de traitement. Seul votre médecin peut vous recommander pour un essai clinique.


Société canadienne du cancer

Ces ressources sont fournies en partenariat avec Société canadienne du cancer