Dose Optimization Study of Idelalisib in Follicular Lymphoma

Official Title

Dose Optimization Study of Idelalisib in Follicular Lymphoma

Summary:

The primary objective of this study is to establish a safe and effective dosing regimen of idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options.

Trial Description

Primary Outcome:

  • Overall Response Rate (ORR)
  • Incidence of Grade ≥ 4 Treatment-Emergent Adverse Events (TEAEs)
Secondary Outcome:
  • Duration of Response (DOR)
  • Overall Response Rate by Week 24
  • Overall Safety Profile of Idelalisib
  • Time to onset of adverse events of interest (AEI)
  • Progression-Free Survival (PFS)
  • Overall Survival (OS)
  • Idelalisib Trough (pre-dose) and Peak (1.5-hour samples) Plasma Concentrations

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society