Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

Official Title

A Phase 3, Randomized, Open-Label, Controlled, Multicentre Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study

Summary:

This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.

Trial Description

Primary Outcome:

  • Progression Free Survival
Secondary Outcome:
  • Overall Response Rate (ORR)
  • Complete Response Rate (CRR)
  • Overall Survival
  • Number of Treatment Emergent AEs (Zandelisib when combined with Rituximab)
  • Number of SAEs (Zandelisib when combined with Rituximab)
  • Number of Lab Abnormalities (Zandelisib when combined with Rituximab)
This is an open label, randomized, two-arm Phase 3 study in subjects with relapsed or refractory FL and MZL to evaluate efficacy and safety of zandelisib in combination with rituximab in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP). Subjects must have relapsed after at least one previous line of systemic immunochemotherapy. Previous treatments must have included an anti-CD20 monoclonal antibody (mAb) with chemotherapy such as Bendamustine (B), CHOP, CVP, FND, or similar regimens, or an anti-CD20 mAb with Lenalidomide (L). Approximately 534 randomized subjects will be enrolled in this study.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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