Decision: Favourable

Decisions Table

Study Title:

A Phase 3, Randomized, Open-Label, Controlled, Multicenter 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

  • NREC Code:

    21-NREC-CT-046-NCP

  • Decision:

    Favourable

  • Meeting Date:

    11/08/2021

  • Study Type:

    CT application

  • Principal Investigator:

    Elisabeth Vandenberghe

  • PI Institution:

    St James's Hospital

  • Sponsor:

    Parexel International (IRL) Limited

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