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

ClinicalTrials.gov ID: NCT04745832

Public ClinicalTrials.gov record NCT04745832. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 25, 2026, 1:05 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04745832
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 3
Lead sponsor: MEI Pharma, Inc.; Industry
Enrollment: 82 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 13, 2021 (Actual)
Primary completion: Mar 20, 2023 (Actual)
Completion: Mar 20, 2023 (Actual)
Last update posted: Nov 4, 2024

2021 – 2023

United States locations

U.S. sites: 14
U.S. states: 9
U.S. cities: 14

Facility	City	State	ZIP	Site status
The Oncology Institute of Hope and Innovation	Tucson	Arizona	85745	—
Orange Coast Memorial Medical Center	Fountain Valley	California	92708	—
Long Beach Memorial Medical Center	Long Beach	California	90806	—
The Oncology Institute of Hope and Innovation	Riverside	California	92506	—
BRCR Medical Center Inc	Hollywood	Florida	33021	—
Henry Ford Hospital	Detroit	Michigan	48202	—
Revive Research Institute	Farmington Hills	Michigan	48334	—
Revive Research Institute	Sterling Heights	Michigan	48314	—
Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center	Springfield	Missouri	65804	—
Inspira Medical Center Mullica Hill	Mullica Hill	New Jersey	08062	—
MetroHealth Medical Center	Cleveland	Ohio	44109	—
Alpha Research Institute, LLC	Baytown	Texas	77521	—
Valley Cancer Associates	Harlingen	Texas	78550	—
Community Cancer Trials of Utah	Ogden	Utah	84405	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 127 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04745832, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 4, 2024 · Synced Oct 25, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04745832 live on ClinicalTrials.gov.

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