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

NCT04745832 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-11-04

Study results available
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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.

Conditions

Interventions

DRUG

Zandelisib

Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3

DRUG

Rituximab

Rituximab IV 375 mg/m2 for 6 cycles

DRUG

Bendamustine

Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles

DRUG

CHOP

Cyclophosphamide, Vindcristine IV, and Prednisone daily orally

Sponsors & Collaborators

  • Kyowa Kirin, Inc.

    collaborator INDUSTRY

  • MEI Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-13
Primary Completion
2023-03-20
Completion
2023-03-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Georgia
  • Greece
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Poland
  • Serbia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04745832 on ClinicalTrials.gov