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Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

NCT04313881 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 539

Last updated 2024-06-27

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).

Conditions

Interventions

DRUG

Magrolimab

Administered intravenously

DRUG

Azacitidine

Administered either subcutaneously (SC) or intravenously (IV) according to region-specific drug labeling

DRUG

Placebo

Placebo to match magrolimab administered intravenously

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2023-09-13
Completion
2023-09-13
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Portugal
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT04313881 on ClinicalTrials.gov