Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia

NCT05079230 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2025-04-04

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Summary

The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy.

Conditions

Interventions

DRUG

Magrolimab

Administered intravenously (IV)

DRUG

Venetoclax

Tablets administered orally

DRUG

Azacitidine

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

DRUG

Placebo

Administered intravenously (IV)

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
2022-07-07
Primary Completion
2024-04-11
Completion
2024-04-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Poland
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

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Entities

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 NCT05079230 on ClinicalTrials.gov