NCT05079230

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-07-07
• Primary completion: 2024-04-11
• Completion: 2024-04-11
• First posted: 2021-10-15
• Last updated: 2025-04-04
• Results posted: 2025-04-04

Locations

164 sites across 20 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

Regulatory

• FDA-regulated drug study