NCT04778397

Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 258 (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 effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Magrolimab	Administered intravenously (IV).
DRUG	Venetoclax	Administered orally at a dose of 100 milligrams (mg) on Day 1, 200 mg on Day 2, 400 mg on Days 3-28 during Cycle 1, followed by 400 mg on Days 1-28 during every cycle (Cycle=28 days).
DRUG	Azacitidine	Administered either subcutaneously (SC) or IV, 75 milligrams per square meter (mg/m\^2) on Days 1-7 or Days 1-5, 8 and 9 during every cycle (Cycle=28 days).
DRUG	Cytarabine	Induction: administered continuous infusion, 100 or 200 mg/m\^2 on Days 1-7 (7+3 induction) and if needed Days 1-5 (5+2 induction) during a cycle (Cycle=Up to 42 Days). Consolidation: administered IV, 1500 or 3000 mg/m\^2 on Days 1, 3, and 5 once every 12 hours for up to 4 cycles.
DRUG	Daunorubicin	Administered IV peripherally (IVP), 60 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).
DRUG	Idarubicin	Administered IV, 12 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).
DRUG	Steroidal Eye Drops	Administered per institutional standard during consolidation.

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-03-25
• Completion: 2024-03-25
• First posted: 2021-03-03
• Last updated: 2025-02-05
• Results posted: 2025-02-05

Locations

156 sites across 15 countries: United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Italy, Japan, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study