NCT04778410

Study of Magrolimab Combinations in Participants With Myeloid Malignancies

A Phase 2 Multi-Arm Study of Magrolimab Combinations in Patients With Myeloid Malignancies

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to learn more about the safety and dosing of the study drug, magrolimab (Mag), in combination with anti-leukemia therapies in participants with acute myeloid leukemia (AML).

Detailed description

The anti-leukemia therapies are defined as follows: * Venetoclax (Ven) * Azacitidine (Aza) * Mitoxantrone, etoposide, and cytarabine (MEC) This study consists of 3 safety run-in cohorts; * Safety Run-in Cohort 1 (1L Unfit AML Mag + Ven + Aza) * Safety Run-in Cohort 2 (R/R AML Mag + MEC) * Safety Run-in Cohort 3 (Post-chemo Maintenance Mag + CC-486) Participants will receive treatment at the assigned dose level for at least 4 cycles in the Safety Run-in cohorts, after which they may continue at the assigned dose level or switch to the RP2D upon agreement between the investigator and the sponsor. After completion of each safety run-in cohort and identification of the RP2D for that cohort, participants may be enrolled into the corresponding Phase 2 cohorts; * Phase 2 Cohort 1 (1L Unfit AML Mag + Ven + Aza) * Phase 2 Cohort 2 (R/R AML Mag + MEC) * Phase 2 Cohort 3 (Post-chemo Maintenance Mag + CC-486) Cycle length is 28 days for both the Safety Run-in and Phase 2 cohorts. Note: All cohorts are closed to screening and enrollment.

Conditions

• Myeloid Malignancies

Interventions

Type	Name	Description
DRUG	Magrolimab	Administered intravenously
DRUG	Azacitidine	Administered either subcutaneously or IV, 75 mg/milligram per square (m\^2) on Days 1 to 7 or Days 1 to 5, 8 and 9 during every cycle
DRUG	Venetoclax	Administered orally at a dose of 100 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
DRUG	Mitoxantrone	Administered intravenously, 8 mg/m\^2 on Days 1-5 during Cycle 1 to Cycle 3
DRUG	Etoposide	Administered intravenously, 100 mg/m\^2 on Days 1-5 during Cycle 1 to Cycle 3
DRUG	Cytarabine	Administered intravenously, 1000 mg/m\^2 on Days 1-5 during Cycle 1 to Cycle 3
DRUG	CC-486	Administered orally, 300 mg on Days 1-14 during each cycle

Timeline

• Start date: 2021-06-28
• Primary completion: 2024-03-04
• Completion: 2024-03-04
• First posted: 2021-03-03
• Last updated: 2025-03-20
• Results posted: 2025-03-20

Locations

21 sites across 3 countries: United States, Australia, United Kingdom

Regulatory

• FDA-regulated drug study