Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Myeloid Malignancies Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Myeloid Malignancies
• Neoplasms

• NCT number: NCT04778410
• Study type: Interventional
• Source: Gilead Sciences
• Status: Completed
• Phase: Phase 2
• Start date: June 28, 2021
• Completion date: March 1, 2024