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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. ;


Study Design


Related Conditions & MeSH terms


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

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