GILEAD-GS-US-546-5857-AML: A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine versus Venetoclax plus Azacitidine in Previously Untreated Patients with TP53 Mutant AML who are Inel

Protocol No

GILEAD-GS-US-546-5857-AML

Principal Investigator

Guru Subramanian Guru Murthy

Phase

III

Summary

The purpose of this study is to compare the effects of Magrolimab in combination with Azacitidine to those of Venetoclax in combination with Azacitidine, or to a standard 7+3 regimen (chemotherapy of Daunorubicin or Idarubicin in combination with Cytarabine) to find out which is better for treating patients with AML who have mutations in the TP53 gene.

Description

Magrolimab plus Azacitidine vs Venetoclax plus Azacitidine in Previously Untreated TP53 Mutant AML

Participating Institutions

Froedtert Hospital

Status

IRB INITIAL APPROVAL

Sub Category

Hematologic/Blood Related Cancers

ClinicalTrials.gov

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GILEAD-GS-US-546-5857-AML: A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine versus Venetoclax plus Azacitidine in Previously Untreated Patients with TP53 Mutant AML who are Ineligible for Intensive Induction Chemotherapy