drugset / Trial / 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

NCT04778397

Phase 3 Terminated 258 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2021-07-01
Primary completion
2024-03-25
Completion
2024-03-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cytarabine Small molecule 1500 mg/m2 Intravenous
Comparator Cytarabine Small molecule 3000 mg/m2 Intravenous
Comparator Daunorubicin Small molecule 60 mg/m2 Intravenous
Comparator Idarubicin Small molecule 12 mg/m2 Intravenous
Subject Magrolimab Monoclonal antibody Intravenous
Comparator Venetoclax Small molecule 400 mg Oral
Background Azacitidine Other / unclassified 75 mg/m2 Subcutaneous