NCT03248479

Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies

A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Patients With Hematological Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are: * To confirm the safety and tolerability of magrolimab monotherapy in a relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) population, and of magrolimab in combination with azacitidine in previously untreated participants with AML or MDS and participants with R/R AML and MDS * To evaluate the efficacy of magrolimab monotherapy in R/R AML/MDS, and of magrolimab in combination with azacitidine in previously untreated participants with AML/MDS, or R/R AML/MDS as measured by complete remission (CR) rate for participants with AML and higher-risk MDS, and duration of complete response for participants with AML and higher-risk MDS, and duration of CR for participants with AML and higher-risk MDS * To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or combination with azacitidine in low-risk MDS participants as measured by red blood cell (RBC) transfusion independence rate

Conditions

• Hematological Malignancies

Interventions

Type	Name	Description
DRUG	Magrolimab	Administered intravenously
DRUG	Azacitidine	Administered according to region-specific drug labeling either subcutaneously or intravenously

Timeline

• Start date: 2017-09-08
• Primary completion: 2023-09-05
• Completion: 2023-09-05
• First posted: 2017-08-14
• Last updated: 2025-01-17
• Results posted: 2025-01-17

Locations

27 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study