Overview

Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

Status:
Recruiting
Trial end date:
2025-02-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Forty Seven, Inc.
Gilead Sciences
Treatments:
Azacitidine
Magrolimab
Criteria
Key Inclusion Criteria:

- Previously untreated individuals with intermediate to very high risk Myelodysplastic
Syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R)

- Adequate performance status and hematological, liver, and kidney function

Key Exclusion Criteria:

- Immediate eligibility for allogenic stem cell transplant (SCT), as determined by the
investigator, with an available donor

- Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein
alpha (SIRPĪ±)-targeting agents

- Any prior antileukemic therapy for treatment of intermediate, high, very high risk MDS
per IPSS-R

- Contraindications to azacitidine

- Clinical suspicion of active central nervous system (CNS) involvement by MDS

- Known active or chronic hepatitis B or C infection or human immunodeficiency virus in
medical history

- Active hepatitis B virus and/or active hepatitis C virus, and/or HIV following testing
at screening

- Pregnancy or active breastfeeding

Note: Other protocol defined Inclusion/Exclusion criteria may apply.