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

ID#: NCT04313881

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: September 09, 2020

End Date: February 01, 2025

Contact Information:
Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
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).
Eligibility: 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 (SIRPα)-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.