Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Funding Agency/Sponsor
Industrial
Disease
Leukemia
Enrollment Eligibility
Key Inclusion Criteria:
- Participants with Myelodysplastic Syndrome (MDS) defined according to World Health
Organization classification, with Revised International Prognostic Scoring System
(IPSS-R) prognostic risk category of intermediate, high, or very high risk.
- 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
- Second malignancy, except treated basal cell or localized squamous skin carcinomas,
localized prostate cancer, or other malignancies for which participants are not on
active anticancer therapies and have had no evidence of active malignancy for at least
≥ 1 year
- 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.