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

Not Recruiting

Trial ID: NCT04313881


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).

Official Title

ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome

Stanford Investigator(s)

Peter Greenberg
Peter Greenberg

Professor of Medicine (Hematology), Emeritus


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.


drug: Azacitidine

drug: Magrolimab

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jack Taw

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