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

Official Title

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


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).

Trial Description

Primary Outcome:

  • Proportion of Participants with Complete Remission (CR)
  • Overall Survival (OS)
Secondary Outcome:
  • Duration of CR
  • Objective Response Rate (ORR)
  • Duration of Response (DOR)
  • Red Blood Cell (RBC) Transfusion Independence Rate
  • Progression Free Survival (PFS)
  • Event Free Survival (EFS)
  • Minimal Residual Disease (MRD)-negative Response Rate
  • Time to Transformation to Acute Myeloid Leukemia (AML)
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events
  • Serum Concentration of Magrolimab
  • Anti-magrolimab Antibody Positivity Occurrence Rate
  • Functional Assessment of Cancer Therapy-Anemia (FACT-Anemia) Response Rate

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society