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

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).

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

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society