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Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated MDS

Trial Status: In Review

This is a randomized, double-blind, placebo-controlled multicenter study investigating magrolimab + azacitidine compared to placebo + azacitidine in previously untreated patients with intermediate / high / very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R). The Primary objective is to evaluate the efficacy of magrolimab + azacitidine, compared to that of placebo + azacitidine, in previously untreated patients with intermediate / high / very high risk MDS by IPSS-R as measured by Complete Remission (CR) and duration of CR.

Inclusion Criteria

  • Previously untreated patients with intermediate to very high risk MDS by Revised International Prognostic Scoring System (IPSS-R)
  • Adequate performance status and hematological, liver, and kidney function

Exclusion Criteria

  • Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein
  • alpha (SIRPα)-targeting agents
  • Any prior antileukemic therapy
  • Contraindications to azacitidine
  • Clinical suspicion of active CNS involvement by MDS
  • Known active or chronic hepatitis B or C infection or human immunodeficiency virus.
  • Pregnancy or active breastfeeding

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: IN_REVIEW
Contact: Bruck Habtemariam
Phone: 310-794-0242

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: IN_REVIEW

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: IN_REVIEW

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Forty Seven, Inc.

  • Primary ID 5F9009
  • Secondary IDs NCI-2020-03406
  • Clinicaltrials.gov ID NCT04313881