Open Actively Recruiting

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

About

Brief 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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Key Inclusion Criteria:

  • Previously untreated individuals with intermediate to very high risk Myelodysplastic Syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R)
  • 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
  • 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.

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Study Stats
Protocol No.
20-000701
Category
Hematology-Oncology
Oncology
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04313881
For detailed technical eligibility, visit ClinicalTrials.gov.