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

  • STATUS
    Recruiting
  • End date
    Feb 10, 2025
  • participants needed
    520
  • sponsor
    Gilead Sciences
Updated on 27 October 2021
remission
azacitidine
high 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).

Details
Condition Bone marrow disorder, Preleukemia, MYELODYSPLASTIC SYNDROME, Myelodysplastic Syndromes (MDS), myelodysplastic syndromes, myelodysplastic syndrome (mds)
Treatment Placebo, Azacitidine, Magrolimab
Clinical Study IdentifierNCT04313881
SponsorGilead Sciences
Last Modified on27 October 2021

Eligibility

Yes No Not Sure

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

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 (SIRP)-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
Pregnancy or active breastfeeding
Active hepatitis B virus and/or active hepatitis C virus, and/or HIV following testing at screening
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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