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

Status
Closed
Cancer Type
Cancer-Related Syndrome
Leukemia
Myelodysplastic Syndromes (MDS)
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04313881
Protocol IDs
5F9009 (primary)
NCI-2020-03406
2020-004287-26
Study Sponsor
Gilead

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).

Eligibility

  1. Participants with Myelodysplastic Syndrome (MDS) defined according to World Health Organization classification, with Revised International Prognostic Scoring System (IPSS-R) prognostic risk category of intermediate, high, or very high risk.
  2. Adequate performance status and hematological, liver, and kidney function

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.