Status:
TERMINATED
Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
Lead Sponsor:
Gilead Sciences
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 int...
Eligibility Criteria
Inclusion
- Key
- 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.
- Adequate performance status and hematological, liver, and kidney function.
- Key
Exclusion
- 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.
- Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which participants are not on active anticancer therapies and have had no evidence of active malignancy for at least ≥ 1 year.
- 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.
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2023
Estimated Enrollment :
539 Patients enrolled
Trial Details
Trial ID
NCT04313881
Start Date
September 9 2020
End Date
September 13 2023
Last Update
June 27 2024
Active Locations (169)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
2
University of Arkansas for Medical Sciences IRB
Little Rock, Arkansas, United States, 72205
3
City of Hope
Duarte, California, United States, 91010
4
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093