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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

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. - 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Magrolimab + Azacitidine 		Participants will receive the following magrolimab and azacitidine dosing regimens: Magrolimab: Magrolimab Priming Dose: 1 mg/kg on Days 1 and 4 15 mg/kg on Day 8 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50) Magrolimab Maintenance Dose: 30 mg/kg on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine: 75 mg/m^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle.
  • Drug: Magrolimab
    Administered intravenously
    Other names:
    • Hu5F9-G4
    • GS-4721
  • Drug: Azacitidine
    Administered either subcutaneously (SC) or intravenously (IV) according to region-specific drug labeling
Placebo Comparator
Control Arm (Placebo + Azacitidine) 		Participants will receive the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo: On Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine: 75 mg/m^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each cycle.
  • Drug: Azacitidine
    Administered either subcutaneously (SC) or intravenously (IV) according to region-specific drug labeling
  • Drug: Placebo
    Placebo to match magrolimab administered intravenously

Recruiting Locations

More Details

NCT ID
NCT04313881
Status
Terminated
Sponsor
Gilead Sciences

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.