Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
Eligible patients will be randomised to receive magrolimab or a magrolimab-placebo, with 75mg/m^2 azacitidine administered on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each cycle. Magrolimab will be administered via the following dosing regimens - Cycle 1: 1mg/kg priming dose on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and 22. Cycle 2: weekly doses of 30 mg/kg on Days 1, 8, 15, and 22. Cycle 3 and onward: 30 mg/kg every 2 weeks on Days 1 and 15.
Conditions
This trial is treating people with myelodysplastic syndrome
Eligibility
Inclusion
- 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
- 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.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Gilead Sciences, Inc.
Scientific Title
A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome
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