Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated to either the Experimental Arm or the Placebo Comparator Arm.
In the Experimental Arm, participants will receive magrolimab + venetoclax + azacitidine. Magrolimab will be administered intravenously at a dose of 1mg/kg priming dose on Days 1 and 4; 15mg/kg on Day 8; and 30mg/kg on Days 11, 15 and then every week for 5 doses and every 2 weeks after that. Venetoclax will be administered orally at a dose of 100mg on Cycle 1 Day 1, 200mg on Cycle 1 Day 2, 400mg on Cycle 1 Day 3 and daily after that. Azacitidine will be administered either subcutaneously or intravenously, at a dose of 75mg/m^2 on Days 1-7 or Days 1-5 and 8-9 of each cycle. Each cycle is 28 days.
In the Placebo Comparator Arm, participants will receive a magrolimab placebo + venetoclax + azacitidine. Magrolimab placebo will be given intravenously on Days 1, 4, 8, 11 and 15, then every week for 5 doses and every 2 weeks after that. Venetoclax and Azacitidine will be administered the same as in the Experimental Arm.
Conditions
This trial is treating people with acute myeloid leukaemia
Eligibility
Inclusion
-
Previously untreated individuals with histological confirmation of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity. Individuals must be considered ineligible for intensive chemotherapy, defined by the following:
-
Individuals with white blood cell (WBC) count ≤ 20 x 10^3/μL prior to randomization. If the individual's WBC is > 20 x10^3/μL prior to randomization, the individual can be enrolled, assuming all other eligibility criteria are met. However, the WBC should be ≤ 20 x 10^3/μL prior to the first dose of study treatment and prior to each magrolimab/placebo dose during Cycle 1.
- Note: Individuals can be treated with hydroxyurea and/or leukapheresis prior to randomization and throughout the study to reduce the WBC to ≤ 20 x 10^3/μL to enable eligibility for study drug dosing
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Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment
- Note: Transfusions are allowed to meet hemoglobin eligibility
- Pretreatment blood cross-match completed
Exclusion
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
- You are able to swallow medication by mouth.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- 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 Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
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