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
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
The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy.
Key Inclusion Criteria:
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:
≥ 75 years of age; Or
≥ 18 to 74 years of age with at least 1 of the following comorbidities:
ECOG performance status:
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.
Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment
Pretreatment blood cross-match completed
Key Exclusion Criteria:
Prior treatment with any of the following:
cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα)-targeting agents
Antileukemic therapy for the treatment of AML (eg, hypomethylating agents (HMAs), low-dose cytarabine, and/or venetoclax), excluding hydroxyurea
Clinical suspicion of or documented active central nervous system (CNS) involvement with AML
Individuals who have acute promyelocytic leukemia
Second malignancy, except MDS, treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anticancer therapies and have had no evidence of active malignancy for at least 1 year
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Duarte, California 91010, United States
Baltimore, Maryland 21201, United States
Hackensack, New Jersey 07601, United States
New York, New York 10029, United States
Chapel Hill, North Carolina 27514, United States
Winston-Salem, North Carolina 27103, United States
Woden, Australian Capital Territory 2606, Australia
Sydney, New South Wales 2217, Australia
Montreal, H1T 2M4, Canada
Jihormoravsky KRAJ, 625 00, Czechia
Prague, 100 34, Czechia
Prague, 128 08, Czechia
Berlin, 13353, Germany
Braunschweig, 38114, Germany
Düsseldorf, 40225, Germany
Düsseldorf, 40479, Germany
Hanover, 30625, Germany
Minden, 32429, Germany
Ulm, 89070, Germany
Hong Kong, Hong Kong
Hajdu-bihar, 4032, Hungary
Pesaro, 61122, Italy
Amsterdam, 1081 HV, Netherlands
Lodz, 93-510, Poland
Lublin, 20090, Poland
Opole, 45-372, Poland