Acute Myeloid Leukemia Clinical Trial
Study Evaluating the Safety and Effectiveness Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia (AML)
Summary
The primary objectives of this study are to compare the efficacy of magrolimab + venetoclax + azacitidine versus placebo + venetoclax + azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.
Eligibility Criteria
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:
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3
Diffusing capacity of the lung of carbon monoxide ≤ 65% or forced expiratory volume in 1 second ≤ 65%
Left ventricular ejection fraction ≤ 50%
Baseline creatinine clearance ≥ 30 mL/min to < 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection
Hepatic disorder with total bilirubin > 1.5 x upper limit of normal (ULN)
Any other comorbidity that the investigator judges to be incompatible with intensive chemotherapy
ECOG performance status:
Of 0 to 2 for individuals ≥ 75 years of age Or
Of 0 to 3 for individuals ≥ 18 to 74 years of age
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
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
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
Note: Individuals with prior MDS who have not received prior HMAs or venetoclax or chemotherapeutic agents for MDS may be enrolled in the study. Prior treatment with myelodysplastic syndrome (MDS) therapies including, but not limited to lenalidomide, erythroid-stimulating agents, or similar red blood cell negative (RBC-), white blood cell negative (WBC-), or platelet-direct therapies or growth factors is allowed for these individuals.
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.
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There are 78 Locations for this study
Little Rock Arkansas, 72205, United States
Duarte California, 91010, United States
Fresno California, 93730, United States
Jacksonville Florida, 32207, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21201, United States
Kansas City Missouri, 64132, United States
Hackensack New Jersey, 07601, United States
New Brunswick New Jersey, 08901, United States
Winston-Salem North Carolina, 27103, United States
Cleveland Ohio, 44106, United States
Providence Rhode Island, 02903, United States
Fort Sam Houston Texas, 78234, United States
Houston Texas, 77030, United States
Seattle Washington, 98101, United States
Milwaukee Wisconsin, 53226, United States
Albury New South Wales, 2640, Australia
Liverpool New South Wales, 2170, Australia
Sydney New South Wales, 2217, Australia
Southport Queensland, 4215, Australia
Box Hill Victoria, 3128, Australia
Linz , , Austria
Wien , 1130, Austria
Antwerp , 2060, Belgium
Gent , 9000, Belgium
Haine-Saint-Paul , 7100, Belgium
Liege , 4000, Belgium
Halifax , B3H 1, Canada
Jihormoravsky KRAJ , 625 0, Czechia
Ostrava , 70852, Czechia
Prague , 100 3, Czechia
Praha 2 , 128 0, Czechia
Angers , 49033, France
Bobigny , 93000, France
Creteil , 94010, France
Lille Cedex , 59037, France
Nantes , 44093, France
Paris , 75010, France
Pierre-Bénite , 69495, France
Toulouse , 31059, France
Vandoeuvre-les-Nancy , 54500, France
Düsseldorf , 40479, Germany
Flensburg , 24939, Germany
Hannover , 30625, Germany
Ulm , 89070, Germany
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Budapest , 1083, Hungary
Jerusalem , 91120, Israel
Petah Tikva , 49100, Israel
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 138-7, Korea, Republic of
Seoul , 6591, Korea, Republic of
's-Hertogenbosch , 5223G, Netherlands
Amersfoort , 3813 , Netherlands
Amsterdam , 1081 , Netherlands
Breda , 4818 , Netherlands
Den Haag , 2545A, Netherlands
Groningen , 9700 , Netherlands
Leeuwarden , 8934 , Netherlands
Maastricht , 62002, Netherlands
Nieuwegein , 3435 , Netherlands
Nijmegen , 6532 , Netherlands
Rotterdam , 3000 , Netherlands
Oslo , 0424, Norway
Lublin , 20090, Poland
Opole , 45-37, Poland
Alava , , Spain
Barcelona , 08036, Spain
Cordoba , 14004, Spain
Madrid , 28009, Spain
Madrid , 28041, Spain
Madrid , 28041, Spain
Madrid , , Spain
Madrid , , Spain
Malaga , 29010, Spain
Salamanca , 37007, Spain
Santiago de Compostela , 15706, Spain
Valencia , 46026, Spain
Taipei , 10002, Taiwan
Taipei , 11490, Taiwan
Newcastle upon Tyne , NE7 7, United Kingdom
Oxford , OX3 7, United Kingdom
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