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.

View Eligibility Criteria

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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

432

Study ID:

NCT05079230

Recruitment Status:

Recruiting

Sponsor:

Gilead Sciences

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There are 49 Locations for this study

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University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte California, 91010, United States
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States
MidAmerica Division, Inc., c/o Research Medical Center
Kansas City Missouri, 64132, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Wake Forest Baptist Health
Winston-Salem North Carolina, 27103, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Virginia Mason Franciscan Health
Seattle Washington, 98101, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Border Medical Oncology Research Unit
Albury New South Wales, 2640, Australia
Liverpool Hospital
Liverpool New South Wales, 2170, Australia
St George Hospital, Clinical Research Unit Haemotology, Division of Cancer Services
Sydney New South Wales, 2217, Australia
Monash University, Eastern Health-Box Hill Hospital
Box Hill Victoria, 3128, Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz , , Austria
Wiener Gesundheitsverbund, Klinik Hietzing
Wien , 1130, Austria
Ziekenhuis Netwerk Antwerp (ZNA) - Stuivenberg
Antwerp , 2060, Belgium
University Hospital Gent
Gent , 9000, Belgium
Hopital de Jolimont
Haine-Saint-Paul , 7100, Belgium
Fakultni nemocnice Ostrava, Klinika hematoonkologie
Ostrava , 70852, Czechia
Fakulti nemocnice Kralovske Vinohrady, Internf hematologicka klinika FNKV a 3. LF UK
Prague , 100 3, Czechia
Hopitaux Universitaires Henri Mondor
Creteil , 94010, France
Institut Universitaire du Cancer de Toulouse (IUCT)-Oncopole
Toulouse , 31059, France
CHU de Nancy - Hopitaux de Brabois
Vandoeuvre-les-Nancy , 54500, France
Marien Hospital Dusseldorf GmbH, Klinik Fur Onkologie, Hamatologie Und Palliativmedizin
Düsseldorf , 40479, Germany
Malteser Krankenhaus St. Franziskus Hospital,Med.Klinik I
Flensburg , 24939, Germany
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong , , Hong Kong
Princess Margaret Hospital
Hong Kong , , Hong Kong
Queen Mary Hospital
Hong Kong , , Hong Kong
Tuen Mun Hospital
Hong Kong , , Hong Kong
Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika
Budapest , 1083, Hungary
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Severance Hospital
Seoul , 120-7, Korea, Republic of
Asan Medical Center
Seoul , 138-7, Korea, Republic of
The Catholic University of Korea Seoul Saint Mary's Hospital
Seoul , 6591, Korea, Republic of
Amsterdam Universitair Medische Centra-Locatie Vrije Universiteit Medisch Centrum
Amsterdam , 1081 , Netherlands
Amphia Hospital, department Oncologie, Route 43
Breda , 4818 , Netherlands
Oslo University Hospital, Department of Hematology
Oslo , 0424, Norway
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli, Oddzial Hematologiczny
Lublin , 20090, Poland
Szpital Wojewodozki w Opolu Sp. z 0.0. Oddzial Klinixzny Hematologii, Onkologii Hematologicznej i Chorob Wemnetrznych
Opole , 45-37, Poland
Hospital Universitario Araba
Alava , , Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital Universitario Reina Sofia
Cordoba , 14004, Spain
Hospital General Universitario Gregorio Maranon
Madrid , 28009, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario La Paz
Madrid , 28041, Spain
Hospital Universitario Quironsalud Madrid
Madrid , , Spain
Hospital Universitario Ramon y Cajal
Madrid , , Spain
Hospital Regional Universitario de Malaga
Malaga , 29010, Spain
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela , 15706, Spain
Hospital Universitari I Politecnic La Fe
Valencia , 46026, Spain
National Taiwan University Hospital
Taipei , 10002, Taiwan
National Cheng Kung University Hospital
Taipei , 11490, Taiwan
Oxford University Hospital NHS Foundation Trust, Churchill Hospital
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

432

Study ID:

NCT05079230

Recruitment Status:

Recruiting

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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