STATUS Terminated

Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia (ENHANCE-3)

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Terminated

GILEAD STUDY ID

GS-US-590-6154

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

April 04, 2025

Clinicaltrials.gov ID

NCT05079230

EudraCT ID

2021-003434-36

STUDY DOCUMENTS

View study documents

OVERVIEW

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 (ENHANCE-3)

PROTOCOL SUMMARY

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.

Participation requirements

Age

18 years +

Sex

All

Healthy Volunteers

Study details

Medical Condition

Acute Myeloid Leukemia

Gender

N/A

Date

July 2022 - April 2024

Study Type

Interventional

Study Phase

Phase 3

Product

Magrolimab, Venetoclax, Azacitidine, Placebo

Eligibility information

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

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.

Locations

Locations (164)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia (ENHANCE-3)

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (164)

University of Arkansas for Medical Sciences

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Community Cancer Institute

UC Irvine Health- Chao Family Comprehensive Cancer Center

Baptist MD Anderson Cancer Center

Moffitt Cancer Center

Loyola University Medical Center

Parkview Research Center

Indiana Blood and Marrow Transplantation - Clinic

The University of Iowa Hospitals and Clinics

University of Maryland, Greenebaum Comprehensive Cancer Center

University of Massachusetts Worcester

MidAmerica Division, Inc., c/o Research Medical Center

SSM Health Saint Louis University Hospital

John Theurer Cancer Center at Hackensack University Medical Center

Rutgers Cancer Institute of New Jersey

New York-Presbyterian/Weill Cornell Medical Center

Icahn School of Medicine at Mount Sinai and The Mount Sinai Hospital

University of Rochester Medical Center

UNC Hospitals, The University of North Carolina at Chapel Hill

Novant Health Cancer Institute Hematology- Charlotte

Novant Health Cancer Institute Hematology - Forsyth

Wake Forest Baptist Health

University Hospitals Cleveland Medical Center

Cleveland Clinic Foundation

OU Health Stephenson Cancer Center

Providence Cancer Institute Franz Clinic

Penn State Hershey Medical Center

Fox Chase Cancer Center

West Penn Hospital

Rhode Island Hospital

Baylor University Medical Center

Brooke Army Medical Center

Houston Methodist Hospital Cancer Center

MD Anderson Cancer Center

Intermountain Health - LDS Hospital

Virginia Mason Franciscan Health

Fred Hutchinson Cancer Center

Froedtert Hospital and the Medical College of Wisconsin

Canberra Hospital

Border Medical Oncology Research Unit

Concord Repatriation General Hospital

Liverpool Hospital

St George Hospital, Clinical Research Unit Haemotology, Division of Cancer Services

Gold Coast University Hospital

Monash University, Eastern Health-Box Hill Hospital

Northern Health

Peter MacCallum Cancer Centre

Ordensklinikum Linz GmbH Elisabethinen

Wiener Gesundheitsverbund, Klinik Hietzing

Hanusch Krankenhaus

Ziekenhuis Netwerk Antwerp (ZNA) - Stuivenberg

Cliniques Universitaires Saint-Luc

University Hospital Gent

Hopital de Jolimont

University Hospital Leuven (UZ Leuven) - Campus Gasthuisberg

Centre Hospitalier Universitaire de Liege

Queen Elizabeth II (QEII) Health Sciences Centre

Centre Integre Universitaire de Sante et de Services Sociaux(CIUSSS) de l'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont

Princess Margaret Cancer Centre - University Health Network

CancerCare Manitoba

Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika FN Brno a LF MU

Fakultni nemocine Olomouc, Hemato-onkologicka klinika

Fakultni nemocnice Ostrava, Klinika hematoonkologie

Fakulti nemocnice Kralovske Vinohrady, Internf hematologicka klinika FNKV a 3. LF UK

Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika, Hematologicka ambulance

CHU Amiens Picardie

CHU d'Angers