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AzTrials

Acute Myeloid LeukemiaPhase 3ENHANCE-3NCT05079230

Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia

A Phase 3 study testing Magrolimab, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia, run by Gilead Sciences at 164 sites in 20 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Magrolimab, Venetoclax and Azacitidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
378 participants
Where
164 sitesin 20 countries
Study dates
7 Jul 2022to 11 Apr 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
Show all 17Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

164 sites in 20 countries.

164 sites in 20 countries

United States39 sites

  • University of Maryland, Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • UNC Hospitals, The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Novant Health Cancer Institute Hematology- Charlotte

    Charlotte, North Carolina, 28204

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Baylor University Medical Center

    Dallas, Texas, 75246

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

    Duarte, California, 91010

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

  • Community Cancer Institute

    Fresno, California, 93730

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Houston Methodist Hospital Cancer Center

    Houston, Texas, 77030

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana Blood and Marrow Transplantation - Clinic

    Indianapolis, Indiana, 46237

  • The University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

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

    Kansas City, Missouri, 64132

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • New York-Presbyterian/Weill Cornell Medical Center

    New York, New York, 10021

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

    New York, New York, 10029

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • UC Irvine Health- Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Intermountain Health - LDS Hospital

    Salt Lake City, Utah, 84143

  • Virginia Mason Franciscan Health

    Seattle, Washington, 98101

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • SSM Health Saint Louis University Hospital

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Novant Health Cancer Institute Hematology - Forsyth

    Winston-Salem, North Carolina, 27103

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27103

  • University of Massachusetts Worcester

    Worcester, Massachusetts, 01655

Other trials in United States

Germany15 sites

  • Charite - Universitatsmedizin Berlin, Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hamatologie, Onkologie und Tumorimmunologie

    Berlin, 13353

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Städtisches Klinikum Braunschweig GmbH Medizinische Klinik III/Hämatologie und Onkologie

    Braunschweig, 38114

  • Universitatsklinikum Dusseldorf, Klink fur Hamatologie, Onkologie und Klinische Immunologie

    Düsseldorf, 40225

  • Marien Hospital Dusseldorf GmbH, Klinik Fur Onkologie, Hamatologie Und Palliativmedizin

    Düsseldorf, 40479

  • Malteser Krankenhaus St. Franziskus Hospital,Med.Klinik I

    Flensburg, 24939

  • Universitatsklinikum Frankfurt Goethe Universitat Med. Klink II

    Frankfurt, 60590

  • Asklepios Klink St.Georg

    Hamburg, 20099

  • Medizinische Hochschule Hannover, Hamatologie, Hamostaseologie, Onkologie und Stammzelltrandsplantation

    Hanover, 30625

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120

  • Johannes Wesling Klinikum Minden Universitätsklinik fur Hämatologie, Onkologie, Hämostaseologie und Pastativrndezin, Universitatsklinik der Ruhr-Unive

    Minden, 32429

  • Klinikum rechts der Isar Technischen Universitat Munchen

    München, 81675

  • Klinikum Oldenburg, Rahel-Straus-Straße 10

    Oldenburg, 26133

  • Universitatsklinikum Regensburg, Klink fur Innere Medizin III

    Regensburg, 93053

  • Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Klinik fur Innere Medizin III

    Ulm, 89070

Other trials in Germany

France14 sites

  • CHU Amiens Picardie

    Amiens, 80054

  • CHU d'Angers

    Angers, 49033

  • Hopital Avicenne

    Bobigny, 93000

  • Hopitaux Universitaires Henri Mondor

    Créteil, 94010

  • Centre Hospitalier Universitaire Grenoble Alpes

    La Tronche, 38700

  • Centre Hospitalier de Versailles

    Le Chesnay, 78157

  • Hôpital Claude Huriez (CHRU de Lillle)

    Lille, 59037

  • Centre Leon Berard

    Lyon, 69373

  • Centre Hospitalier Universitaire Nantes - Hotel Dieu

    Nantes, 44093

  • Hopital Saint-Louis

    Paris, 75010

  • Centre Hospitalier Lyon-Sud (CHLS)

    Pierre-Bénite, 69495

  • Institut de Cancérologie Strasbourg Europe (ICANS)

    Strasbourg, 67033

  • Institut Universitaire du Cancer de Toulouse (IUCT)-Oncopole

    Toulouse, 31059

  • CHU de Nancy - Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Netherlands12 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223GZ

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

  • Amsterdam Universitair Medische Centra-Locatie Vrije Universiteit Medisch Centrum

    Amsterdam, 1081 HV

  • Amphia Hospital, department Oncologie, Route 43

    Breda, 4818 CK

  • Medisch Spectrum Twente - Enschede Koningsplein

    Enschede, 7512 KZ

  • Universitair Medisch Centrum Groningen

    Groningen, 9700 RB

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

  • Masstricht Universitair Medisch Centrum

    Maastricht, 62002

  • St. Antonius Ziekenhuis, Nieuwegein

    Nieuwegein, 3435 CM

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen, 6532 SZ

  • Erasmus Medisch Centrum

    Rotterdam, 3000 CA

  • HagaZiekenhuis

    The Hague, 2545AA

Other trials in Netherlands

Spain12 sites

  • Hospital Universitario Araba

    Alava

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28041

  • Hospital Universitario Quironsalud Madrid

    Madrid

  • Hospital Universitario Ramon y Cajal

    Madrid

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Complejo Asistencial Universitario de Salamanca - Hospital Clinico

    Salamanca, 37007

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago de Compostela, 15706

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026

Other trials in Spain

United Kingdom11 sites

  • Blackpool Teaching Hospitals NHS Foundation Trust

    Blackpool, FY3 8NR

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol, BS2 8ED

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

  • Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, L7 8YA

  • Barts Health NHS Trust

    London, EC1A 7BE

  • King's College Hospital

    London, SE5 9RS

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Newcastle upon Tyne Hospitals Foundation Trust

    Newcastle upon Tyne, NE7 7DN

  • Oxford University Hospitals NHS Foundation Trust, Churchill Hospital

    Oxford, OX3 7LE

  • South Warwickshire University NHS Foundation Trust

    Warwick, CV34 5BW

  • The Royal Wolverhampton NHS Trust

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Australia9 sites

  • Border Medical Oncology Research Unit

    Albury, New South Wales, 2640

  • Monash University, Eastern Health-Box Hill Hospital

    Box Hill, Victoria, 3128

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Northern Health

    Epping, Victoria, 3076

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • Gold Coast University Hospital

    Southport, Queensland, 4215

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

    Sydney, New South Wales, 2217

  • Canberra Hospital

    Woden, Australian Capital Territory, 2606

Other trials in Australia

Italy7 sites

  • Azienda Ospedaliero Universitaria delle Marche - SOD Clinica di Ematologia

    Ancona, I-60126

  • ASST Papa Giovanni XXIII

    Bergamo, 24127

  • Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi

    Bologna, 40138

  • IRCCS Istituto Clinico Humanitas

    Milan, 20089

  • ASST Monza-Ospedale San Gerardo

    Monza, 20052

  • Azienda Ospedaliera di Perugia - Santa Maria della Misericordia

    Perugia

  • Azienda Sanitaria Territoriale Pesaro e Urbino - "Stabilimento Ospedaliero San Salvatore - Muraglia" - U.O. Ematologia e Centro Trapianti

    Pesaro, 61122

Other trials in Italy

Belgium6 sites

  • Ziekenhuis Netwerk Antwerp (ZNA) - Stuivenberg

    Antwerp, 2060

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • University Hospital Gent

    Ghent, 9000

  • Hopital de Jolimont

    Haine-Saint-Paul, 7100

  • University Hospital Leuven (UZ Leuven) - Campus Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Universitaire de Liege

    Liège, 4000

Other trials in Belgium

Czechia5 sites

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

    Jihormoravsky KRAJ, 625 00

  • Fakultni nemocine Olomouc, Hemato-onkologicka klinika

    Olomouc, 77520

  • Fakultni nemocnice Ostrava, Klinika hematoonkologie

    Ostrava, 70852

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

    Prague, 100 34

  • Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika, Hematologicka ambulance

    Prague, 128 08

Other trials in Czechia

Israel5 sites

  • Rambam Health Care Campus

    Haifa, 31096

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah University Hospital Ein Kerem

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

Other trials in Israel

South Korea5 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Samsung Medical Center

    Seoul, 06351

  • Severance Hospital

    Seoul, 120-752

  • Asan Medical Center

    Seoul, 138-736

  • The Catholic University of Korea Seoul Saint Mary's Hospital

    Seoul, 6591

Other trials in South Korea

Canada4 sites

  • Queen Elizabeth II (QEII) Health Sciences Centre

    Halifax, B3H 1V7

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

    Montreal, H1T 2M4

  • Princess Margaret Cancer Centre - University Health Network

    Toronto, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, R3E 0V9

Other trials in Canada

Hong Kong4 sites

  • Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital

    Hong Kong

  • Princess Margaret Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

Other trials in Hong Kong

Hungary4 sites

  • Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika

    Budapest, 1083

  • Petz Aladár Egyetemi Oktató Kórház II. Belgyógyaszat - Haematológia

    Győr, 9024

  • Debreceni Egyetem Klinikai Központ Belgyogyaszati Klinika B epulet Hematologia

    Hajdu-bihar, 4032

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Kozpont

    Szeged, 6725

Other trials in Hungary

Taiwan4 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • China Medical University Hospital

    Taichung, 404

  • National Taiwan University Hospital

    Taipei, 10002

  • National Cheng Kung University Hospital

    Taipei, 11490

Other trials in Taiwan

Austria3 sites

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz

  • Wiener Gesundheitsverbund, Klinik Hietzing

    Vienna, 1130

  • Hanusch Krankenhaus

    Vienna, 1140

Other trials in Austria

Poland3 sites

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M.Kopernika w Lodzi, Oddzial Hematologii Ogolnej

    Lodz, 93-510

  • Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli, Oddzial Hematologiczny

    Lublin, 20090

  • Szpital Wojewodozki w Opolu Sp. z 0.0. Oddzial Klinixzny Hematologii, Onkologii Hematologicznej i Chorob Wemnetrznych

    Opole, 45-372

Other trials in Poland

Norway1 site

  • Oslo University Hospital, Department of Hematology

    Oslo, 0424

Other trials in Norway

Switzerland1 site

  • Inselspital Universitätsspital Bern

    Bern, 3010

Other trials in Switzerland

About this study

Official 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

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.

Being tested
Magrolimab, Venetoclax, Azacitidine, Placebo
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MagrolimabDrug

    Also called GS-4721

    Administered intravenously (IV)

  • VenetoclaxDrug

    Also called VENCLEXTA®

    Tablets administered orally

  • AzacitidineDrug

    Administered according to region-specific drug labeling, either subcutaneously (SC) or intravenously (IV)

  • PlaceboDrug

    Administered intravenously (IV)

Study groups in NCT05079230
Study groupRoleWhat they receive
Magrolimab + Venetoclax + AzacitidineExperimentalParticipants will receive * magrolimab: 1 mg/kg priming dose on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses and every 2 weeks thereafter * venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter * azacitidine: 75 mg/m^2 on Days 1-7 or Days 1-5 and 8-9 of each cycle Each cycle is 28 days.
Receives: Drug: Magrolimab; Drug: Venetoclax; Drug: Azacitidine
Magrolimab Matching Placebo + Venetoclax + AzacitidinePlacebo comparatorParticipants will receive * magrolimab matching placebo: Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter * venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter * azacitidine: 75 mg/m^2 on Days 1-7 or Days 1-5 and 8-9 of each cycle Each cycle is 28 days.
Receives: Drug: Venetoclax; Drug: Azacitidine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS was measured from the date of randomization to the date of death from any cause. Participants were censored at last known alive date. Kaplan-Meier (KM) estimates were used in outcome measure analysis.

    Measured: Up to 1.6 years

Secondary outcomes (16)

  1. Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh)

    The CR + CRh rate was defined as the percentage of participants who achieved a CR (including CR without minimal residual disease (CRMRD-) and CR with positive or unknown MRD (CRMRD+/unk)) or CRh as defined by CR with partial platelet and absolute neutrophil count recovery within 6 cycles of treatment while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT). CRMRD- and CRMRD+/unk: neutrophils >1.0 ×10^9/L, platelets >100 ×10^9/L, <5% bone marrow blasts, no circulating blasts or extramedullary disease (confirmed by flow cytometry <0.1% sensitivity for CRMRD-) within the response assessment window of 1.6 years. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. Each cycle was of 28 days.

    Measured: Up to 1.6 years

  2. Rate of Complete Remission (CR)

    CR was defined as the percentage of the participants who achieved CR (including CRMRD- and CRMRD+/unk) within 6 cycles of treatment as determined by the investigator while on study prior to initiation of any new anti-acute myeloid leukemia (AML) therapy or stem cell transplant (SCT) within the response assessment window of 1.6 years. Definitions for CRMRD- and CRMRD+/unk were mentioned in outcome measure #2. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. Each cycle was of 28 days.

    Measured: Up to 1.6 years

  3. Event-Free Survival (EFS)

    EFS was defined as time from the date of randomization to the earliest date of the documented relapse from CR, treatment failure (defined as failure to achieve CR within 6 cycles of treatment), or death from any cause within the response window. KM estimates were used in outcome measure analysis. CR is defined in outcome measure 2.

    Measured: Up to 1.6 years

  4. Duration of CR + CRh in Participants Who Achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh)

    The duration of CR + CRh was measured from the time the assessment criteria were first met for CR (including CRMRD- and CRMRD+/unk) or CRh within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT). Those who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse on or prior to the data cut off date within the response assessment window of 1.6 years. Participants started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, duration of CR + CRh were censored at the last response assessment before the initiation of the new anti-AML therapies. CR and CRh are defined in Outcome Measure #2. Each cycle was of 28 days.

    Measured: Up to 1.6 years

  5. Duration of Complete Remission (DCR) in Participants Who Achieved Complete Remission (CR)

    The DCR was measured from the time the assessment criteria were first met for CR (including CRMRD- and CRMRD+/unk) within 6 cycles of treatment until the first date of AML relapse or death (including assessments post SCT). Those who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse on or prior to the data cutoff date within the response assessment window of 1.6 years. Participants started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, DCR were censored at the last response assessment before the initiation of the new anti-AML therapies. KM estimates were used in outcome measure analysis. CRMRD- and CRMRD+/unk are defined in outcome measure #2. Each cycle was of 28 days.

    Measured: Up to 1.6 years

  6. Rate of CR/CRh Without Minimal Residual Disease (CR/CRhMRD-)

    The CR/CRhMRD- rate was the percentage of participants who achieved a CRMRD- or CRhMRD- within 6 cycles of treatment while on study prior to initiation of any new anti-AML therapy or SCT within the response assessment window of 1.6 years. Each cycle was of 28 days. KM estimates were used for outcome measure analysis. CRhMRD- : neutrophils > 0.5 x 10^9/L; platelets > 50 x 10^9/L; bone marrow blasts < 5%; MRD negative (determined using multiparameter flow cytometry with a sensitivity of < 0.1%). Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. Percentages were rounded off.

    Measured: Up to 1.6 years

  7. Rate of CR Without Minimal Residual Disease (CRMRD-)

    The CRMRD- rate was the percentage of participants who achieved a CRMRD- within 6 cycles of treatment SCT within the response assessment window of 1.6 years. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. CRMRD is defined in outcome measure #2. Each cycle was of 28 days. Percentages were rounded off

    Measured: Up to 1.6 years

  8. Red Blood Cell (RBC) Transfusion Independence Conversion Rate

    The RBC transfusion independence conversion rate was the percentage of participants who had a 56-day or longer period with no RBC or whole blood transfusions at any time between the date of the first dose of study treatment and discontinuation of study treatment among all participants who were RBC transfusion dependent at baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis.

    Measured: Up to 1.6 years

  9. Platelet Transfusion Independence Conversion Rate

    The platelet transfusion independence conversion rate was the percentage of participants who had a 56-day or longer period with no platelet transfusions at any time between the date of the first dose of study treatment and discontinuation of study treatment among all participants who were platelet transfusion dependent at baseline. Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis.

    Measured: Up to 1.6 years

  10. Time to First Deterioration (TTD) on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale

    The TTD on the EORTC QLQ-C30 GHS/QoL scale was defined as time from the date of randomization to the time a participant experienced at least 1 threshold value deterioration from baseline or death, whichever was earlier. Questionnaire includes 30 questions resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 GHS/QoL scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). After linear transformation, all scales and single item measures range in score from 0-100. Higher score on GHS/QoL scale meant better GHS/QoL. KM estimates were used in outcome measure analysis.

    Measured: Up to 1.6 years

  11. Time to First Deterioration (TTD) on the EORTC QLQ-C30 Physical Functioning Scale

    The TTD on the EORTC QLQ-C30 physical functioning scale was defined as time from the date of randomization to the time a participant experienced at least 1 threshold value deterioration from baseline or death, whichever is earlier. Physical functioning scale is one of the five functional scales of the EORTC QLQ C30 questionnaire. After linear transformation, scale range in score from 0-100. A higher score on functional scales means better functioning and better quality of life. KM estimates were used in outcome measure analysis.

    Measured: Up to 1.6 years

  12. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

    An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 70 days after the study drug last dose date or the day before initiation of new anti-AML therapy including stem cell transplantation, whichever is earlier. Percentages were rounded-off.

    Measured: First dose date up to 1.4 years plus 70 days

  13. Percentage of Participants Experiencing Grade 3 or Higher Treatment-Emergent Laboratory Abnormalities

    Treatment-emergent laboratory abnormalities were defined as values that increased by at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of the last dose of study drug plus 70 days or the day before the initiation of new anti-AML therapy including SCT, whichever came first, and were summarized by treatment group. Severity grades were defined by the CTCAE Version 5.0. 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Life-Threatening; 5 = Death. Percentages were rounded-off.

    Measured: First dose date up to 1.4 years, plus 70 days

  14. Serum Concentration of Magrolimab Over Time

    Measured: Predose on Day 1, Day 8, Day 15, Day 29; Predose on Day 57 and 1 hour post-dose; Predose on Day 113, Day 169, Day 253, and Day 337.

  15. Percentage of Participants With Anti-Magrolimab Antibodies

    Percentages were rounded off.

    Measured: Up to 1.6 years

  16. Maximum Levels of Serum Anti-Magrolimab Antibodies

    Measured: Up to 1.6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study start7 Jul 2022
  3. Primary completion11 Apr 2024
  4. Study completion11 Apr 2024

Why it stopped: Study was terminated due to futility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079230
Sponsor's protocol ID
GS-US-590-6154
Other IDs
2021-003434-36, MOH_2022-08-15_011983
Acronym
ENHANCE-3
Status last verified
Apr 2025
First submitted
4 Oct 2021
Last updated
4 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Publications

  • Daver N, Vyas P, Huls G, Dohner H, Maury S, Novak J, Papayannidis C, Martinez Chamorro C, Montesinos P, Niroula R, Fenaux P, Esteve J, Wu SJ, De Voeght A, Mayer J, Valk PJM, Johnson L, Dong M, Liu K, Kuwahara S, Caldwell K, Guru Murthy GS. The ENHANCE-3 study: venetoclax and azacitidine plus magrolimab or placebo for untreated AML unfit for intensive therapy. Blood. 2025 Jul 31;146(5):601-611. doi: 10.1182/blood.2024027506.

    PubMed 40233321

  • Daver NG, Vyas P, Kambhampati S, Al Malki MM, Larson RA, Asch AS, Mannis G, Chai-Ho W, Tanaka TN, Bradley TJ, Jeyakumar D, Wang ES, Sweet K, Kantarjian HM, Garcia-Manero G, Komrokji R, Xing G, Ramsingh G, Renard C, Zeidner JF, Sallman DA. Tolerability and Efficacy of the Anticluster of Differentiation 47 Antibody Magrolimab Combined With Azacitidine in Patients With Previously Untreated AML: Phase Ib Results. J Clin Oncol. 2023 Nov 1;41(31):4893-4904. doi: 10.1200/JCO.22.02604. Epub 2023 Sep 13.

    PubMed 37703506

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Magrolimab, Venetoclax and Azacitidine in people with Acute Myeloid Leukemia, run by Gilead Sciences at 164 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 164 sites in United States, Germany, France, Netherlands, Spain and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to 1.6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05079230, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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