AzTrials
AzTrials

Myelodysplastic SyndromesPhase 3ENHANCENCT04313881

Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

A Phase 3 study testing Magrolimab and Azacitidine in people with Myelodysplastic Syndromes, run by Gilead Sciences at 169 sites in 21 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 primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
Magrolimab and Azacitidine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
539 participants
Where
169 sitesin 21 countries
Study dates
9 Sep 2020to 13 Sep 2023
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

  • Participants with Myelodysplastic Syndrome (MDS) defined according to World Health Organization classification, with Revised International Prognostic Scoring System (IPSS-R) prognostic risk category of intermediate, high, or very high risk.
  • Adequate performance status and hematological, liver, and kidney function.

Who cannot join

  • Immediate eligibility for allogenic stem cell transplant (SCT), as determined by the investigator, with an available donor.
  • Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents.
  • Any prior antileukemic therapy for treatment of intermediate, high, very high risk MDS per IPSS-R.
  • Second malignancy, except treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which participants are not on active anticancer therapies and have had no evidence of active malignancy for at least ≥ 1 year.
  • Contraindications to azacitidine.
  • Clinical suspicion of active central nervous system (CNS) involvement by MDS.
Show all 10Show fewer
  • Known active or chronic hepatitis B or C infection or human immunodeficiency virus in medical history .
  • Active hepatitis B virus and/or active hepatitis C virus, and/or HIV following testing at screening.
  • Pregnancy or active breastfeeding.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

169 sites in 21 countries.

169 sites in 21 countries

United States47 sites

  • University of Michigan Medical School

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Maryland, Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute (DFCI)

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • The Ohio State University Wexner Medical Center / James Cancer Hospital

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center

    Dallas, Texas, 39090

  • Texas Oncology - Baylor Charles A. Simmons Cancer Center

    Dallas, Texas, 75246

  • City of Hope

    Duarte, California, 91010

  • DUHS Duke Cancer Center

    Durham, North Carolina, 27705

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

  • Prisma Health Cancer Center

    Greenville, South Carolina, 29615

  • Baylor College of Medicine

    Houston, Texas, 77030

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mid America Division, Inc.

    Kansas City, Missouri, 64132

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • University of Arkansas for Medical Sciences IRB

    Little Rock, Arkansas, 72205

  • UCLA Ronald Reagan Medical Center

    Los Angeles, California, 90095

  • University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Froedtert Hospital & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota Medical Center, Fairview

    Minneapolis, Minnesota, 55455

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Tulane Medical Center

    New Orleans, Louisiana, 70112

  • Weill Cornell Medicine-New York Presbyterian Hospital

    New York, New York, 10021

  • Mount Sinai Health System

    New York, New York, 10029

  • Columbia University Medical Center - Herbert Irving Pavilion

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • UC Irvine Health

    Orange, California, 92868

  • Stanford Cancer Institute

    Palo Alto, California, 94305

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University, Sidney Kimmel Cancer Center; Clinical Research Organization

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Oregon Health & Science University Pharmacy Services

    Portland, Oregon, 97239

  • University of California, Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98019

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Australia16 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Flinders Medical Center

    Bedford Park, South Australia, 5042

  • Eastern Health

    Box Hill, Victoria, 3128

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Peninsula Private Hospital

    Frankston, Victoria, 3199

  • Barwon Health, University Hospital Geelong

    Geelong, Victoria, 3220

  • Gosford Hospital

    Gosford, New South Wales, 2250

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Cabrini Hospital Malvern

    Malvern, Victoria, 3144

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Icon Cancer Foundation

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Spain15 sites

  • Area Sanitaria de Santiago de Compostela y Barbanza. Complejo Hospitalario Universitario de SantiagoD

    A Coruña

  • OSI Araba, Hospital Universitario de Alava, Hospital Txagorritxu

    Alava

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Institut Catala d'Oncologia Girona

    Girona, 17007

  • Institut Catala d'Oncologia, Hospital Duran i Reynals

    L'Hospitalet de Llobregat

  • MD Anderson Cancer Center Madrid

    Madrid, 28033

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario La Paz, Edificio General, 6 Planta. Despacho de Hematologia

    Madrid, 28046

  • Hospital Universitario Quironsalud Madrid. Servico de Hematologica y Hemoterapia

    Madrid

  • Hospital Regional Universitario de Malaga

    Málaga

  • Centro Hospitalar Universitario Sao Joao

    Pamplona, 31008

  • Complejo Asistencial Universitario de Salamanca- Hospital Clinico Universitario de Salamanca

    Salamanca

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

France13 sites

  • CHU Amiens-Picardie

    Amiens, 80054

  • Hopital Henri Mondor

    Créteil, 94010

  • CHU de Grenoble Alpes

    La Tronche, 38700

  • Institut Paoli Calmettes

    Marseille

  • Hopital Saint Eloi

    Montpellier, 34295

  • CHU de Nantes

    Nantes, 44000

  • CHU de Nice-l Archet

    Nice, 6200

  • Hopital Saint Louis

    Paris, 75475

  • Institut Gustave Roussy

    Paris, 94805

  • Hopital Haut-Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Poitiers - Hopital de la Miletrie

    Poitiers, 86000

  • CHU de Rennes- Hopital Pontchaillou

    Rennes, 35033

Other trials in France

Italy9 sites

  • SC Ematologica- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo

    Alessandria, 15100

  • U.O Ematologica- ASST degli Spedali Civili di Brescia

    Brescia

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

  • U.O.C Ematologia - Dipartimento di Medicina Interna, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • U.O di Ematologia, Ospedale San Gerardo- ASST Monza

    Monza, 20052

  • S. C. Ematologia Azienda Ospedaliero - Universitaria Maggiore Della Carita

    Novara, 28100

  • Azienda Ospedaliera Ospedali Riuniti Marche Nord

    Pesaro, 61100

  • SC di Oncoematologia - Azienda Ospedaliera Santa Maria

    Terni, 05100

  • SC Ematologica, ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Hungary8 sites

  • Semmelweis Egyetem Belgyógyászati és Hematológiai Kilnika

    Budapest, 1125

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032

  • Petz Aladar Egyetemi Oktato Korhaz II. Belgyogyaszat - Hematologial Osztaly

    Győr, 9024

  • Kaposi Mor Teaching Hospital

    Kaposvár

  • Bács-Kiskun Megyei Kórház

    Kecskemét, 6000

  • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

  • University of Pecs

    Pécs, 7624

  • Szent Borbála Hospital

    Tatabánya, 2800

Other trials in Hungary

Belgium7 sites

  • ZNA Middelheim

    Antwerp, 2060

  • ULB Hopital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Brussel

    Brussels

  • Chu Ucl Namur Site Godinne

    Godinne, 5530

  • UZ Leuven

    Leuven, 3000

  • AZ Turnhout, Campus St. Elisabeth

    Turnhout, 2300

Other trials in Belgium

Germany6 sites

  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz, III. Medizinische Klinik und Poliklinik

    Braunschweig, 38114

  • Universitatsklinikum Carl Gustav Carus

    Dresden, 01307

  • Marien hospital, klinik fur onkologie, hamatologie und palliavmedizin

    Düsseldorf

  • Universitatsklinikum Essen

    Essen, 45122

  • Universitat Leipzig

    Leipzig

  • Robert-Bosch-Krankenhaus, GmBH, Hamatologie, Onkologie und Palliativmedizin

    Stuttgart, 70376

Other trials in Germany

Portugal6 sites

  • Centro Clinico Academico de Braga, Hospital de Braga, E.P.E

    Braga, 4710

  • Champalimaud Foundation

    Lisbon, 1400 - 038

  • Hospital da Luz

    Lisbon, 1500-650

  • Centro Hospitalar Universitario Sao Joao. E.P.E

    Porto, 4200 319

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

  • Centro Hospitalar Vila Nova de Gaia/Espinho

    Porto, 4430-999

Other trials in Portugal

Turkey (Türkiye)6 sites

  • Hematoloji Bilim Dali, Yenimahalle

    Ankara, 06200

  • Gazi Universitesi Tip Fakultesi

    Ankara, 06560

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

    Ankara, 06620

  • Dokuz Eylul Universitesi Tip Fakultesi Onkoloji Enstitusu

    Inciralt, 35340

  • Mersin University Medical

    Mersin, 33110

  • Tekirdag Namik Kemal Universitesi Tip Fakultesi

    Tekirdağ, 59100

Other trials in Turkey (Türkiye)

Hong Kong5 sites

  • Hong Kong Sanatorium & Hospital

    Hong Kong

  • Princess Margaret Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • The Chinese University of Hong Kong, Prince of Wales Hospital

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

Other trials in Hong Kong

New Zealand5 sites

  • Christchurch Hospital

    Christchurch, 8011

  • Southern District Health Board

    Dunedin, 9016

  • Auckland City Hospital

    Grafton, 1142

  • Waikato Hospital

    Hamilton, 3240

  • Midcentral District Health Board

    Palmerston North, 4414

Other trials in New Zealand

Canada4 sites

  • Tom Baker Cancer Centre

    Calgary, T2N 4N2

  • QEII Health Sciences Centre

    Halifax, B3H 2Y9

  • Eastern Regional Health Authority

    St. John's, A1B 3V6

  • University Health Network

    Toronto, M5G 2M9

Other trials in Canada

Norway4 sites

  • Haukeland Universitetssjukehus, seksjon for blodsjukdommar- klinisk studieteam

    Bergen, 5021

  • Akershus University Hospital

    Loerenskog, 1478

  • Oslo University Hospital

    Oslo, 0372

  • Stavanger universitetssjukehus

    Stavanger, 4068

Other trials in Norway

United Kingdom4 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH

  • United Lincolnshire Hospital NHS Trust

    Boston, PE21 9QS

  • Kent and Canterbury Hospital- East Kent Hospitals University NHS Foundation Trust

    Canterbury, CT1 3NG

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU

Other trials in United Kingdom

Poland3 sites

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii

    Krakow, 31-501

  • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

    Lublin, 20090

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-367

Other trials in Poland

Switzerland3 sites

  • Istituto Oncologico Della Svizzera Italiana- IOSI, EOC, Clinica di Ematologia

    Bellinzona, 6500

  • University of Bern

    Bern, 3010

  • Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie

    Zurich, 8091

Other trials in Switzerland

Austria2 sites

  • Uniklinikum Salzburg

    Salzburg, 5020

  • Hanusch kranhenkaus, 3. Medizinische Abteilung

    Vienna, 1140

Other trials in Austria

Czechia2 sites

  • Fakultni nemocnice Olomouc, Hemato-onkologicka klinika

    Olomouc, 77520

  • Fakultni nemocnice Ostrava, Klinika hemato-onkologicka

    Ostrava, 70852

Other trials in Czechia

Finland2 sites

  • Helsinki University Central Hospital

    Helsinki, 00290

  • Oulu University Hospital

    Oulu, 90220

Other trials in Finland

Netherlands2 sites

  • University Medical Center Groningen

    Groningen, 9700 RB

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

Other trials in Netherlands

About this study

Official title: ENHANCE: A Randomized, Double-blind, Multicenter Study Comparing Magrolimab in Combination With Azacitidine Versus Azacitidine Plus Placebo in Treatment-naïve Patients With Higher Risk Myelodysplastic Syndrome

The primary objective of this study is to evaluate the efficacy of magrolimab in combination with azacitidine compared to that of azacitidine plus placebo in previously untreated participants with intermediate/high/very high risk myelodysplastic syndrome (MDS) by Revised International Prognostic Scoring System (IPSS-R) as measured by complete remission (CR) and overall survival (OS).

Being tested
Magrolimab, Azacitidine, Placebo
Medical subject headings
Myelodysplastic Syndromes

What participants receive

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

  • MagrolimabDrug

    Also called Hu5F9-G4, GS-4721

    Administered intravenously

  • AzacitidineDrug

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

  • PlaceboDrug

    Placebo to match magrolimab administered intravenously

Study groups in NCT04313881
Study groupRoleWhat they receive
Magrolimab + AzacitidineExperimentalParticipants will receive the following magrolimab and azacitidine dosing regimens: Magrolimab: Magrolimab Priming Dose: * 1 mg/kg on Days 1 and 4 * 15 mg/kg on Day 8 * 30 mg/kg on Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50) Magrolimab Maintenance Dose: * 30 mg/kg on Day 57 and 30 mg/kg every 2 weeks thereafter. Azacitidine: 75 mg/m^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each 28-day cycle.
Receives: Drug: Magrolimab; Drug: Azacitidine
Control Arm (Placebo + Azacitidine)Placebo comparatorParticipants will receive the following placebo dosing regimens to mirror magrolimab dosing regimen in addition to azacitidine: Placebo: On Days 1 and 4; Day 8; Days 11, 15, followed by weekly administration for 5 doses (on Days 22, 29, 36, 43, and 50). Additionally, placebo was administered on Day 57 and every 2 weeks thereafter. Azacitidine: 75 mg/m^2 on Days 1 to 7 (or Days 1 to 5 and 8 to 9) of each cycle.
Receives: Drug: Azacitidine; Drug: Placebo

What is being measured

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

  1. Percentage of Participants With Complete Remission (CR)

    The percentage of participants (CR rate) are participants who reach morphologic CR (morphological blast of ≤ 5% and recovery of absolute neutrophil count (ANC), platelets, and hemoglobin from complete blood counts as well as peripheral blast) based on Investigator-assessed International Working Group (IWG) myelodysplastic syndrome (MDS) criteria on or prior to initiation of any new anticancer therapy, including stem cell therapy (SCT). Percentages were rounded off.

    Measured: From randomization up to 31.01 months

  2. Overall Survival (OS)

    OS is defined as the number of months measured from the date of randomization to the date of death from any cause. Kaplan Meier (KM) estimates were used for analysis.

    Measured: From randomization up to 32.62 months

Secondary outcomes (13)

  1. Duration of CR (DOCR)

    DOCR=Time from first CR date to the first date of relapse, disease progression (PD) or death, prior to initiation of any new anticancer therapy excluding SCT whichever occurs earlier. PD is defined as: <5% blasts: ≥50 increase in blasts to >5% blasts,5%-10% blasts: ≥50% increase in blasts to >10% blasts, 10%-20% blasts: ≥50% increase in blasts to >20% blasts,20%-30% blasts: ≥50% increase in blasts to >30% blasts, any of the following: at least 50% decrement from maximum remission/response in granulocytes or platelets. Reduction in Hgb by ≥2 g/dL / Transfusion dependence. Relapse is defined as return to pretreatment bone marrow blast percentage / decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets/ reduction in Hgb concentration by ≥ 1.5 g/dL or transfusion dependence. CR is defined in outcome measure 1. KM estimates were used for analysis.

    Measured: From randomization up to 31.01 months

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants who reach objective response including CR, partial remission (PR), marrow CR or hematological improvement prior to initiation of any new anticancer therapy including SCT for MDS per IWG 2006 criteria per investigator's evaluation. CR is defined in outcome measure 1.

    PR is defined as all CR criteria if abnormal before treatment except, one marrow blasts decreased by ≥ 50% over pretreatment but still > 5% cellularity and morphology not relevant.

    Marrow CR is defined as bone marrow ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment, stable disease with any hematological improvement, peripheral blood: if hematological improvement responses, they were noted in addition to marrow CR.

    Stable Disease: Failure to achieve at least PR, but no evidence of progression for > 8 weeks.

    Percentages were rounded off.

    Measured: From randomization up to 31.01 months

  3. Duration of Response (DOR)

    DOR is measured from time measurement criteria are first met for objective response to first date of relapse, disease progression (PD) /death, prior to initiation of any new anticancer therapy excluding SCT whichever occurs earlier.

    Disease progression and relapse have been defined in outcome measure number 3. KM estimates were used for analysis.

    Measured: From randomization up to 31.01 months

  4. Red Blood Cell (RBC) Transfusion Independence Rate

    RBC transfusion independence rate is defined as the percentage of participants who have a 56-day or longer period with no RBC transfusions at any time between randomization and initiation of any new anticancer therapy, including SCT, among all participants who were RBC transfusion-dependent at Baseline. Percentages were rounded off.

    Measured: From randomization up to 31.01 months

  5. Event Free Survival (EFS)

    EFS is defined as the time from randomization to transformation to acute myeloid leukemia (AML) or death from any cause, whichever occurs first.

    Transformation assessments and deaths post SCT were included in the analysis. KM estimates were used for analysis

    Measured: From randomization up to 31.01 months

  6. Percentage of Participants With CR in Participants With TP53 Mutation

    CR in TP53 mutant population is defined as the percentage of participants who achieve a morphologic CR based on investigator assessments using IWG criteria on or prior to initiation of any new anticancer therapy, including SCT in TP53 mutant population. Percentages were rounded off.

    Measured: From randomization up to 31.01 months

  7. Minimal Residual Disease (MRD)-Negative Response Rate

    The MRD-negative response rate is defined as the percentage of participants who achieved a morphologic CR or marrow CR based on Investigator-assessed IWG criteria and reached MRD-negative disease status prior to initiation of any new anticancer therapy, including SCT. MRD-negative disease status was assessed using a multiparameter flow cytometry-based assay performed by a central laboratory.

    Morphologic CR and marrow CR are defined in outcome measures 1 and 4, respectively.

    Percentages were rounded off.

    Measured: From randomization up to 31.01 months

  8. Time to Transformation to AML

    Time to transformation to AML is defined as the time from randomization to the collection date of bone marrow sample leading to documented AML diagnosis. Transformation assessments post SCT were included in the analysis.KM estimates were used for analysis.

    Measured: From randomization up to 31.01 months

  9. Progression Free Survival (PFS)

    PFS is defined as the time from randomization to the date of documented DP (including treatment failure by IWG criteria or relapse after PR/CR), or death from any cause, whichever occurs first. Response assessments and deaths post SCT were included in the analysis. Treatment failure is defined as, Death during treatment or disease progression characterized by worsening cytopenia, increase in percentage of bone marrow blasts, or progression to a more advanced MDS FAB subtype than pretreatment. Relapse after CR or PR = Return to pretreatment bone marrow blast percentage / Decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets / Reduction in Hgb concentration by ≥ 1.5 g/dL or transfusion dependence.

    CR, PR and PD are defined in outcome measures 1, 4 and 5 respectively. KM estimates were used for analysis.

    Measured: From randomization up to 31.01 months

  10. Functional Assessment of Cancer Therapy-Anemia (FACT-Anemia) Response Rate

    The FACT-Anemia response rate is defined as the percentage of participants who showed clinically meaningful improvement in health-related quality of life (HRQoL) based on the score from the FACT-Anemia instrument prior to initiation of any new anticancer therapy, including SCT. The minimal clinically meaningful difference of 7.0 was used as cutoff for clinically meaningful improvement.

    The FACT-Anemia instrument consists of 5 subscales, including physical well-being, emotional well-being, functional well-being, social well-being, and anemia symptoms. Each subscale measures items on a 5-point Likert scale from 0 to 4, where 0 = not at all and 4 = very much. The subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 indicates the poorest quality of life (QOL) and 100 denotes the highest QOL.

    Percentages were rounded off.

    Measured: Up to week 136

  11. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)

    TEAE's are defined as any AEs with an onset date on or after the study drug start date, no later than 70 days after study drug last dose date or day before initiation of new anticancer therapy including SCT. If AE onset date is on or before last dose date, it is considered as TEAE regardless of start of new anticancer therapy. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with use of an investigational product or other protocol imposed intervention, regardless of attribution. An event is considered "serious", if it results death, life-threatening, inpatient or prolongation hospitalization, incapacity or substantial disruption of the ability to conduct normal functions, a congenital anomaly/birth defect, and important medical events.

    Measured: First dose date up to 135.9 weeks plus 70 days (Up to 2.8 years)

  12. Serum Concentration of Magrolimab

    Pretreatment assessments for the initial dose may be collected up to 72 hours before administration of study treatment; thereafter, pretreatment assessments are to be collected within 24 hours prior to study treatment administration.

    Measured: Preinfusion on Days 0, 7, 28, 56, 112, 168, 252 and 336

  13. Percentage of Participants With Positive Anti-magrolimab Antibodies

    Percentages were rounded off.

    Measured: Up to 72 hours before administration of any treatment at Day 1, Cycle 1; within 24 hours prior to any study drug administration at Day 1 of Cycles 2, 3, 5, 7, 10, and 13 and End of Treatment (± 7 Days after last study drug dose); Cycle length is 28 Days

Timeline

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

  1. First posted18 Mar 2020
  2. Study start9 Sep 2020
  3. Primary completion13 Sep 2023
  4. Study completion13 Sep 2023

Why it stopped: Study discontinued due to futility based on a planned analysis

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
539 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04313881
Sponsor's protocol ID
5F9009
Other IDs
2020-004287-26
Acronym
ENHANCE
Status last verified
Jun 2024
First submitted
11 Mar 2020
Last updated
27 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sallman DA, Garcia-Manero G, Daver N, Abboud CN, Stein E, Larkin K, Halpern AB, McCurdy SR, Al Malki MM, Subramanian Guru Murthy G, Silverman LR, Larson RA, Greenberg P, Gojo I, Wrobel T, Platzbecker U, Forsyth C, Vachhani P, Dong M, Shao J, Johnson LDS, Tan A, Lee C, Doshi P, Vyas P, Wei AH. Magrolimab Plus Azacitidine Versus Placebo Plus Azacitidine in Patients With Untreated Higher-Risk Myelodysplastic Syndromes: The Phase III ENHANCE Study. J Clin Oncol. 2026 Jul 13:JCO2500617. doi: 10.1200/JCO-25-00617. Online ahead of print.

    PubMed 42441929

  • Sallman DA, Al Malki MM, Asch AS, Wang ES, Jurcic JG, Bradley TJ, Flinn IW, Pollyea DA, Kambhampati S, Tanaka TN, Zeidner JF, Garcia-Manero G, Jeyakumar D, Komrokji R, Lancet J, Kantarjian HM, Gu L, Zhang Y, Tan A, Chao M, O'Hear C, Ramsingh G, Lal I, Vyas P, Daver NG. Magrolimab in Combination With Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes: Final Results of a Phase Ib Study. J Clin Oncol. 2023 May 20;41(15):2815-2826. doi: 10.1200/JCO.22.01794. Epub 2023 Mar 8.

    PubMed 36888930

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Magrolimab and Azacitidine in people with Myelodysplastic Syndromes, run by Gilead Sciences at 169 sites in 21 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 2 inclusion and 10 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 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in United States, Australia, Spain, France, Italy and 16 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 21 Mar 2024). 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?

Percentage of Participants With Complete Remission (CR) (time frame: From randomization up to 31.01 months). The study lists 2 primary outcomes in all. 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 NCT04313881, 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 27 Jun 2024.

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