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

March 19, 2024 updated by: Gilead Sciences

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).

Study Overview

Status

Terminated

Study Type

Interventional

Enrollment (Actual)

539

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Gosford Hospital
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Icon Cancer Foundation
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Center
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Health
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Frankston, Victoria, Australia, 3199
        • Peninsula Private Hospital
      • Geelong, Victoria, Australia, 3220
        • Barwon Health, University Hospital Geelong
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital Malvern
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Salzburg, Austria, 5020
        • Uniklinikum Salzburg
      • Vienna, Austria, 1140
        • Hanusch kranhenkaus, 3. Medizinische Abteilung
      • Antwerpen, Belgium, 2060
        • ZNA Middelheim
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium
        • UZ Brussel
      • Brussels, Belgium, 1070
        • ULB Hopital Erasme
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Turnhout, Belgium, 2300
        • AZ Turnhout, Campus St. Elisabeth
      • Yvoir-Godinne, Belgium, 5530
        • Chu Ucl Namur Site Godinne
      • Calgary, Canada, T2N 4N2
        • Tom Baker Cancer Centre
      • Halifax, Canada, B3H 2Y9
        • QEII Health Sciences Centre
      • St. John's, Canada, A1B 3V6
        • Eastern Regional Health Authority
      • Toronto, Canada, M5G 2M9
        • University Health Network
      • Olomouc, Czechia, 77520
        • Fakultni nemocnice Olomouc, Hemato-onkologicka klinika
      • Ostrava, Czechia, 70852
        • Fakultni nemocnice Ostrava, Klinika hemato-onkologicka
      • Helsinki, Finland, 00290
        • Helsinki University Central Hospital
      • Oulu, Finland, 90220
        • Oulu University Hospital
      • Amiens Cedex 1, France, 80054
        • CHU Amiens-Picardie
      • Creteil, France, 94010
        • Hôpital Henri Mondor
      • La Tronche, France, 38700
        • CHU de Grenoble Alpes
      • Marseille, France
        • Institut Paoli Calmettes
      • Montpellier, France, 34295
        • Hopital Saint Eloi
      • Nantes, France, 44000
        • CHU de Nantes
      • Nice, France, 6200
        • CHU de Nice-l Archet
      • Paris, France, 75475
        • Hôpital Saint Louis
      • Paris, France, 94805
        • Institut Gustave Roussy
      • Pessac Cedex, France, 33604
        • Hôpital Haut-Lévêque
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86000
        • CHU de Poitiers - Hopital de la Miletrie
      • Rennes Cedex 9, France, 35033
        • CHU de Rennes- Hopital Pontchaillou
      • Braunschweig, Germany, 38114
        • Universitatsmedizin der Johannes Gutenberg Universitat Mainz, III. Medizinische Klinik und Poliklinik
      • Dresden, Germany, 01307
        • Universitatsklinikum Carl Gustav Carus
      • Duesseldorf, Germany
        • Marien hospital, klinik fur onkologie, hamatologie und palliavmedizin
      • Essen, Germany, 45122
        • Universitätsklinikum Essen
      • Leipzig, Germany
        • Universitat Leipzig
      • Stuttgart, Germany, 70376
        • Robert-Bosch-Krankenhaus, GmBH, Hamatologie, Onkologie und Palliativmedizin
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Hong Kong Sanatorium & Hospital
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital
      • Hong Kong, Hong Kong
        • The Chinese University of Hong Kong, Prince of Wales Hospital
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem Belgyógyászati és Hematológiai Kilnika
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Gyor, Hungary, 9024
        • Petz Aladar Egyetemi Oktato Korhaz II. Belgyogyaszat - Hematologial Osztaly
      • Kaposvar, Hungary
        • Kaposi Mor Teaching Hospital
      • Kecskemet, Hungary, 6000
        • Bács-Kiskun Megyei Kórház
      • Nyiregyhaza, Hungary, 4400
        • SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
      • Pecs, Hungary, 7624
        • University of Pecs
      • Tatabanya, Hungary, 2800
        • Szent Borbála Hospital
      • Alessandria, Italy, 15100
        • SC Ematologica- Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo
      • Brescia, Italy
        • U.O Ematologica- ASST degli Spedali Civili di Brescia
      • Firenze, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi
      • Milan, Italy, 20122
        • U.O.C Ematologia - Dipartimento di Medicina Interna, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
      • Monza, Italy, 20052
        • U.O di Ematologia, Ospedale San Gerardo- ASST Monza
      • Novara, Italy, 28100
        • S. C. Ematologia Azienda Ospedaliero - Universitaria Maggiore Della Carita
      • Pesaro, Italy, 61100
        • Azienda Ospedaliera Ospedali Riuniti Marche Nord
      • Terni, Italy, 05100
        • SC di Oncoematologia - Azienda Ospedaliera Santa Maria
      • Varese, Italy, 21100
        • SC Ematologica, ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi
      • Groningen, Netherlands, 9700 RB
        • University Medical Center Groningen
      • Leeuwarden, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
      • Dunedin, New Zealand, 9016
        • Southern District Health Board
      • Grafton, New Zealand, 1142
        • Auckland City Hospital
      • Hamilton, New Zealand, 3240
        • Waikato Hospital
      • Palmerston North, New Zealand, 4414
        • Midcentral District Health Board
      • Bergen, Norway, 5021
        • Haukeland Universitetssjukehus, seksjon for blodsjukdommar- klinisk studieteam
      • Loerenskog, Norway, 1478
        • Akershus University Hospital
      • Oslo, Norway, 0372
        • Oslo University Hospital
      • Stavanger, Norway, 4068
        • Stavanger universitetssjukehus
      • Krakow, Poland, 31-501
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii
      • Lublin, Poland, 20090
        • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
      • Wroclaw, Poland, 50-367
        • Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
      • Braga, Portugal, 4710
        • Centro Clinico Academico de Braga, Hospital de Braga, E.P.E
      • Lisbon, Portugal, 1400 - 038
        • Champalimaud Foundation
      • Lisbon, Portugal, 1500-650
        • Hospital da Luz
      • Porto, Portugal, 4200-072
        • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
      • Porto, Portugal, 4200 319
        • Centro Hospitalar Universitario Sao Joao. E.P.E
      • Porto, Portugal, 4430-999
        • Centro Hospitalar Vila Nova de Gaia/Espinho
      • A Coruña, Spain
        • Area Sanitaria de Santiago de Compostela y Barbanza. Complejo Hospitalario Universitario de SantiagoD
      • Alava, Spain
        • OSI Araba, Hospital Universitario de Alava, Hospital Txagorritxu
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'hebron
      • Girona, Spain, 17007
        • Institut Catala d'Oncologia Girona
      • L´Hospitalet de Llobregat, Spain
        • Institut Catala d'Oncologia, Hospital Duran i Reynals
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center Madrid
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz, Edificio General, 6 Planta. Despacho de Hematologia
      • Madrid, Spain
        • Hospital Universitario Quironsalud Madrid. Servico de Hematologica y Hemoterapia
      • Malaga, Spain
        • Hospital Regional Universitario de Málaga
      • Pamplona, Spain, 31008
        • Centro Hospitalar Universitario Sao Joao
      • Salamanca, Spain
        • Complejo Asistencial Universitario de Salamanca- Hospital Clinico Universitario de Salamanca
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen Del Rocio
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Bellinzona, Switzerland, 6500
        • Istituto Oncologico Della Svizzera Italiana- IOSI, EOC, Clinica di Ematologia
      • Bern, Switzerland, 3010
        • University of Bern
      • Zurich, Switzerland, 8091
        • Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie
      • Ankara, Turkey, 06200
        • Hematoloji Bilim Dali, Yenimahalle
      • Ankara, Turkey, 06560
        • Gazi Universitesi Tip Fakultesi
      • Ankara, Turkey, 06620
        • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
      • Inciralt, Turkey, 35340
        • Dokuz Eylul Universitesi Tip Fakultesi Onkoloji Enstitusu
      • Mersin, Turkey, 33110
        • Mersin University Medical
      • Tekirdag, Turkey, 59100
        • Tekirdag Namik Kemal Universitesi Tip Fakultesi
      • Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust
      • Boston, United Kingdom, PE21 9QS
        • United Lincolnshire Hospital NHS Trust
      • Canterbury, United Kingdom, CT1 3NG
        • Kent and Canterbury Hospital- East Kent Hospitals University NHS Foundation Trust
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Birmingham
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences IRB
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • La Jolla, California, United States, 92093
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, United States, 90095
        • UCLA Ronald Reagan Medical Center
      • Orange, California, United States, 92868
        • UC Irvine Health
      • Palo Alto, California, United States, 94305
        • Stanford Cancer Institute
      • Sacramento, California, United States, 95817
        • University of California, Davis Comprehensive Cancer Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinics / Sylvester Comprehensive Cancer Center
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center
    • Kansas
      • Fairway, Kansas, United States, 66205
        • University of Kansas Clinical Research Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Greenebaum Comprehensive Cancer Center
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute (DFCI)
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical School
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center, Fairview
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Mid America Division, Inc.
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine - Siteman Cancer Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10029
        • Mount Sinai Health System
      • New York, New York, United States, 10021
        • Weill Cornell Medicine-New York Presbyterian Hospital
      • New York, New York, United States, 10032
        • Columbia University Medical Center - Herbert Irving Pavilion
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina At Chapel Hill
      • Durham, North Carolina, United States, 27705
        • DUHS Duke Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center / James Cancer Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University Pharmacy Services
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University, Sidney Kimmel Cancer Center; Clinical Research Organization
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Prisma Health Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A. Simmons Cancer Center
      • Dallas, Texas, United States, 39090
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute/University of Utah
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98019
        • Seattle Cancer Care Alliance
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital & the Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magrolimab + Azacitidine

Participants 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.

Administered intravenously
Other Names:
  • GS-4721
  • Hu5F9-G4
Administered either subcutaneously (SC) or intravenously (IV) according to region-specific drug labeling
Placebo Comparator: Control Arm (Placebo + Azacitidine)

Participants 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Complete Remission (CR)
Time Frame: From randomization up to 31.01 months
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.
From randomization up to 31.01 months
Overall Survival (OS)
Time Frame: From randomization up to 32.62 months
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.
From randomization up to 32.62 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of CR (DOCR)
Time Frame: From randomization up to 31.01 months
DOCR=Time from first CR date to the first date of relapse, disease progression (PD) or death, 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.
From randomization up to 31.01 months
Objective Response Rate (ORR)
Time Frame: From randomization up to 31.01 months

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.

From randomization up to 31.01 months
Duration of Response (DOR)
Time Frame: From randomization up to 31.01 months

DOR is measured from time measurement criteria are first met for objective response to first date of relapse, disease progression (PD) /death, whichever occurs earlier.

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

From randomization up to 31.01 months
Red Blood Cell (RBC) Transfusion Independence Rate
Time Frame: From randomization up to 31.01 months
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.
From randomization up to 31.01 months
Event Free Survival (EFS)
Time Frame: From randomization up to 31.01 months

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

From randomization up to 31.01 months
Percentage of Participants With CR Rate in Participants With TP53 Mutation
Time Frame: From randomization up to 31.01 months
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.
From randomization up to 31.01 months
Minimal Residual Disease (MRD)-Negative Response Rate
Time Frame: From randomization up to 31.01 months

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. Transformation assessments post SCT were to be included in the analysis.

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

Percentages were rounded off.

From randomization up to 31.01 months
Time to Transformation to AML
Time Frame: From randomization up to 31.01 months
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. KM estimates were used for analysis.
From randomization up to 31.01 months
Progression Free Survival (PFS)
Time Frame: From randomization up to 31.01 months

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.

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

From randomization up to 31.01 months
Functional Assessment of Cancer Therapy-Anemia (FACT-Anemia) Response Rate
Time Frame: Up to week 136

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.

Up to week 136
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time Frame: First dose date up to 135.9 weeks plus 70 days (Up to 2.8 years)

Treatment-emergent adverse events (TEAEs) are 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 anticancer therapy including SCT (whichever is earlier). If the AE onset date is on or before the last dose date, the AE is considered as TEAE regardless of the start of new anticancer therapy.

An AE is 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.

An event is considered "serious", if it results in any of the following outcomes: death, life-threatening, inpatient or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, and important medical events.

First dose date up to 135.9 weeks plus 70 days (Up to 2.8 years)
Serum Concentration of Magrolimab
Time Frame: Preinfusion on Days 0, 7, 28, 56, 112, 168, 252 and 336
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.
Preinfusion on Days 0, 7, 28, 56, 112, 168, 252 and 336
Percentage of Participants With Positive Anti-magrolimab Antibodies
Time Frame: 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
Percentages were rounded off.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2020

Primary Completion (Actual)

September 13, 2023

Study Completion (Actual)

September 13, 2023

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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