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

Primary Purpose

Acute Myeloid Leukemia

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Magrolimab
Venetoclax
Azacitidine
Magrolimab Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Previously untreated individuals with histological confirmation of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity. Individuals must be considered ineligible for intensive chemotherapy, defined by the following:

    • ≥ 75 years of age; Or

    • ≥ 18 to 74 years of age with at least 1 of the following comorbidities:

      • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3
      • Diffusing capacity of the lung of carbon monoxide ≤ 65% or forced expiratory volume in 1 second ≤ 65%
      • Left ventricular ejection fraction ≤ 50%
      • Baseline creatinine clearance ≥ 30 mL/min to < 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection
      • Hepatic disorder with total bilirubin > 1.5 x upper limit of normal (ULN)
      • Any other comorbidity that the investigator judges to be incompatible with intensive chemotherapy

    • ECOG performance status:

      • Of 0 to 2 for individuals ≥ 75 years of age Or
      • Of 0 to 3 for individuals ≥ 18 to 74 years of age

  • Individuals with white blood cell (WBC) count ≤ 20 x 10^3/μL prior to randomization. If the individual's WBC is > 20 x10^3/μL prior to randomization, the individual can be enrolled, assuming all other eligibility criteria are met. However, the WBC should be ≤ 20 x 10^3/μL prior to the first dose of study treatment and prior to each magrolimab/placebo dose during Cycle 1.

    • Note: Individuals can be treated with hydroxyurea and/or leukapheresis prior to randomization and throughout the study to reduce the WBC to ≤ 20 x 10^3/μL to enable eligibility for study drug dosing

  • Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment

    • Note: Transfusions are allowed to meet hemoglobin eligibility
  • Pretreatment blood cross-match completed

Key Exclusion Criteria:

  • Prior treatment with any of the following:

    • cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα)-targeting agents

    • Antileukemic therapy for the treatment of AML (eg, hypomethylating agents (HMAs), low-dose cytarabine, and/or venetoclax), excluding hydroxyurea

      • Note: Individuals with prior MDS who have not received prior HMAs or venetoclax or chemotherapeutic agents for MDS may be enrolled in the study. Prior treatment with myelodysplastic syndrome (MDS) therapies including, but not limited to lenalidomide, erythroid-stimulating agents, or similar red blood cell negative (RBC-), white blood cell negative (WBC-), or platelet-direct therapies or growth factors is allowed for these individuals.
  • Clinical suspicion of or documented active central nervous system (CNS) involvement with AML
  • Individuals who have acute promyelocytic leukemia
  • Second malignancy, except MDS, treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anticancer therapies and have had no evidence of active malignancy for at least 1 year

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • University of Arkansas for Medical Sciences
  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
  • Community Cancer Institute
  • UC Irvine Health- Chao Family Comprehensive Cancer Center
  • Baptist MD Anderson Cancer Center
  • Moffitt Cancer Center
  • Loyola University Medical Center
  • Parkview Research Center
  • Indiana Blood and Marrow Transplantation - Clinic
  • The University of Iowa Hospitals and Clinics
  • University of Maryland, Greenebaum Comprehensive Cancer Center
  • University of Massachusetts Worcester
  • MidAmerica Division, Inc., c/o Research Medical Center
  • SSM Health Saint Louis University Hospital
  • John Theurer Cancer Center at Hackensack University Medical Center
  • Rutgers Cancer Institute of New Jersey
  • New York-Presbyterian/Weill Cornell Medical Center
  • Icahn School of Medicine at Mount Sinai and The Mount Sinai Hospital
  • University of Rochester Medical Center
  • UNC Hospitals, The University of North Carolina at Chapel Hill
  • Novant Health Cancer Institute Hematology- Charlotte
  • Novant Health Cancer Institute Hematology - Forsyth
  • Wake Forest Baptist Health
  • University Hospitals Cleveland Medical Center
  • Cleveland Clinic Foundation
  • OU Health Stephenson Cancer Center
  • Providence Cancer Institute Franz Clinic
  • Penn State Hershey Medical Center
  • Fox Chase Cancer Center
  • West Penn Hospital
  • Rhode Island Hospital
  • Baylor University Medical Center
  • Brooke Army Medical Center
  • Houston Methodist Hospital Cancer Center
  • MD Anderson Cancer Center
  • Intermountain Health - LDS Hospital
  • Virginia Mason Franciscan Health
  • Fred Hutchinson Cancer Center
  • Froedtert Hospital and the Medical College of Wisconsin
  • Canberra Hospital
  • Border Medical Oncology Research Unit
  • Concord Repatriation General Hospital
  • Liverpool Hospital
  • St George Hospital, Clinical Research Unit Haemotology, Division of Cancer Services
  • Gold Coast University Hospital
  • Monash University, Eastern Health-Box Hill Hospital
  • Northern Health
  • Peter MacCallum Cancer Centre
  • Ordensklinikum Linz GmbH Elisabethinen
  • Hanusch Krankenhaus
  • Wiener Gesundheitsverbund, Klinik Hietzing
  • Ziekenhuis Netwerk Antwerp (ZNA) - Stuivenberg
  • Cliniques Universitaires Saint-Luc
  • University Hospital Gent
  • Hopital de Jolimont
  • University Hospital Leuven (UZ Leuven) - Campus Gasthuisberg
  • Centre Hospitalier Universitaire de Liege
  • Queen Elizabeth II (QEII) Health Sciences Centre
  • Centre Integre Universitaire de Sante et de Services Sociaux(CIUSSS) de l'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont
  • Princess Margaret Cancer Centre - University Health Network
  • CancerCare Manitoba
  • Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika FN Brno a LF MU
  • Fakultni nemocine Olomouc, Hemato-onkologicka klinika
  • Fakultni nemocnice Ostrava, Klinika hematoonkologie
  • Fakulti nemocnice Kralovske Vinohrady, Internf hematologicka klinika FNKV a 3. LF UK
  • Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika, Hematologicka ambulance
  • CHU Amiens Picardie
  • CHU d'Angers
  • Hopital Avicenne
  • Hopitaux Universitaires Henri Mondor
  • Centre Hospitalier Universitaire Grenoble Alpes
  • Centre Hospitalier de Versailles
  • Hôpital Claude Huriez (CHRU de Lillle)
  • Centre Leon Berard
  • Centre Hospitalier Universitaire Nantes - Hotel Dieu
  • Hopital Saint-Louis
  • Centre Hospitalier Lyon-Sud (CHLS)
  • Institut de Cancérologie Strasbourg Europe (ICANS)
  • Institut Universitaire du Cancer de Toulouse (IUCT)-Oncopole
  • CHU de Nancy - Hopitaux de Brabois
  • Charite - Universitatsmedizin Berlin, Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hamatologie, Onkologie und Tumorimmunologie
  • Universitätsklinikum Bonn
  • Städtisches Klinikum Braunschweig GmbH Medizinische Klinik III/Hämatologie und Onkologie
  • Universitatsklinikum Dusseldorf, Klink fur Hamatologie, Onkologie und Klinische Immunologie
  • Marien Hospital Dusseldorf GmbH, Klinik Fur Onkologie, Hamatologie Und Palliativmedizin
  • Malteser Krankenhaus St. Franziskus Hospital,Med.Klinik I
  • Universitatsklinikum Frankfurt Goethe Universitat Med. Klink II
  • Asklepios Klink St.Georg
  • Medizinische Hochschule Hannover, Hamatologie, Hamostaseologie, Onkologie und Stammzelltrandsplantation
  • Universitätsklinikum Magdeburg
  • Johannes Wesling Klinikum Minden Universitätsklinik fur Hämatologie, Onkologie, Hämostaseologie und Pastativrndezin, Universitatsklinik der Ruhr-Unive
  • Klinikum rechts der Isar Technischen Universitat Munchen
  • Klinikum Oldenburg, Rahel-Straus-Straße 10
  • Universitatsklinikum Regensburg, Klink fur Innere Medizin III
  • Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Klinik fur Innere Medizin III
  • Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
  • Princess Margaret Hospital
  • Queen Mary Hospital
  • Tuen Mun Hospital
  • Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika
  • Petz Aladár Egyetemi Oktató Kórház II. Belgyógyaszat - Haematológia
  • Debreceni Egyetem Klinikai Központ Belgyogyaszati Klinika B epulet Hematologia
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Kozpont
  • Rambam Health Care Campus
  • Shaare Zedek Medical Center
  • Hadassah University Hospital Ein Kerem
  • Rabin Medical Center
  • The Chaim Sheba Medical Center
  • Azienda Ospedaliero Universitaria delle Marche - SOD Clinica di Ematologia
  • ASST Papa Giovanni XXIII
  • Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
  • IRCCS Istituto Clinico Humanitas
  • ASST Monza-Ospedale San Gerardo
  • Azienda Ospedaliera di Perugia - Santa Maria della Misericordia
  • Azienda Sanitaria Territoriale Pesaro e Urbino - "Stabilimento Ospedaliero San Salvatore - Muraglia" - U.O. Ematologia e Centro Trapianti
  • Seoul National University Hospital
  • Samsung Medical Center
  • Severance Hospital
  • Asan Medical Center
  • The Catholic University of Korea Seoul Saint Mary's Hospital
  • Jeroen Bosch Ziekenhuis
  • Meander Medisch Centrum
  • Amsterdam Universitair Medische Centra-Locatie Vrije Universiteit Medisch Centrum
  • Amphia Hospital, department Oncologie, Route 43
  • HagaZiekenhuis
  • Medisch Spectrum Twente - Enschede Koningsplein
  • Universitair Medisch Centrum Groningen
  • Medisch Centrum Leeuwarden
  • Masstricht Universitair Medisch Centrum
  • St. Antonius Ziekenhuis, Nieuwegein
  • Canisius Wilhelmina Ziekenhuis
  • Erasmus Medisch Centrum
  • Oslo University Hospital, Department of Hematology
  • Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli, Oddzial Hematologiczny
  • Szpital Wojewodozki w Opolu Sp. z 0.0. Oddzial Klinixzny Hematologii, Onkologii Hematologicznej i Chorob Wemnetrznych
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M.Kopernika w Lodzi, Oddzial Hematologii Ogolnej
  • Hospital Universitario Araba
  • Hospital Clinic de Barcelona
  • Hospital Universitario Reina Sofia
  • Hospital General Universitario Gregorio Maranon
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Universitario Quironsalud Madrid
  • Hospital Universitario Ramon y Cajal
  • Hospital Regional Universitario de Malaga
  • Complejo Asistencial Universitario de Salamanca - Hospital Clinico
  • Complejo Hospitalario Universitario de Santiago de Compostela
  • Hospital Universitari I Politecnic La Fe
  • Inselspital Universitätsspital Bern
  • Kaohsiung Chang Gung Memorial Hospital
  • China Medical University Hospital
  • National Taiwan University Hospital
  • National Cheng Kung University Hospital
  • Blackpool Teaching Hospitals NHS Foundation Trust
  • University Hospitals Bristol and Weston NHS Foundation Trust
  • Leeds Teaching Hospitals NHS Trust
  • Clatterbridge Cancer Centre NHS Foundation Trust
  • Barts Health NHS Trust
  • King's College Hospital
  • The Christie NHS Foundation Trust
  • Newcastle upon Tyne Hospitals Foundation Trust
  • Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
  • South Warwickshire University NHS Foundation Trust
  • The Royal Wolverhampton NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Magrolimab + Venetoclax + Azacitidine

Magrolimab Placebo + Venetoclax + Azacitidine

Arm Description

Participants 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.

Participants will receive magrolimab 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.

Outcomes

Primary Outcome Measures

Complete Remission (CR)
CR is defined as the proportion of participants who achieve CR 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).
Overall Survival (OS)
OS is measured from the date of randomization to the date of death from any cause.

Secondary Outcome Measures

Rate of Complete Remission Without Minimal Residual Disease (CRMRD-)
The CRMRD- rate is the proportion of participants who achieve a complete remission without minimal residual disease within 6 cycles of treatment as determined by investigators.
Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh)
The CR + CRh rate is the proportion of participants who achieve a CR (including CRMRD- and complete remission with positive or unknown minimal residual disease (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).
Duration of Complete Remission (DCR) in Participants who achieved Complete Remission (CR)
The DCR is measured from the time the assessment criteria are 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).
Duration of CR + CRh in Participants who achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh)
The duration of CR + CRh is measured from the time the assessment criteria are 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).
Transfusion Independence Conversion Rate
The transfusion independence conversion rate includes both red blood cell (RBC) transfusion independence rate and platelet transfusion independence rate. The RBC transfusion independence conversion rate is the proportion of participants who have a 56-day or longer period with no RBC or whole blood transfusions at any time between the date of first dose of study treatment and discontinuation of study treatment among all participants who are RBC transfusion dependent at baseline. The platelet transfusion independence conversion rate is the proportion of participants who have a 56-day or longer period with no platelet transfusions at any time between the date of first dose of study treatment and discontinuation of study treatment among all participants who are platelet transfusion dependent at baseline.
Event-Free Survival (EFS)
EFS is 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.
Time Until Meaningful Definitive Deterioration (TUDD) 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 TUDD on the EORTC QLQ-C30 GHS/QoL scale is defined as time from randomization date to earlier date that score is consistently at least one threshold value worse than the baseline score or death, whichever is 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 means better GHS/QoL.
TUDD on the EORTC QLQ-C30 Physical Functioning Scale
TUDD on the EORTC QLQ C30 physical functioning scale is defined as time from the date of randomization to the date of death or the first date of the consistent deteriorations of at least one threshold value as compared with the baseline score, 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.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Serum Concentration of Magrolimab
Rate of Anti-Magrolimab Antibody Incidence
Rate of anti-magrolimab antibody incidence is defined as the percentage of participants with anti-magrolimab antibodies.
Magnitude of Anti-Magrolimab Antibody Incidence

Full Information

First Posted
October 4, 2021
Last Updated
September 29, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05079230
Brief Title
Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia
Acronym
ENHANCE-3
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
432 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magrolimab + Venetoclax + Azacitidine
Arm Type
Experimental
Arm Description
Participants 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.
Arm Title
Magrolimab Placebo + Venetoclax + Azacitidine
Arm Type
Placebo Comparator
Arm Description
Participants will receive magrolimab 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.
Intervention Type
Drug
Intervention Name(s)
Magrolimab
Other Intervention Name(s)
GS-4721
Intervention Description
Administered intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
VENCLEXTA®
Intervention Description
Tablets administered orally
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Administered according to region-specific drug labeling, either subcutaneously (SC) or intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
Magrolimab Placebo
Intervention Description
Administered intravenously (IV)
Primary Outcome Measure Information:
Title
Complete Remission (CR)
Description
CR is defined as the proportion of participants who achieve CR 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).
Time Frame
Up to 7 months
Title
Overall Survival (OS)
Description
OS is measured from the date of randomization to the date of death from any cause.
Time Frame
Randomization up to death or end of study (up to 5 years) whichever occurs first
Secondary Outcome Measure Information:
Title
Rate of Complete Remission Without Minimal Residual Disease (CRMRD-)
Description
The CRMRD- rate is the proportion of participants who achieve a complete remission without minimal residual disease within 6 cycles of treatment as determined by investigators.
Time Frame
Up to 7 months
Title
Rate of Complete Remission (CR) + Complete Remission With Partial Hematologic Recovery (CRh)
Description
The CR + CRh rate is the proportion of participants who achieve a CR (including CRMRD- and complete remission with positive or unknown minimal residual disease (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).
Time Frame
Up to 7 months
Title
Duration of Complete Remission (DCR) in Participants who achieved Complete Remission (CR)
Description
The DCR is measured from the time the assessment criteria are 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).
Time Frame
Up to 5 years
Title
Duration of CR + CRh in Participants who achieved Complete Remission (CR) or Complete Remission With Partial Hematologic Recovery (CRh)
Description
The duration of CR + CRh is measured from the time the assessment criteria are 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).
Time Frame
Up to 5 years
Title
Transfusion Independence Conversion Rate
Description
The transfusion independence conversion rate includes both red blood cell (RBC) transfusion independence rate and platelet transfusion independence rate. The RBC transfusion independence conversion rate is the proportion of participants who have a 56-day or longer period with no RBC or whole blood transfusions at any time between the date of first dose of study treatment and discontinuation of study treatment among all participants who are RBC transfusion dependent at baseline. The platelet transfusion independence conversion rate is the proportion of participants who have a 56-day or longer period with no platelet transfusions at any time between the date of first dose of study treatment and discontinuation of study treatment among all participants who are platelet transfusion dependent at baseline.
Time Frame
First dose date up to End of Treatment (EOT) (up to 5 years)
Title
Event-Free Survival (EFS)
Description
EFS is 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.
Time Frame
Randomization up to end of study (up to 5 years)
Title
Time Until Meaningful Definitive Deterioration (TUDD) 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
Description
The TUDD on the EORTC QLQ-C30 GHS/QoL scale is defined as time from randomization date to earlier date that score is consistently at least one threshold value worse than the baseline score or death, whichever is 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 means better GHS/QoL.
Time Frame
Randomization up to end of study (up to 5 years)
Title
TUDD on the EORTC QLQ-C30 Physical Functioning Scale
Description
TUDD on the EORTC QLQ C30 physical functioning scale is defined as time from the date of randomization to the date of death or the first date of the consistent deteriorations of at least one threshold value as compared with the baseline score, 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.
Time Frame
Randomization up to end of study (up to 5 years)
Title
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Time Frame
First dose date up to last dose date (up to 5 years) plus 70 days
Title
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Time Frame
First dose date up to last dose date (up to 5 years) plus 70 days
Title
Serum Concentration of Magrolimab
Time Frame
First dose date up to EOT (up to 5 years)
Title
Rate of Anti-Magrolimab Antibody Incidence
Description
Rate of anti-magrolimab antibody incidence is defined as the percentage of participants with anti-magrolimab antibodies.
Time Frame
First dose date up to EOT (up to 5 years)
Title
Magnitude of Anti-Magrolimab Antibody Incidence
Time Frame
First dose date up to EOT (up to 5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Previously untreated individuals with histological confirmation of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity. Individuals must be considered ineligible for intensive chemotherapy, defined by the following: ≥ 75 years of age; Or ≥ 18 to 74 years of age with at least 1 of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3 Diffusing capacity of the lung of carbon monoxide ≤ 65% or forced expiratory volume in 1 second ≤ 65% Left ventricular ejection fraction ≤ 50% Baseline creatinine clearance ≥ 30 mL/min to < 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection Hepatic disorder with total bilirubin > 1.5 x upper limit of normal (ULN) Any other comorbidity that the investigator judges to be incompatible with intensive chemotherapy ECOG performance status: Of 0 to 2 for individuals ≥ 75 years of age Or Of 0 to 3 for individuals ≥ 18 to 74 years of age Individuals with white blood cell (WBC) count ≤ 20 x 10^3/μL prior to randomization. If the individual's WBC is > 20 x10^3/μL prior to randomization, the individual can be enrolled, assuming all other eligibility criteria are met. However, the WBC should be ≤ 20 x 10^3/μL prior to the first dose of study treatment and prior to each magrolimab/placebo dose during Cycle 1. Note: Individuals can be treated with hydroxyurea and/or leukapheresis prior to randomization and throughout the study to reduce the WBC to ≤ 20 x 10^3/μL to enable eligibility for study drug dosing Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment Note: Transfusions are allowed to meet hemoglobin eligibility Pretreatment blood cross-match completed Key Exclusion Criteria: Prior treatment with any of the following: cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα)-targeting agents Antileukemic therapy for the treatment of AML (eg, hypomethylating agents (HMAs), low-dose cytarabine, and/or venetoclax), excluding hydroxyurea Note: Individuals with prior MDS who have not received prior HMAs or venetoclax or chemotherapeutic agents for MDS may be enrolled in the study. Prior treatment with myelodysplastic syndrome (MDS) therapies including, but not limited to lenalidomide, erythroid-stimulating agents, or similar red blood cell negative (RBC-), white blood cell negative (WBC-), or platelet-direct therapies or growth factors is allowed for these individuals. Clinical suspicion of or documented active central nervous system (CNS) involvement with AML Individuals who have acute promyelocytic leukemia Second malignancy, except MDS, treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anticancer therapies and have had no evidence of active malignancy for at least 1 year Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Community Cancer Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93730
Country
United States
Facility Name
UC Irvine Health- Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Baptist MD Anderson Cancer Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Indiana Blood and Marrow Transplantation - Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
The University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Maryland, Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Massachusetts Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
MidAmerica Division, Inc., c/o Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
SSM Health Saint Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
New York-Presbyterian/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai and The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
UNC Hospitals, The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Novant Health Cancer Institute Hematology- Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Novant Health Cancer Institute Hematology - Forsyth
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
OU Health Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Providence Cancer Institute Franz Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Houston Methodist Hospital Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Intermountain Health - LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Virginia Mason Franciscan Health
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Fred Hutchinson Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Froedtert Hospital and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Canberra Hospital
City
Woden
State/Province
Australian Capital Territory
ZIP/Postal Code
2606
Country
Australia
Facility Name
Border Medical Oncology Research Unit
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
St George Hospital, Clinical Research Unit Haemotology, Division of Cancer Services
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Monash University, Eastern Health-Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Northern Health
City
Epping
State/Province
Victoria
ZIP/Postal Code
3076
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Ordensklinikum Linz GmbH Elisabethinen
City
Linz
Country
Austria
Facility Name
Hanusch Krankenhaus
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Wiener Gesundheitsverbund, Klinik Hietzing
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Ziekenhuis Netwerk Antwerp (ZNA) - Stuivenberg
City
Antwerp
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
University Hospital Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Hopital de Jolimont
City
Haine-Saint-Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
University Hospital Leuven (UZ Leuven) - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liege
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Queen Elizabeth II (QEII) Health Sciences Centre
City
Halifax
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Centre Integre Universitaire de Sante et de Services Sociaux(CIUSSS) de l'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont
City
Montreal
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Princess Margaret Cancer Centre - University Health Network
City
Toronto
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika FN Brno a LF MU
City
Jihormoravsky KRAJ
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Fakultni nemocine Olomouc, Hemato-onkologicka klinika
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava, Klinika hematoonkologie
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Fakulti nemocnice Kralovske Vinohrady, Internf hematologicka klinika FNKV a 3. LF UK
City
Prague
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika, Hematologicka ambulance
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
CHU Amiens Picardie
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Hopitaux Universitaires Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier Universitaire Grenoble Alpes
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Centre Hospitalier de Versailles
City
Le Chesnay Cedex
ZIP/Postal Code
78157
Country
France
Facility Name
Hôpital Claude Huriez (CHRU de Lillle)
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Leon Berard
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Hospitalier Universitaire Nantes - Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Hospitalier Lyon-Sud (CHLS)
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Institut de Cancérologie Strasbourg Europe (ICANS)
City
Strasbourg
ZIP/Postal Code
67033
Country
France
Facility Name
Institut Universitaire du Cancer de Toulouse (IUCT)-Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU de Nancy - Hopitaux de Brabois
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Charite - Universitatsmedizin Berlin, Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hamatologie, Onkologie und Tumorimmunologie
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Städtisches Klinikum Braunschweig GmbH Medizinische Klinik III/Hämatologie und Onkologie
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Universitatsklinikum Dusseldorf, Klink fur Hamatologie, Onkologie und Klinische Immunologie
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Marien Hospital Dusseldorf GmbH, Klinik Fur Onkologie, Hamatologie Und Palliativmedizin
City
Düsseldorf
ZIP/Postal Code
40479
Country
Germany
Facility Name
Malteser Krankenhaus St. Franziskus Hospital,Med.Klinik I
City
Flensburg
ZIP/Postal Code
24939
Country
Germany
Facility Name
Universitatsklinikum Frankfurt Goethe Universitat Med. Klink II
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Asklepios Klink St.Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Medizinische Hochschule Hannover, Hamatologie, Hamostaseologie, Onkologie und Stammzelltrandsplantation
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Johannes Wesling Klinikum Minden Universitätsklinik fur Hämatologie, Onkologie, Hämostaseologie und Pastativrndezin, Universitatsklinik der Ruhr-Unive
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Klinikum rechts der Isar Technischen Universitat Munchen
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum Oldenburg, Rahel-Straus-Straße 10
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Universitatsklinikum Regensburg, Klink fur Innere Medizin III
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Klinik fur Innere Medizin III
City
Ulm
ZIP/Postal Code
89070
Country
Germany
Facility Name
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Petz Aladár Egyetemi Oktató Kórház II. Belgyógyaszat - Haematológia
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ Belgyogyaszati Klinika B epulet Hematologia
City
Hajdu-bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Kozpont
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah University Hospital Ein Kerem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Azienda Ospedaliero Universitaria delle Marche - SOD Clinica di Ematologia
City
Ancona
ZIP/Postal Code
I-60126
Country
Italy
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
IRCCS Istituto Clinico Humanitas
City
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
ASST Monza-Ospedale San Gerardo
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia - Santa Maria della Misericordia
City
Perugia
Country
Italy
Facility Name
Azienda Sanitaria Territoriale Pesaro e Urbino - "Stabilimento Ospedaliero San Salvatore - Muraglia" - U.O. Ematologia e Centro Trapianti
City
Pesaro
ZIP/Postal Code
61122
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul Saint Mary's Hospital
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Facility Name
Jeroen Bosch Ziekenhuis
City
's-Hertogenbosch
ZIP/Postal Code
5223GZ
Country
Netherlands
Facility Name
Meander Medisch Centrum
City
Amersfoort
ZIP/Postal Code
3813 TZ
Country
Netherlands
Facility Name
Amsterdam Universitair Medische Centra-Locatie Vrije Universiteit Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Amphia Hospital, department Oncologie, Route 43
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
HagaZiekenhuis
City
Den Haag
ZIP/Postal Code
2545AA
Country
Netherlands
Facility Name
Medisch Spectrum Twente - Enschede Koningsplein
City
Enschede
ZIP/Postal Code
7512 KZ
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Masstricht Universitair Medisch Centrum
City
Maastricht
ZIP/Postal Code
62002
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis, Nieuwegein
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Canisius Wilhelmina Ziekenhuis
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Oslo University Hospital, Department of Hematology
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli, Oddzial Hematologiczny
City
Lublin
ZIP/Postal Code
20090
Country
Poland
Facility Name
Szpital Wojewodozki w Opolu Sp. z 0.0. Oddzial Klinixzny Hematologii, Onkologii Hematologicznej i Chorob Wemnetrznych
City
Opole
ZIP/Postal Code
45-372
Country
Poland
Facility Name
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M.Kopernika w Lodzi, Oddzial Hematologii Ogolnej
City
Łódź
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Hospital Universitario Araba
City
Alava
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Quironsalud Madrid
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca - Hospital Clinico
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago de Compostela
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitari I Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Inselspital Universitätsspital Bern
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Blackpool Teaching Hospitals NHS Foundation Trust
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
University Hospitals Bristol and Weston NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Clatterbridge Cancer Centre NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L7 8YA
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Newcastle upon Tyne Hospitals Foundation Trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
South Warwickshire University NHS Foundation Trust
City
Warwick
ZIP/Postal Code
CV34 5BW
Country
United Kingdom
Facility Name
The Royal Wolverhampton NHS Trust
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-590-6154
Description
Gilead Clinical Trials Website

Learn more about this trial

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

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