Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated
NCT ID: NCT04778397
Last Updated: 2025-02-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
258 participants
INTERVENTIONAL
2021-07-01
2024-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Magrolimab + Azacitidine
Participants will receive an escalating dose of magrolimab and a fixed dose of azacitidine.
Magrolimab
Administered intravenously (IV).
Azacitidine
Administered either subcutaneously (SC) or IV, 75 milligrams per square meter (mg/m\^2) on Days 1-7 or Days 1-5, 8 and 9 during every cycle (Cycle=28 days).
Control Arm: Venetoclax + Azacitidine
Participants who are appropriate for non-intensive therapy will receive an escalating dose of venetoclax and a fixed dose of azacitidine.
Venetoclax
Administered orally at a dose of 100 milligrams (mg) on Day 1, 200 mg on Day 2, 400 mg on Days 3-28 during Cycle 1, followed by 400 mg on Days 1-28 during every cycle (Cycle=28 days).
Azacitidine
Administered either subcutaneously (SC) or IV, 75 milligrams per square meter (mg/m\^2) on Days 1-7 or Days 1-5, 8 and 9 during every cycle (Cycle=28 days).
Control Arm: 7+3 Chemotherapy
Participants who are appropriate for intensive therapy will receive 7+3 chemotherapy: 7 day treatment with cytarabine and 3 day treatment with daunorubicin or idarubicin during induction and high-dose cytarabine and steroidal eye drops during consolidation.
Cytarabine
Induction: administered continuous infusion, 100 or 200 mg/m\^2 on Days 1-7 (7+3 induction) and if needed Days 1-5 (5+2 induction) during a cycle (Cycle=Up to 42 Days).
Consolidation: administered IV, 1500 or 3000 mg/m\^2 on Days 1, 3, and 5 once every 12 hours for up to 4 cycles.
Daunorubicin
Administered IV peripherally (IVP), 60 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).
Idarubicin
Administered IV, 12 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).
Steroidal Eye Drops
Administered per institutional standard during consolidation.
Interventions
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Magrolimab
Administered intravenously (IV).
Venetoclax
Administered orally at a dose of 100 milligrams (mg) on Day 1, 200 mg on Day 2, 400 mg on Days 3-28 during Cycle 1, followed by 400 mg on Days 1-28 during every cycle (Cycle=28 days).
Azacitidine
Administered either subcutaneously (SC) or IV, 75 milligrams per square meter (mg/m\^2) on Days 1-7 or Days 1-5, 8 and 9 during every cycle (Cycle=28 days).
Cytarabine
Induction: administered continuous infusion, 100 or 200 mg/m\^2 on Days 1-7 (7+3 induction) and if needed Days 1-5 (5+2 induction) during a cycle (Cycle=Up to 42 Days).
Consolidation: administered IV, 1500 or 3000 mg/m\^2 on Days 1, 3, and 5 once every 12 hours for up to 4 cycles.
Daunorubicin
Administered IV peripherally (IVP), 60 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).
Idarubicin
Administered IV, 12 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days).
Steroidal Eye Drops
Administered per institutional standard during consolidation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Individuals with white blood cell (WBC) count ≤ 20×10\^3/microliter (μL) prior to randomization. If the individual's WBC is \> 20×10\^3/μL prior to randomization, the individual can be enrolled, assuming all other eligibility criteria are met. However, the WBC should be ≤ 20×10\^3/μL prior to the first dose of study treatment and prior to each magrolimab dose the first 4 weeks (if the individual is randomized to the experimental arm) Note: Individuals can be treated with hydroxyurea and/or leukapheresis throughout the study or prior to randomization to reduce the WBC to ≤ 20×10\^3/μL to enable eligibility for study drug dosing.
* The hemoglobin must be ≥ 9 grams per deciliter (g/dL) prior to initial dose of study treatment.
Notes: Transfusions are allowed to meet hemoglobin eligibility.
* Individual has provided informed consent.
* Individual is willing and able to comply with clinic visits and procedure outlined in the study protocol.
* Individuals must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, except for individuals less than 75 years of age and appropriate for non-intensive treatment. For these individuals, the ECOG performance status score may be 0 to 3.
* Individuals must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 milliliters per minute calculated by the Cockcroft Gault formula.
* Adequate cardiac function as demonstrated by:
* Lack of symptomatic congestive heart failure and clinically significant cardiac arrhythmias and ischemic heart disease.
* Left ventricular ejection fraction (LVEF) \> 50% for individuals appropriate for intensive therapy.
* Adequate liver function as demonstrated by:
* Aspartate aminotransferase ≤ 3.0 × upper limit of normal (ULN).
* Alanine aminotransferase ≤ 3.0 × ULN.
* Total bilirubin ≤ 1.5 × ULN, or primary unconjugated bilirubin ≤ 3.0 × ULN if individual has a documented history of Gilbert's syndrome or genetic equivalent.
* Pretreatment blood cross-match completed.
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
* Individuals must be willing to consent to mandatory pretreatment and on-treatment bone marrow biopsies (aspirate and trephines).
Exclusion Criteria
* Breastfeeding female.
* Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
* 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 (excluding hydroxyurea), hypomethylating agent (HMA), low dose cytarabine and/or venetoclax.
Note: Individuals with prior myelodysplastic syndrome (MDS) who have not received prior HMAs or chemotherapeutic agents for MDS are allowed on study. Other prior MDS therapies including, but not limited to, lenalidomide, erythroid stimulating agents, or similar red blood cell (RBC)-direct therapies, were allowed. Localized non-central nervous system (CNS) radiotherapy, erythroid and/or myeloid growth factors, hormonal therapy with luteinizing hormone-releasing hormone agonists for prostate cancer, hormonal therapy or maintenance for breast cancer, and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B ligand inhibitors are also not criteria for exclusion.
* Individuals who are appropriate for intensive treatment but who have been previously treated with maximum cumulative doses of idarubicin and/or other anthracyclines and anthracenediones will be excluded.
* Individuals receiving any live vaccine within 4 weeks prior to initiation of study treatments.
* For individuals appropriate for intensive therapy, individuals treated with trastuzumab within 7 months prior to initiation of study treatments.
* Current participation in another interventional clinical study.
* Known inherited or acquired bleeding disorders.
* Individuals appropriate for non-intensive therapy, who have received treatment with strong and/or moderate cytochrome P450 enzyme 3A (CYP3A) inducers within 7 days prior to the initiation of study treatments.
* Individuals appropriate for non-intensive therapy who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days prior to the initiation of study treatment.
* Individuals appropriate for non-intensive therapy who have malabsorption syndrome or other conditions that preclude enteral route of administration.
* Clinical suspicion of active CNS involvement with AML.
* Individuals who have acute promyelocytic leukemia.
* Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV.
* 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 anti-cancer therapies and have had no evidence of active malignancy for at least ≥ 1 year Note: Individuals on maintenance therapy alone who have no evidence of active malignancy for at least ≥ 1 year are eligible.
* Known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or human immunodeficiency virus (HIV) infection in medical history.
* Active HBV, and/or active HCV, and/or HIV following testing at screening:
* Individuals who test positive for hepatitis B surface antigen (HBsAg). Individuals who test positive for hepatitis B core antibody (anti-HBc) will require HBV deoxyribose nucleic acid (DNA) by quantitative polymerase chain reaction (PCR) for confirmation of active disease.
* Individuals who test positive for HCV antibody. These individuals will require HCV ribose nucleic acid (RNA) quantitative PCR for confirmation of active disease.
* Individuals who test positive for HIV antibody.
* Individuals not currently receiving antiviral therapy and who have an undetectable viral load in the prior 3 months may be eligible for the study.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Nagasaki University Hospital
Nagasaki, , Japan
University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
USC/ Norris Comprehensive Cancer Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UC Irvine Health
Orange, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Miami Cancer Institute
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Memorial Cancer Institute
Pembroke Pines, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Northwestern Memorial Hospital/Main Lab
Chicago, Illinois, United States
The University of Chicago Medical Centre
Chicago, Illinois, United States
University of Kansas Hospital
Fairway, Kansas, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Tulane Medical center
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic Cancer Center Outpatient Pharmacy
Rochester, Minnesota, United States
MidAmerica Division, Inc., c/o Research Medical Center
Kansas City, Missouri, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke Blood Cancer Center
Durham, North Carolina, United States
The Ohio State University Wexner Medical Center/ James Cancer Hospital
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center - OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
Philadelphia, Pennsylvania, United States
St. Francis Cancer Center
Greenville, South Carolina, United States
Prisma Health Cancer Institute
Greenville, South Carolina, United States
Baylor College of Medicine Medical Center
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute ,The University of Utah
Salt Lake City, Utah, United States
Froedtert Hospital / Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Canberra Hospital
Garran, Australian Capital Territory, Australia
Calvary Master Newcastle
Waratah, New South Wales, Australia
Westmead Hospital / Department of Haematology and Bone Marrow Transplantation
Westmead, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Andrew Love Cancer Centre, University Hospital Geelong
Geelong, Victoria, Australia
The Alfred
Melbourne, Victoria, Australia
St Vincents Hospital Melbourne
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Univ. -Klinik für Hämatologie und Internistische Onkologie, Kepler Universitätskilkun GmbHMed
Linz, , Austria
Uniklinikum Salzburg, Universitatsklinik f. Innere Medizin III der PMU
Salzburg, , Austria
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende AV
Bruges, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Grand Hôpital De Charleroi - Notre Dame
Charleroi, , Belgium
Universitaire Ziekenhuis Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
AZ Delta vzw
Roeselare, , Belgium
Tom Baker Cancer Center
Calgary, , Canada
Queen Elizabeth II Health Sciences Centre
Halifax, , Canada
CIUSSS de L'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont
Montreal, , Canada
McGill University Health Centre
Montreal, , Canada
Sunnybrook Research Institute
Toronto, , Canada
Princess Margaret Cancer Centre
Toronto, , Canada
Aalborg University Hospital
Aalborg, , Denmark
Odense University Hospital
Odense C, , Denmark
CHU d'Angers
Angers, , France
CHU de Caen
Caen, , France
CHRU Lille - Hospital Claude Huriez
Lille, , France
CHU Limoges
Limoges, , France
Central Hospital Lyon Sud
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
CHU de Nantes, Hotel Dieu
Nantes, , France
CHU Nice - Hopital Archet 1
Nice, , France
Gustave Roussy
Paris, , France
Hopital Haut-Leveque
Pessac, , France
IUCT Oncopole
Toulouse, , France
Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Uniklinik RWTH Aachen, Medizinische Klunuk IV - Klinik fur Hamatologie, Onkologie, Hamastaseologie und Srammzelltransplantation
Aachen, , Germany
Dept. of Hematology, Oncology and Tumor Immunology, Charite- University Medicine Berlin, Campus Virchow Klinikum
Berlin, , Germany
Department of Hematology and Oncology, Braunschweig Community Hospital
Braunschweig, , Germany
Universitatsklinikum Koln
Cologne, , Germany
Universitatsklinikum Carl Gustav Carus Dresden an der Technische Universitat Dresden, Medizinische Klinik und Poliklinik 1, Bereich Hamatologie
Dresden, , Germany
Universitätsklinikum Düsseldorf -Klinik für Hämatologie, Onkologie und Klinische Immunologie
Düsseldorf, , Germany
Dept. of Medicine II, University Hospital Hamburg-Eppendorf
Hamburg, , Germany
Universitatsklinikum Heidelberg, Innere Medizin V, Hamatologie, Onkologie und Rheumatologie
Heidelberg, , Germany
Universitatsklinikum Schleswig-Holstein
Kiel, , Germany
Klinikum Ludwigshafen Medizinische Klinik A
Ludwigshafen, , Germany
LMU - Klinikum der Universitat Munchen, Medizinische Klinik und Poliklinik III, Campus Grosshadern
München, , Germany
Klinikum rechts der Isar der Technischen Universitat Munchen, Klinik und Poliklinik fur Innere Medizin III
München, , Germany
Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Innere Medizin III
Ulm, , Germany
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Azienda Ospedaliero Universitaria delle Marche
Ancona, , Italy
AOU Consorziale Policlinico Bari
Bari, , Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola-Malphigi U.O Ematologia
Bologna, , Italy
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRS - Oncologia Medica
Meldola, , Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli U.O.S.C. di Ematologia con Trapianto di Midollo Osseo
Napoli, , Italy
SC Ematologia, Azienda Ospedaliera di Perugia - Santa Maria della Misericordia
Perugia, , Italy
AORM - AO Riuniti Marche Norde - Pesaro Presidio "San Salvatore" - Muraglia
Pesaro, , Italy
Fondazione PTV Policinico Tor Vergata
Roma, , Italy
SCDU Ematologia e Terrapie cellulari AO O Ordine Mauriziano Torino
Torino, , Italy
ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, , Japan
Chiba Aoba Municipal Hospital
Chiba, , Japan
University of Yamanashi Hospital
Chūō, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Aiiku Hospital
Hokkaido, , Japan
Tokai University School of Medicine
Isehara, , Japan
Kanazawa University Hospital
Kanazawa, , Japan
National Cancer Center Hospital East
Kashiwa, , Japan
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-shi, , Japan
Kobe City Medical Center General Hospital
Kobe, , Japan
Gunmaken Saiseikai Maebashi Hospital
Maebashi, , Japan
Ehime Prefectural Center Hospital
Matsuyama, , Japan
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Nagoya, , Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, , Japan
Okayama University Hospital
Okayama, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Kindai University Hospital
Sayama, , Japan
National University Corporation Tohoku University Tohoku University Hospital
Sendai, , Japan
NTT Medical Center Tokyo
Shinagawa-Ku, , Japan
Yamagata University Hospital
Yamagata, , Japan
University of Fukui Hospital
Yoshida-gun, , Japan
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital del la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Institut Catala d'Oncologia
Barcelona, , Spain
Complejo Asistencial Universitario de Burgos/H.U. de Burgos
Burgos, , Spain
Complejo Hospitalario San Pedro de Alcantara
Cáceres, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
MD Anderson Cancer Center Madrid
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Clinica Universidad de Navarra - Pamplona (Main Site)
Pamplona, , Spain
Complejo Asistencial Universitario de Salamanca - Hsopital Clinico
Salamanca, , Spain
Hospital U. Marques de Valdecilla
Santander, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitari I Politècnic La Fe
Valencia, , Spain
Universitetssjukhus, Hematologimottagnungen
Lund, , Sweden
Universitatsspital Basel - Klinik fur Hamatrologie, Bereich Innere Medizin
Basel, , Switzerland
Inselspital, Universitatsspital Bern - Universitatsklinik fur Medizinisch Onkologie
Bern, , Switzerland
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
United Lincolnshire Hospitals NHS Trust, Pilgrim Hospital, Sibsey Road
Boston, , United Kingdom
Cambridge University Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Cardiff and Vale University Health Board
Cardiff Wales, , United Kingdom
Barts Health NHS Trust
City of London, , United Kingdom
NHS Tayside
Dundee, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
King's College NHS Foundation Trust
London, , United Kingdom
Oxford University Hospital NHS Foundation Trust
Oxford, , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
The Christie NHS Foundation Trust
Withington, , United Kingdom
Countries
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References
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Zeidner JF, Sallman DA, Recher C, Daver NG, Leung AYH, Hiwase DK, Subklewe M, Pabst T, Montesinos P, Larson RA, Wilde L, Enjeti AK, Kawashima I, Papayannidis C, O'Nions J, Johnson L, Dong M, Huang J, Bagheri T, Hacohen Kleiman G, Lee C, Vyas P. Magrolimab plus azacitidine vs physician's choice for untreated TP53-mutated acute myeloid leukemia: the ENHANCE-2 study. Blood. 2025 Jul 31;146(5):590-600. doi: 10.1182/blood.2024027408.
Daver NG, Vyas P, Kambhampati S, Al Malki MM, Larson RA, Asch AS, Mannis G, Chai-Ho W, Tanaka TN, Bradley TJ, Jeyakumar D, Wang ES, Sweet K, Kantarjian HM, Garcia-Manero G, Komrokji R, Xing G, Ramsingh G, Renard C, Zeidner JF, Sallman DA. Tolerability and Efficacy of the Anticluster of Differentiation 47 Antibody Magrolimab Combined With Azacitidine in Patients With Previously Untreated AML: Phase Ib Results. J Clin Oncol. 2023 Nov 1;41(31):4893-4904. doi: 10.1200/JCO.22.02604. Epub 2023 Sep 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2020-003949-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
jRCT2071220076
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-546-5857
Identifier Type: -
Identifier Source: org_study_id
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