Back to resultsStudy 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 (ENHANCE-2)
Primary Purpose
Acute Myeloid Leukemia
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Magrolimab
Venetoclax
Azacitidine
Cytarabine
Daunorubicin
Idarubicin
Steroidal Eye Drops
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility Criteria
Key Inclusion Criteria:
- Individuals with confirmation of AML by World Health Organization criteria, previously untreated for AML, and who have presence of at least 1 TP53 gene mutation that is not benign or likely benign based on evaluation by either central laboratory or an approved local laboratory (after central review of the bone marrow TP53 mitigation next-generation sequencing test results) (individuals with biallelic 17p deletions, loss of both 17p alleles, are eligible based on locally evaluated cytogenetics/karyotype/fluorescence in situ hybridization (FISH) report)
- 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
- 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 ontreatment bone marrow biopsies (aspirate and trephines).
Key Exclusion Criteria:
- Positive serum pregnancy test
- 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 RBC-direct therapies, are 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- University of Alabama at Birmingham
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
- USC/ Norris Comprehensive Cancer Center
- Ronald Reagan UCLA Medical Center
- UC Irvine Health
- Colorado Blood Cancer Institute
- Mayo Clinic Florida
- Miami Cancer Institute
- AdventHealth Orlando
- Memorial Cancer Institute
- Moffitt Cancer Center
- Winship Cancer Institute
- Northwestern Memorial Hospital/Main Lab
- The University of Chicago Medical Centre
- University of Kansas Hospital
- University of Kentucky Medical Center
- Tulane Medical center
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- Mayo Clinic Cancer Center Outpatient Pharmacy
- MidAmerica Division, Inc., c/o Research Medical Center
- SSM Health Saint Louis University Hospital
- Roswell Park Cancer Institute
- Columbia University Medical Center - Herbert Irving Pavilion
- UNC Hospitals, The University of North Carolina at Chapel Hill
- Duke Blood Cancer Center
- The Ohio State University Wexner Medical Center/ James Cancer Hospital
- University of Oklahoma Health Sciences Center - OU Health Stephenson Cancer Center
- Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
- St. Francis Cancer Center
- Prisma Health Cancer Institute
- Baylor College of Medicine Medical Center
- The University of Texas MD Anderson Cancer Center
- Huntsman Cancer Institute ,The University of Utah
- Froedtert Hospital / Medical College of Wisconsin
- Canberra Hospital
- Calvary Master Newcastle
- Westmead Hospital / Department of Haematology and Bone Marrow Transplantation
- Princess Alexandra Hospital
- Royal Adelaide Hospital
- Andrew Love Cancer Centre, University Hospital Geelong
- The Alfred
- St Vincents Hospital Melbourne
- Fiona Stanley Hospital
- Royal Perth Hospital
- Univ. -Klinik für Hämatologie und Internistische Onkologie, Kepler Universitätskilkun GmbHMed
- Uniklinikum Salzburg, Universitatsklinik f. Innere Medizin III der PMU
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende AV
- Universitair Ziekenhuis Brussel
- Grand Hôpital De Charleroi - Notre Dame
- Universitaire Ziekenhuis Antwerpen
- Universitair Ziekenhuis Gent
- AZ Delta vzw
- Tom Baker Cancer Center
- Queen Elizabeth II Health Sciences Centre
- CIUSSS de L'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont
- McGill University Health Centre
- Sunnybrook Research Institute
- Princess Margaret Cancer Centre
- Aalborg University Hospital
- Odense University Hospital
- CHU d'Angers
- CHU de Caen
- CHRU Lille - Hospital Claude Huriez
- CHU Limoges
- Central Hospital Lyon Sud
- Institut Paoli Calmettes
- CHU de Nantes, Hotel Dieu
- CHU Nice - Hopital Archet 1
- Gustave Roussy
- Hopital Haut-Leveque
- IUCT Oncopole
- Hopitaux de Brabois
- Uniklinik RWTH Aachen, Medizinische Klunuk IV - Klinik fur Hamatologie, Onkologie, Hamastaseologie und Srammzelltransplantation
- Dept. of Hematology, Oncology and Tumor Immunology, Charite- University Medicine Berlin, Campus Virchow Klinikum
- Department of Hematology and Oncology, Braunschweig Community Hospital
- Universitatsklinikum Carl Gustav Carus Dresden an der Technische Universitat Dresden, Medizinische Klinik und Poliklinik 1, Bereich Hamatologie
- Universitätsklinikum Düsseldorf -Klinik für Hämatologie, Onkologie und Klinische Immunologie
- Dept. of Medicine II, University Hospital Hamburg-Eppendorf
- Universitatsklinikum Heidelberg, Innere Medizin V, Hamatologie, Onkologie und Rheumatologie
- Universitatsklinikum Schleswig-Holstein
- Universitatsklinikum Koln
- Klinikum Ludwigshafen Medizinische Klinik A
- Klinikum rechts der Isar der Technischen Universitat Munchen, Klinik und Poliklinik fur Innere Medizin III
- LMU - Klinikum der Universitat Munchen, Medizinische Klinik und Poliklinik III, Campus Grosshadern
- Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Innere Medizin III
- Prince of Wales Hospital, The Chinese University of Hong Kong
- Queen Mary Hospital
- Azienda Ospedaliero Universitaria delle Marche
- AOU Consorziale Policlinico Bari
- Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola-Malphigi U.O Ematologia
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRS - Oncologia Medica
- Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli U.O.S.C. di Ematologia con Trapianto di Midollo Osseo
- SC Ematologia, Azienda Ospedaliera di Perugia - Santa Maria della Misericordia
- AORM - AO Riuniti Marche Norde - Pesaro Presidio "San Salvatore" - Muraglia
- Fondazione PTV Policinico Tor Vergata
- SCDU Ematologia e Terrapie cellulari AO O Ordine Mauriziano Torino
- ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi
- Hyogo Prefectural Amagasaki General Medical Center
- Chiba Aoba Municipal Hospital
- University of Yamanashi Hospital
- Kyushu University Hospital
- Fukushima Medical University Hospital
- Aiiku Hospital
- Tokai University School of Medicine
- Kanazawa University Hospital
- National Cancer Center Hospital East
- Hospital of the University of Occupational and Environmental Health, Japan
- Kobe City Medical Center General Hospital
- Gunmaken Saiseikai Maebashi Hospital
- Ehime Prefectural Center Hospital
- Nagasaki University Hospital
- Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
- Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
- Okayama University Hospital
- Osaka Metropolitan University Hospital
- Kindai University Hospital
- National University Corporation Tohoku University Tohoku University Hospital
- NTT Medical Center Tokyo
- Yamagata University Hospital
- University of Fukui Hospital
- Hospital General Universitario de Alicante
- Hospital del la Santa Creu i Sant Pau
- Hospital Universitari Vall d'Hebron
- Hospital Clinic de Barcelona
- Institut Catala d'Oncologia
- Complejo Asistencial Universitario de Burgos/H.U. de Burgos
- Hospital Universitario Reina Sofia
- Complejo Hospitalario San Pedro de Alcantara
- Hospital Universitario de Gran Canaria Doctor Negrin
- Hospital Universitario de La Princesa
- Hospital General Universitario Gregorio Maranon
- MD Anderson Cancer Center Madrid
- Hospital Regional Universitario de Malaga
- Hospital Universitario Central de Asturias
- Clinica Universidad de Navarra - Pamplona (Main Site)
- Complejo Asistencial Universitario de Salamanca - Hsopital Clinico
- Hospital U. Marques de Valdecilla
- Hospital Clinico Universitario de Valencia
- Hospital Universitari I Politècnic La Fe
- Universitetssjukhus, Hematologimottagnungen
- Universitatsspital Basel - Klinik fur Hamatrologie, Bereich Innere Medizin
- Inselspital, Universitatsspital Bern - Universitatsklinik fur Medizinisch Onkologie
- University Hospitals Birmingham NHS Foundation Trust
- United Lincolnshire Hospitals NHS Trust, Pilgrim Hospital, Sibsey Road
- Cambridge University Hospital NHS Foundation Trust
- Cardiff and Vale University Health Board
- Barts Health NHS Trust
- NHS Tayside
- Beatson West of Scotland Cancer Centre
- University College London Hospitals NHS Foundation Trust
- King's College NHS Foundation Trust
- Oxford University Hospital NHS Foundation Trust
- The Royal Marsden NHS Foundation Trust
- The Christie NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Magrolimab + Azacitidine
Control Arm: Venetoclax + Azacitidine
Control Arm: 7+3 Chemotherapy
Arm Description
Participants will receive an escalating dose of magrolimab and a fixed dose of azacitidine.
Participants who are appropriate for non-intensive therapy will receive an escalating dose of venetoclax and a fixed dose of azacitidine.
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.
Outcomes
Primary Outcome Measures
Overall Survival (OS) in Participants Appropriate for Non-intensive Therapy
The OS is measured from the date of randomization to the date of death from any cause. Those whose deaths are not observed during the study will be censored at their last known alive date.
Secondary Outcome Measures
Overall Survival in All Participants
The OS is measured from the date of randomization to the date of death from any cause. Those whose deaths are not observed during the study will be censored at their last known alive date.
Event-Free Survival (EFS) in All Participants
The EFS is defined as time from the date of randomization to the earliest date of documented relapse from complete remission (CR), treatment failure (defined as failure to achieve CR within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or up to 2 months of treatment with 7 + 3 chemotherapy), or death from any cause. Response assessments or death post SCT or new anti-AML therapies will be included. Those who are not observed to have one of these events during the study will be censored at the date of their last response assessment with clear documentation of no relapse during the study. The date of randomization will be assigned as the event date for participants with treatment failure.
Transfusion Independence Conversion Rate in All Participants
The transfusion independence conversion rate is the percentage of participants who have a 56-day or longer period with no RBC or whole blood or platelet 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 transfusion dependence at baseline is defined as having received a transfusion within the 28 days prior to the first dose of study treatment.
Rate of Complete Remission (CR) in All Participants
The rate of CR is the percentage of participants who achieve a CR, including complete remission without minimal residual disease (CR MRD-) and complete remission with positive or unknown minimal residual disease (CR MRD+/unk) as defined by investigators based on European Leukemia Net 2017 recommendations for AML (ELN 2017 AML) with modifications, while on study prior to initiation of any new anti-AML therapy or stem cell transplant (SCT).
Rate of CR Without Minimal Residual Disease (CR MRD-) in All Participants
The rate of CR MRD- is the percentage of participants who achieve a CR MRD- as defined by investigators based on ELN 2017 AML with modifications, while on study prior to initiation of any new anti-AML therapy or SCT.
Time Until Meaningful Definitive Deterioration (TUDD) on the EORTC QLQ-C30 GHS/QoL Scale in All Participants
TUDD on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) scale is defined as time from randomization date to earlier date that score is consistently at least 1 threshold value worse than baseline score/death. 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. Those whose score does not reach meaningful definitive deterioration and whose deaths are not observed during study will be censored at their last GHS/QoL scale assessment.
TUDD on the EORTC QLQ-C30 Physical Functioning Scale in All Participants
TUDD on the EORTC QLQ C30 physical functioning scale is defined as time from the date of randomization to the earlier date that the score is consistently at least 10 points worse than the baseline score or death. 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. Those whose score does not reach meaningful definitive deterioration and whose deaths are not observed during the study will be censored at their last physical functioning scale assessment date.
Rate of CR and Complete Remission with Partial Hematologic Recovery (CR+CRh) in All Participants
The CR+CRh rate is the percentage of participants who achieve a CR (including CR MRD- and CR MRD+/unk) or CRh as defined by CR with partial platelet and absolute neutrophil count (ANC) recovery while on study prior to initiation of any new anti-AML therapy or SCT.
Duration of Complete Remission (DCR)
The DCR is measured from the time the assessment criteria are first met for CR (including CR MRD- and CR MRD+/unk) until the first date of AML relapse or death (including assessments post SCT). Those who are not observed to have relapsed disease or death while on study will be censored at the date of their last response assessment with no evidence of relapse.
Duration of CR+CRh
The duration of CR+CRh is measured from the time the assessment criteria are first met for CR (including CR MRD- and CR MRD+/unk) or CRh until the first date of AML relapse or death (including assessments post SCT). Those who are not observed to have relapsed disease or death while on study will be censored at the date of their last response assessment with no evidence of relapse.
Percentage of Participants Experiencing Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Percentage of Participants Experiencing Grade ≥ 3 Treatment-Emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04778397
Brief Title
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
Acronym
ENHANCE-2
Official Title
A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Previously Untreated Patients With TP53 Mutant Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (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 effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).
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
None (Open Label)
Allocation
Randomized
Enrollment
346 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magrolimab + Azacitidine
Arm Type
Experimental
Arm Description
Participants will receive an escalating dose of magrolimab and a fixed dose of azacitidine.
Arm Title
Control Arm: Venetoclax + Azacitidine
Arm Type
Active Comparator
Arm Description
Participants who are appropriate for non-intensive therapy will receive an escalating dose of venetoclax and a fixed dose of azacitidine.
Arm Title
Control Arm: 7+3 Chemotherapy
Arm Type
Active Comparator
Arm Description
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.
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
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Idarubicin
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Steroidal Eye Drops
Intervention Description
Administered per institutional standard during consolidation.
Primary Outcome Measure Information:
Title
Overall Survival (OS) in Participants Appropriate for Non-intensive Therapy
Description
The OS is measured from the date of randomization to the date of death from any cause. Those whose deaths are not observed during the study will be censored at their last known alive date.
Time Frame
Randomization up to death or end of study (up to 27 months) whichever occurs first
Secondary Outcome Measure Information:
Title
Overall Survival in All Participants
Description
The OS is measured from the date of randomization to the date of death from any cause. Those whose deaths are not observed during the study will be censored at their last known alive date.
Time Frame
Randomization up to death or end of study (up to 27 months) whichever occurs first
Title
Event-Free Survival (EFS) in All Participants
Description
The EFS is defined as time from the date of randomization to the earliest date of documented relapse from complete remission (CR), treatment failure (defined as failure to achieve CR within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or up to 2 months of treatment with 7 + 3 chemotherapy), or death from any cause. Response assessments or death post SCT or new anti-AML therapies will be included. Those who are not observed to have one of these events during the study will be censored at the date of their last response assessment with clear documentation of no relapse during the study. The date of randomization will be assigned as the event date for participants with treatment failure.
Time Frame
Randomization up to end of study (up to 27 months)
Title
Transfusion Independence Conversion Rate in All Participants
Description
The transfusion independence conversion rate is the percentage of participants who have a 56-day or longer period with no RBC or whole blood or platelet 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 transfusion dependence at baseline is defined as having received a transfusion within the 28 days prior to the first dose of study treatment.
Time Frame
First dose date up to last dose date (Maximum: 24 months)
Title
Rate of Complete Remission (CR) in All Participants
Description
The rate of CR is the percentage of participants who achieve a CR, including complete remission without minimal residual disease (CR MRD-) and complete remission with positive or unknown minimal residual disease (CR MRD+/unk) as defined by investigators based on European Leukemia Net 2017 recommendations for AML (ELN 2017 AML) with modifications, while on study prior to initiation of any new anti-AML therapy or stem cell transplant (SCT).
Time Frame
6 months for the Magrolimab + Azacitidine; Control Arm: Venetoclax + Azacitidine arm, and 2 months for Control Arm: 7+3 Chemotherapy
Title
Rate of CR Without Minimal Residual Disease (CR MRD-) in All Participants
Description
The rate of CR MRD- is the percentage of participants who achieve a CR MRD- as defined by investigators based on ELN 2017 AML with modifications, while on study prior to initiation of any new anti-AML therapy or SCT.
Time Frame
6 months for the Magrolimab + Azacitidine; Control Arm: Venetoclax + Azacitidine arm, and 2 months for Control Arm: 7+3 Chemotherapy
Title
Time Until Meaningful Definitive Deterioration (TUDD) on the EORTC QLQ-C30 GHS/QoL Scale in All Participants
Description
TUDD on European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) scale is defined as time from randomization date to earlier date that score is consistently at least 1 threshold value worse than baseline score/death. 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. Those whose score does not reach meaningful definitive deterioration and whose deaths are not observed during study will be censored at their last GHS/QoL scale assessment.
Time Frame
Day 1 of each cycle (up to 24 months); Cycle=28 days
Title
TUDD on the EORTC QLQ-C30 Physical Functioning Scale in All Participants
Description
TUDD on the EORTC QLQ C30 physical functioning scale is defined as time from the date of randomization to the earlier date that the score is consistently at least 10 points worse than the baseline score or death. 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. Those whose score does not reach meaningful definitive deterioration and whose deaths are not observed during the study will be censored at their last physical functioning scale assessment date.
Time Frame
Day 1 of each cycle (up to 24 months); Cycle=28 days
Title
Rate of CR and Complete Remission with Partial Hematologic Recovery (CR+CRh) in All Participants
Description
The CR+CRh rate is the percentage of participants who achieve a CR (including CR MRD- and CR MRD+/unk) or CRh as defined by CR with partial platelet and absolute neutrophil count (ANC) recovery while on study prior to initiation of any new anti-AML therapy or SCT.
Time Frame
6 months for the Magrolimab + Azacitidine; Control Arm: Venetoclax + Azacitidine arm, and 2 months for Control Arm: 7+3 Chemotherapy
Title
Duration of Complete Remission (DCR)
Description
The DCR is measured from the time the assessment criteria are first met for CR (including CR MRD- and CR MRD+/unk) until the first date of AML relapse or death (including assessments post SCT). Those who are not observed to have relapsed disease or death while on study will be censored at the date of their last response assessment with no evidence of relapse.
Time Frame
First CR achieved within 6 months for the Magrolimab + Azacitidine; Control Arm: Venetoclax + Azacitidine arm, and 2 months for Control Arm: 7+3 Chemotherapy up to the end of study (up to 27 months)
Title
Duration of CR+CRh
Description
The duration of CR+CRh is measured from the time the assessment criteria are first met for CR (including CR MRD- and CR MRD+/unk) or CRh until the first date of AML relapse or death (including assessments post SCT). Those who are not observed to have relapsed disease or death while on study will be censored at the date of their last response assessment with no evidence of relapse.
Time Frame
First CR or CRh achieved within 6 months for the Magrolimab + Azacitidine; Control Arm: Venetoclax + Azacitidine arm, and 2 months for Control Arm: 7+3 Chemotherapy up to the end of study (up to 27 months)
Title
Percentage of Participants Experiencing Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Time Frame
First dose date up to last dose date (Maximum: 24 months) plus 70 days
Title
Percentage of Participants Experiencing Grade ≥ 3 Treatment-Emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0
Time Frame
First dose date up to last dose date (Maximum: 24 months) plus 70 days
Title
Serum Concentration of Magrolimab
Time Frame
Within 72 hours predose on Day 1 of Cycle 1, within 12 hours predose on Day 8 of Cycle 1 and Day 1 of Cycles 2, 3, 5, 7, 10, 13, and end of treatment (EOT) EOT=Maximum: 24 months (Cycle=28 days)
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
Within 72 hours predose on Day 1 of Cycle 1, within 12 hours predose on Day 1 of Cycles 2, 3, 5, 7, 10, 13 and end of treatment (EOT) EOT=Maximum: 24 months (Cycle=28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Individuals with confirmation of AML by World Health Organization criteria, previously untreated for AML, and who have presence of at least 1 TP53 gene mutation that is not benign or likely benign based on evaluation by either central laboratory or an approved local laboratory (after central review of the bone marrow TP53 mitigation next-generation sequencing test results) (individuals with biallelic 17p deletions, loss of both 17p alleles, are eligible based on locally evaluated cytogenetics/karyotype/fluorescence in situ hybridization (FISH) report)
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
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 ontreatment bone marrow biopsies (aspirate and trephines).
Key Exclusion Criteria:
Positive serum pregnancy test
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 RBC-direct therapies, are 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.
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 Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
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
USC/ Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UC Irvine Health
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Memorial Cancer Institute
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern Memorial Hospital/Main Lab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Chicago Medical Centre
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Kansas Hospital
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Tulane Medical center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic Cancer Center Outpatient Pharmacy
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
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
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Columbia University Medical Center - Herbert Irving Pavilion
City
New York
State/Province
New York
ZIP/Postal Code
10032
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
27599
Country
United States
Facility Name
Duke Blood Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
The Ohio State University Wexner Medical Center/ James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma Health Sciences Center - OU Health Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
St. Francis Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Prisma Health Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Baylor College of Medicine Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute ,The University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Froedtert Hospital / Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Calvary Master Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital / Department of Haematology and Bone Marrow Transplantation
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Andrew Love Cancer Centre, University Hospital Geelong
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
St Vincents Hospital Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3122
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Univ. -Klinik für Hämatologie und Internistische Onkologie, Kepler Universitätskilkun GmbHMed
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Uniklinikum Salzburg, Universitatsklinik f. Innere Medizin III der PMU
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
Country
Belgium
Facility Name
Grand Hôpital De Charleroi - Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Universitaire Ziekenhuis Antwerpen
City
Edegem
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Delta vzw
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Tom Baker Cancer Center
City
Calgary
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
CIUSSS de L'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont
City
Montreal
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Sunnybrook Research Institute
City
Toronto
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
CHU d'Angers
City
Angers cedex
ZIP/Postal Code
49933
Country
France
Facility Name
CHU de Caen
City
Caen cedex
ZIP/Postal Code
14033
Country
France
Facility Name
CHRU Lille - Hospital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Central Hospital Lyon Sud
City
Lyon
ZIP/Postal Code
69495
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
CHU de Nantes, Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU Nice - Hopital Archet 1
City
Nice
ZIP/Postal Code
6200
Country
France
Facility Name
Gustave Roussy
City
Paris
ZIP/Postal Code
94805
Country
France
Facility Name
Hopital Haut-Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
IUCT Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Hopitaux de Brabois
City
Vandoeuvre-lès-Nancy
Country
France
Facility Name
Uniklinik RWTH Aachen, Medizinische Klunuk IV - Klinik fur Hamatologie, Onkologie, Hamastaseologie und Srammzelltransplantation
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Dept. of Hematology, Oncology and Tumor Immunology, Charite- University Medicine Berlin, Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Department of Hematology and Oncology, Braunschweig Community Hospital
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus Dresden an der Technische Universitat Dresden, Medizinische Klinik und Poliklinik 1, Bereich Hamatologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf -Klinik für Hämatologie, Onkologie und Klinische Immunologie
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Dept. of Medicine II, University Hospital Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitatsklinikum Heidelberg, Innere Medizin V, Hamatologie, Onkologie und Rheumatologie
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitatsklinikum Koln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Klinikum Ludwigshafen Medizinische Klinik A
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Klinikum rechts der Isar der Technischen Universitat Munchen, Klinik und Poliklinik fur Innere Medizin III
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
LMU - Klinikum der Universitat Munchen, Medizinische Klinik und Poliklinik III, Campus Grosshadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Innere Medizin III
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Azienda Ospedaliero Universitaria delle Marche
City
Ancona
ZIP/Postal Code
I-60126
Country
Italy
Facility Name
AOU Consorziale Policlinico Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola-Malphigi U.O Ematologia
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRS - Oncologia Medica
City
Meldola
ZIP/Postal Code
40174
Country
Italy
Facility Name
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli U.O.S.C. di Ematologia con Trapianto di Midollo Osseo
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
SC Ematologia, Azienda Ospedaliera di Perugia - Santa Maria della Misericordia
City
Perugia
ZIP/Postal Code
06129
Country
Italy
Facility Name
AORM - AO Riuniti Marche Norde - Pesaro Presidio "San Salvatore" - Muraglia
City
Pesaro
ZIP/Postal Code
61122
Country
Italy
Facility Name
Fondazione PTV Policinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
SCDU Ematologia e Terrapie cellulari AO O Ordine Mauriziano Torino
City
Torino
ZIP/Postal Code
10122
Country
Italy
Facility Name
ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Hyogo Prefectural Amagasaki General Medical Center
City
Amagasaki
ZIP/Postal Code
660-8550
Country
Japan
Facility Name
Chiba Aoba Municipal Hospital
City
Chiba
ZIP/Postal Code
260-0852
Country
Japan
Facility Name
University of Yamanashi Hospital
City
Chuo-City
ZIP/Postal Code
409-3898
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima-Shi
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Aiiku Hospital
City
Hokkaido
ZIP/Postal Code
064-0804
Country
Japan
Facility Name
Tokai University School of Medicine
City
Isehara
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Hospital of the University of Occupational and Environmental Health, Japan
City
Kitakyushu-shi
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe-city
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Gunmaken Saiseikai Maebashi Hospital
City
Maebashi
ZIP/Postal Code
371-0821
Country
Japan
Facility Name
Ehime Prefectural Center Hospital
City
Matsuyama
ZIP/Postal Code
790-0024
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
City
Nagoya-Shi
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
City
Nagoya
ZIP/Postal Code
453-8511
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama-Shi
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka Metropolitan University Hospital
City
Osaka-Shi
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
National University Corporation Tohoku University Tohoku University Hospital
City
Sendai
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Shinagawa-Ku
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
University of Fukui Hospital
City
Yoshida-gun
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Hospital del la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Institut Catala d'Oncologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Complejo Asistencial Universitario de Burgos/H.U. de Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Complejo Hospitalario San Pedro de Alcantara
City
Cáceres
ZIP/Postal Code
10001
Country
Spain
Facility Name
Hospital Universitario de Gran Canaria Doctor Negrin
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
MD Anderson Cancer Center Madrid
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Clinica Universidad de Navarra - Pamplona (Main Site)
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca - Hsopital Clinico
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital U. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitari I Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Universitetssjukhus, Hematologimottagnungen
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Universitatsspital Basel - Klinik fur Hamatrologie, Bereich Innere Medizin
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital, Universitatsspital Bern - Universitatsklinik fur Medizinisch Onkologie
City
Berne
ZIP/Postal Code
CH 3010
Country
Switzerland
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
United Lincolnshire Hospitals NHS Trust, Pilgrim Hospital, Sibsey Road
City
Boston
ZIP/Postal Code
PE21 9QS
Country
United Kingdom
Facility Name
Cambridge University Hospital NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Cardiff and Vale University Health Board
City
Cardiff Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
City of London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
NHS Tayside
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
University College London Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
King's College NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Oxford University Hospital NHS Foundation Trust
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Withington
ZIP/Postal Code
M20 4BX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-546-5857
Description
Gilead Clinical Trials Website
Learn more about this trial
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
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