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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003949-11 | EudraCT Number | ||
| jRCT2071220076 | Other Identifier | Japan Registry of Clinical Trials |
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Study discontinued due to futility.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magrolimab + Azacitidine | Experimental | Participants will receive an escalating dose of magrolimab and a fixed dose of azacitidine. |
|
| Control Arm: Venetoclax + Azacitidine | Active Comparator | Participants who are appropriate for non-intensive therapy will receive an escalating dose of venetoclax and a fixed dose of azacitidine. |
|
| Control Arm: 7+3 Chemotherapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magrolimab | Drug | Administered intravenously (IV). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in Participants Appropriate for Non-intensive Therapy | OS was measured from the date of randomization to the date of death from any cause. Deaths which were not observed during the study were censored at their last known alive date. Kaplan-Meier (KM) estimates were used in outcome measure analysis. | Up to 2.1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival in All Participants | OS was measured from the date of randomization to the date of death from any cause. Deaths which were not observed during the study were censored at their last known alive date. KM estimates were used in outcome measure analysis. | Up to 2.1 years |
| Event-Free Survival (EFS) in All Participants |
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Key Inclusion Criteria:
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:
Adequate liver function as demonstrated by:
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).
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:
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:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40009500 | Derived | 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. | |
| 37703506 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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Participants were enrolled at study sites in North America, the United Kingdom, Europe, Asia, and, Australia. 1 participant was enrolled but was not randomized.
841 participants were screened.
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| ID | Title | Description |
|---|---|---|
| FG000 | Magrolimab + Azacitidine (Non-Intensive Therapy) | Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then every week (QW) x 5 weekly 30 mg/kg dose; 30 mg/kg every 2 weeks (Q2W) beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2023 | Sep 10, 2024 |
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| Venetoclax | Drug | 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 | Drug | 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 | Drug | 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 | Drug | 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 | Drug | 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 | Drug | Administered per institutional standard during consolidation. |
|
EFS: time from randomization to earliest relapse from CR (CR without minimal residual disease (CRMRD-) and CR with MRD positive/MRD unknown (CRMRD+/unk)), treatment failure (failure to achieve CR in 6 months of magrolimab/venetoclax+azacitidine; 2 months after chemotherapy), or death within the response window. CRMRD- and CRMRD+/unk: neutrophils >1.0 ×10^9/L, platelets >100 ×10^9/L, <5% bone marrow blasts, no circulating blasts or extramedullary disease (confirmed by flow cytometry <0.1% sensitivity for CRMRD-). Post-SCT assessments or new AML therapies were included. Date of randomization was assigned as event date for participants with treatment failure. Participants without events were censored at their last assessment. KM estimates were used for analysis. |
| Up to 2.1 years |
| Rate of Complete Remission (CR) in All Participants | The rate of CR was the percentage of participants who achieved a CR, including CR without minimal residual disease (CR MRD-) and CR with positive or unknown minimal residual disease (CR MRD+/unk) within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy, as defined by investigators based on European Leukemia Net (ELN) 2017 AML (ELN 2017 AML) with modifications, while on study prior to initiation of any new anti-AML therapy or stem cell transplant (SCT) within the response assessment window of 2.1 years. CR MRD- and CR MRD+/unk are defined in Outcome Measure#3 (EFS). Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Up to 2.1 years |
| Rate of CR Without Minimal Residual Disease (CR MRD-) in All Participants | Rate of CR MRD- was the percentage of participants who achieve a CR MRD- within 6 months treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy, 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 within the response assessment window of 2.1 years. CR MRD- is defined in Outcome Measure #3 (EFS). Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Up to 2.1 years |
| Rate of CR and CR With Partial Hematologic Recovery (CR+CRh) in All Participants | The CR+CRh rate was the percentage of participants who achieved a CR (including CR MRD- and CR MRD+/unk) or CRh as defined by CR with partial platelet and absolute neutrophil count (ANC) recovery within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy while on study prior to initiation of any new anti-AML therapy or SCT up to the response assessment window of 2.1 years. CRh is defined as neutrophils > 0.5 x 10^9/L; platelets > 50 x 10^9/L; bone marrow blasts < 5%; Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CR MRD- and CR MRD+/unk are defined in Outcome Measure#3 (EFS). Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Up to 2.1 years |
| Duration of CR (DCR) | DCR was measured from the time the assessment criteria were first met for CR (including CR MRD- and CR MRD+/unk) within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy, until the first date of AML relapse or death (including assessments post SCT). Participants who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse. Participants who started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, the DCR were censored at the last response assessment before the initiation of the new anti-AML therapies. CR MRD- and CR MRD+/unk are defined in Outcome Measure#3 (EFS). KM estimates were used in outcome measure analysis. | Up to 2.1 years |
| Duration of CR+CRh | Duration of CR+CRh was measured from the time the assessment criteria were first met for CR (including CR MRD- and CR MRD+/unk) or CRh within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy, until the first date of AML relapse or death (including assessments post SCT). Participants who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse. Participants who started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, the duration of CR + CRh were censored at the last response assessment before the initiation of the new anti-AML therapies. CR MRD- and CR MRD+/un are defined in Outcome Measure #3. CRh is defined in Outcome Measure #6. KM estimates were used for outcome measure analysis. | Up to 2.1 years |
| Percentage of Participants Experiencing Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as any AE that began on or after the date of first dose of study treatment up to the date of last dose of study treatment plus 70 days or the day before initiation of new anti-AML therapy including SCT, whichever occurred first. Percentages were rounded-off. | First dose date up to 1.3 years plus 70 days |
| Percentage of Participants Experiencing Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study treatment plus 70 days or the day before initiation of any new anti-AML therapy including SCT, whichever occurred first. Percentages were rounded-off. | First dose date up to 1.3 years plus 70 days |
| Serum Concentration of Magrolimab | Predose on Days 1, 4, 8, 11; Days 29 and 57 Predose and 1 hour Postdose; Predose on Days 113, 169, 253, 281 and 337 |
| Percentage of Participants With Anti-Magrolimab Antibodies | Percentages were rounded-off. | Up to 2 years |
| Duarte |
| California |
| 91010 |
| United States |
| USC/ Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| UC Irvine Health | Orange | California | 92868 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| Miami Cancer Institute | Miami | Florida | 33176 | United States |
| AdventHealth Orlando | Orlando | Florida | 32804 | United States |
| Memorial Cancer Institute | Pembroke Pines | Florida | 33028 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Northwestern Memorial Hospital/Main Lab | Chicago | Illinois | 60611 | United States |
| The University of Chicago Medical Centre | Chicago | Illinois | 60637 | United States |
| University of Kansas Hospital | Fairway | Kansas | 66205 | United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| Tulane Medical center | New Orleans | Louisiana | 70112 | United States |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic Cancer Center Outpatient Pharmacy | Rochester | Minnesota | 55905 | United States |
| MidAmerica Division, Inc., c/o Research Medical Center | Kansas City | Missouri | 64132 | United States |
| SSM Health Saint Louis University Hospital | St Louis | Missouri | 63110 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Columbia University Medical Center - Herbert Irving Pavilion | New York | New York | 10032 | United States |
| UNC Hospitals, The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke Blood Cancer Center | Durham | North Carolina | 27705 | United States |
| The Ohio State University Wexner Medical Center/ James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| University of Oklahoma Health Sciences Center - OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization | Philadelphia | Pennsylvania | 19107 | United States |
| St. Francis Cancer Center | Greenville | South Carolina | 29607 | United States |
| Prisma Health Cancer Institute | Greenville | South Carolina | 29615 | United States |
| Baylor College of Medicine Medical Center | Houston | Texas | 77030 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Huntsman Cancer Institute ,The University of Utah | Salt Lake City | Utah | 84112 | United States |
| Froedtert Hospital / Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Canberra Hospital | Garran | Australian Capital Territory | 2605 | Australia |
| Calvary Master Newcastle | Waratah | New South Wales | 2298 | Australia |
| Westmead Hospital / Department of Haematology and Bone Marrow Transplantation | Westmead | New South Wales | 2145 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Andrew Love Cancer Centre, University Hospital Geelong | Geelong | Victoria | 3220 | Australia |
| The Alfred | Melbourne | Victoria | 3004 | Australia |
| St Vincents Hospital Melbourne | Melbourne | Victoria | 3122 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Univ. -Klinik für Hämatologie und Internistische Onkologie, Kepler Universitätskilkun GmbHMed | Linz | 4021 | Austria |
| Uniklinikum Salzburg, Universitatsklinik f. Innere Medizin III der PMU | Salzburg | 5020 | Austria |
| Algemeen Ziekenhuis Sint-Jan Brugge-Oostende AV | Bruges | 8000 | Belgium |
| Universitair Ziekenhuis Brussel | Brussels | Belgium |
| Grand Hôpital De Charleroi - Notre Dame | Charleroi | 6000 | Belgium |
| Universitaire Ziekenhuis Antwerpen | Edegem | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| AZ Delta vzw | Roeselare | 8800 | Belgium |
| Tom Baker Cancer Center | Calgary | T2N 4N2 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | B3H 1V7 | Canada |
| CIUSSS de L'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont | Montreal | H1T 2M4 | Canada |
| McGill University Health Centre | Montreal | H4A 3J1 | Canada |
| Sunnybrook Research Institute | Toronto | M4N 3M5 | Canada |
| Princess Margaret Cancer Centre | Toronto | M5G 2M9 | Canada |
| Aalborg University Hospital | Aalborg | 9000 | Denmark |
| Odense University Hospital | Odense C | 5000 | Denmark |
| CHU d'Angers | Angers | 49933 | France |
| CHU de Caen | Caen | 14033 | France |
| CHRU Lille - Hospital Claude Huriez | Lille | 59037 | France |
| CHU Limoges | Limoges | 87042 | France |
| Central Hospital Lyon Sud | Lyon | 69495 | France |
| Institut Paoli Calmettes | Marseille | 13009 | France |
| CHU de Nantes, Hotel Dieu | Nantes | 44093 | France |
| CHU Nice - Hopital Archet 1 | Nice | 6200 | France |
| Gustave Roussy | Paris | 94805 | France |
| Hopital Haut-Leveque | Pessac | 33604 | France |
| IUCT Oncopole | Toulouse | 31059 | France |
| Hopitaux de Brabois | Vandœuvre-lès-Nancy | France |
| Uniklinik RWTH Aachen, Medizinische Klunuk IV - Klinik fur Hamatologie, Onkologie, Hamastaseologie und Srammzelltransplantation | Aachen | 52074 | Germany |
| Dept. of Hematology, Oncology and Tumor Immunology, Charite- University Medicine Berlin, Campus Virchow Klinikum | Berlin | 13353 | Germany |
| Department of Hematology and Oncology, Braunschweig Community Hospital | Braunschweig | 38114 | Germany |
| Universitatsklinikum Koln | Cologne | 50937 | Germany |
| Universitatsklinikum Carl Gustav Carus Dresden an der Technische Universitat Dresden, Medizinische Klinik und Poliklinik 1, Bereich Hamatologie | Dresden | 01307 | Germany |
| Universitätsklinikum Düsseldorf -Klinik für Hämatologie, Onkologie und Klinische Immunologie | Düsseldorf | 40225 | Germany |
| Dept. of Medicine II, University Hospital Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Universitatsklinikum Heidelberg, Innere Medizin V, Hamatologie, Onkologie und Rheumatologie | Heidelberg | 69120 | Germany |
| Universitatsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| Klinikum Ludwigshafen Medizinische Klinik A | Ludwigshafen | 67063 | Germany |
| LMU - Klinikum der Universitat Munchen, Medizinische Klinik und Poliklinik III, Campus Grosshadern | München | 81377 | Germany |
| Klinikum rechts der Isar der Technischen Universitat Munchen, Klinik und Poliklinik fur Innere Medizin III | München | 81675 | Germany |
| Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Innere Medizin III | Ulm | 89081 | 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 | I-60126 | Italy |
| AOU Consorziale Policlinico Bari | Bari | 70124 | Italy |
| Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola-Malphigi U.O Ematologia | Bologna | 40138 | Italy |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRS - Oncologia Medica | Meldola | 40174 | Italy |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli U.O.S.C. di Ematologia con Trapianto di Midollo Osseo | Naples | 80131 | Italy |
| SC Ematologia, Azienda Ospedaliera di Perugia - Santa Maria della Misericordia | Perugia | 06129 | Italy |
| AORM - AO Riuniti Marche Norde - Pesaro Presidio "San Salvatore" - Muraglia | Pesaro | 61122 | Italy |
| Fondazione PTV Policinico Tor Vergata | Roma | 00133 | Italy |
| SCDU Ematologia e Terrapie cellulari AO O Ordine Mauriziano Torino | Torino | 10122 | Italy |
| ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi | Varese | 21100 | Italy |
| Hyogo Prefectural Amagasaki General Medical Center | Amagasaki | 660-8550 | Japan |
| Chiba Aoba Municipal Hospital | Chiba | 260-0852 | Japan |
| University of Yamanashi Hospital | Chūō | 409-3898 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960-1295 | Japan |
| Aiiku Hospital | Hokkaido | 064-0804 | Japan |
| Tokai University School of Medicine | Isehara | 259-1193 | Japan |
| Kanazawa University Hospital | Kanazawa | 920-8641 | Japan |
| National Cancer Center Hospital East | Kashiwa | 277-8577 | Japan |
| Hospital of the University of Occupational and Environmental Health, Japan | Kitakyushu-shi | 807-8555 | Japan |
| Kobe City Medical Center General Hospital | Kobe | 650-0047 | Japan |
| Gunmaken Saiseikai Maebashi Hospital | Maebashi | 371-0821 | Japan |
| Ehime Prefectural Center Hospital | Matsuyama | 790-0024 | Japan |
| Nagasaki University Hospital | Nagasaki | 852-8501 | Japan |
| Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital | Nagoya | 453-8511 | Japan |
| Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital | Nagoya | 466-8650 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Osaka Metropolitan University Hospital | Osaka | 545-8586 | Japan |
| Kindai University Hospital | Sayama | 589-8511 | Japan |
| National University Corporation Tohoku University Tohoku University Hospital | Sendai | 980-8574 | Japan |
| NTT Medical Center Tokyo | Shinagawa-Ku | 141-8625 | Japan |
| Yamagata University Hospital | Yamagata | 990-9585 | Japan |
| University of Fukui Hospital | Yoshida-gun | 910-1193 | Japan |
| Hospital General Universitario de Alicante | Alicante | 3010 | Spain |
| Hospital del la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Institut Catala d'Oncologia | Barcelona | 08907 | Spain |
| Complejo Asistencial Universitario de Burgos/H.U. de Burgos | Burgos | 09006 | Spain |
| Complejo Hospitalario San Pedro de Alcantara | Cáceres | 10001 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrin | Las Palmas de Gran Canaria | 35010 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| MD Anderson Cancer Center Madrid | Madrid | 28033 | Spain |
| Hospital Regional Universitario de Malaga | Málaga | 29010 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| Clinica Universidad de Navarra - Pamplona (Main Site) | Pamplona | 31008 | Spain |
| Complejo Asistencial Universitario de Salamanca - Hsopital Clinico | Salamanca | 37007 | Spain |
| Hospital U. Marques de Valdecilla | Santander | 39008 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitari I Politècnic La Fe | Valencia | 46026 | Spain |
| Universitetssjukhus, Hematologimottagnungen | Lund | 221 85 | Sweden |
| Universitatsspital Basel - Klinik fur Hamatrologie, Bereich Innere Medizin | Basel | 4031 | Switzerland |
| Inselspital, Universitatsspital Bern - Universitatsklinik fur Medizinisch Onkologie | Bern | CH 3010 | Switzerland |
| University Hospitals Birmingham NHS Foundation Trust | Birmingham | B15 2GW | United Kingdom |
| United Lincolnshire Hospitals NHS Trust, Pilgrim Hospital, Sibsey Road | Boston | PE21 9QS | United Kingdom |
| Cambridge University Hospital NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| Cardiff and Vale University Health Board | Cardiff Wales | CF14 4XW | United Kingdom |
| Barts Health NHS Trust | City of London | EC1A 7BE | United Kingdom |
| NHS Tayside | Dundee | DD1 9SY | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | NW1 2PG | United Kingdom |
| King's College NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| Oxford University Hospital NHS Foundation Trust | Oxford | OX3 7LE | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | SM2 5PT | United Kingdom |
| The Christie NHS Foundation Trust | Withington | M20 4BX | United Kingdom |
| Derived |
| 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. |
| FG001 | Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) | Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. |
| FG002 | Magrolimab + Azacitidine (Intensive Therapy) | Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. |
| FG003 | Control Arm: 7+3 Chemotherapy (Intensive Therapy) | Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m^2 IV push or idarubicin 60 mg/m^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-To-Treat Analysis Set included all participants who were randomized in the study, with treatment assignment designated according to the treatment arm the participant was randomized to.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Magrolimab + Azacitidine (Non-Intensive Therapy) | Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. |
| BG001 | Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) | Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. |
| BG002 | Magrolimab + Azacitidine (Intensive Therapy) | Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. |
| BG003 | Control Arm: 7+3 Chemotherapy (Intensive Therapy) | Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m^2 IV push or idarubicin 60 mg/m^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation up to 32 months. Each cycle was 28 days. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) in Participants Appropriate for Non-intensive Therapy | OS was measured from the date of randomization to the date of death from any cause. Deaths which were not observed during the study were censored at their last known alive date. Kaplan-Meier (KM) estimates were used in outcome measure analysis. | Participants from the Intent-to-Treat Analysis (ITT) Set who were appropriate for non-intensive therapy were analyzed. As per the pre-specified analysis, the data in this outcome measure was reported only for the non-intensive therapy groups. | Posted | Median | 95% Confidence Interval | months | Up to 2.1 years |
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| Secondary | Overall Survival in All Participants | OS was measured from the date of randomization to the date of death from any cause. Deaths which were not observed during the study were censored at their last known alive date. KM estimates were used in outcome measure analysis. | Participants from the Intend-To-Treat Analysis Set were analyzed. As per the pre-specified analysis, the data for this outcome measure were analyzed together for all participants who received magrolimab + azacitidine and participants who received venetoclax + azacitidine or 7+3 chemotherapy. | Posted | Median | 95% Confidence Interval | months | Up to 2.1 years |
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| Secondary | Event-Free Survival (EFS) in All Participants | EFS: time from randomization to earliest relapse from CR (CR without minimal residual disease (CRMRD-) and CR with MRD positive/MRD unknown (CRMRD+/unk)), treatment failure (failure to achieve CR in 6 months of magrolimab/venetoclax+azacitidine; 2 months after chemotherapy), or death within the response window. CRMRD- and CRMRD+/unk: neutrophils >1.0 ×10^9/L, platelets >100 ×10^9/L, <5% bone marrow blasts, no circulating blasts or extramedullary disease (confirmed by flow cytometry <0.1% sensitivity for CRMRD-). Post-SCT assessments or new AML therapies were included. Date of randomization was assigned as event date for participants with treatment failure. Participants without events were censored at their last assessment. KM estimates were used for analysis. | Participants from the Intend-To-Treat Analysis Set were analyzed. As per the pre-specified analysis, the data for this outcome measure were analyzed together for all participants who received magrolimab + azacitidine and participants who received venetoclax + azacitidine or 7+3 chemotherapy. | Posted | Median | 95% Confidence Interval | months | Up to 2.1 years |
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| Secondary | Rate of Complete Remission (CR) in All Participants | The rate of CR was the percentage of participants who achieved a CR, including CR without minimal residual disease (CR MRD-) and CR with positive or unknown minimal residual disease (CR MRD+/unk) within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy, as defined by investigators based on European Leukemia Net (ELN) 2017 AML (ELN 2017 AML) with modifications, while on study prior to initiation of any new anti-AML therapy or stem cell transplant (SCT) within the response assessment window of 2.1 years. CR MRD- and CR MRD+/unk are defined in Outcome Measure#3 (EFS). Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Participants from the Intent-To-Treat Analysis Set were analyzed. As per the pre-specified analysis, the data for this outcome measure were analyzed together for all participants who received magrolimab + azacitidine and participants who received venetoclax + azacitidine or 7+3 chemotherapy. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2.1 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of CR Without Minimal Residual Disease (CR MRD-) in All Participants | Rate of CR MRD- was the percentage of participants who achieve a CR MRD- within 6 months treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy, 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 within the response assessment window of 2.1 years. CR MRD- is defined in Outcome Measure #3 (EFS). Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Participants from the Intent-To-Treat Analysis Set were analyzed. As per the pre-specified analysis, the data for this outcome measure were analyzed together for all participants who received magrolimab + azacitidine and participants who received venetoclax + azacitidine or 7+3 chemotherapy. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2.1 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of CR and CR With Partial Hematologic Recovery (CR+CRh) in All Participants | The CR+CRh rate was the percentage of participants who achieved a CR (including CR MRD- and CR MRD+/unk) or CRh as defined by CR with partial platelet and absolute neutrophil count (ANC) recovery within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy while on study prior to initiation of any new anti-AML therapy or SCT up to the response assessment window of 2.1 years. CRh is defined as neutrophils > 0.5 x 10^9/L; platelets > 50 x 10^9/L; bone marrow blasts < 5%; Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CR MRD- and CR MRD+/unk are defined in Outcome Measure#3 (EFS). Percentages were rounded-off. Clopper-Pearson method were used in outcome measure analysis. | Participants from the Intent-To-Treat Analysis Set were analyzed. As per the pre-specified analysis, the data for this outcome measure were analyzed together for all participants who received magrolimab + azacitidine and participants who received venetoclax + azacitidine or 7+3 chemotherapy. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2.1 years |
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| Secondary | Duration of CR (DCR) | DCR was measured from the time the assessment criteria were first met for CR (including CR MRD- and CR MRD+/unk) within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy, until the first date of AML relapse or death (including assessments post SCT). Participants who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse. Participants who started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, the DCR were censored at the last response assessment before the initiation of the new anti-AML therapies. CR MRD- and CR MRD+/unk are defined in Outcome Measure#3 (EFS). KM estimates were used in outcome measure analysis. | Participants from the Intent-To-Treat Analysis Set who achieved CR within 6 months in all participants (2 months for participants receiving 7 + 3 chemotherapy) were analyzed. As per the pre-specified analysis, the data for this outcome measure were analyzed together for all participants who received magrolimab + azacitidine and participants who received venetoclax + azacitidine or 7+3 chemotherapy. | Posted | Median | 95% Confidence Interval | months | Up to 2.1 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of CR+CRh | Duration of CR+CRh was measured from the time the assessment criteria were first met for CR (including CR MRD- and CR MRD+/unk) or CRh within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy, until the first date of AML relapse or death (including assessments post SCT). Participants who were not observed to have relapsed disease or death while on study were censored at the date of their last response assessment with no evidence of relapse. Participants who started taking new anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, the duration of CR + CRh were censored at the last response assessment before the initiation of the new anti-AML therapies. CR MRD- and CR MRD+/un are defined in Outcome Measure #3. CRh is defined in Outcome Measure #6. KM estimates were used for outcome measure analysis. | Participants from the Intent-To-Treat Analysis Set with who achieved CR+CRh within 6 months in all participants (2 months for participants receiving 7 + 3 chemotherapy) were analyzed. As per the pre-specified analysis, the data for this outcome measure were analyzed together for all participants who received magrolimab + azacitidine and participants who received venetoclax + azacitidine or 7+3 chemotherapy. | Posted | Median | 95% Confidence Interval | months | Up to 2.1 years |
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| Secondary | Percentage of Participants Experiencing Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as any AE that began on or after the date of first dose of study treatment up to the date of last dose of study treatment plus 70 days or the day before initiation of new anti-AML therapy including SCT, whichever occurred first. Percentages were rounded-off. | The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received. | Posted | Number | percentage of participants | First dose date up to 1.3 years plus 70 days |
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| Secondary | Percentage of Participants Experiencing Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study treatment plus 70 days or the day before initiation of any new anti-AML therapy including SCT, whichever occurred first. Percentages were rounded-off. | Participants from Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | First dose date up to 1.3 years plus 70 days |
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| Secondary | Serum Concentration of Magrolimab | The Pharmacokinetic (PK) Analysis Set included all randomized participants who took at least one dose of magrolimab and have at least 1 measurable (non-below the limit of quantitation (BLQ) numeric values) posttreatment serum concentration of magrolimab. Participants with available data were analyzed. | Posted | Mean | Standard Deviation | μg/mL | Predose on Days 1, 4, 8, 11; Days 29 and 57 Predose and 1 hour Postdose; Predose on Days 113, 169, 253, 281 and 337 |
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| Secondary | Percentage of Participants With Anti-Magrolimab Antibodies | Percentages were rounded-off. | The Immunogenicity Analysis Set included all randomized participants who received at least one dose of magrolimab and had at least one evaluable anti-magrolimab antibody test result. | Posted | Number | percentage of participants | Up to 2 years |
|
All-cause mortality: Up to 2.1 years; Adverse events: Up to 1.3 years plus 70 days
All-cause mortality: The Intent-To-Treat Analysis Set included all participants who were randomized in the study, with treatment assignment designated according to the treatment arm the participant was randomized to.
Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study treatment, with treatment assignment designated according to the actual treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magrolimab + Azacitidine (Non-Intensive Therapy) | Participants who were appropriate for non-intensive therapy received 1 mg/kg magrolimab intravenously (IV) on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine subcutaneously (SC) or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. | 61 | 101 | 84 | 96 | 92 | 96 |
| EG001 | Control Arm: Venetoclax + Azacitidine (Non-Intensive Therapy) | Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. | 57 | 104 | 76 | 98 | 94 | 98 |
| EG002 | Magrolimab + Azacitidine (Intensive Therapy) | Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. | 14 | 27 | 20 | 27 | 27 | 27 |
| EG003 | Control Arm: 7+3 Chemotherapy (Intensive Therapy) | Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m^2 IV push or idarubicin 60 mg/m^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days. | 10 | 25 | 14 | 23 | 23 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Cytopenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Red blood cell abnormality | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Orbital haematoma | Eye disorders | 26.1 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | 26.1 | Systematic Assessment |
| |
| Retinal vascular thrombosis | Eye disorders | 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Abdominal strangulated hernia | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Haemorrhoids thrombosed | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Neutropenic colitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 26.1 | Systematic Assessment |
| |
| Device related thrombosis | General disorders | 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 26.1 | Systematic Assessment |
| |
| Sudden death | General disorders | 26.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | 26.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | 26.1 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | 26.1 | Systematic Assessment |
| |
| Anal fistula infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Anorectal infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Clostridial sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Dermo-hypodermitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Diverticulitis intestinal perforated | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Endophthalmitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Lymph node tuberculosis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Mediastinitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Periorbital infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Respiratory tract infection fungal | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Rhinocerebral mucormycosis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | 26.1 | Systematic Assessment |
| |
| Liver function test increased | Investigations | 26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hyperglycaemic hyperosmolar nonketotic syndrome | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Ovarian cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 26.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Cerebral small vessel ischaemic disease | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | 26.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Tongue coated | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | 26.1 | Systematic Assessment |
| |
| Chills | General disorders | 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | 26.1 | Systematic Assessment |
| |
| Generalised oedema | General disorders | 26.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | 26.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | 26.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 26.1 | Systematic Assessment |
| |
| Oedema | General disorders | 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | 26.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | 26.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 26.1 | Systematic Assessment |
| |
| Allergic transfusion reaction | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 26.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 26.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | 26.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 26.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 7, 2024 | Sep 10, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629291 | magrolimab |
| C579720 | venetoclax |
| D001374 | Azacitidine |
| D003561 | Cytarabine |
| D003630 | Daunorubicin |
| D015255 | Idarubicin |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D001087 | Arabinonucleosides |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Spain |
|
| France |
|
| United Kingdom |
|
| Australia |
|
| Japan |
|
| Italy |
|
| Germany |
|
| Switzerland |
|
| Hong Kong |
|
| Belgium |
|
| Canada |
|
| Austria |
|
| Sweden |
|
|
|
|
| OG001 | Control Arm: Venetoclax + Azacitidine or 7+3 Chemotherapy | Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m^2 IV push or idarubicin 60 mg/m^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days. |
|
|
|
| OG001 | Control Arm: Venetoclax + Azacitidine or 7+3 Chemotherapy | Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m^2 IV push or idarubicin 60 mg/m^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days. |
|
|
|
Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m^2 IV push or idarubicin 60 mg/m^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days. |
|
|
|
| OG001 | Control Arm: Venetoclax + Azacitidine or 7+3 Chemotherapy | Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m^2 IV push or idarubicin 60 mg/m^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days. |
|
|
|
| OG001 | Control Arm: Venetoclax + Azacitidine or 7+3 Chemotherapy | Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m^2 IV push or idarubicin 60 mg/m^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days. |
|
|
| OG001 | Control Arm: Venetoclax + Azacitidine or 7+3 Chemotherapy | Participants who were appropriate for non-intensive therapy received Venetoclax 100 mg orally on Cycle 1 Day 1; 200 mg orally on Cycle 1 Day 2; 400 mg orally on Cycle 1 Day 3 everyday and throughout all the cycles. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m^2 IV push or idarubicin 60 mg/m^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days. |
|
|
| OG002 | Magrolimab + Azacitidine (Intensive Therapy) | Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. |
| OG003 | Control Arm: 7+3 Chemotherapy (Intensive Therapy) | Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m^2 IV push or idarubicin 60 mg/m^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days. |
|
|
| OG002 | Magrolimab + Azacitidine (Intensive Therapy) | Participants who were appropriate for intensive therapy received 1 mg/kg magrolimab IV on Days 1, 4; 15 mg/kg on Day 8; 30 mg/kg on Days 11, 15, and then QW x 5 weekly 30 mg/kg dose; 30 mg/kg Q2W beginning 1 week after the 5 weekly 30 mg/kg dose. Participants received azacitidine SC or IV, 75 mg/m^2 on Days 1-7 or Days 1-5, 8 and 9 during every cycle of 28 days. The treatment duration was up to a maximum of 1.3 years. |
| OG003 | Control Arm: 7+3 Chemotherapy (Intensive Therapy) | Participants who were appropriate for intensive therapy received 7+3 chemotherapy: 7 day treatment with cytarabine 100 or 200 mg/m^2 continuous infusion and 3 day treatment with daunorubicin 60 mg/m^2 IV push or idarubicin 60 mg/m^2 IV during induction and high-dose cytarabine 1500 or 3000 mg/m^2 IV every 12 hours on Days 1, 3, and 5 up to 4 cycles and steroidal eye drops during consolidation. Each cycle was 28 days. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|