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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003117-33 | EudraCT Number | ||
| U1111-1239-7581 | Registry Identifier | WHO |
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The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy.
Participants will receive either pevonedistat + venetoclax + azacitidine or venetoclax + azacitidine in 28-day treatment cycles. Bone marrow samples (biopsy) will be collected throughout the study. Pevonedistat will be given as an intravenous (IV) infusion and Azacitidine will be given through IV or subcutaneous (under the skin).
Study treatments may continue as long as the participant is receiving benefit from it. Participants may choose to stop treatment at any time.
The drug being tested in this study is called Pevonedistat. Pevonedistat is being tested to treat people who have AML. This study will compare the improvement in EFS in Arm A: Pevonedistat + Venetoclax + Azacitidine combination arm group when compared with Arm B: Venetoclax + Azacitidine.
The study will enroll approximately 164 patients. Participants will be randomly assigned in 1:1 ratio to one of the two treatment groups in 28-day treatment cycles and which will remain disclosed to the patient and study doctor during the study:
This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 3 years. Participants will attend the end-of-treatment visit 30 days after the last dose of study drug or before the start of subsequent anti-neoplastic therapy if that occurs sooner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2 | Active Comparator | Venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m^2 intravenous (IV) or subcutaneous (SC) dosing on Days 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022. |
|
| Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2 | Experimental | Pevonedistat 20 mg/m^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle plus venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m^2 IV or SC dosing on Day 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pevonedistat | Drug | Pevonedistat IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event-Free Survival (EFS) | EFS was defined as time from study randomization to date of failure to achieve complete remission (CR)/CR with incomplete blood count recovery (CRi), relapse from CR/CRi, or death. Assessments of disease response based on criteria: European Leukemia Net (ELN) 2017 guidelines. CR was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC)≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). For participants who achieved CR/CRi, if relapse is not observed by time of analysis, was censored at the date of last disease assessment. If failed to achieve CR/CRi, date of treatment failure was set on day of randomization. | Up to 22 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as time from randomization to death from any cause. Participants without documentation of death at the time of analysis will be censored at the date last known to be alive. | Up to 36 months |
| Thirty-day Mortality Rate |
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Inclusion Criteria:
Has morphologically confirmed diagnosis of AML (World Health Organization [WHO] criteria 2008). Participants may have newly diagnosed primary de novo AML or secondary AML (sAML), defined as AML after myelodysplastic syndromes (MDS) or myeloproliferative neoplasm (MPN), or therapy-related AML (t-AML) following cytotoxic therapy, and/or radiotherapy for a malignant or nonmalignant disease.
Is unfit for treatment with a standard arabinosylcytosine (Ara-C) and anthracycline induction regimen due to age or co-morbidities defined by 1 of the following:
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3.
Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina).
Severe pulmonary disorder (e.g., carbon monoxide lung diffusion capacity ≤65% or forced expiratory volume in 1 second ≤65%).
Creatinine clearance (CrCl) <45 mL/min (but ≥30 mL/min as part of general eligibility criteria).
Hepatic disorder with total bilirubin >1.5 times the upper limit of the normal range (ULN).
Has clinical laboratory values within the following parameters (repeat within 3 days before the first dose of study drug if laboratory values used for randomization were obtained more than 3 days before the first dose of study drug):
White blood cell (WBC) count <25 × 10^9/L. Participants who are cytoreduced with leukapheresis or with hydroxyurea may be enrolled if they meet the eligibility criteria before starting therapy.
Exclusion Criteria:
Has history of MPN with BCR-ABL1 translocation or AML with BCR-ABL1 translocation.
Has genetic diagnosis of acute promyelocytic leukemia.
Is eligible for intensive chemotherapy and/or allogeneic stem cell transplantation.
Has extramedullary AML without evidence of bone marrow involvement.
Had prior treatment with hypomethylating agents for AML (hypomethylating agent treatment for prior MDS is not exclusionary).
Has clinical evidence of or history of central nervous system involvement by AML.
Had diagnosed or treated for another malignancy (except for adequately treated carcinoma in situ of any organ or nonmelanoma skin cancer) within 1 year before randomization or previously diagnosed with another malignancy and have any evidence of residual disease that may compromise the administration of pevonedistat, venetoclax or azacitidine. Prior MDS is also allowed, but the participant cannot have received treatment for MDS within 14 days before first dose of any study drug.
Has a WBC count ≥25 × 10^9/L
Has uncontrolled human immunodeficiency virus (HIV) infection. Note: Known HIV positive participants who meet the following criteria will be considered eligible:
Participant is known to be positive for hepatitis B or C infection, with the exception of those with an undetectable viral load within 3 months (hepatitis B or C testing is not required for eligibility assessment).
Has hepatic cirrhosis.
Has uncontrolled coagulopathy or bleeding disorder.
Has high blood pressure which cannot be controlled by standard treatments.
Has prolonged rate QTc interval ≥500 msec, calculated according to institutional guidelines.
Has left ventricular ejection fraction (LVEF) <40%, based on echocardiogram or multi gated acquisition (MUGA) scan at screening (data to be available within last 3 months of screening).
As infection is a common feature of AML, participants with active infection are permitted to enroll provided that the infection is under control and no signs of systemic inflammatory response beyond low grade fever that makes participant clinically unstable in the opinion of the investigator. Participants with uncontrolled infection shall not be enrolled until infection is treated and brought under control.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| UC San Diego Moores Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39606906 | Derived | Short NJ, Wierzbowska A, Cluzeau T, Laribi K, Recher C, Czyz J, Ochrem B, Ades L, Gallego-Hernanz MP, Heiblig M, Audisio E, Zarzycka E, Li S, Ferenc N, Yeh T, Faller DV, Sedarati F, Papayannidis C. Azacitidine and venetoclax with or without pevonedistat in patients with newly diagnosed acute myeloid leukemia. Leuk Lymphoma. 2025 Mar;66(3):458-468. doi: 10.1080/10428194.2024.2431878. Epub 2024 Nov 28. |
| Label | URL |
|---|---|
| To obtain more information about this study, click this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a diagnosis of Acute Myeloid Leukemia (AML) were randomized in a 1:1 ratio to receive either pevonedistat + venetoclax + azacytidine or venetoclax + azacitidine.
Participants took part in the study at 51 investigative sites in France, Italy, Poland, United States and Canada from 13 October 2020 to 05 January 2024. The data is reported for primary outcome measure up to primary completion date: 06 September 2022. This study is ongoing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2 | Venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m^2 intravenous (IV) or subcutaneous (SC) dosing on Days 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022. |
| 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 | Jan 21, 2022 | Aug 17, 2023 |
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| Venetoclax | Drug | Venetoclax tablets. |
|
| Azacitidine | Drug | Azacitidine IV or SC injection. |
|
Mortality rate is defined as percentage of participants who survive at most 30 days from the first dose of study drug. |
| Day 30 |
| Sixty-day Mortality Rate | Mortality rate is defined as percentage of participants who survive at most 60 days from the first dose of study drug. | Day 60 |
| Percentage of Participants With Complete Remission (CR) | CR rate is defined as the percentage of participants who achieve the CR as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). | Up to 36 months |
| Percentage of Participants With Composite Complete Remission (CCR) | CCR rate is defined as the percentage of participants who achieve the CR + CRi as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). | Up to 36 months |
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve the CR + CRi + Partial Remission (PR) as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). PR is defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. | Up to 36 months |
| Percentage of Participants With CR + CRh | CR + CRh rate is defined as the percentage of participants who achieve the CR + CRh as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRh is defined as bone marrow with <5% blasts, peripheral blood neutrophil count >0.5×10^3/µL and peripheral blood platelet count >0.5×10^5/µL. | Up to 36 months |
| Percentage of Participants With Leukemia Response | Leukemia response rate is defined as the percentage of participants who achieve the CR + CRi + PR + morphological leukemia-free state [MLFS, marrow CR (mCR)]) as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥ 1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). PR is defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. MLFS is defined as bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. | Up to 36 months |
| Duration of CR and CRi | Duration of CR and CRi is defined as the time from first documentation of CR or CRi to the date of first documentation of PD or relapse from CR or CRi, and will be summarized descriptively using the K-M method based on the responders. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥ 1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). | Up to 36 months |
| Time to First CR, CRi and PR | Time to first CR, CRi, and PR is defined as the time from randomization until the first documented CR, CRi or PR, whichever occurs first, and will be analyzed using the K-M method. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥ 1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). PR is defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. | Up to 36 months |
| Plasma Concentration of Pevonedistat | At multiple time points pre-dose and post-dose on Days 1, 3 and 5 in Cycle 1 and post-dose on Day 1 in Cycles 2 and 4 (cycle length= 28 days) |
| La Jolla |
| California |
| 92093 |
| United States |
| UC Irvine Medical Center | Orange | California | 92868 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| AdventHealth (Florida Hospital) - Transplant Institute | Orlando | Florida | 32804 | United States |
| Norton Cancer Institute - Suburban | Louisville | Kentucky | 40207 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| HCA Midwest Health - SCRI - PPDS | Kansas City | Missouri | 64132 | United States |
| Northwell Health Cancer Institute | Lake Success | New York | 11042 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029-6574 | United States |
| Stony Brook Medicine | Stony Brook | New York | 11794 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514-4221 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| The University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Houston Methodist Cancer Center | Houston | Texas | 77030 | United States |
| Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | 79410 | United States |
| Intermountain LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| University of Alberta | Edmonton | Alberta | T6G 2G3 | Canada |
| Tom Baker Cancer Centre | Tom Baker Cancer Centre | Alberta | T2N 4N2 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Hopital de L'enfant Jesus | Québec | Quebec | G1J 1Z4 | Canada |
| Centre Hospitalier Le Mans | Le Mans | Sarthe | 72000 | France |
| Hopital Avicenne | Bobigny | 93009 | France |
| Institut dHematologie de Basse Normandie | Caen | 14033 | France |
| CHU de Grenoble | Grenoble | 38043 | France |
| CHRU Lille | Lille | 59037 | France |
| CHRU Nantes | Nantes | 44093 | France |
| CHU de Nice | Nice | 06202 | France |
| Hopital Saint Antoine | Paris | 75012 | France |
| Hopital Saint Louis | Paris | 75475 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| CHRU de Poitiers La Miletrie | Poitiers | 86021 | France |
| EDOG - Institut Claudius Regaud - PPDS | Toulouse | 31059 | France |
| Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli | Reggio Calabria | Calabria | 89133 | Italy |
| ASST di Monza - Azienda Ospedaliera San Gerardo | Monza | Lombardy | 20900 | Italy |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Azienda Sanitaria Ospedaliera S Luigi Gonzaga | Orbassano | Piedmont | 10043 | Italy |
| Azienda Ospedaliera Citta della Salute e della Scienza di Torino | Turin | Piedmont | 10126 | Italy |
| Ospedale Santa Maria Della Misericordia Di Perugia | Perugia | Umbria | 06156 | Italy |
| Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi | Bologna | 40138 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| Fondazione IRCCS Policlinico San Matteo di Pavia | Pavia | 27100 | Italy |
| Szpital Uniwersytecki w Krakowie | Krakow | Lesser Poland Voivodeship | 31-501 | Poland |
| MTZ Clinical Research Sp z o o | Warsaw | Masovian Voivodeship | 02-106 | Poland |
| Instytut Hematologii i Transfuzjologii | Warsaw | Masovian Voivodeship | 02-776 | Poland |
| Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | Podlaskie Voivodeship | 15-276 | Poland |
| Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy | Bydgoszcz | 85-168 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie | Lublin | 20-081 | Poland |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lodz | Łódź Voivodeship | 93-513 | Poland |
| FG001 | Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2 | Pevonedistat 20 mg/m^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle plus venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m^2 IV or SC dosing on Day 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022. |
| Safety Population | Safety population was defined as all participants who received at least 1 dose of any of the study medications (pevonedistat, venetoclax, or azacitidine). |
|
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat (ITT) population was defined as all participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2 | Venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m^2 IV or SC dosing on Days 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022. |
| BG001 | Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2 | Pevonedistat 20 mg/m^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle plus venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m^2 IV or SC dosing on Day 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Event-Free Survival (EFS) | EFS was defined as time from study randomization to date of failure to achieve complete remission (CR)/CR with incomplete blood count recovery (CRi), relapse from CR/CRi, or death. Assessments of disease response based on criteria: European Leukemia Net (ELN) 2017 guidelines. CR was defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC)≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). For participants who achieved CR/CRi, if relapse is not observed by time of analysis, was censored at the date of last disease assessment. If failed to achieve CR/CRi, date of treatment failure was set on day of randomization. | ITT population was defined as all participants who were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 22 months |
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| Secondary | Overall Survival (OS) | OS is defined as time from randomization to death from any cause. Participants without documentation of death at the time of analysis will be censored at the date last known to be alive. | Not Posted | Jun 2026 | Up to 36 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Thirty-day Mortality Rate | Mortality rate is defined as percentage of participants who survive at most 30 days from the first dose of study drug. | Not Posted | Jun 2026 | Day 30 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sixty-day Mortality Rate | Mortality rate is defined as percentage of participants who survive at most 60 days from the first dose of study drug. | Not Posted | Jun 2026 | Day 60 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Remission (CR) | CR rate is defined as the percentage of participants who achieve the CR as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). | Not Posted | Jun 2026 | Up to 36 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Composite Complete Remission (CCR) | CCR rate is defined as the percentage of participants who achieve the CR + CRi as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). | Not Posted | Jun 2026 | Up to 36 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve the CR + CRi + Partial Remission (PR) as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). PR is defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. | Not Posted | Jun 2026 | Up to 36 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CR + CRh | CR + CRh rate is defined as the percentage of participants who achieve the CR + CRh as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRh is defined as bone marrow with <5% blasts, peripheral blood neutrophil count >0.5×10^3/µL and peripheral blood platelet count >0.5×10^5/µL. | Not Posted | Jun 2026 | Up to 36 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Leukemia Response | Leukemia response rate is defined as the percentage of participants who achieve the CR + CRi + PR + morphological leukemia-free state [MLFS, marrow CR (mCR)]) as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥ 1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). PR is defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. MLFS is defined as bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. | Not Posted | Jun 2026 | Up to 36 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of CR and CRi | Duration of CR and CRi is defined as the time from first documentation of CR or CRi to the date of first documentation of PD or relapse from CR or CRi, and will be summarized descriptively using the K-M method based on the responders. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥ 1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). | Not Posted | Jun 2026 | Up to 36 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First CR, CRi and PR | Time to first CR, CRi, and PR is defined as the time from randomization until the first documented CR, CRi or PR, whichever occurs first, and will be analyzed using the K-M method. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥ 1.0×10^9/L (1000/µL); platelet count≥100×10^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (<1.0×10^9/L [1000/µL]) or thrombocytopenia (<100×10^9/L [100,000/µL]). PR is defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. | Not Posted | Jun 2026 | Up to 36 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Pevonedistat | Not Posted | Jun 2026 | At multiple time points pre-dose and post-dose on Days 1, 3 and 5 in Cycle 1 and post-dose on Day 1 in Cycles 2 and 4 (cycle length= 28 days) | Participants |
From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
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 | Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2 | Venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m^2 IV or SC dosing on Days 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022. | 15 | 80 | 55 | 80 | 79 | 80 |
| EG001 | Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2 | Pevonedistat 20 mg/m^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle plus venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m^2 IV or SC dosing on Day 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022. | 18 | 81 | 62 | 81 | 79 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Acinetobacter bacteraemia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Catheter site cellulitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 24 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Cryptococcosis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 24 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Enterobacter bacteraemia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 24 | Systematic Assessment |
| |
| Hyperleukocytosis | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypotensive crisis | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Portal vein cavernous transformation | Hepatobiliary disorders | MedDRA 24 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Soft tissue inflammation | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 24 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 24 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 24 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 24 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2022 | Aug 17, 2023 | 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 |
|---|---|
| C539933 | pevonedistat |
| C579720 | venetoclax |
| D001374 | Azacitidine |
| 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 |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Not reported |
|
| Unknown |
|
| Italy |
|
| Poland |
|
| United States |
|
| Canada |
|