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Une étude sur le pevonedistat et le vénétoclax associés à l'azacitidine pour traiter la leucémie myéloïde aiguë (LMA) chez les adultes incapables de recevoir une chimiothérapie intensive (PEVENAZA)

26 août 2026 mis à jour par: Takeda

Une étude de phase 2 randomisée, ouverte et contrôlée comparant le pevonedistat, le vénétoclax et l'azacitidine au vénétoclax plus l'azacitidine chez des adultes atteints d'une leucémie myéloïde aiguë nouvellement diagnostiquée et inaptes à une chimiothérapie intensive

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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 participants. 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 participant and study doctor during the study:

  • Pevonedistat 20 mg/m^2 + Venetoclax 400 mg (ramp-up dose, Cycle 1 only: 100-400mg) + Azacitidine 75 mg/m^2
  • Venetoclax 400 mg (ramp-up dose, Cycle 1 only: 100-400 mg) + Azacitidine 75 mg/m^2

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.

Type d'étude

Interventionnel

Inscription (Réel)

164

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 2G3
        • University of Alberta
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital
    • Quebec
      • Québec, Quebec, Canada, G1J 1Z4
        • Hopital de L'enfant Jesus
  • France
      • Bobigny, France, 93009
        • Hopital Avicenne
      • Caen, France, 14033
        • Institut dHematologie de Basse Normandie
      • Grenoble, France, 38043
        • CHU de Grenoble
      • Lille, France, 59037
        • CHRU Lille
      • Nantes, France, 44093
        • CHRU Nantes
      • Nice, France, 06202
        • CHU de Nice
      • Paris, France, 75012
        • Hopital Saint Antoine
      • Paris, France, 75475
        • Hopital Saint Louis
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86021
        • CHRU de Poitiers La Miletrie
      • Toulouse, France, 31059
        • EDOG - Institut Claudius Regaud - PPDS
    • Sarthe
      • Le Mans, Sarthe, France, 72000
        • Centre Hospitalier Le Mans
  • Italie
      • Bologna, Italie, 40138
        • Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
      • Florence, Italie, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Pavia, Italie, 27100
        • Fondazione IRCCS Policlinico San Matteo di Pavia
    • Calabria
      • Reggio Calabria, Calabria, Italie, 89133
        • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli
    • Lombardy
      • Monza, Lombardy, Italie, 20900
        • ASST di Monza - Azienda Ospedaliera San Gerardo
    • Milano
      • Rozzano, Milano, Italie, 20089
        • Istituto Clinico Humanitas
    • Piedmont
      • Orbassano, Piedmont, Italie, 10043
        • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
      • Turin, Piedmont, Italie, 10126
        • Azienda Ospedaliera Citta della Salute e della Scienza di Torino
    • Umbria
      • Perugia, Umbria, Italie, 06156
        • Ospedale Santa Maria Della Misericordia Di Perugia
  • Pologne
      • Bydgoszcz, Pologne, 85-168
        • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
      • Gdansk, Pologne, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Lublin, Pologne, 20-081
        • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Pologne, 31-501
        • Szpital Uniwersytecki w Krakowie
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Pologne, 02-776
        • Instytut Hematologii i Transfuzjologii
      • Warsaw, Masovian Voivodeship, Pologne, 02-106
        • MTZ Clinical Research Sp z o o
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Pologne, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Pologne, 93-513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
  • États-Unis
    • Arizona
      • Gilbert, Arizona, États-Unis, 85234
        • Banner MD Anderson Cancer Center
    • California
      • La Jolla, California, États-Unis, 92093
        • UC San Diego Moores Cancer Center
      • Orange, California, États-Unis, 92868
        • UC Irvine Medical Center
    • Florida
      • Miami, Florida, États-Unis, 33136
        • University of Miami Miller School of Medicine
      • Orlando, Florida, États-Unis, 32804
        • AdventHealth (Florida Hospital) - Transplant Institute
    • Kentucky
      • Louisville, Kentucky, États-Unis, 40207
        • Norton Cancer Institute - Suburban
    • Louisiana
      • New Orleans, Louisiana, États-Unis, 70112
        • Tulane Medical Center
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02114
        • Massachusetts General Hospital
    • Missouri
      • Kansas City, Missouri, États-Unis, 64132
        • HCA Midwest Health - SCRI - PPDS
    • New York
      • Lake Success, New York, États-Unis, 11042
        • Northwell Health Cancer Institute
      • New York, New York, États-Unis, 10029-6574
        • Icahn School of Medicine at Mount Sinai
      • Stony Brook, New York, États-Unis, 11794
        • Stony Brook Medicine
    • North Carolina
      • Chapel Hill, North Carolina, États-Unis, 27514-4221
        • University of North Carolina at Chapel Hill
    • Ohio
      • Cleveland, Ohio, États-Unis, 44106
        • University Hospitals Cleveland Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, États-Unis, 73104
        • The University of Oklahoma Health Sciences Center
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02903
        • Rhode Island Hospital
    • South Dakota
      • Sioux Falls, South Dakota, États-Unis, 57105
        • Avera Cancer Institute
    • Texas
      • Houston, Texas, États-Unis, 77030
        • Houston Methodist Cancer Center
      • Lubbock, Texas, États-Unis, 79410
        • Joe Arrington Cancer Research and Treatment Center
    • Utah
      • Salt Lake City, Utah, États-Unis, 84143
        • Intermountain LDS Hospital
    • Virginia
      • Charlottesville, Virginia, États-Unis, 22908
        • University of Virginia Health System
    • West Virginia
      • Morgantown, West Virginia, États-Unis, 26506
        • West Virginia University Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, États-Unis, 53226
        • Medical College of Wisconsin

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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:

    • ≥75 years of age. OR
    • ≥18 to <75 years of age with at least one 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):

    • Total bilirubin ≤1.5 times the ULN except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll with direct bilirubin ≤3 times the ULN of the direct bilirubin. Elevated indirect bilirubin due to posttransfusion hemolysis is allowed.
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 times the ULN.
    • Creatinine clearance (CrCl) ≥30 mL/min (calculated by the Modification of Diet in Renal Disease [MDRD] Study equation).
    • Albumin >2.7 g/dL.

  • 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:

    • Cluster difference 4 (CD4) count >350 cells/mm^3.
    • Undetectable viral load.
    • Maintained on modern therapeutic regimens utilizing non-cytochrome P (CYP)-interactive agents.
    • No history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections.

  • 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Venetoclax + Azacitidine

Participants received venetoclax 100 milligram (mg) tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Days 3 through 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 Days 1 through 21 or 28 as per Investigator's discretion. In addition, participants received azacitidine 75 milligrams per square meter (mg/m^2) intravenous (IV) or subcutaneous (SC) dosing on Days 1 through 7 or Days 1 through 5, 8, and 9 in each cycle.
Médicament: Venetoclax

Venetoclax tablets.

Médicament: Azacitidine

Azacitidine IV or SC injection.
Expérimental: Pevonedistat + Venetoclax + Azacitidine

Participants received pevonedistat 20 mg/m^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle. In addition participants received venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Days 3 through 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. Participants also received azacitidine 75 mg/m^2 IV or SC dosing on Days 1 through 7 or Days 1 through 5, 8, and 9 in each cycle.
Médicament: Venetoclax

Venetoclax tablets.

Médicament: Azacitidine

Azacitidine IV or SC injection.

Médicament: Pevonedistat

Pevonedistat IV infusion.

Autres noms:
  • MLN4924
  • TAK-924

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Event-Free Survival (EFS)
Délai: Up to 22 months

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 percent (%); absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) greater than or equal to (≥) 1.0×10^9 per liter (10^9/L) (1000/microliter [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 was not observed by time of analysis, data 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Overall Survival (OS)
Délai: Up to 36 months

OS was defined as the time from randomization to death from any cause. Participants without documentation of death at the time of analysis were censored at the date last known to be alive. OS was analyzed using the Kaplan-Meier method.
Up to 36 months
30-Day Mortality Rate
Délai: Day 30

30-day mortality rate was defined as the percentage of participants who survived at most 30 days from the first dose of study drug.
Day 30
60-Day Mortality Rate
Délai: Day 60

60-day mortality rate was defined as the percentage of participants who survived at most 60 days from the first dose of study drug.
Day 60
Percentage of Participants With Complete Remission (CR)
Délai: Up to 36 months

CR rate was defined as the percentage of participants who achieved the CR as evaluated by the investigator. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was 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)
Délai: Up to 36 months

CCR rate was defined as the percentage of participants who achieved the CR + CRi as evaluated by the investigator. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was 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 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]).
Up to 36 months
Overall Response Rate (ORR)
Délai: Up to 36 months

ORR was defined as the percentage of participants who achieved the CR + CRi + Partial Remission (PR) as evaluated by the investigator. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was 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 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]). PR was 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
Délai: Up to 36 months

CR + CRh rate was defined as the percentage of participants who achieved the CR + CRh as evaluated by the investigator. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was 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 was 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
Délai: Up to 36 months

Leukemia response rate was defined as the percentage of participants who achieved the CR + CRi + PR + morphological leukemia-free state [MLFS, marrow CR (mCR)]) as evaluated by the investigator. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was 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 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]). PR was 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
Délai: Up to 36 months

Duration of CR and CRi was defined as the time from first documentation of CR or CRi to the date of first documentation of progressive disease (PD) or relapse from CR or CRi, and was summarized descriptively using the Kaplan Meier method based on the responders. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was 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 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]).
Up to 36 months
Time to First CR, CRi and PR
Délai: Up to 36 months

Time to first CR, CRi, and PR was defined as the time from randomization until the first documented CR, CRi or PR, whichever occurs first. Assessments of disease response were based on the criteria outlined in the ELN 2017 guidelines. CR was 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 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]). PR was 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
Délai: 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)

As pre-specified in the protocol, plasma concentration-time data were planned to contribute to future pharmacokinetic (PK) population and exposure response (safety/efficacy) analyses 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Takeda

Les enquêteurs

  • Directeur d'études: Medical Director, Takeda

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 octobre 2020

Achèvement primaire (Réel)

6 septembre 2022

Achèvement de l'étude (Réel)

6 octobre 2025

Dates d'inscription aux études

Première soumission

4 février 2020

Première soumission répondant aux critères de contrôle qualité

11 février 2020

Première publication (Réel)

12 février 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Pevonedistat-2002
  • 2019-003117-33 (Numéro EudraCT)
  • U1111-1239-7581 (Identificateur de registre: WHO)
  • 2019 (Subvention/contrat des NIH des États-Unis)
  • 2024-515424-36-00 (Ctis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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