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En undersøgelse af Pevonedistat og Venetoclax kombineret med azacitidin til behandling af akut myeloid leukæmi (AML) hos voksne, der ikke er i stand til at modtage intensiv kemoterapi (PEVENAZA)

26. august 2026 opdateret af: Takeda

Et randomiseret, åbent, kontrolleret, fase 2-studie af Pevonedistat, Venetoclax og Azacitidin versus Venetoclax Plus Azacitidin hos voksne med nyligt diagnosticeret akut myeloid leukæmi, som er uegnede til intensiv kemoterapi

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

164

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Medicin: Venetoclax

Venetoclax tablets.

Medicin: Azacitidine

Azacitidine IV or SC injection.
Eksperimentel: 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.
Medicin: Venetoclax

Venetoclax tablets.

Medicin: Azacitidine

Azacitidine IV or SC injection.

Medicin: Pevonedistat

Pevonedistat IV infusion.

Andre navne:
  • MLN4924
  • TAK-924

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Event-Free Survival (EFS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Takeda

Efterforskere

  • Studieleder: Medical Director, Takeda

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. oktober 2020

Primær færdiggørelse (Faktiske)

6. september 2022

Studieafslutning (Faktiske)

6. oktober 2025

Datoer for studieregistrering

Først indsendt

4. februar 2020

Først indsendt, der opfyldte QC-kriterier

11. februar 2020

Først opslået (Faktiske)

12. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pevonedistat-2002
  • 2019-003117-33 (EudraCT nummer)
  • U1111-1239-7581 (Registry Identifier: WHO)
  • 2019 (U.S. NIH-bevilling/kontrakt)
  • 2024-515424-36-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner