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집중 화학 요법을 받을 수 없는 성인의 급성 골수성 백혈병(AML) 치료를 위한 페보네디스타트 및 베네토클락스를 아자시티딘과 병용한 연구 (PEVENAZA)

2026년 8월 26일 업데이트: Takeda

집중 화학 요법에 부적합한 새로 진단된 급성 골수성 백혈병 성인을 대상으로 Pevonedistat, Venetoclax 및 Azacitidine과 Venetoclax + Azacitidine을 비교한 무작위, 공개, 통제, 2상 연구

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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

164

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
의약품: Venetoclax

Venetoclax tablets.

의약품: Azacitidine

Azacitidine IV or SC injection.
실험적: 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.
의약품: Venetoclax

Venetoclax tablets.

의약품: Azacitidine

Azacitidine IV or SC injection.

의약품: Pevonedistat

Pevonedistat IV infusion.

다른 이름들:
  • MLN4924
  • 탁-924

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Event-Free Survival (EFS)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Takeda

수사관

  • 연구 책임자: Medical Director, Takeda

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 10월 13일

기본 완료 (실제)

2022년 9월 6일

연구 완료 (실제)

2025년 10월 6일

연구 등록 날짜

최초 제출

2020년 2월 4일

QC 기준을 충족하는 최초 제출

2020년 2월 11일

처음 게시됨 (실제)

2020년 2월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 26일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Pevonedistat-2002
  • 2019-003117-33 (EudraCT 번호)
  • U1111-1239-7581 (레지스트리 식별자: WHO)
  • 2019 (미국 NIH 보조금/계약)
  • 2024-515424-36-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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