Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML)
PANTHER
A Phase 3, Randomized, Controlled, Open-label, Clinical Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Patients With Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia
6 other identifiers
interventional
454
20 countries
242
Brief Summary
The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with single-agent azacitidine. (An event is defined as death or transformation to AML in participants with MDS or CMML, whichever occurs first, and is defined as death in participants with low-blast AML).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2017
Longer than P75 for phase_3
242 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2017
CompletedFirst Posted
Study publicly available on registry
August 31, 2017
CompletedStudy Start
First participant enrolled
November 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2021
CompletedResults Posted
Study results publicly available
September 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2024
CompletedOctober 29, 2025
October 1, 2025
3.5 years
August 30, 2017
May 25, 2022
October 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event-Free Survival (EFS)
EFS was defined as the time from randomization to the date of an EFS event. An EFS event was defined as death or transformation to acute myelogenous leukemia (AML) (World Health Organization \[WHO\] classification as a participant having greater than 20 % blasts in the blood or marrow and an increase of blast count by 50%), whichever event occurred first, in participants with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemias (CMML). An EFS event was defined as death in participants with low-blast AML.
From randomization until transformation to acute myeloid leukemia, or death due to any cause: up to approximately 42 months
Secondary Outcomes (28)
Overall Survival (OS)
Up to approximately 6.9 years
Kaplan-Meier Estimates of Six-Month Survival Rate
Month 6
Kaplan-Meier Estimates of One-Year Survival Rate
Year 1
Thirty-Day Mortality Reported as Number of Participants Who Died Up to Day 30
Up to Day 30
Sixty-Day Mortality Reported as Number of Participants Who Died Up to Day 60
Up to Day 60
- +23 more secondary outcomes
Study Arms (2)
Azacitidine 75 mg/m^2
EXPERIMENTALParticipants were administered azacitidine 75 milligram per square meter (mg/m\^2) intravenous (IV) or subcutaneous (SC) injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2
EXPERIMENTALParticipants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
Interventions
Azacitidine intravenous or subcutaneous formulation.
Eligibility Criteria
You may qualify if:
- Has morphologically confirmed diagnosis of myelodysplastic syndromes (MDS) or CMML (i.e., with white blood cell \[WBC\] \<13,000/microliter \[mcL\]) or low-blast acute myelogenous leukemia (AML).
- Has MDS or CMML and must also have one of the following Prognostic Risk Categories, based on the Revised International Prognostic Scoring System (IPSS-R):
- Very high (\>6 points).
- High (\>4.5-6 points).
- Intermediate (\>3-4.5 points): a participant determined to be in the Intermediate Prognostic Risk Category is only allowable in the setting of \>=5% bone marrow myeloblasts.
- Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2.
- Participants with AML (20%-30% blasts) must have a treatment-related mortality (TRM) score \>=4 for intensive, induction chemotherapy as calculated using the simplified model described by Walter and coworkers.
- Calculation of TRM score:
- for (age \<61 years), +2 for (age 61-70 years), +4 for (age \>=71 years).
- \+ 0 for (PS=0), +2 for (PS=1), +4 for (PS \>1).
- \+ 0 for (platelets \<50), +1 for (platelets \>=50).
You may not qualify if:
- Has previous treatment for HR MDS or CMML or low-blast AML with chemotherapy or other antineoplastic agents including hypomethylating agent (HMAs) such as decitabine or azacitidine. Previous treatment is permitted with hydroxyurea and with lenalidomide, except that lenalidomide may not be given within 8 weeks before the first dose of study drug.
- Has acute promyelocytic leukemia as diagnosed by morphologic examination of bone marrow, by fluorescent in situ hybridization or cytogenetics of peripheral blood or bone marrow, or by other accepted analysis.
- Participants with AML with a WBC count \>50,000/mcL. Participants who are cytoreduced with leukapheresis or with hydroxyurea may be enrolled if they meet the eligibility criteria.
- Is eligible for intensive chemotherapy and/or allogeneic stem cell transplantation. The reason a participant is not eligible for intensive chemotherapy and/or allogeneic stem cell transplantation may consist of one or more of the following factors:
- Age \>75.
- Comorbidities.
- Inability to tolerate intensive chemotherapy (e.g., participants with AML with 20%-30% blasts and TRM \>=4).
- Physician decision (e.g., lack of available stem cell donor).
- The reason a participant is not eligible should be documented in the electronic case report form (eCRF).
- Has either clinical evidence of or history of central nervous system involvement by AML.
- Has active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.
- Is diagnosed or treated for another malignancy within 2 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease.
- Has nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone resection.
- Has prothrombin time (PT) or aPTT \>1.5× upper limit of normal (ULN) or active uncontrolled coagulopathy or bleeding disorder. Participants therapeutically anticoagulated with warfarin, direct thrombin inhibitors, direct factor Xa inhibitors, or heparin are excluded from enrollment.
- Has known human immunodeficiency virus (HIV) seropositive.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
- Takeda Development Center Americas, Inc.collaborator
Study Sites (242)
Southern Cancer Center - USOR
Daphne, Alabama, 36526, United States
Southern Cancer Center - USOR
Mobile, Alabama, 36607, United States
Southern Cancer Center - USOR
Mobile, Alabama, 36608, United States
Southern Cancer Center- USOR
Mobile, Alabama, 36608, United States
Southeastern Regional Medical Center - CTCA - PPDS
Goodyear, Arizona, 85338, United States
Arizona Oncology Associates (Orange HOPE) - USOR
Tucson, Arizona, 85704, United States
Arizona Oncology Associates (Rudasill HOPE) - USOR
Tucson, Arizona, 85704, United States
Arizona Oncology Associates (Wilmot HOPE) - USOR
Tucson, Arizona, 85711, United States
Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc
Corona, California, 92879, United States
Compassionate Cancer Care Medical Group Inc
Fountain Valley, California, 92708, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Emad Ibrahim, MD, Inc
Redlands, California, 92373, United States
Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc
Riverside, California, 92501, United States
Rocky Mountain Cancer Centers (Aurora) - USOR
Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Centers (Boulder) - USOR
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers (Colorado Springs) - USOR
Colorado Springs, Colorado, 80907, United States
Quest Diagnostics, INC
Denver, Colorado, 80209, United States
Colorado Blood Cancer Institute - PPDS
Denver, Colorado, 80218, United States
Presbyterian Saint Lukes Medical Center Laboratory
Denver, Colorado, 80218, United States
Presbyterian/St. Luke's Medical Center
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers (Williams) - USOR
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers (Denver) - USOR
Denver, Colorado, 80220, United States
Kaiser Foundation Health Plan
Denver, Colorado, 80239, United States
Laboratory Corporation of America
Englewood, Colorado, 80112, United States
Rocky Mountain Cancer Centers (Lakewood) - USOR
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers (Littleton) - USOR
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers (Lone Tree) - USOR
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers (Longmont) - USOR
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers (Parker) - USOR
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers (Pueblo) - USOR
Pueblo, Colorado, 81008, United States
Rocky Mountain Cancer Centers (Thornton) - USOR
Thornton, Colorado, 80260, United States
Medstar Research Institute
Washington D.C., District of Columbia, 20010, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Altamonte Springs, Florida, 32701, United States
SCRI Florida Cancer Specialists South
Bonita Springs, Florida, 34135, United States
SCRI Florida Cancer Specialists South
Bradenton, Florida, 34209, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Brandon, Florida, 33511, United States
SCRI Florida Cancer Specialists South
Cape Coral, Florida, 33914, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Clearwater, Florida, 33761, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, 33905, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, 33908, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, 33916, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Gainesville, Florida, 32605, United States
Mayo Clinic Jacksonville - PPDS
Jacksonville, Florida, 32224, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Largo, Florida, 33770, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Lecanto, Florida, 34461, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Baptist Health System (N Kendall) - USOR
Miami, Florida, 33176, United States
SCRI Florida Cancer Specialists South
Naples, Florida, 34102, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
New Port Richey, Florida, 34655, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Ocala, Florida, 34471, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Orange City, Florida, 32763, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Orlando, Florida, 32806, United States
SCRI Florida Cancer Specialists South
Port Charlotte, Florida, 33980, United States
SCRI Florida Cancer Specialists South
Sarasota, Florida, 34232, United States
SCRI Florida Cancer Specialists South
Sarasota, Florida, 34236, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Spring Hill, Florida, 34608, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Tampa, Florida, 33607, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Tavares, Florida, 32778, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
The Villages, Florida, 32159, United States
SCRI Florida Cancer Specialists South
Venice, Florida, 34285, United States
SCRI Florida Cancer Specialists South
Venice, Florida, 34292, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Florida Cancer Specialists - NORTH - SCRI - PPDS
Winter Park, Florida, 32792, United States
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Saint Alphonsus Caldwell Cancer Care Center
Caldwell, Idaho, 83605, United States
Saint Alphonsus Medical Center
Nampa, Idaho, 83687, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Centerpoint Medical Center
Independence, Missouri, 64057, United States
HCA Midwest Health - SCRI - PPDS
Kansas City, Missouri, 64132, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
New Jersey Hematology Oncology Associates LLC
Brick, New Jersey, 08724, United States
John Theurer Cancer Center
Hackensack, New Jersey, 07601, United States
New Jersey Hematology and Oncology
Toms River, New Jersey, 08755, United States
Weill Cornell Medical Center - Monitoring Location
New York, New York, 10021, United States
Weill Cornell Medical Center
New York, New York, 10021, United States
Strong Memorial Hospital
Rochester, New York, 14642, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45211, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45230, United States
Oncology Hematology Care Inc - USOR
Cincinnati, Ohio, 45236, United States
Oncology Hematology Care Inc - USOR
Cincinnati, Ohio, 45242, United States
Fairview Hospital
Cleveland, Ohio, 44111, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oncology Hematology Care, Inc - Fairfield
Fairfield, Ohio, 45014, United States
Hillcrest Hospital Cancer Care Center
Mayfield, Ohio, 44124, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015, United States
St. Luke's University Health Network
Easton, Pennsylvania, 18045, United States
Greenville Health System
Easley, South Carolina, 29640, United States
Greenville Health System
Greenville, South Carolina, 29605, United States
Greenville Health System Cancer Institute
Greenville, South Carolina, 29615, United States
Greenville Health System
Greer, South Carolina, 29650, United States
Greenville Health System
Seneca, South Carolina, 29672, United States
Greenville Health System
Spartanburg, South Carolina, 29307, United States
Tennessee Oncology - DICKSON - SCRI - PPDS
Dickson, Tennessee, 37055, United States
Tennessee Oncology - FRANKLIN - SCRI - PPDS
Franklin, Tennessee, 37067, United States
Tennessee Oncology - GALLATIN - SCRI - PPDS
Gallatin, Tennessee, 37066, United States
Tennessee Oncology - SUMMIT - SCRI - PPDS
Hermitage, Tennessee, 37076, United States
Tennessee Oncology - LEBANON - SCRI - PPDS
Lebanon, Tennessee, 37090, United States
Tennessee Oncology - MURFREESBORO - SCRI - PPDS
Murfreesboro, Tennessee, 37129, United States
Sarah Cannon Center for Blood Centers - SCRI - PPDS
Nashville, Tennessee, 37203, United States
Tennessee Oncolgy - BAPTIST - SCRI - PPDS
Nashville, Tennessee, 37203, United States
Tennessee Oncology NASH - SCRI - PPDS
Nashville, Tennessee, 37203, United States
Tennessee Oncology - ST THOMAS WEST - SCRI - PPDS
Nashville, Tennessee, 37205, United States
Tennessee Oncology SKYLINE - SCRI - PPDS
Nashville, Tennessee, 37207, United States
Tennessee Oncology - SOUTHERN HILLS - SCRI - PPDS
Nashville, Tennessee, 37211, United States
Tennessee Oncology - SHELBYVILLE - SCRI - PPDS
Shelbyville, Tennessee, 37160, United States
Tennessee Oncology - SMYRNA - SCRI - PPDS
Smyrna, Tennessee, 37167, United States
Texas Oncology (West 38) - USOR
Austin, Texas, 78705, United States
Texas Oncology (Balcones) - USOR
Austin, Texas, 78731, United States
Texas Oncology (James Casey) - USOR
Austin, Texas, 78745, United States
Texas Oncology (Medical City) - USOR
Dallas, Texas, 75230, United States
Baylor Sammons Cancer Center
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Texas Oncology (Tyler) - USOR
Longview, Texas, 75601, United States
Texas Oncology (E Common) - USOR
New Braunfels, Texas, 78130, United States
Texas Oncology (Round Rock) - USOR
Round Rock, Texas, 78681, United States
Texas Oncology - San Antonio Medical Center - USOR
San Antonio, Texas, 78240, United States
Texas Oncology (Tyler) - USOR
Tyler, Texas, 75702, United States
Oncology and Hematology Associates of Southwest Virginia (Blacksburg) - USOR
Blacksburg, Virginia, 24060, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Oncology and Hematology Associates of Southwest Virginia (Low Moor) - USOR
Low Moor, Virginia, 24457, United States
Oncology and Hematology Associates of Southwest Virginia (Roanoke) - USOR
Roanoke, Virginia, 24014, United States
Oncology and Hematology Associates of Southwest Virginia Inc
Salem, Virginia, 24153, United States
Oncology and Hematology Associates of Southwest Virginia
Wytheville, Virginia, 24382, United States
Icon Cancer Care Wesley
Auchenflower, Queensland, 4066, Australia
Icon Cancer Care Chermside
Chermside, Queensland, 4032, Australia
Icon Cancer Care South Brisbane
South Brisbane, Queensland, 4101, Australia
Icon Cancer Care
South Brisbane, Queensland, 4101, Australia
Icon Cancer Care Southport
Southport, Queensland, 4215, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Liverpool Hospital
Liverpool, 1871, Australia
Algemeen Ziekenhuis Klina
Brasschaat, Antwerpen, 2930, Belgium
CHU UCL Namur asbl - Site Godinne
Yvoir, Namur, 5530, Belgium
AZ Sint-Jan AV
Bruges, West-Vlaanderen, 8000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
UZ Leuven
Leuven, 3000, Belgium
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Rio Grande do Norte, 59075-740, Brazil
Centro de Pesquisas Oncologicas
Florianópolis, Santa Catarina, 88034-000, Brazil
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre, 90035-903, Brazil
Universidade Federal do Rio de Janeiro - UFRJ
Rio de Janeiro, 21941-913, Brazil
Hospital Santa Marcelina
São Paulo, 08270-120, Brazil
Hospital Santa Marcelina
São Paulo, 08270-270, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4, Canada
University of Alberta
Edmonton, Alberta, T6G 2B7, Canada
Kaye Edmonton Clinic
Edmonton, Alberta, T6G1Z1, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G2M9, Canada
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053, China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
Fakultni nemocnice Hradec Kralove
Hradec Králové, Kralovehradeck Kraj, 500 05, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, 128 08, Czechia
Hopital Cote de Nacre
Caen, Calvados, 14033, France
CHU Angers
Angers, Maine-et-Loire, 49100, France
Centre Hospitalier Le Mans
Le Mans, 74000, France
Hopital Saint Louis
Paris, 75010, France
Hopital Saint Louis
Paris, 75475, France
Universitatsklinikum Tubingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitatsklinikum Leipzig
Leipzig, Saxony, 4103, Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 1307, Germany
Marien Hospital Akademisches Lehrkrankenhaus
Düsseldorf, 40479, Germany
Laiko General Hospital of Athens
Athens, Attica, 115 27, Greece
Athens General Hospital 'G Gennimatas'
Athens, Attica, 11527, Greece
Attikon University General Hospital
Athens, Attica, 12462, Greece
University Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
Laiko General Hospital of Athens
Athens, 11527, Greece
University General Hospital of Ioannina
Ioannina, 45500, Greece
University General Hospital of Larissa
Larissa, 41110, Greece
University General Hospital of Patras
Pátrai, 26504, Greece
Georgios Papanikolaou General Hospital of Thessaloniki
Thessaloniki, 57010, Greece
Edith Wolfson Medical Center
Holon, 58100, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Medical Center PPDS -
Jerusalem, 91120, Israel
Galilee Medical Center
Nahariya, Israel
ZIV Medical Center
Safed, 13100, Israel
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, 64239, Israel
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna, Emilia-Romagna, 40138, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN
Brescia, Lombardy, 25123, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
IRCCS Centro Di Riferimento Oncologico Della Basilicata
Rionero in Vulture, 85028, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino
Torino, 10126, Italy
Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital
Fukuyama, Hiroshima, 720-0001, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060 8638, Japan
Fukushima Medical University Hospital
Fukushima, Hukusima, 960-1295, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Kindai University Hospital
Sayama, Osaka, 589-8511, Japan
Saitama Medical Center
Kawagoe, Saitama, 3508550, Japan
Juntendo University Hospital
Bunkyo, Tokyo, 113-8431, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Dokkyo Medical University Hospital
Mibu, 321-0293, Japan
Nagasaki University Hospital
Nagasaki, 8528102, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Yokohama City University Hospital
Yokohama, 232-0024, Japan
University of Fukui Hospital
Yoshida-gun, 910-1193, Japan
Hematologica Alta Especialidad S.C.
Huixquilucan, 52787, Mexico
Capital Humano para Investigacion Clinica SC
México, Mexico
Instytut Hematologii i Transfuzjologii
Warsaw, Masovian Voivodeship, 02-776, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii I Transplantologii, Budynek Centrum Medycyny N
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-952, Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin, 20-090, Poland
Zaklad Diagnostyki Obrazowej SOR
Opole, 45-061, Poland
Szpital Wojewodzki w Opolu
Opole, 45-372, Poland
Swietokrzyskie Centrum Onkologii
Kielce, Świętokrzyskie Voivodeship, 25-734, Poland
City Clinical Hospital # 40
Moscow, 129301, Russia
Russian Research Institute of Hematology and Blood Transfusion
Saint Petersburg, 191024, Russia
North-West Federal Medical Research Center n.a. V.A. Almazov
Saint Petersburg, 197341, Russia
Pusan National University Hospital
Busan, 49241, South Korea
Kyungpook National University Hospital
Daegu, 41944, South Korea
Chonnam National University Hwasun Hospital
Jeongnam, 58128, South Korea
Asan Medical Center - PPDS
Seoul, 5505, South Korea
Samsung Medical Center - PPDS
Seoul, 6351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 6591, South Korea
ICO lHospitalet Hospital Duran i Reynals
LHospitalet de Llobregat, Barcelona, 8907, Spain
Complejo Asistencial Universitario de Leon
León, Castille and León, 24071, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28009, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz - PPDS
Madrid, 28046, Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, 37007, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Gazi University Medical Faculty Gazi Hospital
Ankara, 6500, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33343, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55139, Turkey (Türkiye)
Namik Kemal University
Tekirdağ, 59100, Turkey (Türkiye)
Karadeniz Technical University Faculty of Medicine
Trabzon, 61080, Turkey (Türkiye)
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
Maidstone Hospital
Maidstone, Kent, ME16 9QQ, United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
Singleton Hospital - PPDS
Swansea, SA2 8QA, United Kingdom
Related Publications (1)
Ades L, Girshova L, Doronin VA, Diez-Campelo M, Valcarcel D, Kambhampati S, Viniou NA, Woszczyk D, De Paz Arias R, Symeonidis A, Anagnostopoulos A, Munhoz EC, Platzbecker U, Santini V, Fram RJ, Yuan Y, Friedlander S, Faller DV, Sekeres MA. Pevonedistat plus azacitidine vs azacitidine alone in higher-risk MDS/chronic myelomonocytic leukemia or low-blast-percentage AML. Blood Adv. 2022 Sep 13;6(17):5132-5145. doi: 10.1182/bloodadvances.2022007334.
PMID: 35728048DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2017
First Posted
August 31, 2017
Study Start
November 28, 2017
Primary Completion
May 28, 2021
Study Completion
October 14, 2024
Last Updated
October 29, 2025
Results First Posted
September 22, 2022
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- 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.
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.