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A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Lower Risk Myelodysplastic Syndromes (LR-MDS) Who Need Regular Blood Transfusions (ELRiSE MDS)

5 novembre 2026 mis à jour par: Takeda

Étude de phase 3, multicentrique, ouverte, randomisée comparant l'efficacité et l'innocuité de l'elritercept par rapport à l'époétine alfa pour le traitement de l'anémie liée aux syndromes myélodysplasiques de risque IPSS-R très faible, faible ou intermédiaire chez des participants adultes naïfs d'ESA nécessitant des transfusions de globules rouges

The main aim of this study is to assess how much elritercept reduces the need for RBC (red blood cell) transfusions and improves hemoglobin blood values in addition to how safe elritercept is when compared with epoetin alfa. Other key aims are to learn how much elritercept improves tiredness and quality of life as reported by participants compared with epoetin alfa; to assess what risks (side effects) and how often they occur with elritercept compared with epoetin alfa. The study will also collect information for researchers to see how the disease in the bone marrow or other body areas may be affected by elritercept compared with epoetin alfa to try to learn how to better treat this disease.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

300

Phase

  • Phase 3

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.

Coordonnées de l'étude

Lieux d'étude

  • Allemagne
      • Berlin, Allemagne, 12200
        • Recrutement
        • Charite Campus Benjamin Franklin
        • Chercheur principal:
          • Kathrin Rieger
        • Contact:
      • Berlin, Allemagne, 10715
    • Bavaria
      • Bayreuth, Bavaria, Allemagne, 95445
        • Recrutement
        • Universitatsklinikum Bayreuth, Med. Klinik IV
        • Chercheur principal:
          • Alexander Kiani
        • Contact:
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Allemagne, 48153
        • Recrutement
        • Gemeinschaftspraxis fuer Haematologie und Onkologie - Praxis Steinfurter Strasse
        • Chercheur principal:
          • Ruediger Liersch
        • Contact:
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Allemagne, 06120
        • Recrutement
        • University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
        • Chercheur principal:
          • Haifa Al-Ali
        • Contact:
  • Argentine
      • Buenos Aires, Argentine, 1425
        • Recrutement
        • Swiss Medical Center - Barrio Parque
        • Contact:
        • Chercheur principal:
          • Claudio Marcelo Iastrebner
      • Córdoba, Argentine, 5000
        • Pas encore de recrutement
        • Sanatorio Allende S.A. - Nueva Cordoba
        • Contact:
        • Chercheur principal:
          • Gustavo D Jarchum
      • Córdoba, Argentine, X5000
        • Recrutement
        • Hospital Privado de Cordoba
        • Contact:
        • Chercheur principal:
          • Ana Basquiera
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentine, 2000
        • Recrutement
        • Instituto Medico de la Fundacion Estudios Clinicos
        • Contact:
        • Chercheur principal:
          • Gustavo Jorge Braidot
  • Australie
    • New South Wales
      • Coffs Harbour, New South Wales, Australie, 2450
        • Pas encore de recrutement
        • Mid North Coast Local Health District - Mid North Coast Cancer Institute (MNCCI) - Coffs Harbour
        • Chercheur principal:
          • Kyle Crassini
        • Contact:
      • Sydney, New South Wales, Australie, 2217
        • Recrutement
        • South Eastern Sydney Local Health District
        • Contact:
        • Chercheur principal:
          • Sundreswran Ramanathan
      • Waratah, New South Wales, Australie, 2282
        • Pas encore de recrutement
        • Calvary Mater Newcastle
        • Contact:
        • Chercheur principal:
          • Anoop Enjeti
    • South Australia
      • Adelaide, South Australia, Australie, 5000
        • Pas encore de recrutement
        • Royal Adelaide Hospital
        • Chercheur principal:
          • Devendra Hiwase
        • Contact:
      • Bedford Park, South Australia, Australie, 5042
        • Pas encore de recrutement
        • Flinders Medical Centre
        • Contact:
        • Chercheur principal:
          • Ashanka Beliasgwatte
    • Victoria
      • Clayton, Victoria, Australie, 3168
        • Pas encore de recrutement
        • Monash University-Monash Medical Centre (MMC) - Clayton
        • Chercheur principal:
          • Jake Shortt
        • Contact:
      • Fitzroy, Victoria, Australie, 3065
        • Pas encore de recrutement
        • St. Vincent's Hospital Melbourne
        • Chercheur principal:
          • Shuhying Tan
        • Contact:
      • Heidelberg, Victoria, Australie, 3084
        • Recrutement
        • Eastern Haematology & Oncology Group or Austin Hospital
        • Chercheur principal:
          • Chun Yew Fong
        • Contact:
      • Richmond, Victoria, Australie, 3004
        • Pas encore de recrutement
        • Alfred Hospital
        • Contact:
        • Chercheur principal:
          • Shaun Fleming
    • Western Australia
      • Perth, Western Australia, Australie, 6150
        • Pas encore de recrutement
        • Fiona Stanley Hospital
        • Contact:
        • Chercheur principal:
          • Jasmine Singh
  • Belgique
    • Namur
      • Yvoir, Namur, Belgique, 5530
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgique, 3000
        • Recrutement
        • UZ Leuven
        • Chercheur principal:
          • Marielle Beckers
        • Contact:
    • West Flanders
      • Roeselare, West Flanders, Belgique, 8800
        • Recrutement
        • AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Rumbeke
        • Chercheur principal:
          • Dries Deeren
        • Contact:
  • Brésil
      • São Paulo, Brésil, 01409-000
        • Recrutement
        • Hospital 9 de Julho (Rede Americas/DASA)
        • Contact:
        • Chercheur principal:
          • Vinicius Molla
      • São Paulo, Brésil, 01321-001
        • Recrutement
        • Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
        • Chercheur principal:
          • Phillip Scheinberg
        • Contact:
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brésil, 41253-190
        • Pas encore de recrutement
        • D'OR Institute for Research and Education
        • Contact:
        • Chercheur principal:
          • Laine Santos Fiscina Alvarenga
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brésil, 90110-270
        • Recrutement
        • Hospital Mae de Deus, Clinical Research Unit - Cancer Institute
        • Chercheur principal:
          • Marcelo Capra
        • Contact:
      • Porto Alegre, Rio Grande do Sul, Brésil, 90035903
        • Recrutement
        • Porto Alegre Clinical Hospital (HCPA)
        • Chercheur principal:
          • Laura Maria Fogliatto
        • Contact:
    • Santa Catarina
      • Joinville, Santa Catarina, Brésil, 89201-260
        • Recrutement
        • Centro de Hematologia e Oncologia (CHO)
        • Chercheur principal:
          • Ana Claudia Dall'Oglio
        • Contact:
    • São Paulo
      • Jaú, São Paulo, Brésil, 17210080
        • Recrutement
        • Hospital Amaral Carvalho (HAC)
        • Contact:
        • Chercheur principal:
          • Ederson Mattos
      • Santos, São Paulo, Brésil, 11075-101
        • Recrutement
        • Irmandade da Santa Casa da Misericordia de Santos (ISCMS)
        • Chercheur principal:
          • Elaine Mancilha
        • Contact:
  • Bulgarie
      • Plovdiv, Bulgarie, 4000
        • Recrutement
        • Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
        • Chercheur principal:
          • Pencho Georgiev
        • Contact:
      • Sofia, Bulgarie, 1756
        • Recrutement
        • Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
        • Chercheur principal:
          • Tanya Yankova
        • Contact:
  • Corée du Sud
      • Seoul, Corée du Sud, 03080
        • Recrutement
        • Seoul National University Hospital
        • Chercheur principal:
          • Junshik Hong
        • Contact:
      • Seoul, Corée du Sud, 06351
        • Recrutement
        • Samsung Medical Center
        • Chercheur principal:
          • Jun Ho Jang
        • Contact:
      • Seoul, Corée du Sud, 02841
        • Recrutement
        • Korea University Anam Hospital
        • Chercheur principal:
          • Yong Park
        • Contact:
      • Seoul, Corée du Sud, 06591
        • Recrutement
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Contact:
        • Chercheur principal:
          • Yoo-Jin Kim
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Corée du Sud, 13620
        • Recrutement
        • Seoul National University Bundang Hospital
        • Chercheur principal:
          • Soo-Mee Bang
        • Contact:
    • Yongsan-gu
      • Seoul, Yongsan-gu, Corée du Sud, 04401
        • Recrutement
        • Soon Chun Hyang University Hospital Seoul
        • Chercheur principal:
          • Seug Yun Yoon
        • Contact:
  • Espagne
      • Barcelona, Espagne, 8035
        • Recrutement
        • Hospital Universitari Vall d'Hebron-Institut de Recerca (VHIR)
        • Chercheur principal:
          • David Valcarcel Ferreiras
        • Contact:
      • Madrid, Espagne, 28034
        • Recrutement
        • University Hospital Ramon y Cajal
        • Chercheur principal:
          • Kyra Velazquez Kennedy
        • Contact:
      • Málaga, Espagne, 29010
        • Recrutement
        • Hospital Universitario Virgen de la Victoria (HUVV)
        • Contact:
        • Chercheur principal:
          • Regina Garcia-Delgado
      • Salamanca, Espagne, 37007
        • Recrutement
        • Universidad de Salamanca - Hospital Universitario de Salamanca
        • Chercheur principal:
          • Maria Diez Campelo
        • Contact:
      • Valencia, Espagne, 46026
        • Recrutement
        • University and Polytechnic Hospital La Fe
        • Chercheur principal:
          • Elvira Mora Castera
        • Contact:
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Espagne, 08908
        • Recrutement
        • Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals Location
        • Chercheur principal:
          • Montserrat Arnan Sangerman
        • Contact:
    • Seville
      • Seville, Seville, Espagne, 41013
        • Pas encore de recrutement
        • Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
        • Chercheur principal:
          • Jose Francisco Falantes Gonzalez
        • Contact:
  • France
      • Nice, France, 06200
        • Recrutement
        • Centre Hospitalier Universitaire (CHU) de Nice - Hopital L'Archet I - Hematologie Clinique
        • Chercheur principal:
          • Thomas Cluzeau
        • Contact:
      • Paris, France, 75010
        • Pas encore de recrutement
        • Saint-Louis Hospital
        • Chercheur principal:
          • Lionel Ades
        • Contact:
    • Isere
      • La Tronche, Isere, France, 38700
        • Recrutement
        • Centre Hospitalier Universitaire Grenoble Alpes
        • Chercheur principal:
          • Mathieu Meunier
        • Contact:
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Recrutement
        • Poitiers University Hospital Center - Miletrie Site
        • Chercheur principal:
          • Jose Miguel Torregrosa-Diaz
        • Contact:
    • X
      • Villejuif, X, France, 94805
        • Pas encore de recrutement
        • Gustave Roussy
        • Contact:
        • Chercheur principal:
          • Christophe Willekens
  • Grèce
      • Ioannina, Grèce, 45500
        • Recrutement
        • Faculty of Medicine, School of Health Sciences, University of Ioannina
        • Chercheur principal:
          • Eleftheria Hatzimichael
        • Contact:
          • Site Contact
          • Numéro de téléphone: 2651099650
          • E-mail: ehatzim@uoi.gr
    • Central Athens
      • Athens, Central Athens, Grèce, 11526
        • Pas encore de recrutement
        • Laiko General Hospital
        • Chercheur principal:
          • Theodoros Vassilakopoulos
        • Contact:
      • Athens, Central Athens, Grèce, 11527
        • Recrutement
        • National and Kapodistrian University of Athens (NKUA)-Laiko General Hospital
        • Contact:
        • Chercheur principal:
          • Panagiotis Diamantopoulos
    • Evros
      • Alexandroupoli, Evros, Grèce, 68100
        • Recrutement
        • Democritus University of Thrace (DUTH) - University General Hospital of Alexandroupolis
        • Contact:
        • Chercheur principal:
          • Ioannis Kotsianidis
    • Macedonia
      • Thessaloniki, Macedonia, Grèce, 55133
        • Recrutement
        • General Hospital of Thessaloniki "Ippokratio"
        • Contact:
        • Chercheur principal:
          • Eleni Gavriilaki
    • West Athens
      • Athens, West Athens, Grèce, 12462
        • Pas encore de recrutement
        • National and Kapodistrian University of Athens-University General Hospital Attikon
        • Chercheur principal:
          • Vassiliki Pappa
        • Contact:
  • Hongrie
    • H-B
      • Debrecen, H-B, Hongrie, 500096
        • Recrutement
        • University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
        • Chercheur principal:
          • Arpad Illes
        • Contact:
    • Komárom-Esztergom
      • Tatabánya, Komárom-Esztergom, Hongrie, 2800
        • Recrutement
        • Szent Borbala Korhaz, Department of Internal Medicine and Haematology, Division of Hematology
        • Contact:
        • Chercheur principal:
          • Zsofia Simon
  • Inde
      • Chandigarh, Inde, 160012
        • Pas encore de recrutement
        • Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh
        • Chercheur principal:
          • Pankaj Malhotra
        • Contact:
      • Delhi, Inde, 110017
        • Recrutement
        • Max SuperSpeciality Saket, Delhi
        • Contact:
        • Chercheur principal:
          • Rayaz Ahmed
    • Kerala
      • Kochi, Kerala, Inde, 682041
        • Pas encore de recrutement
        • AIMS, Kochi
        • Contact:
        • Chercheur principal:
          • Neeraj Sidharthan
      • Kochi, Kerala, Inde, 682041
        • Pas encore de recrutement
        • Tata Medical Center, Kolkata
        • Chercheur principal:
          • Arijit Nag
        • Contact:
    • Maharashtra
      • Pune, Maharashtra, Inde, 411004
        • Recrutement
        • Sahyadri Hospitals, Pune
        • Contact:
        • Chercheur principal:
          • Shashikant Apte
    • Tamil Nadu
      • Vellore, Tamil Nadu, Inde, 632517
        • Pas encore de recrutement
        • Christian Medical College
        • Chercheur principal:
          • Biju George
        • Contact:
    • Telangana
      • Hyderabad, Telangana, Inde, 500096
        • Recrutement
        • Apollo Hospital Hyderabad
        • Contact:
        • Chercheur principal:
          • Padmaja Lokireddy
  • Irlande
      • Cork, Irlande, T12 DC4A
        • Recrutement
        • Cork University Hospital
        • Chercheur principal:
          • Vitaliy Mykytiv
        • Contact:
      • Dublin, Irlande, Dublin 7
        • Recrutement
        • Mater Misericordiae University Hospital
        • Chercheur principal:
          • Su Maung
        • Contact:
      • Dublin, Irlande, 091 524411
        • Pas encore de recrutement
        • St. James's Hospital
        • Chercheur principal:
          • Catherine Flynn
        • Contact:
      • Galway, Irlande, H91 YR71
        • Pas encore de recrutement
        • University Hospital Galway
        • Chercheur principal:
          • Janusz Krawczyk
        • Contact:
  • Italie
      • Bologna, Italie, 40138
        • Pas encore de recrutement
        • Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Lorenzo e Ariosto Seragnoli"
        • Contact:
        • Chercheur principal:
          • Stefania Paolini
      • Milan, Italie, 20132
        • Recrutement
        • IRCCS Ospedale San Raffaele
        • Contact:
        • Chercheur principal:
          • Elisa Diral
      • Naples, Italie, 80131
        • Recrutement
        • Ospedale Cardarelli
        • Chercheur principal:
          • Mario Annunziata
        • Contact:
      • Novara, Italie, 28100
        • Recrutement
        • Ospedale di Novara
        • Chercheur principal:
          • Andrea Patriarca
        • Contact:
      • Padua, Italie, 35128
        • Recrutement
        • Universita degli Studi di Padova-Azienda Ospedaliera di Padova
        • Contact:
        • Chercheur principal:
          • Gianni Binotto
      • Rome, Italie, 00133
        • Pas encore de recrutement
        • Universita Degli Studi di Roma "Tor Vergata"
        • Chercheur principal:
          • Maria Teresa Voso
        • Contact:
    • Florence
      • Florence, Florence, Italie, 50141
        • Recrutement
        • Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
        • Chercheur principal:
          • Valeria Santini
        • Contact:
    • Milan
      • Rozzano, Milan, Italie, 20089
        • Pas encore de recrutement
        • Gruppo Humanitas-Humanitas Research Hospital (Istituto Clinico Humanitas)
        • Contact:
        • Chercheur principal:
          • Matteo Giovanni Della Porta
    • PV
      • Pavia, PV, Italie, 27100
        • Pas encore de recrutement
        • Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
        • Chercheur principal:
          • Luca Malcovati
        • Contact:
    • Rome
      • Roma, Rome, Italie, 00161
        • Recrutement
        • Policlinico Umberto I
        • Contact:
        • Chercheur principal:
          • Massima Breccia
    • Torino
      • Candiolo, Torino, Italie, 10060
        • Recrutement
        • Institute of Cancer Research and Treatment of Candiolo
        • Chercheur principal:
          • Elena Crisa
        • Contact:
  • Japon
    • Aichi-ken
      • Nagoya, Aichi-ken, Japon, 460-0001
        • Recrutement
        • NHO Nagoya Medical Center
        • Chercheur principal:
          • Hiroatsu Iida
        • Contact:
    • Fukushima, Japan
      • Fukushima, Fukushima, Japan, Japon, 960-1295
        • Recrutement
        • Fukushima Medical University Hospital
        • Chercheur principal:
          • Takayuki Ikezoe
        • Contact:
          • Site Contact
          • Numéro de téléphone: +81-24-547-1111
    • Gifu
      • Gifu, Gifu, Japon, 500-8323
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japon, 720-0001
        • Recrutement
        • Chugoku Central Hospital
        • Chercheur principal:
          • Masanori Makita
        • Contact:
    • Hyōgo
      • Amagasaki-shi, Hyōgo, Japon, 660-8550
        • Recrutement
        • Hyogo Prefectural Amagasaki General Medical Center
        • Chercheur principal:
          • Mitsumasa Watanabe
        • Contact:
    • Tochigi
      • Mibu, Tochigi, Japon, 321-0293
        • Recrutement
        • Dokkyo Medical University Hospital
        • Chercheur principal:
          • Yoichi Imai
        • Contact:
    • Tokyo
      • Bunkyo-ku, Tokyo, Japon, 113-8677
        • Recrutement
        • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
        • Chercheur principal:
          • Tomomi Tobai
        • Contact:
      • Shinagawa-ku, Tokyo, Japon, 141-8625
        • Recrutement
        • NTT Medical Center Tokyo
        • Chercheur principal:
          • Motoshi Ichikawa
        • Contact:
  • Lituanie
      • Vilnius, Lituanie, 08661
        • Pas encore de recrutement
        • Vilniaus Universiteto Ligonine Santaros Klinikos (VULSK) (Vilniaus Universiteto Ligonines Santariskiu Klinikos)
        • Chercheur principal:
          • Andrius Degulys
        • Contact:
    • LT
      • Kaunas, LT, Lituanie, 50161
        • Recrutement
        • Hospital of Lithuania University of Health Sciences Kaunas, Clinic of Oncology and Hematology
        • Chercheur principal:
          • Milda Rudzianskiene
        • Contact:
  • Malaisie
    • Johor
      • Johor Bahru, Johor, Malaisie, 80100
        • Recrutement
        • Hospital Sultanah Aminah Johor Bahru (HSAJB)
        • Contact:
        • Chercheur principal:
          • Wong Yih Seong
    • Kedah
      • Alor Star, Kedah, Malaisie, 11450
        • Recrutement
        • Hospital Sultanah Bahiyah (HSB) (Klinik Kesihatan Bandar Alor Setar/Hospital Alor Setar)
        • Contact:
        • Chercheur principal:
          • Liew Hong Keng
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaisie, 59200
        • Recrutement
        • Universiti Malaya - Faculty of Medicine (FOM)
        • Contact:
        • Chercheur principal:
          • Bee Ping Chong
  • Mexique
      • Mexico City, Mexique, 14080
        • Pas encore de recrutement
        • National Institute of Medical Sciences and Nutrition Salvado
        • Contact:
        • Chercheur principal:
          • Elia Apodaca
      • Oaxaca City, Mexique, 68000
        • Pas encore de recrutement
        • Oaxaca Site Management Organization S.C. - Oaxaca
        • Contact:
        • Chercheur principal:
          • Eva Fabiola Ramirez Romero
    • Michoacán
      • Morelia, Michoacán, Mexique, 58260
        • Pas encore de recrutement
        • Centro de Investigacion Clinica Chapultepec (CICC), S.A. de C.V
        • Contact:
        • Chercheur principal:
          • Gregorio Campos Cabrera
    • Nuevo León
      • Monterrey, Nuevo León, Mexique, 64460
        • Pas encore de recrutement
        • Universidad Autonoma de Nuevo Leon-Hospital Universitario "Dr. Jose Eleuterio Gonzalez" - Servicio de Hematologia
        • Chercheur principal:
          • David Gomez Almaguer
        • Contact:
  • Norvège
      • Oslo, Norvège, 0372
        • Pas encore de recrutement
        • Oslo Universitetssykehus HF
        • Contact:
        • Chercheur principal:
          • Synne Torkildsen
    • Vest
      • Bergen, Vest, Norvège, 5021
        • Recrutement
        • Helse Bergen HF
        • Contact:
        • Chercheur principal:
          • Astrid Olsnes
    • Vestfold
      • Tønsberg, Vestfold, Norvège, 3116
        • Recrutement
        • Sykehuset Vestfold HF
        • Contact:
        • Chercheur principal:
          • Emil Nyquist
  • Pays-Bas
    • North Holland
      • Amsterdam, North Holland, Pays-Bas, 1081HV
        • Recrutement
        • Amsterdam UMC-Locatie VUMC (Vrije Universiteit Medisch Centrum)
        • Contact:
        • Chercheur principal:
          • Arjan A. van de Loosdrecht
  • Pologne
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Pologne, 50-019
        • Recrutement
        • Pratia Wroclaw
        • Contact:
        • Chercheur principal:
          • Elzbieta Kalicinska
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Pologne, 02-172
        • Recrutement
        • Warszawski Uniwersytet Medyczny (WUM) (Medical University of Warsaw)
        • Chercheur principal:
          • Krzysztof Madry
        • Contact:
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Pologne, 40-519
        • Recrutement
        • Pratia Onkologia Katowice
        • Chercheur principal:
          • Sebastian Grosicki
        • Contact:
    • Wielkopolska
      • Skorzewo, Wielkopolska, Pologne, 60185
        • Recrutement
        • AidPort
        • Contact:
        • Chercheur principal:
          • Michael Kwiatek
    • maAopolska
      • Krakow, maAopolska, Pologne, 50-727
        • Pas encore de recrutement
        • Pratia MCM Krakow
        • Chercheur principal:
          • Wojciech Jurczak
        • Contact:
  • Roumanie
    • Cluj
      • Cluj-Napoca, Cluj, Roumanie, 400124
        • Recrutement
        • Institutul Oncologic Prof. Dr. I. Chiricu
        • Chercheur principal:
          • Ciprian Tomuleasa
        • Contact:
    • Dolj
      • Craiova, Dolj, Roumanie, 20014
        • Recrutement
        • Filantropia Municipal Clinical Hospital
        • Contact:
          • Site Contact
        • Chercheur principal:
          • Luminita Ocroteala
  • Royaume-Uni
      • London, Royaume-Uni, SE5 9RS
        • Recrutement
        • King's College Hospital
        • Chercheur principal:
          • Austin Kulasekararaj
        • Contact:
      • Manchester, Royaume-Uni, M20 4BX
        • Pas encore de recrutement
        • The Christie NHS Foundation Trust
        • Chercheur principal:
          • Daniel Wiseman
        • Contact:
    • Leicestershire
      • Leicester, Leicestershire, Royaume-Uni, LE1 5WW
        • Pas encore de recrutement
        • University Hospitals of Leicester NHS Trust
        • Chercheur principal:
          • Matthew Lee
        • Contact:
    • Lincolnshire
      • Boston, Lincolnshire, Royaume-Uni, PE227BU
        • Recrutement
        • Pilgrim Hospital
        • Chercheur principal:
          • Ciro Rinaldi
        • Contact:
    • OXON
      • Oxford, OXON, Royaume-Uni, OX3 7LE
        • Recrutement
        • Churchill Hospital
        • Contact:
        • Chercheur principal:
          • Oni Chowdhury
    • West Midlands
      • Birmingham, West Midlands, Royaume-Uni, B15 2TH
        • Pas encore de recrutement
        • Queen Elizabeth Hospital Birmingham
        • Chercheur principal:
          • Vidhya Murthy
        • Contact:
  • Suisse
      • Bern, Suisse, 3010
        • Pas encore de recrutement
        • Insel Gruppe AG
        • Chercheur principal:
          • Natalia Baran
        • Contact:
    • Canton of Zurich
      • Zurich, Canton of Zurich, Suisse, 8091
        • Pas encore de recrutement
        • Universitatsspital Zurich
        • Chercheur principal:
          • Stefan Balabanov
        • Contact:
    • Kanton Graubünden
      • Chur, Kanton Graubünden, Suisse, 7000
        • Pas encore de recrutement
        • Kantonsspital Graubunden
        • Chercheur principal:
          • Tobias Silzle
        • Contact:
  • Taïwan
      • Changhua, Taïwan, 505029
        • Recrutement
        • Chang Bing Show Chwan Memorial Hospital
        • Chercheur principal:
          • Cheng-Shyong Chang
        • Contact:
      • Kaohsiung City, Taïwan, 807
        • Recrutement
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Chercheur principal:
          • Yi-Chang Liu
        • Contact:
      • Tainan, Taïwan, 704
        • Recrutement
        • National Cheng Kung University Hospital
        • Chercheur principal:
          • Tsai-Yun Chen
        • Contact:
      • Taipei, Taïwan, 112201
        • Recrutement
        • Taipei Veterans General Hospital
        • Contact:
        • Chercheur principal:
          • Chia-Jen Liu
      • Taipei, Taïwan, 100225
        • Recrutement
        • National Taiwan University Hospital - East Campus
        • Chercheur principal:
          • Chien-Chin Lin
        • Contact:
    • TW
      • Taichung, TW, Taïwan, 404
        • Recrutement
        • China Medical University Hospital
        • Chercheur principal:
          • Su-Peng Yeh
        • Contact:
  • Thaïlande
      • Bangkok, Thaïlande, 10330
        • Recrutement
        • King Chulalongkorn Memorial Hospital
        • Chercheur principal:
          • Noppacharn Uaprasert
        • Contact:
    • Chiang Mai
      • Chiang Mai, Chiang Mai, Thaïlande, 50200
        • Recrutement
        • Maharaj Nakorn Chiangmai Hospital
        • Chercheur principal:
          • Thanawat Rattanathammethee
        • Contact:
    • Samutsakorn
      • Ban Phaeo, Samutsakorn, Thaïlande, 74120
        • Recrutement
        • Banphaeo General Hospital
        • Chercheur principal:
          • Busakorn Sae-Aeng
        • Contact:
  • Turquie (Türkiye)
      • Istanbul, Turquie (Türkiye), 34381
        • Pas encore de recrutement
        • Istanbul Florence Nightingale Hospital
        • Contact:
        • Chercheur principal:
          • Omur Gokmen Sevindik
      • Izmir, Turquie (Türkiye), 35100
        • Pas encore de recrutement
        • Ege University Medical Faculty
        • Chercheur principal:
          • Guray Saydam
        • Contact:
    • Ankara, Turkey
      • Ankara, Ankara, Turkey, Turquie (Türkiye), 06520
        • Pas encore de recrutement
        • Ankara Universitesi, TAp FakAltesi, Hematoloji BD
        • Contact:
        • Chercheur principal:
          • Pervin Topcuoglu
    • Atakum
      • Samsun, Atakum, Turquie (Türkiye), 55139
        • Pas encore de recrutement
        • Ondokuz Mayis University School of Medicine, Department of Hematology
        • Chercheur principal:
          • Engin Kelkitli
        • Contact:
    • Mezitli
      • Mersin, Mezitli, Turquie (Türkiye), 33000
        • Pas encore de recrutement
        • Mersin Medicalpark Hospital
        • Chercheur principal:
          • Anil Tombak
        • Contact:
  • États-Unis
    • Arizona
      • Gilbert, Arizona, États-Unis, 85234
        • Pas encore de recrutement
        • Banner MD Anderson Cancer Center
        • Contact:
          • Site Contact
        • Chercheur principal:
          • Mark Faber
    • California
      • Duarte, California, États-Unis, 91010
        • Pas encore de recrutement
        • City of Hope - Comprehensive Cancer Center (CCC)
        • Chercheur principal:
          • Andrew Artz
        • Contact:
          • Site Contact
          • Numéro de téléphone: 626-218-2404
          • E-mail: aartz@coh.org
      • Santa Rosa, California, États-Unis, 95403
        • Pas encore de recrutement
        • Providence Medical Group
        • Chercheur principal:
          • Jarrod Holmes
        • Contact:
      • Whittier, California, États-Unis, 94538
        • Pas encore de recrutement
        • Cancer & Blood Research Center
        • Contact:
          • Site Contact
        • Chercheur principal:
          • Merrill Shum
    • Connecticut
      • New Haven, Connecticut, États-Unis, 06510
        • Pas encore de recrutement
        • Yale
        • Chercheur principal:
          • Amer Zeidan
        • Contact:
    • Florida
      • Fort Myers, Florida, États-Unis, 33912
        • Pas encore de recrutement
        • Florida Oncology & Hematology
        • Contact:
        • Chercheur principal:
          • Magali Van den Bergh
      • Miami, Florida, États-Unis, 33136
        • Pas encore de recrutement
        • University of Miami
        • Contact:
        • Chercheur principal:
          • Mikkael Sekeres
      • Tamarac, Florida, États-Unis, 33321
        • Recrutement
        • BRCR Medical Center Inc
        • Contact:
        • Chercheur principal:
          • Chintan Gandhi
      • Tampa, Florida, États-Unis, 33612
        • Pas encore de recrutement
        • Moffitt Cancer Center
        • Chercheur principal:
          • Rami Komrokji
        • Contact:
    • Georgia
      • Atlanta, Georgia, États-Unis, 30322
        • Recrutement
        • Emory University
        • Chercheur principal:
          • Nikolaos Papadantonakis
        • Contact:
    • Idaho
      • Boise, Idaho, États-Unis, 83712
        • Pas encore de recrutement
        • Saint Luke's Cancer Institute
        • Chercheur principal:
          • William Kreisle
        • Contact:
    • Illinois
      • Skokie, Illinois, États-Unis, 60077
        • Recrutement
        • Orchard Healthcare Research Inc. (OHR) - Skokie
        • Chercheur principal:
          • Ira Oliff
        • Contact:
    • Kentucky
      • Louisville, Kentucky, États-Unis, 40207
        • Recrutement
        • Norton Cancer Institute
        • Chercheur principal:
          • Don Stevens
        • Contact:
    • Louisiana
      • Monroe, Louisiana, États-Unis, 71201
        • Pas encore de recrutement
        • Epic Medical Research
        • Contact:
        • Chercheur principal:
          • Tharwat Ghattas
      • Shreveport, Louisiana, États-Unis, 71106
        • Pas encore de recrutement
        • Epic Medical Research - Shreveport
        • Contact:
        • Chercheur principal:
          • Kirtan Koticha
    • Michigan
      • Grand Rapids, Michigan, États-Unis, 49503
        • Pas encore de recrutement
        • The Cancer and Hematology Centers
        • Contact:
        • Chercheur principal:
          • Daniel Foley
    • Missouri
      • Kansas City, Missouri, États-Unis, 64132
        • Recrutement
        • American Oncology Partners P.A. MidAmerica Cancer Care
        • Contact:
        • Chercheur principal:
          • Benjamin Fangman
    • New York
      • New York, New York, États-Unis, 10029
        • Pas encore de recrutement
        • Icahn School of Medicine at Mount Sinai
        • Chercheur principal:
          • Lewis Silverman
        • Contact:
      • Nyack, New York, États-Unis, 10960
        • Pas encore de recrutement
        • Hematology Oncology Associates of Rockland
        • Chercheur principal:
          • Sung Ho Lee
        • Contact:
      • Rochester, New York, États-Unis, 14642
        • Pas encore de recrutement
        • UR Medicine (University of Rochester Medical Center)
        • Contact:
        • Chercheur principal:
          • Jason Mendler
      • The Bronx, New York, États-Unis, 10467
        • Recrutement
        • Albert Einstein College - Montefiore
        • Chercheur principal:
          • Aditi Shastri
        • Contact:
    • North Carolina
      • Winston-Salem, North Carolina, États-Unis, 27106
        • Pas encore de recrutement
        • Novant Health Care Institute
        • Chercheur principal:
          • James Dugan
        • Contact:
    • Ohio
      • Cleveland, Ohio, États-Unis, 44195
        • Pas encore de recrutement
        • Cleveland clinic OH
        • Chercheur principal:
          • Hetty Carraway
        • Contact:
          • Site Contact
          • Numéro de téléphone: 216-287-5665
          • E-mail: carrawh@ccf.org
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19111
        • Recrutement
        • Fox Chase Cancer Center
        • Chercheur principal:
          • Iberia Sosa
        • Contact:
      • Philadelphia, Pennsylvania, États-Unis, 19107
        • Pas encore de recrutement
        • Thomas Jefferson University
        • Chercheur principal:
          • Lindsay Wilde
        • Contact:
    • Tennessee
      • Nashville, Tennessee, États-Unis, 37203
        • Recrutement
        • Tennessee Oncology, PLLC
        • Contact:
        • Chercheur principal:
          • Constantine Logothetis
    • Texas
      • Baytown, Texas, États-Unis, 77521
      • Denton, Texas, États-Unis, 76201
        • Recrutement
        • Texas Oncology - Denton
        • Chercheur principal:
          • Charles Kurkul
        • Contact:
          • Site Contact
      • Fort Worth, Texas, États-Unis, 76104
        • Recrutement
        • The Center for Cancer and Blood Disorders
        • Chercheur principal:
          • Ray Page
        • Contact:
      • Houston, Texas, États-Unis, 77030
        • Recrutement
        • The University of Texas-MD Anderson Cancer Center - Leukemia Center
        • Chercheur principal:
          • Guillermo Garcia-Manero
        • Contact:
      • Houston, Texas, États-Unis, 90603
        • Recrutement
        • LUMI Research
        • Contact:
          • Site Contact
        • Chercheur principal:
          • David Nguyen
      • The Woodlands, Texas, États-Unis, 77380
    • Utah
      • Salt Lake City, Utah, États-Unis, 84124
        • Pas encore de recrutement
        • Huntsman Cancer Institute
        • Contact:
        • Chercheur principal:
          • Zaker Schwabkey
    • Virginia
      • Richmond, Virginia, États-Unis, 23298
        • Pas encore de recrutement
        • Virginia Commonwealth University (VCU)-Medical Center - North Hospital
        • Contact:
        • Chercheur principal:
          • Ruchi Desai
    • West Virginia
      • Wheeling, West Virginia, États-Unis, 26003
        • Recrutement
        • West Virginia University Cancer Institute
        • Chercheur principal:
          • Konstantinos Sdrimas
        • Contact:

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

  1. Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF).

  2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.

  3. Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System - Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (HgB), platelet, and absolute neutrophil count (ANC) values should be collected greater than (>) 14 days after red blood cell (RBC) transfusion or > 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.

  4. Bone marrow less than (<) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.

  5. Endogenous serum erythropoietin (EPO) level of <500 units per liter (U/L). Should be results from blood samples collected >14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values.

  6. Participant requires RBC transfusion, as documented by the following criteria. A transfusion requirement of 2 to 6 pRBCs units/8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization.

    • Hgb levels at the time of or within 3 days prior to administration of a RBC transfusion must have been less than or equal to (≤) 9.0 grams per deciliter (g/dL) (5.6 millimoles per liter (mmol/L)) with symptoms of anemia (or ≤7 g/dL [4.3 mmol/L] in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria.
    • RBC transfusions administered when hemoglobin (Hgb) levels were >9.0 g/dL (or >7 g/dL in the absence of symptoms) and/or RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification.

  7. Hgb <11.0 g/dL (6.8 mmol/L) before randomization. Local laboratory is acceptable to facilitate randomization.

  8. Eastern Cooperative Oncology Group score of 0, 1, or 2.

Exclusion Criteria

  1. Prior therapy with any of the following:

    1. Epoetin alfa

      • At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 2 doses of only epoetin alfa ≥8 weeks prior to randomization.

    2. Darbepoetin

      • At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 1 dose of only darbepoetin ≥8 weeks prior to randomization.

    3. Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administered ≤8 weeks (56 days) prior to randomization unless given for treatment of febrile neutropenia.

    4. Immunomodulatory drug (IMiDs) including lenalidomide

      • At the investigator's discretion in consultation with the medical monitor may be allowed if received ≤1 week of an IMiD ≥8 weeks prior to randomization.

    5. Hypomethylating agent

      • At the investigator's discretion, in consultation with the medical monitor may be allowed if received no more than 2 doses ≥8 weeks prior to randomization.

    6. Luspatercept, sotatercept, imetelstat, or elritercept

    7. Immunosuppressive therapy for the disease under study.

    8. Hematopoeitic cell transplant

    9. Iron chelation if initiated ≤8 weeks prior to randomization. Participants on stable or decreasing doses of iron chelation therapy for ≥8 weeks are allowed.

    10. Vitamin B12 or folate therapy initiated within 4 weeks prior to randomization. Participants on stable or decreasing replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.

    11. Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed

    12. High-dose systemic corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone ≤10 millligrams per day (mg/day) or corticosteroid equivalent for ≥4 weeks are allowed. Other disease modifying treatments for autoimmune diseases may be allowed upon medical monitor review.

    13. Investigational agent or any other agent intended for MDS treatment

  2. Diagnosed to have MDS with presence of del(5q) cytogenetic abnormality or MDS unclassifiable according to WHO 2016 classification or secondary MDS.

  3. Known history of diagnosis of acute myeloid leukemia (AML).

  4. Anemia due to any other known cause including but not limited to thalassemia; hypothyroidism, autoimmune or hereditary hemolytic anemia, any type of known clinically significant bleeding or sequestration or drug induced anemia, hemolytic anemia, bleeding events, or other deficiencies (that is, iron, folate, or vitamin B12).

  5. Clinically significant cardiovascular disease defined as:

    1. New York Heart Association heart disease class III or IV
    2. Fridericia corrected QT (QTcF) interval >500 milliseconds during screening
    3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening

  6. Known ejection fraction <35%, confirmed by a local echocardiogram performed during screening, or a previously performed echocardiogram if collected within 6 months before screening.

  7. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (DVT; including proximal and distal), pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.

  8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimeters of mercury (mmHg) and/or diastolic blood pressure ≥100 mmHg despite adequate treatment.

  9. Prior history of malignancies, other than MDS. Participants who are free of other malignant disease for ≥3 years and have completed treatment, including maintenance are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:

    1. Basal or squamous cell carcinoma of the skin;
    2. Carcinoma in situ of the cervix;
    3. Carcinoma in situ of the breast;
    4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] or early papillary thyroid cancer (Stage I [T1-T2, N0, M0]) clinical staging system).

  10. History of solid organ or bone marrow transplantation.

  11. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before randomization.

  12. Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.

  13. Body mass index ≥ 40 kilograms per square meter (kg/m^2).

  14. Major surgery within 28 days before randomization.

  15. New-onset seizures or poorly controlled seizures within 12 weeks prior to randomization are excluded from trial participation.

  16. History of allergy/anaphylaxis to investigational product (including epoetin alfa) excipients (refer to the current elritercept investigator's brochure for a list of excipients) or recombination proteins.

  17. History of pure red cell aplasia and/or antibody against erythropoietin (EPO).

  18. Any of the following laboratory abnormalities:

    1. ANC <500/microliter (μL) (0.5×10^9/liter [L]).
    2. Platelet count <50,000/μL (50×10^9/L) or ≥800,000/μL (800×10^9/L).
    3. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3× upper limit of the normal (ULN).
    4. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin <3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.
    5. Estimated glomerular filtration rate <30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) as determined by the Chronic Kidney Disease Epidemiology (CKD-EPI) collaboration equation.
    6. Ferritin ≤50 micrograms per liter (μg/L).
    7. Folate ≤2.0 nanograms per milliliter (ng/mL).
    8. Vitamin B12 ≤200 picograms per milliliter (pg/mL).

  19. Ongoing participation in another interventional clinical trial or use of any other investigational medicinal product within 5 times the half-life.

  20. Participant is unwilling or in the opinion of the investigator the participant is unable to comply with the requirements of the protocol.

  21. Is a participant of childbearing potential (POCBP) but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of trial intervention.

  22. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom during the entire trial intervention period until at least 60 days after the last dose of trial intervention.

  23. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire trial intervention period until at least 60 days after the last dose of trial intervention.

  24. For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.

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
Expérimental: Elritercept

Participants will receive elritercept at a starting dose of 3.75 milligrams per kilogram (mg/kg) administered subcutaneously (SC) once every 4 weeks, and may have the dose escalated to 5.0 mg/kg if needed.
Médicament: Elritercept

Elritercept, SC injection.

Autres noms:
  • TAK-226
Comparateur actif: Epoetin Alfa

Participants will receive epoetin alfa at a starting dose of 450 international units per kilograms (IU/kg) administered SC once every week, and may have the dose escalated up to 1050 IU/kg (maximum 80,000 IU).
Médicament: Epoetin Alfa

Epoetin Alfa, SC injection.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of Participants who are RBC Transfusion Independent (RBC-TI) for any Consecutive Greater Than Equal to (≥) 12-Week Period From Day 1 Through 24 Weeks With Concurrent Mean Hemoglobin (Hgb) Increase ≥ 1.5 Grams per Deciliter (g/dL) From Baseline
Délai: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)

RBC-TI is defined as no red blood cell (RBC) transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Proportion de participants présentant une indépendance transfusionnelle des globules rouges pendant une période consécutive minimale de 8 semaines entre le jour 1 et la semaine 24
Délai: Du jour 1 du cycle 1 jusqu'à la semaine 24 (chaque cycle dure 28 jours)
Du jour 1 du cycle 1 jusqu'à la semaine 24 (chaque cycle dure 28 jours)
Proportion de participants présentant une indépendance transfusionnelle de globules rouges (RBC-TI) pendant une période consécutive minimale de 24 semaines entre le jour 1 et la semaine 48
Délai: Du Jour 1 du Cycle 1 jusqu'à la Semaine 48 (chaque cycle dure 28 jours)
Du Jour 1 du Cycle 1 jusqu'à la Semaine 48 (chaque cycle dure 28 jours)
Changement moyen de l'Hgb par rapport à la valeur initiale à 24 semaines et 48 semaines
Délai: De la valeur initiale à la semaine 24 et à la semaine 48
De la valeur initiale à la semaine 24 et à la semaine 48
Durée maximale de l'indépendance transfusionnelle érythrocytaire (RBC-TI) pour les participants ayant atteint une RBC-TI pendant ≥12 semaines consécutives et ≥16 semaines consécutives
Délai: Du jour 1 du cycle 1 jusqu'à la semaine 24 (chaque cycle dure 28 jours)
Du jour 1 du cycle 1 jusqu'à la semaine 24 (chaque cycle dure 28 jours)
Nombre total d'unités de concentrés érythrocytaires (CE) reçues pendant le traitement de l'étude
Délai: Du Cycle 1 Jour 1 jusqu'à la fin du traitement (environ 5 ans) (chaque cycle dure 28 jours)
Du Cycle 1 Jour 1 jusqu'à la fin du traitement (environ 5 ans) (chaque cycle dure 28 jours)
Moyenne mensuelle des unités de CGR reçues pendant la période de traitement de l'étude
Délai: Du Cycle 1 Jour 1 à la Fin du Traitement (environ 5 ans) (chaque cycle dure 28 jours)
Du Cycle 1 Jour 1 à la Fin du Traitement (environ 5 ans) (chaque cycle dure 28 jours)
Temps écoulé entre la date de la première dose du médicament de l'étude et la date de la première transfusion de globules rouges reçue pendant la période de traitement
Délai: Du Cycle 1 Jour 1 jusqu'à la Fin du Traitement (environ 5 ans) (chaque cycle dure 28 jours)
Du Cycle 1 Jour 1 jusqu'à la Fin du Traitement (environ 5 ans) (chaque cycle dure 28 jours)
Délai entre la date de la première dose du médicament de l'étude et la première apparition de l'atteinte d'une HI-E pendant une période minimale consécutive de 8 semaines
Délai: Du jour 1 du cycle 1 jusqu'à la semaine 24 (chaque cycle dure 28 jours)
Du jour 1 du cycle 1 jusqu'à la semaine 24 (chaque cycle dure 28 jours)
Concentration du médicament de l'étude dans le plasma en fonction du temps pour les participants traités avec l'elritercept
Délai: Avant la dose et à plusieurs reprises après la dose, du Cycle 1 Jour 1 jusqu'au Cycle 13 Jour 1 (environ 49 semaines) (chaque cycle dure 28 jours)
Avant la dose et à plusieurs reprises après la dose, du Cycle 1 Jour 1 jusqu'au Cycle 13 Jour 1 (environ 49 semaines) (chaque cycle dure 28 jours)
Proportion de participants traités avec l'Elritercept présentant des anticorps anti-médicament (ADA)
Délai: Du jour 1 du cycle 1 jusqu'à 60 jours après la dernière dose (environ 5 ans) (chaque cycle dure 28 jours)
Du jour 1 du cycle 1 jusqu'à 60 jours après la dernière dose (environ 5 ans) (chaque cycle dure 28 jours)
Temps entre la randomisation et le décès d'un participant, quelle qu'en soit la cause
Délai: De la randomisation à la semaine 48
De la randomisation à la semaine 48
Proportion of Participants who are RBC-TI for any Consecutive ≥16-Week Period From Day 1 to 24 Weeks
Délai: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)

RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants who are RBC-TI for any Consecutive ≥12-Week Period From Day 1 to 24 Weeks
Délai: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)

RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants who are RBC-TI for a Consecutive 24-Week Period From Day 1
Délai: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)

RBC-TI is defined as no RBC transfusions administered for the specified time period during study treatment.
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants Who Have Meaningful Improvement or Maintain a High Score With no Meaningful Deterioration in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Score With no RBC Transfusions Based on the Average of Scores
Délai: From End of Week 12 to End of Week 24

The FACT-An questionnaire is used to assess the effects of disease symptoms on functioning and well-being in participants with anemia. The FACT-An Anemia scale includes 13 fatigue-specific items (which together comprise the FACIT-Fatigue scale).
From End of Week 12 to End of Week 24
Proportion of Participants who Achieved Hematological Improvement-Erythroid (HI-E) for a Minimum 8-Week Period From Day 1 to 24 Weeks
Délai: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)

HI-E is defined as percentage of participants meeting HI-E criteria sustained over any consecutive 56-day period over the first 24 weeks.
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants who Achieved Hematological Improvement-Erythroid (HI-E) for a Minimum 12-Week Period From Day 1 to 48 Weeks
Délai: From Cycle 1 Day 1 through Week 48 (each cycle is 28 days)

HI-E is defined as percentage of participants meeting HI-E criteria sustained over any consecutive 84-day period over the 48 weeks.
From Cycle 1 Day 1 through Week 48 (each cycle is 28 days)
Time From Date of First Dose to First Onset of Achieving RBC-TI
Délai: From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)

RBC-TI is defined as the absence of RBC transfusions for a prespecified period of time during continued treatment. Time from date of first dose to first onset of achieving RBC-TI for minimum consecutive 12 weeks and for minimum consecutive 16 weeks.
From Cycle 1 Day 1 through Week 24 (each cycle is 28 days)
Proportion of Participants with Meaningful Improvement in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Scores
Délai: From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)

EORTC QLQ-C30 is a 30-item,participant-reported multidomain questionnaire designed to assess the functioning,well-being,and symptom experience of patients with cancer.
From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)
Proportion of Participants with Meaningful Improvement in FACT-Anemia (FACT-An) Scale Scores
Délai: From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)

The FACT-An questionnaire is used to assess the effects of disease symptoms on functioning and well-being in participants with anemia.
From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)
Proportion of Participants with Meaningful Improvement in FACIT-Fatigue Scale Scores
Délai: From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)

The FACT-An Anemia scale includes 13 fatigue-specific items (which together comprise the FACIT-Fatigue scale).
From Cycle 1 Day 1 through Week 24 and 48 (each cycle is 28 days)
Time to Confirmed Improvement and Time to Confirmed Deterioration in EORTC QLQ-C30 Scale Scores
Délai: Baseline through Week 24 and 48

EORTC QLQ-C30 is a 30-item,participant-reported multidomain questionnaire designed to assess the functioning,well-being,and symptom experience of patients with cancer.
Baseline through Week 24 and 48
Time to Confirmed Improvement and Time to Confirmed Deterioration in FACT-An Scale Scores
Délai: Baseline through Week 24 and 48

The FACT-An questionnaire is used to assess the effects of disease symptoms on functioning and well-being in participants with anemia.
Baseline through Week 24 and 48
Time to Confirmed Improvement and Time to Confirmed Deterioration in FACIT-Fatigue Scale Scores
Délai: Baseline through Week 24 and 48

The FACT-An Anemia scale includes 13 fatigue-specific items (which together comprise the FACIT-Fatigue scale).
Baseline through Week 24 and 48
Average Changes in EORTC QLQ-C 30 Scale Scores Through 48 Weeks
Délai: Up to Week 48

EORTC QLQ-C30 is a 30-item,participant-reported multidomain questionnaire designed to assess the functioning,well-being,and symptom experience of patients with cancer.
Up to Week 48
Average Changes in FACT-An Scale Scores Through 48 Weeks
Délai: Up to Week 48

The FACT-An questionnaire is used to assess the effects of disease symptoms on functioning and well-being in participants with anemia.
Up to Week 48
Average Changes in FACIT-Fatigue Scale Scores Through 48 Weeks
Délai: Up to Week 48

The FACT-An Anemia scale includes 13 fatigue-specific items (which together comprise the FACIT-Fatigue scale).
Up to Week 48
Time from Randomization to First Diagnosis of Acute Myeloid Leukemia (AML)
Délai: From Randomization to Week 48

Progression of disease to diagnosis of AML as per world health organisation (WHO) classification of ≥20 percent (%) blasts in peripheral blood or bone.
From Randomization to Week 48

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: Study 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.

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)

21 mai 2026

Achèvement primaire (Estimé)

30 avril 2029

Achèvement de l'étude (Estimé)

1 octobre 2033

Dates d'inscription aux études

Première soumission

6 février 2026

Première soumission répondant aux critères de contrôle qualité

18 février 2026

Première publication (Réel)

20 février 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • TAK-226-3001
  • 2025-523544-12-00 (Ctis)
  • 2025 (Subvention/contrat des NIH des États-Unis)
  • jRCT2061250089 (Identificateur de registre: jRCT)

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

produit fabriqué et exporté des États-Unis.

Oui

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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