Effekten og sikkerheden af Elritercept hos voksne deltagere med meget lav, lav eller mellemrisiko myelodysplastiske syndromer (MDS) med anæmi (FORNYET)
En fase 3, randomiseret, dobbeltblind, placebokontrolleret undersøgelse til evaluering af effektiviteten og sikkerheden af Elritercept (KER-050) til behandling af transfusionsafhængig anæmi hos voksne deltagere med meget lav, lav eller mellemrisiko Myelodysplastiske syndromer (MDS) (FORNYT)
The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
This is a Phase 3, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of elritercept (TAK-226, KER-050) versus placebo. Elritercept (TAK-226, KER-050) is an investigational medicinal product being developed for the treatment of anemia in adult participants with a diagnosis of lower-risk myelodysplastic neoplasms/syndromes. After all required Screening Period assessments are completed, and eligibility is confirmed, participants will be randomized and enter the Primary Phase of the Double-Blind Treatment Period. Participants will be randomly assigned in a 2:1 ratio to receive either elritercept (TAK-226, KER-050) or placebo subcutaneously (SC) every 4 weeks (Q4W). Participants will be stratified according to their ring sideroblasts (RS) status (RS-positive versus non-RS) and baseline transfusion burden (low-transfusion burden [LTB] versus high transfusion burden [HTB]). The Primary Phase of the Double-blind Treatment Period will last 24 weeks. The Secondary Phase of the Double-Blind Treatment Period will last an additional 24 weeks. During the Secondary Phase of the Double-Blind Treatment Period, all participants will continue to receive the same double-blind treatment they received during the Primary Phase. Study visits will occur approximately every 2 weeks from Cycle 1 through Cycle 6 and every 4 weeks from Cycle 7 through the remainder of the Double-Blind Treatment Period. During the Extension Phase of the Double-Blind Treatment Period, all eligible participants will continue to receive the same double-blind treatment they received during the Primary and Secondary Phases. Participants will continue in the Extension Phase until they individually discontinue or until the study is unblinded. For participants to remain on double-blind treatment, they must meet the criteria outlined in the MDS disease assessment criteria every 24 weeks. Based on the outcome of the Week 24 MDS disease assessment, participants will either continue in the Extension Phase of the Double-blind Treatment Period or will be discontinued from treatment and proceed to End of Treatment and then into the Safety Follow-up Period. The Safety Follow-Up Period will extend from the last dose of study treatment through 8 weeks after the last dose of study treatment. Study visits should occur every 4 weeks within the Safety Follow-Up Period. Long-term follow-up will take place quarterly after a participant has completed the Safety Follow-Up Period. Long-term follow-up will continue for 5 years from the first dose of study treatment, or until a participant is deceased, is lost to follow-up, withdraws consent, or the study closes, whichever is earliest.
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Takeda Contact
- Telefonnummer: +1-877-825-3327
- E-mail: medinfoUS@takeda.com
Studiesteder
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Australian Capital Territory
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Garran, Australian Capital Territory, Australien, 2605
- Ikke rekrutterer endnu
- The Canberra Hospital
-
Ledende efterforsker:
- Philip Choi
-
Kontakt:
- Site Contact
- E-mail: phil.choi@act.gov.au
-
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New South Wales
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Sydney, New South Wales, Australien, 2145
- Rekruttering
- Westmead Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +61 () 424275524
- E-mail: lachlin.vaughan@health.nsw.gov.au
-
Ledende efterforsker:
- Lachlin Vaughan
-
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Queensland
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Douglas, Queensland, Australien, 4814
- Rekruttering
- Townsville University Hospital
-
Ledende efterforsker:
- Joel Wight
-
Kontakt:
- Site Contact
- Telefonnummer: 61-7-4433-1111
- E-mail: Joel.Wight@health.qld.gov.au
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South Australia
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Adelaide, South Australia, Australien, 5000
- Rekruttering
- Royal Adelaide Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +61 (8) 8222 3369
- E-mail: Devendra.hiwase@sa.gov.au
-
Ledende efterforsker:
- Devendra Hiwase
-
Adelaide, South Australia, Australien, 5042
- Rekruttering
- Flinders Medical Centre
-
Kontakt:
- Site Contact
- Telefonnummer: +61 (8) 8222 4000
- E-mail: Ashanka.Beligaswatte@sa.gov.au
-
Ledende efterforsker:
- Ashanka Beligaswatte
-
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Victoria
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Box Hill, Victoria, Australien, 3128
- Rekruttering
- Box Hill Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +61 (3) 8396 8442
- E-mail: genevieve.douglas@easternhealth.org.au
-
Ledende efterforsker:
- Genevieve Douglas
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Fitzroy, Victoria, Australien, 3065
- Rekruttering
- St Vincent's Hospital (Melbourne) Ltd
-
Kontakt:
- Site Contact
- Telefonnummer: 61-3-9231-2211
- E-mail: ShuhYing.TAN@svha.org.au
-
Ledende efterforsker:
- ShuhYing Tan
-
Melbourne, Victoria, Australien, 3004
- Ikke rekrutterer endnu
- Alfred Health
-
Ledende efterforsker:
- Shaun Fleming
-
Kontakt:
- Site Contact
- E-mail: shaun.fleming1@monash.edu
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Parkville, Victoria, Australien, 3000
- Rekruttering
- Peter MacCallum Cancer Center
-
Kontakt:
- Site Contact
- Telefonnummer: +61 (0) 3 8559 5000
- E-mail: Lynette.Chee@mh.org.au
-
Ledende efterforsker:
- Lynette Chee
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-
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Rio de Janeiro, Brasilien, 22775-001
- Rekruttering
- Americas Institute
-
Ledende efterforsker:
- Fernando Correia Pinto
-
Kontakt:
- Site Contact
- Telefonnummer: 21-3385-2000
- E-mail: fernandomonteiro@americasoncologia.com.br
-
São Paulo, Brasilien, 01323-900
- Rekruttering
- Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
-
Kontakt:
- Site Contact
- Telefonnummer: +55 (11) 3505 6615
- E-mail: scheinbp@gmail.com
-
Ledende efterforsker:
- Phillip Scheinberg
-
São Paulo, Brasilien, 01509-900
- Rekruttering
- Hospital A.C.Camargo ("Antonio Prudente" Foundation)
-
Ledende efterforsker:
- Marina Nascimento
-
Kontakt:
- Site Contact
- Telefonnummer: 55-11-9-9901-3833
- E-mail: marina.nascimento@accamargo.org.br
-
São Paulo, Brasilien, 11075-900
- Rekruttering
- Santa Casa of Mercy of Santos
-
Ledende efterforsker:
- Elaine Mancilha
-
Kontakt:
- Site Contact
- Telefonnummer: 13-3221-5508
- E-mail: elaine_mancilha@hotmail.com
-
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Paraná
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Curitiba, Paraná, Brasilien, 81520-060
- Rekruttering
- Hosptial Erasto Gaertner
-
Kontakt:
- Site Contact
- E-mail: drciliao@gmail.com
-
Ledende efterforsker:
- Eduardo Munhoz
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90610-000
- Rekruttering
- Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
-
Ledende efterforsker:
- Mariza Schaan
-
Kontakt:
- Site Contact
- Telefonnummer: 55-51-3320-3660
- E-mail: mzschaan@hotmail.com
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
- Rekruttering
- Porto Alegre Clinical Hospital (HCPA)
-
Ledende efterforsker:
- Laura Maria Fogliatto
-
Kontakt:
- Site Contact
- Telefonnummer: 55-51-3359-8000
- E-mail: fogliattopesquisa@gmail.com
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90110-270
- Rekruttering
- Hospital Mae de Deus, Clinical Research Unit - Cancer Institute
-
Ledende efterforsker:
- Marcelo Capra
-
Kontakt:
- Site Contact
- Telefonnummer: +55 (51) 33789927
- E-mail: marcelocapra@hotmail.com
-
-
Santa Catarina
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Joinville, Santa Catarina, Brasilien, 89201-260
- Rekruttering
- Instituto Joinvilense de Hematologia e Oncologia
-
Kontakt:
- Site Contact
- E-mail: marcelolacerda001@gmail.com
-
Ledende efterforsker:
- Lacerda Marcelo
-
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São Paulo
-
Jaú, São Paulo, Brasilien, 17210-080
- Rekruttering
- FundaAAo Doutor Amaral Carvalho
-
Kontakt:
- Site Contact
- E-mail: pesquisafac.edersonmattos@gmail.com
-
Ledende efterforsker:
- Guilherme Mattos
-
Santo André, São Paulo, Brasilien, 09060-650
- Rekruttering
- Cepho- Fmabc
-
Kontakt:
- Site Contact
- E-mail: vitormauad.medabc@gmail.com
-
Ledende efterforsker:
- Vitor Mauad
-
São José do Rio Preto, São Paulo, Brasilien, 15090-000
- Rekruttering
- Sao Jose do Rio Preto Regional Faculty of Medicine Foundation
-
Ledende efterforsker:
- Mariana Buka
-
Kontakt:
- Site Contact
- Telefonnummer: 55-17-3201-5000
- E-mail: marianabuka@outlook.com
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-
-
-
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Plovdiv, Bulgarien, 4002
- Rekruttering
- Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
-
Kontakt:
- Site Contact
- Telefonnummer: +359 (32) 602 298
- E-mail: penchogeorgiev@yahoo.com
-
Ledende efterforsker:
- Pencho Georgiev
-
Sofia, Bulgarien, 1431
- Rekruttering
- University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology
-
Ledende efterforsker:
- Atanas Radinoff
-
Kontakt:
- Site Contact
- Telefonnummer: 359-52-978-288
- E-mail: aradinoff@hotmail.com
-
Sofia, Bulgarien, 1606
- Rekruttering
- Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy, Clinic of Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: +359 (884) 674 160
- E-mail: viktoriia1982@abv.bg
-
Ledende efterforsker:
- Viktoria Barbukova
-
Sofia, Bulgarien, 1797
- Rekruttering
- Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: +359 (898) 719 792
- E-mail: drtanyayankova@gmail.com
-
Ledende efterforsker:
- Tanya Yankova
-
Varna, Bulgarien, 9010
- Ikke rekrutterer endnu
- University Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Clinical Hematology
-
Ledende efterforsker:
- Ilina Micheva
-
Kontakt:
- Site Contact
- Telefonnummer: +359 (52) 978 288
- E-mail: IlinaMichevailinamicheva@gmail.com
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-
-
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Alberta
-
Edmonton, Alberta, Canada, T6G 2B7
- Rekruttering
- University of Alberta Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +1 (780) 407 1584
- E-mail: yannancy@ualberta.ca
-
Ledende efterforsker:
- Nancy Zhu
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 2A5
- Rekruttering
- Providence Hematology - Vancouver
-
Kontakt:
- Site Contact
- Telefonnummer: +1 (604) 684 5794
- E-mail: hleitch@pacifichematology.ca
-
Ledende efterforsker:
- Heather Leitch
-
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Rekruttering
- Nova Scotia Health Authority, Centre for Clinical Research
-
Kontakt:
- Site Contact
- Telefonnummer: +1 (902) 473 3498
- E-mail: amy2.trottier@nshealth.ca
-
Ledende efterforsker:
- Amy Trottier
-
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Ontario
-
London, Ontario, Canada, N6A 4L6
- Rekruttering
- London Health Sciences Centre
-
Ledende efterforsker:
- Lalit Saini
-
Kontakt:
- Site Contact
- Telefonnummer: 519-685-8380
- E-mail: Lalit.Saini@lhsc.on.ca
-
Toronto, Ontario, Canada, M5G 2M9
- Rekruttering
- Princess Margaret Cancer Centre
-
Kontakt:
- Site Contact
- Telefonnummer: +1 (416) 946 4501
- E-mail: Karen.Yee@uhn.ca
-
Ledende efterforsker:
- Karen Yee
-
Toronto, Ontario, Canada, M4N 3M5
- Rekruttering
- Sunnybrook Research Institute, Odette Cancer Center
-
Ledende efterforsker:
- Rena Buckstein
-
Kontakt:
- Site Contact
- Telefonnummer: +416 (480) 5847
- E-mail: Rena.Buckstein@sunnybrook.ca
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-
-
-
-
Santiago, Chile, 7500653
- Rekruttering
- SAGA Clinical Research Center SpA
-
Ledende efterforsker:
- Ada Hernandez
-
Kontakt:
- Site Contact
- Telefonnummer: 56-9-8326-9755
- E-mail: ahernandez@cecsaga.cl
-
Santiago, Chile, 7580206
- Rekruttering
- Clinic Inmunocel
-
Kontakt:
- Site Contact
- E-mail: jvinuela@inmunocel.com
-
Ledende efterforsker:
- Jose Vinuela
-
Santiago, Chile, 8320000
- Rekruttering
- Center for Clinical Studies and Medical Research (CECIM)
-
Ledende efterforsker:
- Alexander Arellano
-
Kontakt:
- Site Contact
- Telefonnummer: 56-9-5826-3308
- E-mail: alexander.arellano@cecim.cl
-
-
Biobio
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Concepción, Biobio, Chile, 4070356
- Rekruttering
- Dr. Guillermo Grant Benavente - Concepcion Regional Hospital
-
Ledende efterforsker:
- Monica Romero
-
Kontakt:
- Site Contact
- Telefonnummer: 56-41-272-2500
- E-mail: mpromero@hospitalinfantildesanjose.org.co
-
-
Coquimbo Region
-
La Serena, Coquimbo Region, Chile, 1720430
- Rekruttering
- IC La Serena Research
-
Ledende efterforsker:
- Cleiden Villegas
-
Kontakt:
- Site Contact
- Telefonnummer: 56-51-286127
- E-mail: cleiden.villegas@iclsr.cl
-
-
-
-
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Birmingham, Det Forenede Kongerige, B15 2TH
- Rekruttering
- Queen Elizabeth Hospital Birmingham
-
Ledende efterforsker:
- Vidhya Murthy
-
Kontakt:
- Site Contact
- Telefonnummer: 44-121-627-2000
- E-mail: Vidhya.Murthy2@uhb.nhs.uk
-
Cambridge, Det Forenede Kongerige, CB2 0QQ
- Rekruttering
- Addenbrooke's Hospital
-
Ledende efterforsker:
- Duncan Brian
-
Kontakt:
- Site Contact
- Telefonnummer: 44-1223-805000
- E-mail: duncanbrian@nhs.net
-
Leeds, Det Forenede Kongerige, LS9 7TF
- Rekruttering
- St James's University Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: 44-113-243-3144
- E-mail: catherine.cargo@nhs.net
-
Ledende efterforsker:
- Catherine Cargo
-
London, Det Forenede Kongerige, SE5 9RS
- Rekruttering
- King's College Hospital
-
Ledende efterforsker:
- Austin Kulasekararaj
-
Kontakt:
- Site Contact
- Telefonnummer: +44 (79) 6768 6823
- E-mail: austin.kulasekararaj@nhs.net
-
London, Det Forenede Kongerige, W1G 6AD
- Rekruttering
- Sarah Cannon Research Institute (SCRI)
-
Ledende efterforsker:
- Jennifer O'Sullivan (Dillon)
-
Kontakt:
- Site Contact
- Telefonnummer: 615-329-7274
- E-mail: jenniferosullivan@nhs.net
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Manchester, Det Forenede Kongerige, M20 4BX
- Rekruttering
- The Christie NHS Foundation Trust
-
Ledende efterforsker:
- Daniel Wiseman
-
Kontakt:
- Site Contact
- Telefonnummer: 44-161-446-3000
- E-mail: daniel.wiseman@nhs.net
-
Nottingham, Det Forenede Kongerige, NG5 1PB
- Rekruttering
- Nottingham City Hospital
-
Ledende efterforsker:
- Jennifer Byrne
-
Kontakt:
- Site Contact
- Telefonnummer: 44-115-969-1169
- E-mail: Jennifer.Byrne@nuh.nhs.uk
-
Oxford, Det Forenede Kongerige, OX3 7LE
- Rekruttering
- Churchill Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: 44-300-304-7777
- E-mail: Oni.Chowdhury@ouh.nhs.uk
-
Ledende efterforsker:
- Oni Chowdhury
-
-
Aberdeen City
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Aberdeen, Aberdeen City, Det Forenede Kongerige, AB25 2ZN
- Rekruttering
- Aberdeen Royal Infirmary
-
Ledende efterforsker:
- Dominic Culligan
-
Kontakt:
- Site Contact
- E-mail: dominic.culligan@nhs.scot
-
-
Denbighshire
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Rhyl, Denbighshire, Det Forenede Kongerige, LL18 5UJ
- Rekruttering
- Glan Clwyd Hospital
-
Ledende efterforsker:
- Earnest Heartin
-
Kontakt:
- Site Contact
- E-mail: earnest.heartin@wales.nhs.uk
-
-
Leics
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Leicester, Leics, Det Forenede Kongerige, LE1 5WW
- Rekruttering
- University Hospitals of Leicester
-
Ledende efterforsker:
- Matthew Lee
-
Kontakt:
- Site Contact
- E-mail: matthew.lee3@nhs.net
-
-
Lincolnshire
-
Lincoln, Lincolnshire, Det Forenede Kongerige, LN2 5QY
- Rekruttering
- Lincolnshire Community and Hospitals NHS group
-
Ledende efterforsker:
- Ciro Rinaldi
-
Kontakt:
- Site Contact
- E-mail: crinaldi@nhs.net
-
-
Tyne and Wear
-
High Heaton, Tyne and Wear, Det Forenede Kongerige, NE7 7DN
- Rekruttering
- The Newcastle Upon Tyne University Hospitals Foundation Trust
-
Kontakt:
- Site Contact
- E-mail: michelle.lannon@nhs.net
-
Ledende efterforsker:
- Michelle Lannon
-
Sunderland, Tyne and Wear, Det Forenede Kongerige, SR4 7TP
- Ikke rekrutterer endnu
- South Tyneside and Sunderland Foundation Trust
-
Ledende efterforsker:
- Scott Marshall
-
Kontakt:
- Site Contact
- E-mail: scott.marshall3@nhs.net
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-
-
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California
-
Duarte, California, Forenede Stater, 91010
- Rekruttering
- City of Hope
-
Ledende efterforsker:
- Andrew Artz
-
Kontakt:
- Site Contact
- Telefonnummer: 626-218-2404
- E-mail: aartz@coh.org
-
Glendale, California, Forenede Stater, 91206
- Rekruttering
- Los Angeles Cancer Network
-
Ledende efterforsker:
- Eric Lee
-
Kontakt:
- Site Contact
- Telefonnummer: 215-707-7312
- E-mail: eric.lee@lahomg.com
-
La Jolla, California, Forenede Stater, 92037
- Rekruttering
- UC San Diego Moores Cancer Center
-
Ledende efterforsker:
- Amanda Kagan
-
Kontakt:
- Site Contact
- Telefonnummer: 858-822-6100
- E-mail: amanda.kagan@jhmi.edu
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06511
- Rekruttering
- Smilow Cancer Hospital at Yale-New Haven
-
Ledende efterforsker:
- Amer Zeidan
-
Kontakt:
- Site Contact
- Telefonnummer: 203-737-7103
- E-mail: amer.zeidan@yale.edu
-
-
Florida
-
Miami, Florida, Forenede Stater, 33136
- Rekruttering
- University of Miami Hospital and Clinics
-
Kontakt:
- Site Contact
- Telefonnummer: 305-243-9974
- E-mail: msekeres@med.miami.edu
-
Ledende efterforsker:
- Mikkael Sekeres
-
Tampa, Florida, Forenede Stater, 33612
- Rekruttering
- Moffitt Cancer Center
-
Kontakt:
- Site Contact
- Telefonnummer: 888-860-2778
- E-mail: rami.komrokji@moffitt.org
-
Ledende efterforsker:
- Rami Komrokji
-
-
Illinois
-
Peoria, Illinois, Forenede Stater, 61645
- Rekruttering
- ILCC. Illinois Cancer Centers
-
Kontakt:
- Site Contact
- Telefonnummer: 309-240-6388
- E-mail: paul.fishkin@usoncology.com
-
Ledende efterforsker:
- Paul Fishkin
-
-
Kentucky
-
Louisville, Kentucky, Forenede Stater, 40207
- Rekruttering
- Norton Cancer Institute
-
Ledende efterforsker:
- Don Stevens
-
Kontakt:
- Site Contact
- Telefonnummer: 502-906-7543
- E-mail: Don.Stevens@nortonhealthcare.org
-
-
Louisiana
-
Monroe, Louisiana, Forenede Stater, 71201
- Rekruttering
- Ghattas Oncology
-
Ledende efterforsker:
- Tharwat Ghattas
-
Kontakt:
- Site Contact
- E-mail: tghattas@epicmedresearch.com
-
-
Maryland
-
Columbia, Maryland, Forenede Stater, 21044
- Rekruttering
- Maryland Oncology Hematolofy
-
Ledende efterforsker:
- Mohit Narang
-
Kontakt:
- Site Contact
- Telefonnummer: 410-581-2100
- E-mail: mohit.narang@usoncology.com
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64132
- Rekruttering
- MidAmerica Cancer Care
-
Kontakt:
- Site Contact
- Telefonnummer: 816-974-5050
- E-mail: benjamin.fangman@aoncology.com
-
Ledende efterforsker:
- Benjamin Fangman
-
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Nevada
-
Henderson, Nevada, Forenede Stater, 89169
- Rekruttering
- Comprehensive Cancer Centers of Nevada
-
Ledende efterforsker:
- Edwin Kingsley
-
Kontakt:
- Site Contact
- Telefonnummer: 702-952-3444
- E-mail: edwin.kingsley@usoncology.com
-
-
New York
-
Westbury, New York, Forenede Stater, 11590
- Rekruttering
- Clinical Research Alliance NY
-
Ledende efterforsker:
- Jonathan Goldberg
-
Kontakt:
- Site Contact
- Telefonnummer: 516-488-2918
- E-mail: jgoldberg@caremount.com
-
-
North Carolina
-
Winston-Salem, North Carolina, Forenede Stater, 27013
- Rekruttering
- Novant Health-Cancer Institute
-
Ledende efterforsker:
- James Dugan
-
Kontakt:
- Site Contact
- Telefonnummer: 336-718-5570
- E-mail: jpdugan@novanthealth.org
-
-
Ohio
-
Canton, Ohio, Forenede Stater, 44718
- Rekruttering
- Gabrail Cancer Center Research
-
Ledende efterforsker:
- Nashat Gabrail
-
Kontakt:
- Site Contact
- Telefonnummer: 330-492-3345
- E-mail: research@gabrailcancercenter.com
-
Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Cleveland Clinic - Cleveland
-
Kontakt:
- Site Contact
- Telefonnummer: 216-445-7942
- E-mail: jaina9@ccf.org
-
Ledende efterforsker:
- Akriti Jain
-
-
Tennessee
-
Knoxville, Tennessee, Forenede Stater, 37909
- Rekruttering
- Tennessee Cancer Specialists
-
Kontakt:
- Site Contact
- Telefonnummer: 865-934-5800
- E-mail: tracy.dobbs@tncancer.com
-
Ledende efterforsker:
- Tracy Dobbs
-
Nashville, Tennessee, Forenede Stater, 37232
- Rekruttering
- Vanderbilt University Medical Center
-
Ledende efterforsker:
- Ashwin Kishtagari
-
Kontakt:
- Site Contact
- Telefonnummer: 615-322-5000
- E-mail: Ashwin.Kishtagari@vumc.org
-
-
Texas
-
Denison, Texas, Forenede Stater, 75020
- Rekruttering
- Texas Oncology Northeast Texas
-
Ledende efterforsker:
- Amir Faridi
-
Kontakt:
- Site Contact
- Telefonnummer: 903-868-4700
- E-mail: amir.faridi@texasoncology.com
-
Houston, Texas, Forenede Stater, 77090
- Rekruttering
- LUMI Research
-
Ledende efterforsker:
- David Nguyen
-
Kontakt:
- Site Contact
- E-mail: dmnguyen@lumiresearch.com
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- U.T. MD Anderson Cancer Center, Division of Cancer Medicine
-
Ledende efterforsker:
- Guillermo Garcia-Manero
-
Kontakt:
- Site Contact
- Telefonnummer: 713-792-6161
- E-mail: ggarciam@mdanderson.org
-
Red Oak, Texas, Forenede Stater, 75154
- Rekruttering
- Epic Medical Research
-
Ledende efterforsker:
- Kirtan Koticha
-
Kontakt:
- Site Contact
- E-mail: kkoticha@epicmedresearch.com
-
The Woodlands, Texas, Forenede Stater, 77380
- Rekruttering
- Texas Oncology Gulf Coast
-
Ledende efterforsker:
- Andrew Jackson
-
Kontakt:
- Site Contact
- Telefonnummer: 409-938-8600
- E-mail: andrew.jackson@usoncology.com
-
Webster, Texas, Forenede Stater, 77598-4085
- Rekruttering
- Tranquil Research
-
Ledende efterforsker:
- John Knecht
-
Kontakt:
- Site Contact
- Telefonnummer: 713-907-6054
- E-mail: drknecht@cls.health
-
-
Washington
-
Issaquah, Washington, Forenede Stater, 98029
- Ikke rekrutterer endnu
- Epic Care Emeryville
-
Kontakt:
- Site Contact
- E-mail: behlr@sutterhealth.org
-
Ledende efterforsker:
- Rajesh Behl
-
-
-
-
-
Nice, Frankrig, 06200
- Rekruttering
- Archet 1 and 2 hospital
-
Ledende efterforsker:
- Thomas Cluzeau
-
Kontakt:
- Site Contact
- Telefonnummer: +33 (4) 9203 7777
- E-mail: cluzeau.t@chu-nice.fr
-
Paris, Frankrig, 75010
- Rekruttering
- Saint-Louis Hospital
-
Ledende efterforsker:
- Lionel Ades
-
Kontakt:
- Site Contact
- Telefonnummer: +33 (1) 7120 7021
- E-mail: lionel.ades@aphp.fr
-
Poitiers, Frankrig, 86000
- Rekruttering
- Poitiers University Hospital Center - Miletrie Site
-
Ledende efterforsker:
- Jose Miguel Torregrosa-Diaz
-
Kontakt:
- Site Contact
- Telefonnummer: +33 (5) 4944 5415
- E-mail: Jose-Miguel.Torregrosa-Diaz@chu-poitiers.fr
-
Toulouse, Frankrig, 31059
- Rekruttering
- IUCT-Oncopole
-
Kontakt:
- Site Contact
- Telefonnummer: +33 (531) 156 266
- E-mail: Comont.Thibault@iuct-oncopole.fr
-
Ledende efterforsker:
- Thibault Comont
-
-
-
-
-
Delhi, Indien, 110085
- Ikke rekrutterer endnu
- Rajiv Gandhi Cancer Institute & Research Centre
-
Kontakt:
- Site Contact
- Telefonnummer: 9971500861
- E-mail: Bhurani@gmail.com
-
Ledende efterforsker:
- Dinesh Bhurani
-
Gūrgaon, Indien, 122018
- Rekruttering
- Medanta the Medicity
-
Kontakt:
- Site Contact
- Telefonnummer: 9717265111
- E-mail: nitin.sood@medanta.org
-
Ledende efterforsker:
- Nitin Sood
-
-
Gujarat
-
Ahmedabad, Gujarat, Indien, 380009
- Rekruttering
- Heamto Oncology Clinic Ahmedabad Pvt. Ltd.
-
Kontakt:
- Site Contact
- Telefonnummer: 9824041170
- E-mail: sandip60@yahoo.com
-
Ledende efterforsker:
- Sandip Shah
-
Ahmedabad, Gujarat, Indien, 382428
- Rekruttering
- Apollo Hospital International Ltd
-
Kontakt:
- Site Contact
- Telefonnummer: 9920273063
- E-mail: profvelunair@gmail.com
-
Ledende efterforsker:
- Velu Nair
-
-
Kerala
-
Ernākulam, Kerala, Indien, 682041
- Ikke rekrutterer endnu
- Amrita Institute of Medical Sciences
-
Kontakt:
- Site Contact
- Telefonnummer: 9946047464
- E-mail: neerajsidharthan@aims.amrita.edu
-
Ledende efterforsker:
- Neeraj Siddharthan
-
-
Maharashtra
-
Mumbai, Maharashtra, Indien, 400012
- Ikke rekrutterer endnu
- Tata Memorial Centre
-
Kontakt:
- Site Contact
- Telefonnummer: 9632006180
- E-mail: dralokshetty@gmail.com
-
Ledende efterforsker:
- Alok Shetty
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, Indien, 110029
- Rekruttering
- All India Institute of Medical Science
-
Kontakt:
- Site Contact
- Telefonnummer: 911126588499
- E-mail: drtulikaseth@gmail.com
-
Ledende efterforsker:
- Tulika Seth
-
-
Punjab
-
Ludhiana, Punjab, Indien, 380006
- Rekruttering
- Christian Medical College, Ludhianana
-
Kontakt:
- Site Contact
- Telefonnummer: 8054959525
- E-mail: mjosephjohn@gmail.com
-
Ledende efterforsker:
- Joseph John
-
-
Tamil Nadu
-
Vellore, Tamil Nadu, Indien, 632004
- Rekruttering
- Christian Medical College
-
Kontakt:
- Site Contact
- Telefonnummer: 4172224553
- E-mail: biju@cmcvellore.ac.in
-
Ledende efterforsker:
- Biju George
-
-
Uttar Pradesh
-
Ghaziabad, Uttar Pradesh, Indien, 201012
- Ikke rekrutterer endnu
- Max Super Speciality Hospital Vaishali (A Unit Of Crosslay Remedies Ltd.)
-
Kontakt:
- Site Contact
- Telefonnummer: 9451405842
- E-mail: pradeep.kumar9@maxhealthcare.com
-
Ledende efterforsker:
- Pradeep Kumar
-
-
West Bengal
-
Kolkata, West Bengal, Indien, 700014
- Rekruttering
- NRS Medical College and Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: 9874890275
- E-mail: tkdolai@hotmail.com
-
Ledende efterforsker:
- Tuphan Kanti Dolai
-
Kolkata, West Bengal, Indien, 700156
- Rekruttering
- Tata Medical Center, Kolkata
-
Kontakt:
- Site Contact
- Telefonnummer: 3366057620
- E-mail: arijit.nag@tmckolkata.com
-
Ledende efterforsker:
- Arijit Nag
-
-
-
-
-
Cork, Irland, T12 DC4A
- Rekruttering
- Cork University Hospital
-
Ledende efterforsker:
- Vitaliy Mykytiv
-
Kontakt:
- Site Contact
- Telefonnummer: 353-21-492-2000
- E-mail: Vitaliy.mykytiv@hse.ie
-
Dublin, Irland, D07 R2WY
- Rekruttering
- Mater Misericordiae University Hospital
-
Ledende efterforsker:
- Su Maung
-
Kontakt:
- Site Contact
- Telefonnummer: 353-1-803-2000
- E-mail: SuMaung@mater.ie
-
Dublin, Irland, D24 NR0A
- Rekruttering
- Tallaght University Hospital
-
Ledende efterforsker:
- Helen Enright
-
Kontakt:
- Site Contact
- Telefonnummer: 353-1-221-4000
- E-mail: Helen.Enright@tuh.ie
-
Dublin, Irland, D05 DK31
- Rekruttering
- Beaumont Hospital
-
Ledende efterforsker:
- Philip Murphy
-
Kontakt:
- Site Contact
- Telefonnummer: +353 (1) 809 2373
- E-mail: philipmurphy@beaumont.ie
-
Dublin, Irland, DO4 T6F4
- Rekruttering
- St Vincent's University Hospital (SVUH)
-
Ledende efterforsker:
- Claire Andrews
-
Kontakt:
- Site Contact
- Telefonnummer: 353-1-221-4000
- E-mail: claireandrews@st-vincents.ie
-
Limerick, Irland, V94 F858
- Rekruttering
- University Hospital Limerick
-
Kontakt:
- Site Contact
- Telefonnummer: +353 (877) 385 852
- E-mail: cian.mcellistrim@hse.ie
-
Ledende efterforsker:
- Cian McEllistrim
-
-
-
-
-
Jerusalem, Israel, 9112001
- Rekruttering
- Hadassah Medical Center, Department of Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: +972 (2) 677 6748
- E-mail: sabanre@hadassah.org.il
-
Ledende efterforsker:
- Revital Saban
-
Petah Tikva, Israel, 49100
- Rekruttering
- Rabin Medical Center, Davidoff Cancer Center, Hemato-Oncology Institute
-
Ledende efterforsker:
- Ofir Wolach
-
Kontakt:
- Site Contact
- Telefonnummer: +972 (3) 937 8116
- E-mail: owolach@gmail.com
-
Ramat Gan, Israel, 5266202
- Rekruttering
- Chaim Sheba Medical Center, Department of Hematology, Myelodysplastic Syndromes Center
-
Ledende efterforsker:
- Drorit Merkel
-
Kontakt:
- Site Contact
- Telefonnummer: +972 (3) 530 5213
- E-mail: Drorit.Merkel@sheba.health.gov.il
-
Tel Aviv, Israel, 6423906
- Rekruttering
- The Tel Aviv Sourasky Medical Center, Department of Hematology and Bone Marrow Transplantation, Leukemia Service
-
Ledende efterforsker:
- Yakir Moshe
-
Kontakt:
- Site Contact
- Telefonnummer: 972-3-697-4444
- E-mail: yakirm@tlvmc.gov.il
-
-
-
-
-
Florence, Italien, 50134
- Rekruttering
- Careggi University Hospital
-
Ledende efterforsker:
- Valeria Santini
-
Kontakt:
- Site Contact
- Telefonnummer: +39 (55) 794 7296
- E-mail: valeria.santini@unifi.it
-
Milan, Italien, 20122
- Rekruttering
- Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
-
Ledende efterforsker:
- Bruno Fattizzo
-
Kontakt:
- Site Contact
- Telefonnummer: 02-5503-4422
- E-mail: bruno.fattizzo@policlinico.mi.it
-
Pavia, Italien, 27100
- Rekruttering
- Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: +39 (382) 503 062
- E-mail: luca.malcovati@unipv.it
-
Ledende efterforsker:
- Luca Malcovati
-
Reggio Calabria, Italien, 89133
- Rekruttering
- Granda Ospedale Metropolitano 'Bianchi-Melacrino-Morelli'
-
Kontakt:
- Site Contact
- E-mail: caterina.alati@gmail.com
-
Ledende efterforsker:
- Caterina Alati
-
Rome, Italien, 00133
- Rekruttering
- Foundation PTV - Polyclinic Tor Vergata
-
Ledende efterforsker:
- Maria Teresa Voso
-
Kontakt:
- Site Contact
- Telefonnummer: +39 (6) 2090 3210
- E-mail: mtvoso@rm.unicatt.it
-
Rozzano, Italien, 20089
- Rekruttering
- Clinical Institute Humanitas, IRCCS
-
Ledende efterforsker:
- Matteo Giovanni Della Porta
-
Kontakt:
- Site Contact
- Telefonnummer: 39-02-82241
- E-mail: matteo.della_porta@hunimed.eu
-
Turin, Italien, 10060
- Rekruttering
- Institute of Cancer Research and Treatment of Candiolo
-
Ledende efterforsker:
- Elena Crisa
-
Kontakt:
- Site Contact
- Telefonnummer: 39-011-993-3111
- E-mail: elena.crisa@ircc.it
-
-
AN
-
Ancona, AN, Italien, 60126
- Rekruttering
- Aou Delle Marche
-
Ledende efterforsker:
- Antonella Poloni
-
Kontakt:
- Site Contact
- E-mail: a.poloni@staff.univpm.it
-
-
Piedmont
-
Turin, Piedmont, Italien, 10128
- Rekruttering
- AO Ordine Mauriziano
-
Ledende efterforsker:
- Daniela Cilloni
-
Kontakt:
- Site Contact
- E-mail: daniela.cilloni@unito.it
-
-
-
-
-
Kaunas, Litauen, LT-50161
- Rekruttering
- Hospital of Lithuanian University of Health Sciences Kauno Klinikos
-
Kontakt:
- Site Contact
- Telefonnummer: +370 (614) 84 658
- E-mail: milda.rudzianskiene@gmail.com
-
Ledende efterforsker:
- Milda Rudzianskiene
-
Vilnius, Litauen, LT-08406
- Rekruttering
- Vilnius University Hospital Santaros Klinikos
-
Ledende efterforsker:
- Andrius Degulys
-
Kontakt:
- Site Contact
- Telefonnummer: 370-5-250-1717
- E-mail: andrius.degulys@santa.lt
-
-
-
-
-
Bellavista, Peru, 07016
- Ikke rekrutterer endnu
- Daniel Alcides Carrion National Hospital
-
Ledende efterforsker:
- Jose Chinen Pemberton
-
Kontakt:
- Site Contact
- Telefonnummer: 997-889-111
- E-mail: joserevi7@yahoo.com
-
Lima, Peru, 15038
- Ikke rekrutterer endnu
- National Institute of Neoplastic Diseases
-
Kontakt:
- Site Contact
- Telefonnummer: +51 (942) 136-304
- E-mail: jufravas1ro@hotmail.com
-
Ledende efterforsker:
- Jule Vasquez
-
-
Jesus Maria
-
Lima, Jesus Maria, Peru, 15073
- Ikke rekrutterer endnu
- Edgardo Rebagliati Martins National Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +51 (987) 245-661
- E-mail: lourdesaranda@gmail.com
-
Ledende efterforsker:
- Lourdes Aranda
-
-
La Molina
-
Lima, La Molina, Peru, 15023
- Rekruttering
- Anglo American Clinic
-
Ledende efterforsker:
- Antonio Carrasco
-
Kontakt:
- Site Contact
- Telefonnummer: 51-1-6168900
- E-mail: antonio1carrasco@hotmail.com
-
-
San Isidro Lima
-
Lima, San Isidro Lima, Peru, 02002
- Rekruttering
- IPOR: Peruvian Institute of Oncology & Radiotherapy
-
Ledende efterforsker:
- Maria Vera Vasquez
-
Kontakt:
- Site Contact
- Telefonnummer: 51-1-2241779
- E-mail: maria.vera.vasquez1@gmail.com
-
-
-
-
-
Katowice, Polen, 40-519
- Rekruttering
- Pratia Oncology Katowice
-
Ledende efterforsker:
- Sebastian Grosicki
-
Kontakt:
- Site Contact
- Telefonnummer: 48-501-714-019
- E-mail: sebastian.grosicki@pratia.com
-
Lodz, Polen, 93-513
- Rekruttering
- Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz, General Hematology Unit
-
Ledende efterforsker:
- Tadeusz Robak
-
Kontakt:
- Site Contact
- Telefonnummer: +48 (42) 689 5191
- E-mail: robaktad@csk.umed.lodz.pl
-
Olsztyn, Polen, 10-228
- Rekruttering
- Clinical Hospital Of The Ministry Of Internal Affairs And Administration With Warmia And Mazury Oncology Centre In Olsztyn, Clinical Department of Hematology and Internal Medicine with Bone Marrow Transplantation Center
-
Ledende efterforsker:
- Janusz Halka
-
Kontakt:
- Site Contact
- Telefonnummer: + (48) 602 120 684
- E-mail: janusz.halka@poliklinika.net
-
-
Greater
-
Poznan, Greater, Polen, 60-192
- Rekruttering
- Pratia Poznan
-
Kontakt:
- Site Contact
- E-mail: anna.hoppe@pratia.com
-
Ledende efterforsker:
- Anna Hoppe
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, Polen, 50-019
- Rekruttering
- Pratia Onkologia Wroclaw
-
Kontakt:
- Site Contact
- E-mail: rybka.justyna@o2.pl
-
Ledende efterforsker:
- Justyna Rybka
-
-
-
-
-
Bern, Schweiz, 3010
- Ikke rekrutterer endnu
- Insel Gruppe AG, University Clinic for Hematology and Central Hematological Laboratory
-
Kontakt:
- Site Contact
- E-mail: natalia.baran@insel.ch
-
Ledende efterforsker:
- Natalia Baran
-
Zurich, Schweiz, 8091
- Rekruttering
- Universitatsspital Zurich, Klinik fur Medizinische Onkologie und Hamatologie
-
Kontakt:
- Site Contact
- E-mail: stefan.balabanov@usz.ch
-
Ledende efterforsker:
- Stefan Balabanov
-
-
Canton of Basel-City
-
Basel, Canton of Basel-City, Schweiz, 4031
- Ikke rekrutterer endnu
- University Hosptial Basel
-
Kontakt:
- Site Contact
- E-mail: gregor.stehle@usb.ch
-
Ledende efterforsker:
- Gregor Stehle
-
-
-
-
Castille and León
-
Salamanca, Castille and León, Spanien, 37007
- Rekruttering
- University Clinical Hospital of Salamanca, Department of Hematology
-
Ledende efterforsker:
- Maria Diez Campelo
-
Kontakt:
- Site Contact
- Telefonnummer: +34 (923) 291 100
- E-mail: mdiezcampelo@usal.es
-
-
Catalonia
-
Barcelona, Catalonia, Spanien, 08035
- Rekruttering
- University Hospital Vall d'Hebron, Department of Hematology
-
Ledende efterforsker:
- David Valcarcel Ferreiras
-
Kontakt:
- Site Contact
- Telefonnummer: +34 (932) 746 100
- E-mail: dvalcarcel@vhio.net
-
-
Girona
-
L'Hospitalet de Llobregat, Girona, Spanien, 08908
- Rekruttering
- Catalan Institute of Oncology, Hospital Duran i Reynals, Department of Clinical Hematology
-
Ledende efterforsker:
- Montserrat Arnan Sangerman
-
Kontakt:
- Site Contact
- Telefonnummer: +34 (932) 607 750
- E-mail: marnan@iconcologia.net
-
-
Madrid
-
Madrid, Madrid, Spanien, 28034
- Rekruttering
- University Hospital Ramon y Cajal
-
Ledende efterforsker:
- Kyra Velazquez Kennedy
-
Kontakt:
- Site Contact
- Telefonnummer: 34-913-36-8000
- E-mail: kyra.vkennedy@gmail.com
-
Madrid, Madrid, Spanien, 28040
- Rekruttering
- University Hospital Foundation Jimenez Diaz
-
Ledende efterforsker:
- Teresa Arquero Portero
-
Kontakt:
- Site Contact
- Telefonnummer: 34-915-50-4800
- E-mail: tarquero@fjd.es
-
-
Valencia
-
Valencia, Valencia, Spanien, 46026
- Rekruttering
- University and Polytechnic Hospital La Fe
-
Ledende efterforsker:
- Elvira Mora Castera
-
Kontakt:
- Site Contact
- Telefonnummer: 34-961-24-4000
- E-mail: mora_elv@gva.es
-
-
-
-
-
Lund, Sverige, 221 85
- Rekruttering
- Skane University Hospital - Lund, Department of Hematology and Vascular Disorders
-
Kontakt:
- Site Contact
- Telefonnummer: +46 (46) 171 000
- E-mail: lars.nilsson@skane.se
-
Ledende efterforsker:
- Lars Nilsson
-
-
A-rebro County
-
Örebro, A-rebro County, Sverige, 70185
- Ikke rekrutterer endnu
- A-rebro University Hospital, Hematology Department
-
Kontakt:
- Site Contact
- E-mail: bengt.rasmussen@regionorebrolan.se
-
Ledende efterforsker:
- Bengt Rasmussen
-
-
Stockholm County
-
Huddinge, Stockholm County, Sverige, 141 57
- Rekruttering
- Karolinska University Hospital
-
Ledende efterforsker:
- Magnus Tobiasson
-
Kontakt:
- Site Contact
- Telefonnummer: 46-8-123-700000
- E-mail: magnus.tobiasson@ki.se
-
-
VG
-
Gothenburg, VG, Sverige, 41345
- Ikke rekrutterer endnu
- Sahlgrenska University Hospital
-
Kontakt:
- Site Contact
- E-mail: lena.von.bahr@vgregion.se
-
Ledende efterforsker:
- Lena Von Bahr
-
-
-
-
-
Cape Town, Sydafrika, 7580
- Rekruttering
- Haemalife
-
Kontakt:
- Site Contact
- Telefonnummer: +27 (21) 581 0717
- E-mail: michael.cass@haemalife.co.za
-
Ledende efterforsker:
- Michael Cass
-
Durban, Sydafrika, 4091
- Rekruttering
- Capital Haematology Hospital
-
Ledende efterforsker:
- Jaimendra Singh
-
Kontakt:
- Site Contact
- Telefonnummer: 27-31-832-9700
- E-mail: jaimendra.singh@gmail.com
-
Johannesburg, Sydafrika, 2193
- Rekruttering
- Charlotte Maxeke Johannesburg Academic Hospital, Hemophilia Comprehensive Care Center
-
Kontakt:
- Site Contact
- Telefonnummer: +27 (11) 489 8413
- E-mail: johnny.mahlangu@nhls.ac.za
-
Ledende efterforsker:
- Johnny Mahlangu
-
Pretoria, Sydafrika, 0181
- Rekruttering
- Alberts Cellular Therapy
-
Ledende efterforsker:
- Andrew McDonald
-
Kontakt:
- Site Contact
- Telefonnummer: +27 (12) 993 2555
- E-mail: andrew@actlife.co.za
-
-
-
-
-
Daegu, Sydkorea, 41944
- Rekruttering
- Kyungpook National University Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +82 (53) 200 5570
- E-mail: jhmoon74@knuh.kr
-
Ledende efterforsker:
- Joon ho Moon
-
Seoul, Sydkorea, 05505
- Rekruttering
- Asan Medical Center
-
Ledende efterforsker:
- Je-Hwan Lee
-
Kontakt:
- Site Contact
- Telefonnummer: +82 (2) 3010 3218
- E-mail: jhlee3@amc.seoul.kr
-
Seoul, Sydkorea, 03080
- Rekruttering
- Seoul National University Hospital
-
Ledende efterforsker:
- Junshik Hong
-
Kontakt:
- Site Contact
- Telefonnummer: +82 (2) 2072-0834
- E-mail: hongjblood@snu.ac.kr
-
Seoul, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
-
Ledende efterforsker:
- Jun Ho Jang
-
Kontakt:
- Site Contact
- Telefonnummer: +82 (2) 3410 0918
- E-mail: smcjunhojang@gmail.com
-
Seoul, Sydkorea, 04401
- Rekruttering
- Soon Chun Hyang University Hospital Seoul
-
Ledende efterforsker:
- Seug Yun Yoon
-
Kontakt:
- Site Contact
- Telefonnummer: 82-2-709-9144
- E-mail: ysy6496@schmc.ac.kr
-
Seoul, Sydkorea, 06591
- Rekruttering
- The Catholic University of Korea, Seoul St. Mary's Hospital
-
Ledende efterforsker:
- Yoo Jin Kim
-
Kontakt:
- Site Contact
- Telefonnummer: 82-1588-1511
- E-mail: yoojink@catholic.ac.kr
-
-
-
-
-
Taichung, Taiwan, 407219
- Rekruttering
- Taichung Veterans General Hospital
-
Ledende efterforsker:
- Cheng-Hsien Lin
-
Kontakt:
- Site Contact
- Telefonnummer: 886-4-2359-2525
- E-mail: briefsummer@gmail.com
-
Tainan, Taiwan, 704302
- Rekruttering
- National Cheng Kung University Hospital
-
Ledende efterforsker:
- Tsai-Yun Chen
-
Kontakt:
- Site Contact
- Telefonnummer: +886 (6) 235 3535
- E-mail: teresa@mail.ncku.edu.tw
-
Taipei, Taiwan, 100225
- Rekruttering
- National Taiwan University Hospital
-
Ledende efterforsker:
- Wen-Chien Chou
-
Kontakt:
- Site Contact
- Telefonnummer: 886-2-2312-3456
- E-mail: wchou@ntu.edu.tw
-
Taoyuan City, Taiwan, 333
- Rekruttering
- Linkou Chang Gung Memorial Hospital
-
Ledende efterforsker:
- Ming-Chung Kuo
-
Kontakt:
- Site Contact
- Telefonnummer: 886-3-328-1200
- E-mail: kmc12069@gmail.com
-
-
Changhua County
-
Changhua, Changhua County, Taiwan, 500209
- Rekruttering
- Changhua Christian Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: 886-4-723-8595
- E-mail: 155627@cch.org.tw
-
Ledende efterforsker:
- Ruo-Han Tseng
-
Changhua, Changhua County, Taiwan, 50544
- Rekruttering
- Chang Bing Show Chwan Memorial Hospital
-
Ledende efterforsker:
- Cheng-Shyong Chang
-
Kontakt:
- Site Contact
- Telefonnummer: 886-4-781-3888
- E-mail: cs4816@gmail.com
-
-
-
-
-
Bangkok, Thailand, 10330
- Rekruttering
- King Chulalongkorn Memorial Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +66 (2) 251 6704
- E-mail: drnoppacharn@yahoo.com
-
Ledende efterforsker:
- Noppacharn Uaprasert
-
Bangkok, Thailand, 10400
- Rekruttering
- Ramathibodi Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +66 (2) 201 2373
- E-mail: Nickero059@hotmail.com
-
Ledende efterforsker:
- Piyajaroenkij Thanakrit
-
Bangkok, Thailand, 10400
- Rekruttering
- Rajavithi Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +66 (2) 206 2900
- E-mail: kunapa@gmail.com
-
Ledende efterforsker:
- Kunapa Iam-arunthai
-
Bangkok, Thailand, 74210
- Rekruttering
- Banphaeo General Hospital
-
Ledende efterforsker:
- Busakorn Sae-Aeng
-
Kontakt:
- Site Contact
- Telefonnummer: 034-419555-6
- E-mail: Himatologist55@gmail.com
-
Chiang Mai, Thailand, 50200
- Rekruttering
- Maharaj Nakorn Chiangmai Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +66 (53) 945 482
- E-mail: thanawat_r@outlook.com
-
Ledende efterforsker:
- Thanawat Rattanathammethee
-
-
-
-
-
Brno, Tjekkiet, 625 00
- Rekruttering
- University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
-
Ledende efterforsker:
- Jiri Mayer
-
Kontakt:
- Site Contact
- Telefonnummer: + (420) 532 231 111
- E-mail: Mayer.Jiri@fnbrno.cz
-
Hradec Králové, Tjekkiet, 500 05
- Rekruttering
- University Hospital Hradec Kralove, 4th Internal Clinic of Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: + (420) 495 833 837
- E-mail: petra.belohlavkova@fnhk.cz
-
Ledende efterforsker:
- Petra Belohlavkova
-
Ostrava, Tjekkiet, 70852
- Rekruttering
- Charles University General Hospital
-
Ledende efterforsker:
- Anna Jonasova
-
Kontakt:
- Site Contact
- E-mail: anna.jonasova@vfn.cz
-
Ostrava, Tjekkiet, 70852
- Rekruttering
- University Hospital Ostrava and Faculty of Medicine, University of Ostrava
-
Kontakt:
- Site Contact
- E-mail: barbora.dluhosova@fno.cz
-
Ledende efterforsker:
- Zdenek Koristek
-
Prague, Tjekkiet, 100 00
- Rekruttering
- University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: + (420) 267 162 887
- E-mail: olga.cerna@fnkv.cz
-
Ledende efterforsker:
- Olga Cerna
-
Prague, Tjekkiet, 12800
- Rekruttering
- Institute of Hematology and Blood Transfusion, Division of Training and Development
-
Ledende efterforsker:
- Marketa Stastna-Markova
-
Kontakt:
- Site Contact
- Telefonnummer: 420-221-977-296
- E-mail: marketa.markova@uhkt.cz
-
-
-
-
-
Adana, Tyrkiet (Türkiye), 01370
- Rekruttering
- Adana City Hospital
-
Kontakt:
- Site Contact
- Telefonnummer: +90 (542) 630 8353
- E-mail: elifsuyani@hotmail.com
-
Ledende efterforsker:
- Elif Suyani
-
Ankara, Tyrkiet (Türkiye), 06170
- Rekruttering
- Ankara Etlik City Hospital
-
Ledende efterforsker:
- Merih Kizil Cakar
-
Kontakt:
- Site Contact
- Telefonnummer: 90-362-312-1919
- E-mail: merihkizil@yahoo.com
-
Ankara, Tyrkiet (Türkiye), 06600
- Ikke rekrutterer endnu
- Ankara University Medical Faculty Cebeci Hospital
-
Ledende efterforsker:
- Selami Toprak
-
Kontakt:
- Site Contact
- Telefonnummer: 90-312-595-6000
- E-mail: sktoprak@yahoo.com
-
Antalya, Tyrkiet (Türkiye), 07100
- Rekruttering
- Antalya Education and Training Hospital
-
Ledende efterforsker:
- Volkan Karakus
-
Kontakt:
- Site Contact
- Telefonnummer: +90 (505) 765 6778
- E-mail: dr_v_karakus@yahoo.com
-
Mersin, Tyrkiet (Türkiye), 33200
- Rekruttering
- Mersin Medicalpark Hospital
-
Ledende efterforsker:
- Anil Tombak
-
Kontakt:
- Site Contact
- Telefonnummer: +90 (532) 346 0767
- E-mail: aniltombak@hotmail.com
-
Sakarya, Tyrkiet (Türkiye), 54290
- Rekruttering
- Sakarya University Medical Faculty Hospital
-
Ledende efterforsker:
- Cenk Sunu
-
Kontakt:
- Site Contact
- Telefonnummer: 90-4445400
- E-mail: SunuCenk@gmail.com
-
Samsun, Tyrkiet (Türkiye), 55139
- Rekruttering
- Ondokuz Mayis University School of Medicine, Department of Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: +90 (505) 272 2289
- E-mail: engink@omu.edu.tr
-
Ledende efterforsker:
- Engin Kelkitli
-
-
-
-
-
Berlin, Tyskland, 10715
- Rekruttering
- Praxis am Volkspark Berlin
-
Ledende efterforsker:
- Jan-Piet Habbel
-
Kontakt:
- Site Contact
- Telefonnummer: 49-30-84723535
- E-mail: jp.habbel@praxis-am-volkspark-berlin.de
-
Berlin, Tyskland, 12203
- Rekruttering
- Charite Universitatsmedizin Berlin
-
Ledende efterforsker:
- Kathrin Rieger
-
Kontakt:
- Site Contact
- Telefonnummer: +49 (30) 450 513 535
- E-mail: kathrin.rieger@charite.de
-
-
North Rhine-Westphalia
-
Bonn, North Rhine-Westphalia, Tyskland, 53127
- Ikke rekrutterer endnu
- University Hospital Bronn
-
Ledende efterforsker:
- Karin Mayer
-
Kontakt:
- Site Contact
- Telefonnummer: 49-228-2870
- E-mail: karin.mayer@ukb.uni-bonn.de
-
Düsseldorf, North Rhine-Westphalia, Tyskland, 40479
- Rekruttering
- Marien Hospital Duesseldorf GmbH, Clinic for Oncology, Hematology and Palliative Medicine
-
Kontakt:
- Site Contact
- Telefonnummer: +49 (211) 4400 2501
- E-mail: Aristoteles.giagounidis@vkkd-kliniken.de
-
Ledende efterforsker:
- Aristoteles Giagounidis
-
-
Saxony
-
Leipzig, Saxony, Tyskland, 04103
- Rekruttering
- University Hospital Leipzig, Clinic and Policlinic for Internal Medicine I Haematology and Stem Cell Therapy, Medical Oncology, Haemostaseology
-
Ledende efterforsker:
- Dominic Brauer
-
Kontakt:
- Site Contact
- Telefonnummer: 49-341-9713081
- E-mail: Dominic.Brauer@medizin.uni-leipzig.de
-
-
Saxony-Anhalt
-
Halle, Saxony-Anhalt, Tyskland, 06120
- Rekruttering
- University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
-
Kontakt:
- Site Contact
- Telefonnummer: +49 (345) 557 3080
- E-mail: haifa.al-ali@uk-halle.de
-
Ledende efterforsker:
- Haifa Al-Ali
-
Magdeburg, Saxony-Anhalt, Tyskland, 39120
- Ikke rekrutterer endnu
- University Clinic of Hematology, Oncology and Cell Therapy
-
Ledende efterforsker:
- Berisha Mirjeta
-
Kontakt:
- Site Contact
- Telefonnummer: 646-501-0194
- E-mail: mirjeta.berisha@med.ovgu.de
-
-
-
-
-
Budapest, Ungarn, H-1088
- Rekruttering
- Semmelweis University, Department of Internal Medicine and Haematology, Division of Hematology
-
Ledende efterforsker:
- Zsolt Nagy
-
Kontakt:
- Site Contact
- Telefonnummer: +36 (20) 825 8660
- E-mail: nagy.zsolt@med.semmelweis-univ.hu
-
Debrecen, Ungarn, 4032
- Rekruttering
- University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
-
Ledende efterforsker:
- Arpad Illes
-
Kontakt:
- Site Contact
- Telefonnummer: +36 (52) 255 480
- E-mail: illesarpaddr@gmail.com
-
Kaposvár, Ungarn, H-7400
- Rekruttering
- Mor Kaposi General Hospital, Department of Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: +36 (82) 501 363
- E-mail: dregyedmiklos@yahoo.com
-
Ledende efterforsker:
- Miklos Egyed
-
Nyíregyháza, Ungarn, 4400
- Rekruttering
- Szabolcs-Szatmar-Bereg County Teaching Hospital, Department of Hematology
-
Ledende efterforsker:
- Laszlo Rejto
-
Kontakt:
- Site Contact
- Telefonnummer: +36 (42) 599 719
- E-mail: lrejto@med.unideb.hu
-
Székesfehérvár, Ungarn, H-8000
- Rekruttering
- Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine III, Hematology
-
Kontakt:
- Site Contact
- Telefonnummer: +36 (20) 970 9318
- E-mail: aszomor@clinics.pote.hu
-
Ledende efterforsker:
- Arpad Szomor
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
-
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and/or protected personal data in accordance with national and local study participant data protections and privacy regulations.
-
Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.
-
Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow sample, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease. In cases where a local bone marrow (BM) assessment establishing an MDS diagnosis was conducted within 12 weeks prior to informed consent form (ICF) signature, the associated local BM samples and/or reports may be permitted.
-
Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:
a. LTB, defined as 4 to 7 RBC units per 16 weeks; or b. HTB, defined as ≥8 RBC units per 16 weeks; and c. For all participants: i. Only transfusion events for a pretransfusion hemoglobin (Hgb) lesser than (<)10 grams per deciliter (g/dL) are counted toward eligibility; ii. At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥7 days within the 16-week period immediately preceding randomization; and iii. No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.
-
Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows:
a. Refractory to prior ESA treatment: documentation of nonresponse or a response that was no longer maintained with a prior ESA-containing regimen, either as a single agent or combination (e.g., with granulocyte colony-stimulating factor [G-CSF]); ESA regimen must have been either: i. Recombinant human erythropoietin (EPO) ≥30,000 international units per week (IU/week) for ≥8 doses or equivalent; or ii. Darbepoetin alpha ≥500 micrograms (μg) every 3 weeks for ≥3 doses or ≥ 120 μg every week for ≥ 8 doses or equivalent.
b. Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA-containing regimen, either as a single agent or combination (e.g., with G-CSF), at any time after introduction due to intolerance or an AE.
c. Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level greater than (>)200 units per liter (U/L).
-
Less than 5 percent (%) blasts in an evaluable bone marrow sample collected at Screening.
-
Eastern Cooperative Oncology Group performance status of 0 to 2.
-
Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.
-
In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).
Exclusion Criteria:
-
Del(5q) MDS, secondary MDS (MDS with a documented history of prior exposure to chemotherapy, radiotherapy, or other leukemogenic agents that is considered causally related to the development of MDS).
-
Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate).
-
Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.
-
Clinically significant cardiovascular disease defined as:
- New York Heart Association heart disease class III or IV;
- Fridericia corrected QT (QTcF) interval >500 milliseconds during Screening;
- Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 millimeters of mercury (mm Hg) or diastolic blood pressure ≥100 mm Hg during Screening; or
- Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before Screening.
-
Known ejection fraction <35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening.
-
Child-Pugh class C hepatic impairment.
-
Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening.
-
Any known history of acute myeloid leukemia (AML).
-
Prior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 2 years. However, participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:
- Basal or squamous cell carcinoma of the skin;
- Carcinoma in situ of the cervix;
- Carcinoma in situ of the breast; and/or
- Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] clinical staging system).
- Early papillary thyroid cancer (stage I [T1-T2, N0, M0]).
-
History of solid organ or bone marrow transplantation.
-
Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization.
-
Active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants with a history of HIV infection may be enrolled if they are receiving antiretroviral therapy and have a documented CD4+ T cell count > 200 cells per microliter (cells/μL) at screening. Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.
-
Body mass index ≥ 40 kilograms per meter square (kg/m^2).
-
Major surgery within 28 days before randomization.
-
History of allergy/anaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept IB for a list of excipients) or recombinant proteins.
-
Prior use of elritercept, luspatercept, or sotatercept.
-
Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immunosuppressive therapy given for treatment of MDS.
-
Iron chelation therapy initiated within 8 weeks before randomization. Participants on stable or decreasing doses of iron chelation therapy for ≥ 8 weeks are allowed.
-
Vitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥ 4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.
-
Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥ 8 weeks are allowed.
-
High-dose systemic corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 milligrams per day (mg/day) or corticosteroid equivalent for ≥ 4 weeks are allowed.10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed.
-
Treatment with any investigational drug within 28 days before Screening or, if the half-life of the product is known, within 5 times the half-life before Screening, whichever is longer.
-
Ongoing participation in another interventional clinical study.
-
Serum EPO level >500 U/L.
-
Platelet count ≥800 × 10^9 per liter (/L) or ≤25 × 10^9/L.
-
Absolute neutrophil count ≤ 500 per microliter (/µL).
-
Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).
-
Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome. 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.
-
Ferritin ≤ 50 micrograms per litre (μg/L).
-
Folate ≤2.0 nanograms per milliliter (ng/mL).
-
Vitamin B12 ≤200 picograms per milliliter (pg/mL).
-
Estimated glomerular filtration rate <30 milliliters per minute per 1.73 meter square (mL/min/1.73m^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Collaboration equation.
-
Pregnant or lactating female.
-
Any other condition not specifically noted above that, in the opinion of the Investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study.
-
Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the Investigator, employees of the Sponsor or CRO directly involved in the conduct of the study, or immediate family members (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).
-
For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law [Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1]).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Elritercept
Participants will be administered elritercept (TAK-226, KER-050), subcutaneously every 4 weeks, up to 48 weeks or until the end of treatment period. |
Elritercept (TAK-226, KER-050) administered subcutaneously every 4 weeks.
Andre navne:
|
|
Placebo komparator: Placebo
Participants will be administered elritercept (TAK-226, KER-050) matching-placebo, subcutaneously every 4 weeks, up to 48 weeks or until the end of treatment period. |
Elritercept (TAK-226, KER-050) matching-placebo administered subcutaneously every 4 weeks. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Achieving Transfusion Independence (TI) for ≥8 Weeks
Tidsramme: Baseline through Week 24
|
Transfusion independence is defined as the absence of any red blood cells (RBC) transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24. |
Baseline through Week 24
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants Achieving TI for ≥24 Weeks
Tidsramme: Baseline through Week 48
|
Transfusion independence is defined as the absence of any RBC transfusions in a period of at least 24 weeks after the first dose of the study treatment through week 48. |
Baseline through Week 48
|
|
Percentage of Participants with High-transfusion Burden (HTB) Achieving TI for ≥8 weeks
Tidsramme: Baseline through Week 24
|
Transfusion independence is defined as the absence of any RBC transfusions in a period of at least 8 weeks after the first dose of the study treatment through week 24. |
Baseline through Week 24
|
|
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tidsramme: From the time of signing the informed consent form through 60 days after the last dose of study treatment, approximately 6 years
|
An adverse event (AE) is defined as any untoward medical occurrence, in a clinical study participant administered a medicinal product, that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not it is related to study treatment. A TEAE is defined as an AE that commences on or after the first dose of the study treatment and within 60 days after the last dose of the study treatment, or analysis cutoff date, whichever is earlier. An SAE is any untoward medical occurrence that, at any dose: results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. |
From the time of signing the informed consent form through 60 days after the last dose of study treatment, approximately 6 years
|
|
Change from Baseline in Clinical Laboratory Values, Vital Signs, and Electrocardiograms (ECGs)
Tidsramme: From the time of signing the informed consent form through safety follow-up, approximately 16 months
|
Change from baseline in clinical laboratory values, vital signs, and ECGs will be assessed. |
From the time of signing the informed consent form through safety follow-up, approximately 16 months
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Study Director, Takeda
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- KER-050-D301
- 2024-516009-22-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD-delingsadgangskriterier
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .