A eficácia e segurança do Elritercept em participantes adultos com síndromes mielodisplásicas (SMD) de risco muito baixo, baixo ou intermediário com anemia (RENEW)
Um estudo de fase 3, randomizado, duplo-cego e controlado por placebo para avaliar a eficácia e segurança do Elritercept (KER-050) para o tratamento da anemia dependente de transfusão em participantes adultos com risco muito baixo, baixo ou intermediário Síndromes Mielodisplásicas (SMD) (RENEW)
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.
Visão geral do estudo
Status
Status
Condições
Condições
Intervenção / Tratamento
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Tipo de estudo
Inscrição (Estimado)
Inscrição
Estágio
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
Contato de estudo
- Nome: Takeda Contact
- Número de telefone: +1-877-825-3327
- E-mail: medinfoUS@takeda.com
Locais de estudo
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Berlin, Alemanha, 10715
- Recrutamento
- Praxis am Volkspark Berlin
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Investigador principal:
- Jan-Piet Habbel
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Contato:
- Site Contact
- Número de telefone: 49-30-84723535
- E-mail: jp.habbel@praxis-am-volkspark-berlin.de
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Berlin, Alemanha, 12203
- Recrutamento
- Charite Universitatsmedizin Berlin
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Investigador principal:
- Kathrin Rieger
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Contato:
- Site Contact
- Número de telefone: +49 (30) 450 513 535
- E-mail: kathrin.rieger@charite.de
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North Rhine-Westphalia
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Bonn, North Rhine-Westphalia, Alemanha, 53127
- Ainda não está recrutando
- University Hospital Bronn
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Investigador principal:
- Karin Mayer
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Contato:
- Site Contact
- Número de telefone: 49-228-2870
- E-mail: karin.mayer@ukb.uni-bonn.de
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Düsseldorf, North Rhine-Westphalia, Alemanha, 40479
- Recrutamento
- Marien Hospital Duesseldorf GmbH, Clinic for Oncology, Hematology and Palliative Medicine
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Contato:
- Site Contact
- Número de telefone: +49 (211) 4400 2501
- E-mail: Aristoteles.giagounidis@vkkd-kliniken.de
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Investigador principal:
- Aristoteles Giagounidis
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Saxony
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Leipzig, Saxony, Alemanha, 04103
- Recrutamento
- University Hospital Leipzig, Clinic and Policlinic for Internal Medicine I Haematology and Stem Cell Therapy, Medical Oncology, Haemostaseology
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Investigador principal:
- Dominic Brauer
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Contato:
- Site Contact
- Número de telefone: 49-341-9713081
- E-mail: Dominic.Brauer@medizin.uni-leipzig.de
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Saxony-Anhalt
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Halle, Saxony-Anhalt, Alemanha, 06120
- Recrutamento
- University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology
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Contato:
- Site Contact
- Número de telefone: +49 (345) 557 3080
- E-mail: haifa.al-ali@uk-halle.de
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Investigador principal:
- Haifa Al-Ali
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Magdeburg, Saxony-Anhalt, Alemanha, 39120
- Ainda não está recrutando
- University Clinic of Hematology, Oncology and Cell Therapy
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Investigador principal:
- Berisha Mirjeta
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Contato:
- Site Contact
- Número de telefone: 646-501-0194
- E-mail: mirjeta.berisha@med.ovgu.de
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Australian Capital Territory
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Garran, Australian Capital Territory, Austrália, 2605
- Ainda não está recrutando
- The Canberra Hospital
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Investigador principal:
- Philip Choi
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Contato:
- Site Contact
- E-mail: phil.choi@act.gov.au
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New South Wales
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Sydney, New South Wales, Austrália, 2145
- Recrutamento
- Westmead Hospital
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Contato:
- Site Contact
- Número de telefone: +61 () 424275524
- E-mail: lachlin.vaughan@health.nsw.gov.au
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Investigador principal:
- Lachlin Vaughan
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Queensland
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Douglas, Queensland, Austrália, 4814
- Recrutamento
- Townsville University Hospital
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Investigador principal:
- Joel Wight
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Contato:
- Site Contact
- Número de telefone: 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, Austrália, 5000
- Recrutamento
- Royal Adelaide Hospital
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Contato:
- Site Contact
- Número de telefone: +61 (8) 8222 3369
- E-mail: Devendra.hiwase@sa.gov.au
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Investigador principal:
- Devendra Hiwase
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Adelaide, South Australia, Austrália, 5042
- Recrutamento
- Flinders Medical Centre
-
Contato:
- Site Contact
- Número de telefone: +61 (8) 8222 4000
- E-mail: Ashanka.Beligaswatte@sa.gov.au
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Investigador principal:
- Ashanka Beligaswatte
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Victoria
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Box Hill, Victoria, Austrália, 3128
- Recrutamento
- Box Hill Hospital
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Contato:
- Site Contact
- Número de telefone: +61 (3) 8396 8442
- E-mail: genevieve.douglas@easternhealth.org.au
-
Investigador principal:
- Genevieve Douglas
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Fitzroy, Victoria, Austrália, 3065
- Recrutamento
- St Vincent's Hospital (Melbourne) Ltd
-
Contato:
- Site Contact
- Número de telefone: 61-3-9231-2211
- E-mail: ShuhYing.TAN@svha.org.au
-
Investigador principal:
- ShuhYing Tan
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Melbourne, Victoria, Austrália, 3004
- Ainda não está recrutando
- Alfred Health
-
Investigador principal:
- Shaun Fleming
-
Contato:
- Site Contact
- E-mail: shaun.fleming1@monash.edu
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Parkville, Victoria, Austrália, 3000
- Recrutamento
- Peter MacCallum Cancer Center
-
Contato:
- Site Contact
- Número de telefone: +61 (0) 3 8559 5000
- E-mail: Lynette.Chee@mh.org.au
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Investigador principal:
- Lynette Chee
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Rio de Janeiro, Brasil, 22775-001
- Recrutamento
- Americas Institute
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Investigador principal:
- Fernando Correia Pinto
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Contato:
- Site Contact
- Número de telefone: 21-3385-2000
- E-mail: fernandomonteiro@americasoncologia.com.br
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São Paulo, Brasil, 01323-900
- Recrutamento
- Portuguese Charity of Sao Paulo, Clinical Hematology / Oncology Center
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Contato:
- Site Contact
- Número de telefone: +55 (11) 3505 6615
- E-mail: scheinbp@gmail.com
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Investigador principal:
- Phillip Scheinberg
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São Paulo, Brasil, 01509-900
- Recrutamento
- Hospital A.C.Camargo ("Antonio Prudente" Foundation)
-
Investigador principal:
- Marina Nascimento
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Contato:
- Site Contact
- Número de telefone: 55-11-9-9901-3833
- E-mail: marina.nascimento@accamargo.org.br
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São Paulo, Brasil, 11075-900
- Recrutamento
- Santa Casa of Mercy of Santos
-
Investigador principal:
- Elaine Mancilha
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Contato:
- Site Contact
- Número de telefone: 13-3221-5508
- E-mail: elaine_mancilha@hotmail.com
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Paraná
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Curitiba, Paraná, Brasil, 81520-060
- Recrutamento
- Hosptial Erasto Gaertner
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Contato:
- Site Contact
- E-mail: drciliao@gmail.com
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Investigador principal:
- Eduardo Munhoz
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90610-000
- Recrutamento
- Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital
-
Investigador principal:
- Mariza Schaan
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Contato:
- Site Contact
- Número de telefone: 55-51-3320-3660
- E-mail: mzschaan@hotmail.com
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Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
- Recrutamento
- Porto Alegre Clinical Hospital (HCPA)
-
Investigador principal:
- Laura Maria Fogliatto
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Contato:
- Site Contact
- Número de telefone: 55-51-3359-8000
- E-mail: fogliattopesquisa@gmail.com
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Porto Alegre, Rio Grande do Sul, Brasil, 90110-270
- Recrutamento
- Hospital Mae de Deus, Clinical Research Unit - Cancer Institute
-
Investigador principal:
- Marcelo Capra
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Contato:
- Site Contact
- Número de telefone: +55 (51) 33789927
- E-mail: marcelocapra@hotmail.com
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Santa Catarina
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Joinville, Santa Catarina, Brasil, 89201-260
- Recrutamento
- Instituto Joinvilense de Hematologia e Oncologia
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Contato:
- Site Contact
- E-mail: marcelolacerda001@gmail.com
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Investigador principal:
- Lacerda Marcelo
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São Paulo
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Jaú, São Paulo, Brasil, 17210-080
- Recrutamento
- FundaAAo Doutor Amaral Carvalho
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Contato:
- Site Contact
- E-mail: pesquisafac.edersonmattos@gmail.com
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Investigador principal:
- Guilherme Mattos
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Santo André, São Paulo, Brasil, 09060-650
- Recrutamento
- Cepho- Fmabc
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Contato:
- Site Contact
- E-mail: vitormauad.medabc@gmail.com
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Investigador principal:
- Vitor Mauad
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São José do Rio Preto, São Paulo, Brasil, 15090-000
- Recrutamento
- Sao Jose do Rio Preto Regional Faculty of Medicine Foundation
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Investigador principal:
- Mariana Buka
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Contato:
- Site Contact
- Número de telefone: 55-17-3201-5000
- E-mail: marianabuka@outlook.com
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Plovdiv, Bulgária, 4002
- Recrutamento
- Dr. Pencho Georgiev - Outpatient Center for Individual Practice for Specialized Medical Care in Internal Medicine and Clinical Hematology (EOOD)
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Contato:
- Site Contact
- Número de telefone: +359 (32) 602 298
- E-mail: penchogeorgiev@yahoo.com
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Investigador principal:
- Pencho Georgiev
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Sofia, Bulgária, 1431
- Recrutamento
- University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology
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Investigador principal:
- Atanas Radinoff
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Contato:
- Site Contact
- Número de telefone: 359-52-978-288
- E-mail: aradinoff@hotmail.com
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Sofia, Bulgária, 1606
- Recrutamento
- Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy, Clinic of Hematology
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Contato:
- Site Contact
- Número de telefone: +359 (884) 674 160
- E-mail: viktoriia1982@abv.bg
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Investigador principal:
- Viktoria Barbukova
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Sofia, Bulgária, 1797
- Recrutamento
- Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Clinic of Hematology
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Contato:
- Site Contact
- Número de telefone: +359 (898) 719 792
- E-mail: drtanyayankova@gmail.com
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Investigador principal:
- Tanya Yankova
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Varna, Bulgária, 9010
- Ainda não está recrutando
- University Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Clinical Hematology
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Investigador principal:
- Ilina Micheva
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Contato:
- Site Contact
- Número de telefone: +359 (52) 978 288
- E-mail: IlinaMichevailinamicheva@gmail.com
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Alberta
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Edmonton, Alberta, Canadá, T6G 2B7
- Recrutamento
- University of Alberta Hospital
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Contato:
- Site Contact
- Número de telefone: +1 (780) 407 1584
- E-mail: yannancy@ualberta.ca
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Investigador principal:
- Nancy Zhu
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British Columbia
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Vancouver, British Columbia, Canadá, V6Z 2A5
- Recrutamento
- Providence Hematology - Vancouver
-
Contato:
- Site Contact
- Número de telefone: +1 (604) 684 5794
- E-mail: hleitch@pacifichematology.ca
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Investigador principal:
- Heather Leitch
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 1V7
- Recrutamento
- Nova Scotia Health Authority, Centre for Clinical Research
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Contato:
- Site Contact
- Número de telefone: +1 (902) 473 3498
- E-mail: amy2.trottier@nshealth.ca
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Investigador principal:
- Amy Trottier
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Ontario
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London, Ontario, Canadá, N6A 4L6
- Recrutamento
- London Health Sciences Centre
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Investigador principal:
- Lalit Saini
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Contato:
- Site Contact
- Número de telefone: 519-685-8380
- E-mail: Lalit.Saini@lhsc.on.ca
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Toronto, Ontario, Canadá, M5G 2M9
- Recrutamento
- Princess Margaret Cancer Centre
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Contato:
- Site Contact
- Número de telefone: +1 (416) 946 4501
- E-mail: Karen.Yee@uhn.ca
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Investigador principal:
- Karen Yee
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Toronto, Ontario, Canadá, M4N 3M5
- Recrutamento
- Sunnybrook Research Institute, Odette Cancer Center
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Investigador principal:
- Rena Buckstein
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Contato:
- Site Contact
- Número de telefone: +416 (480) 5847
- E-mail: Rena.Buckstein@sunnybrook.ca
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Santiago, Chile, 7500653
- Recrutamento
- SAGA Clinical Research Center SpA
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Investigador principal:
- Ada Hernandez
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Contato:
- Site Contact
- Número de telefone: 56-9-8326-9755
- E-mail: ahernandez@cecsaga.cl
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Santiago, Chile, 7580206
- Recrutamento
- Clinic Inmunocel
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Contato:
- Site Contact
- E-mail: jvinuela@inmunocel.com
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Investigador principal:
- Jose Vinuela
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Santiago, Chile, 8320000
- Recrutamento
- Center for Clinical Studies and Medical Research (CECIM)
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Investigador principal:
- Alexander Arellano
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Contato:
- Site Contact
- Número de telefone: 56-9-5826-3308
- E-mail: alexander.arellano@cecim.cl
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Biobio
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Concepción, Biobio, Chile, 4070356
- Recrutamento
- Dr. Guillermo Grant Benavente - Concepcion Regional Hospital
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Investigador principal:
- Monica Romero
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Contato:
- Site Contact
- Número de telefone: 56-41-272-2500
- E-mail: mpromero@hospitalinfantildesanjose.org.co
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Coquimbo Region
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La Serena, Coquimbo Region, Chile, 1720430
- Recrutamento
- IC La Serena Research
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Investigador principal:
- Cleiden Villegas
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Contato:
- Site Contact
- Número de telefone: 56-51-286127
- E-mail: cleiden.villegas@iclsr.cl
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Daegu, Coréia do Sul, 41944
- Recrutamento
- Kyungpook National University Hospital
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Contato:
- Site Contact
- Número de telefone: +82 (53) 200 5570
- E-mail: jhmoon74@knuh.kr
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Investigador principal:
- Joon ho Moon
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Seoul, Coréia do Sul, 05505
- Recrutamento
- Asan Medical Center
-
Investigador principal:
- Je-Hwan Lee
-
Contato:
- Site Contact
- Número de telefone: +82 (2) 3010 3218
- E-mail: jhlee3@amc.seoul.kr
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Seoul, Coréia do Sul, 03080
- Recrutamento
- Seoul National University Hospital
-
Investigador principal:
- Junshik Hong
-
Contato:
- Site Contact
- Número de telefone: +82 (2) 2072-0834
- E-mail: hongjblood@snu.ac.kr
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Seoul, Coréia do Sul, 06351
- Recrutamento
- Samsung Medical Center
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Investigador principal:
- Jun Ho Jang
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Contato:
- Site Contact
- Número de telefone: +82 (2) 3410 0918
- E-mail: smcjunhojang@gmail.com
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Seoul, Coréia do Sul, 04401
- Recrutamento
- Soon Chun Hyang University Hospital Seoul
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Investigador principal:
- Seug Yun Yoon
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Contato:
- Site Contact
- Número de telefone: 82-2-709-9144
- E-mail: ysy6496@schmc.ac.kr
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Seoul, Coréia do Sul, 06591
- Recrutamento
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Investigador principal:
- Yoo Jin Kim
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Contato:
- Site Contact
- Número de telefone: 82-1588-1511
- E-mail: yoojink@catholic.ac.kr
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Castille and León
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Salamanca, Castille and León, Espanha, 37007
- Recrutamento
- University Clinical Hospital of Salamanca, Department of Hematology
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Investigador principal:
- Maria Diez Campelo
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Contato:
- Site Contact
- Número de telefone: +34 (923) 291 100
- E-mail: mdiezcampelo@usal.es
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Catalonia
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Barcelona, Catalonia, Espanha, 08035
- Recrutamento
- University Hospital Vall d'Hebron, Department of Hematology
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Investigador principal:
- David Valcarcel Ferreiras
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Contato:
- Site Contact
- Número de telefone: +34 (932) 746 100
- E-mail: dvalcarcel@vhio.net
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Girona
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L'Hospitalet de Llobregat, Girona, Espanha, 08908
- Recrutamento
- Catalan Institute of Oncology, Hospital Duran i Reynals, Department of Clinical Hematology
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Investigador principal:
- Montserrat Arnan Sangerman
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Contato:
- Site Contact
- Número de telefone: +34 (932) 607 750
- E-mail: marnan@iconcologia.net
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Madrid
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Madrid, Madrid, Espanha, 28034
- Recrutamento
- University Hospital Ramon y Cajal
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Investigador principal:
- Kyra Velazquez Kennedy
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Contato:
- Site Contact
- Número de telefone: 34-913-36-8000
- E-mail: kyra.vkennedy@gmail.com
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Madrid, Madrid, Espanha, 28040
- Recrutamento
- University Hospital Foundation Jimenez Diaz
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Investigador principal:
- Teresa Arquero Portero
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Contato:
- Site Contact
- Número de telefone: 34-915-50-4800
- E-mail: tarquero@fjd.es
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Valencia
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Valencia, Valencia, Espanha, 46026
- Recrutamento
- University and Polytechnic Hospital La Fe
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Investigador principal:
- Elvira Mora Castera
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Contato:
- Site Contact
- Número de telefone: 34-961-24-4000
- E-mail: mora_elv@gva.es
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California
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Duarte, California, Estados Unidos, 91010
- Recrutamento
- City of Hope
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Investigador principal:
- Andrew Artz
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Contato:
- Site Contact
- Número de telefone: 626-218-2404
- E-mail: aartz@coh.org
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Glendale, California, Estados Unidos, 91206
- Recrutamento
- Los Angeles Cancer Network
-
Investigador principal:
- Eric Lee
-
Contato:
- Site Contact
- Número de telefone: 215-707-7312
- E-mail: eric.lee@lahomg.com
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La Jolla, California, Estados Unidos, 92037
- Recrutamento
- UC San Diego Moores Cancer Center
-
Investigador principal:
- Amanda Kagan
-
Contato:
- Site Contact
- Número de telefone: 858-822-6100
- E-mail: amanda.kagan@jhmi.edu
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06511
- Recrutamento
- Smilow Cancer Hospital at Yale-New Haven
-
Investigador principal:
- Amer Zeidan
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Contato:
- Site Contact
- Número de telefone: 203-737-7103
- E-mail: amer.zeidan@yale.edu
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Florida
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Miami, Florida, Estados Unidos, 33136
- Recrutamento
- University of Miami Hospital and Clinics
-
Contato:
- Site Contact
- Número de telefone: 305-243-9974
- E-mail: msekeres@med.miami.edu
-
Investigador principal:
- Mikkael Sekeres
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Tampa, Florida, Estados Unidos, 33612
- Recrutamento
- Moffitt Cancer Center
-
Contato:
- Site Contact
- Número de telefone: 888-860-2778
- E-mail: rami.komrokji@moffitt.org
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Investigador principal:
- Rami Komrokji
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Illinois
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Peoria, Illinois, Estados Unidos, 61645
- Recrutamento
- ILCC. Illinois Cancer Centers
-
Contato:
- Site Contact
- Número de telefone: 309-240-6388
- E-mail: paul.fishkin@usoncology.com
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Investigador principal:
- Paul Fishkin
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40207
- Recrutamento
- Norton Cancer Institute
-
Investigador principal:
- Don Stevens
-
Contato:
- Site Contact
- Número de telefone: 502-906-7543
- E-mail: Don.Stevens@nortonhealthcare.org
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Louisiana
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Monroe, Louisiana, Estados Unidos, 71201
- Recrutamento
- Ghattas Oncology
-
Investigador principal:
- Tharwat Ghattas
-
Contato:
- Site Contact
- E-mail: tghattas@epicmedresearch.com
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Maryland
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Columbia, Maryland, Estados Unidos, 21044
- Recrutamento
- Maryland Oncology Hematolofy
-
Investigador principal:
- Mohit Narang
-
Contato:
- Site Contact
- Número de telefone: 410-581-2100
- E-mail: mohit.narang@usoncology.com
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Missouri
-
Kansas City, Missouri, Estados Unidos, 64132
- Recrutamento
- MidAmerica Cancer Care
-
Contato:
- Site Contact
- Número de telefone: 816-974-5050
- E-mail: benjamin.fangman@aoncology.com
-
Investigador principal:
- Benjamin Fangman
-
-
Nevada
-
Henderson, Nevada, Estados Unidos, 89169
- Recrutamento
- Comprehensive Cancer Centers of Nevada
-
Investigador principal:
- Edwin Kingsley
-
Contato:
- Site Contact
- Número de telefone: 702-952-3444
- E-mail: edwin.kingsley@usoncology.com
-
-
New York
-
Westbury, New York, Estados Unidos, 11590
- Recrutamento
- Clinical Research Alliance NY
-
Investigador principal:
- Jonathan Goldberg
-
Contato:
- Site Contact
- Número de telefone: 516-488-2918
- E-mail: jgoldberg@caremount.com
-
-
North Carolina
-
Winston-Salem, North Carolina, Estados Unidos, 27013
- Recrutamento
- Novant Health-Cancer Institute
-
Investigador principal:
- James Dugan
-
Contato:
- Site Contact
- Número de telefone: 336-718-5570
- E-mail: jpdugan@novanthealth.org
-
-
Ohio
-
Canton, Ohio, Estados Unidos, 44718
- Recrutamento
- Gabrail Cancer Center Research
-
Investigador principal:
- Nashat Gabrail
-
Contato:
- Site Contact
- Número de telefone: 330-492-3345
- E-mail: research@gabrailcancercenter.com
-
Cleveland, Ohio, Estados Unidos, 44195
- Recrutamento
- Cleveland Clinic - Cleveland
-
Contato:
- Site Contact
- Número de telefone: 216-445-7942
- E-mail: jaina9@ccf.org
-
Investigador principal:
- Akriti Jain
-
-
Tennessee
-
Knoxville, Tennessee, Estados Unidos, 37909
- Recrutamento
- Tennessee Cancer Specialists
-
Contato:
- Site Contact
- Número de telefone: 865-934-5800
- E-mail: tracy.dobbs@tncancer.com
-
Investigador principal:
- Tracy Dobbs
-
Nashville, Tennessee, Estados Unidos, 37232
- Recrutamento
- Vanderbilt University Medical Center
-
Investigador principal:
- Ashwin Kishtagari
-
Contato:
- Site Contact
- Número de telefone: 615-322-5000
- E-mail: Ashwin.Kishtagari@vumc.org
-
-
Texas
-
Denison, Texas, Estados Unidos, 75020
- Recrutamento
- Texas Oncology Northeast Texas
-
Investigador principal:
- Amir Faridi
-
Contato:
- Site Contact
- Número de telefone: 903-868-4700
- E-mail: amir.faridi@texasoncology.com
-
Houston, Texas, Estados Unidos, 77090
- Recrutamento
- LUMI Research
-
Investigador principal:
- David Nguyen
-
Contato:
- Site Contact
- E-mail: dmnguyen@lumiresearch.com
-
Houston, Texas, Estados Unidos, 77030
- Recrutamento
- U.T. MD Anderson Cancer Center, Division of Cancer Medicine
-
Investigador principal:
- Guillermo Garcia-Manero
-
Contato:
- Site Contact
- Número de telefone: 713-792-6161
- E-mail: ggarciam@mdanderson.org
-
Red Oak, Texas, Estados Unidos, 75154
- Recrutamento
- Epic Medical Research
-
Investigador principal:
- Kirtan Koticha
-
Contato:
- Site Contact
- E-mail: kkoticha@epicmedresearch.com
-
The Woodlands, Texas, Estados Unidos, 77380
- Recrutamento
- Texas Oncology Gulf Coast
-
Investigador principal:
- Andrew Jackson
-
Contato:
- Site Contact
- Número de telefone: 409-938-8600
- E-mail: andrew.jackson@usoncology.com
-
Webster, Texas, Estados Unidos, 77598-4085
- Recrutamento
- Tranquil Research
-
Investigador principal:
- John Knecht
-
Contato:
- Site Contact
- Número de telefone: 713-907-6054
- E-mail: drknecht@cls.health
-
-
Washington
-
Issaquah, Washington, Estados Unidos, 98029
- Ainda não está recrutando
- Epic Care Emeryville
-
Contato:
- Site Contact
- E-mail: behlr@sutterhealth.org
-
Investigador principal:
- Rajesh Behl
-
-
-
-
-
Nice, França, 06200
- Recrutamento
- Archet 1 and 2 hospital
-
Investigador principal:
- Thomas Cluzeau
-
Contato:
- Site Contact
- Número de telefone: +33 (4) 9203 7777
- E-mail: cluzeau.t@chu-nice.fr
-
Paris, França, 75010
- Recrutamento
- Saint-Louis Hospital
-
Investigador principal:
- Lionel Ades
-
Contato:
- Site Contact
- Número de telefone: +33 (1) 7120 7021
- E-mail: lionel.ades@aphp.fr
-
Poitiers, França, 86000
- Recrutamento
- Poitiers University Hospital Center - Miletrie Site
-
Investigador principal:
- Jose Miguel Torregrosa-Diaz
-
Contato:
- Site Contact
- Número de telefone: +33 (5) 4944 5415
- E-mail: Jose-Miguel.Torregrosa-Diaz@chu-poitiers.fr
-
Toulouse, França, 31059
- Recrutamento
- IUCT-Oncopole
-
Contato:
- Site Contact
- Número de telefone: +33 (531) 156 266
- E-mail: Comont.Thibault@iuct-oncopole.fr
-
Investigador principal:
- Thibault Comont
-
-
-
-
-
Budapest, Hungria, H-1088
- Recrutamento
- Semmelweis University, Department of Internal Medicine and Haematology, Division of Hematology
-
Investigador principal:
- Zsolt Nagy
-
Contato:
- Site Contact
- Número de telefone: +36 (20) 825 8660
- E-mail: nagy.zsolt@med.semmelweis-univ.hu
-
Debrecen, Hungria, 4032
- Recrutamento
- University of Debrecen Clinical Center, Clinic of Internal Medicine, Department of Hematology
-
Investigador principal:
- Arpad Illes
-
Contato:
- Site Contact
- Número de telefone: +36 (52) 255 480
- E-mail: illesarpaddr@gmail.com
-
Kaposvár, Hungria, H-7400
- Recrutamento
- Mor Kaposi General Hospital, Department of Hematology
-
Contato:
- Site Contact
- Número de telefone: +36 (82) 501 363
- E-mail: dregyedmiklos@yahoo.com
-
Investigador principal:
- Miklos Egyed
-
Nyíregyháza, Hungria, 4400
- Recrutamento
- Szabolcs-Szatmar-Bereg County Teaching Hospital, Department of Hematology
-
Investigador principal:
- Laszlo Rejto
-
Contato:
- Site Contact
- Número de telefone: +36 (42) 599 719
- E-mail: lrejto@med.unideb.hu
-
Székesfehérvár, Hungria, H-8000
- Recrutamento
- Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine III, Hematology
-
Contato:
- Site Contact
- Número de telefone: +36 (20) 970 9318
- E-mail: aszomor@clinics.pote.hu
-
Investigador principal:
- Arpad Szomor
-
-
-
-
-
Cork, Irlanda, T12 DC4A
- Recrutamento
- Cork University Hospital
-
Investigador principal:
- Vitaliy Mykytiv
-
Contato:
- Site Contact
- Número de telefone: 353-21-492-2000
- E-mail: Vitaliy.mykytiv@hse.ie
-
Dublin, Irlanda, D07 R2WY
- Recrutamento
- Mater Misericordiae University Hospital
-
Investigador principal:
- Su Maung
-
Contato:
- Site Contact
- Número de telefone: 353-1-803-2000
- E-mail: SuMaung@mater.ie
-
Dublin, Irlanda, D24 NR0A
- Recrutamento
- Tallaght University Hospital
-
Investigador principal:
- Helen Enright
-
Contato:
- Site Contact
- Número de telefone: 353-1-221-4000
- E-mail: Helen.Enright@tuh.ie
-
Dublin, Irlanda, D05 DK31
- Recrutamento
- Beaumont Hospital
-
Investigador principal:
- Philip Murphy
-
Contato:
- Site Contact
- Número de telefone: +353 (1) 809 2373
- E-mail: philipmurphy@beaumont.ie
-
Dublin, Irlanda, DO4 T6F4
- Recrutamento
- St Vincent's University Hospital (SVUH)
-
Investigador principal:
- Claire Andrews
-
Contato:
- Site Contact
- Número de telefone: 353-1-221-4000
- E-mail: claireandrews@st-vincents.ie
-
Limerick, Irlanda, V94 F858
- Recrutamento
- University Hospital Limerick
-
Contato:
- Site Contact
- Número de telefone: +353 (877) 385 852
- E-mail: cian.mcellistrim@hse.ie
-
Investigador principal:
- Cian McEllistrim
-
-
-
-
-
Jerusalem, Israel, 9112001
- Recrutamento
- Hadassah Medical Center, Department of Hematology
-
Contato:
- Site Contact
- Número de telefone: +972 (2) 677 6748
- E-mail: sabanre@hadassah.org.il
-
Investigador principal:
- Revital Saban
-
Petah Tikva, Israel, 49100
- Recrutamento
- Rabin Medical Center, Davidoff Cancer Center, Hemato-Oncology Institute
-
Investigador principal:
- Ofir Wolach
-
Contato:
- Site Contact
- Número de telefone: +972 (3) 937 8116
- E-mail: owolach@gmail.com
-
Ramat Gan, Israel, 5266202
- Recrutamento
- Chaim Sheba Medical Center, Department of Hematology, Myelodysplastic Syndromes Center
-
Investigador principal:
- Drorit Merkel
-
Contato:
- Site Contact
- Número de telefone: +972 (3) 530 5213
- E-mail: Drorit.Merkel@sheba.health.gov.il
-
Tel Aviv, Israel, 6423906
- Recrutamento
- The Tel Aviv Sourasky Medical Center, Department of Hematology and Bone Marrow Transplantation, Leukemia Service
-
Investigador principal:
- Yakir Moshe
-
Contato:
- Site Contact
- Número de telefone: 972-3-697-4444
- E-mail: yakirm@tlvmc.gov.il
-
-
-
-
-
Florence, Itália, 50134
- Recrutamento
- Careggi University Hospital
-
Investigador principal:
- Valeria Santini
-
Contato:
- Site Contact
- Número de telefone: +39 (55) 794 7296
- E-mail: valeria.santini@unifi.it
-
Milan, Itália, 20122
- Recrutamento
- Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
-
Investigador principal:
- Bruno Fattizzo
-
Contato:
- Site Contact
- Número de telefone: 02-5503-4422
- E-mail: bruno.fattizzo@policlinico.mi.it
-
Pavia, Itália, 27100
- Recrutamento
- Polyclinic San Matteo, IRCCS, Department of Oncohematology, Operative Unit of Hematology
-
Contato:
- Site Contact
- Número de telefone: +39 (382) 503 062
- E-mail: luca.malcovati@unipv.it
-
Investigador principal:
- Luca Malcovati
-
Reggio Calabria, Itália, 89133
- Recrutamento
- Granda Ospedale Metropolitano 'Bianchi-Melacrino-Morelli'
-
Contato:
- Site Contact
- E-mail: caterina.alati@gmail.com
-
Investigador principal:
- Caterina Alati
-
Rome, Itália, 00133
- Recrutamento
- Foundation PTV - Polyclinic Tor Vergata
-
Investigador principal:
- Maria Teresa Voso
-
Contato:
- Site Contact
- Número de telefone: +39 (6) 2090 3210
- E-mail: mtvoso@rm.unicatt.it
-
Rozzano, Itália, 20089
- Recrutamento
- Clinical Institute Humanitas, IRCCS
-
Investigador principal:
- Matteo Giovanni Della Porta
-
Contato:
- Site Contact
- Número de telefone: 39-02-82241
- E-mail: matteo.della_porta@hunimed.eu
-
Turin, Itália, 10060
- Recrutamento
- Institute of Cancer Research and Treatment of Candiolo
-
Investigador principal:
- Elena Crisa
-
Contato:
- Site Contact
- Número de telefone: 39-011-993-3111
- E-mail: elena.crisa@ircc.it
-
-
AN
-
Ancona, AN, Itália, 60126
- Recrutamento
- Aou Delle Marche
-
Investigador principal:
- Antonella Poloni
-
Contato:
- Site Contact
- E-mail: a.poloni@staff.univpm.it
-
-
Piedmont
-
Turin, Piedmont, Itália, 10128
- Recrutamento
- AO Ordine Mauriziano
-
Investigador principal:
- Daniela Cilloni
-
Contato:
- Site Contact
- E-mail: daniela.cilloni@unito.it
-
-
-
-
-
Kaunas, Lituânia, LT-50161
- Recrutamento
- Hospital of Lithuanian University of Health Sciences Kauno Klinikos
-
Contato:
- Site Contact
- Número de telefone: +370 (614) 84 658
- E-mail: milda.rudzianskiene@gmail.com
-
Investigador principal:
- Milda Rudzianskiene
-
Vilnius, Lituânia, LT-08406
- Recrutamento
- Vilnius University Hospital Santaros Klinikos
-
Investigador principal:
- Andrius Degulys
-
Contato:
- Site Contact
- Número de telefone: 370-5-250-1717
- E-mail: andrius.degulys@santa.lt
-
-
-
-
-
Bellavista, Peru, 07016
- Ainda não está recrutando
- Daniel Alcides Carrion National Hospital
-
Investigador principal:
- Jose Chinen Pemberton
-
Contato:
- Site Contact
- Número de telefone: 997-889-111
- E-mail: joserevi7@yahoo.com
-
Lima, Peru, 15038
- Ainda não está recrutando
- National Institute of Neoplastic Diseases
-
Contato:
- Site Contact
- Número de telefone: +51 (942) 136-304
- E-mail: jufravas1ro@hotmail.com
-
Investigador principal:
- Jule Vasquez
-
-
Jesus Maria
-
Lima, Jesus Maria, Peru, 15073
- Ainda não está recrutando
- Edgardo Rebagliati Martins National Hospital
-
Contato:
- Site Contact
- Número de telefone: +51 (987) 245-661
- E-mail: lourdesaranda@gmail.com
-
Investigador principal:
- Lourdes Aranda
-
-
La Molina
-
Lima, La Molina, Peru, 15023
- Recrutamento
- Anglo American Clinic
-
Investigador principal:
- Antonio Carrasco
-
Contato:
- Site Contact
- Número de telefone: 51-1-6168900
- E-mail: antonio1carrasco@hotmail.com
-
-
San Isidro Lima
-
Lima, San Isidro Lima, Peru, 02002
- Recrutamento
- IPOR: Peruvian Institute of Oncology & Radiotherapy
-
Investigador principal:
- Maria Vera Vasquez
-
Contato:
- Site Contact
- Número de telefone: 51-1-2241779
- E-mail: maria.vera.vasquez1@gmail.com
-
-
-
-
-
Katowice, Polônia, 40-519
- Recrutamento
- Pratia Oncology Katowice
-
Investigador principal:
- Sebastian Grosicki
-
Contato:
- Site Contact
- Número de telefone: 48-501-714-019
- E-mail: sebastian.grosicki@pratia.com
-
Lodz, Polônia, 93-513
- Recrutamento
- Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz, General Hematology Unit
-
Investigador principal:
- Tadeusz Robak
-
Contato:
- Site Contact
- Número de telefone: +48 (42) 689 5191
- E-mail: robaktad@csk.umed.lodz.pl
-
Olsztyn, Polônia, 10-228
- Recrutamento
- 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
-
Investigador principal:
- Janusz Halka
-
Contato:
- Site Contact
- Número de telefone: + (48) 602 120 684
- E-mail: janusz.halka@poliklinika.net
-
-
Greater
-
Poznan, Greater, Polônia, 60-192
- Recrutamento
- Pratia Poznan
-
Contato:
- Site Contact
- E-mail: anna.hoppe@pratia.com
-
Investigador principal:
- Anna Hoppe
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, Polônia, 50-019
- Recrutamento
- Pratia Onkologia Wroclaw
-
Contato:
- Site Contact
- E-mail: rybka.justyna@o2.pl
-
Investigador principal:
- Justyna Rybka
-
-
-
-
-
Birmingham, Reino Unido, B15 2TH
- Recrutamento
- Queen Elizabeth Hospital Birmingham
-
Investigador principal:
- Vidhya Murthy
-
Contato:
- Site Contact
- Número de telefone: 44-121-627-2000
- E-mail: Vidhya.Murthy2@uhb.nhs.uk
-
Cambridge, Reino Unido, CB2 0QQ
- Recrutamento
- Addenbrooke's Hospital
-
Investigador principal:
- Duncan Brian
-
Contato:
- Site Contact
- Número de telefone: 44-1223-805000
- E-mail: duncanbrian@nhs.net
-
Leeds, Reino Unido, LS9 7TF
- Recrutamento
- St James's University Hospital
-
Contato:
- Site Contact
- Número de telefone: 44-113-243-3144
- E-mail: catherine.cargo@nhs.net
-
Investigador principal:
- Catherine Cargo
-
London, Reino Unido, SE5 9RS
- Recrutamento
- King's College Hospital
-
Investigador principal:
- Austin Kulasekararaj
-
Contato:
- Site Contact
- Número de telefone: +44 (79) 6768 6823
- E-mail: austin.kulasekararaj@nhs.net
-
London, Reino Unido, W1G 6AD
- Recrutamento
- Sarah Cannon Research Institute (SCRI)
-
Investigador principal:
- Jennifer O'Sullivan (Dillon)
-
Contato:
- Site Contact
- Número de telefone: 615-329-7274
- E-mail: jenniferosullivan@nhs.net
-
Manchester, Reino Unido, M20 4BX
- Recrutamento
- The Christie NHS Foundation Trust
-
Investigador principal:
- Daniel Wiseman
-
Contato:
- Site Contact
- Número de telefone: 44-161-446-3000
- E-mail: daniel.wiseman@nhs.net
-
Nottingham, Reino Unido, NG5 1PB
- Recrutamento
- Nottingham City Hospital
-
Investigador principal:
- Jennifer Byrne
-
Contato:
- Site Contact
- Número de telefone: 44-115-969-1169
- E-mail: Jennifer.Byrne@nuh.nhs.uk
-
Oxford, Reino Unido, OX3 7LE
- Recrutamento
- Churchill Hospital
-
Contato:
- Site Contact
- Número de telefone: 44-300-304-7777
- E-mail: Oni.Chowdhury@ouh.nhs.uk
-
Investigador principal:
- Oni Chowdhury
-
-
Aberdeen City
-
Aberdeen, Aberdeen City, Reino Unido, AB25 2ZN
- Recrutamento
- Aberdeen Royal Infirmary
-
Investigador principal:
- Dominic Culligan
-
Contato:
- Site Contact
- E-mail: dominic.culligan@nhs.scot
-
-
Denbighshire
-
Rhyl, Denbighshire, Reino Unido, LL18 5UJ
- Recrutamento
- Glan Clwyd Hospital
-
Investigador principal:
- Earnest Heartin
-
Contato:
- Site Contact
- E-mail: earnest.heartin@wales.nhs.uk
-
-
Leics
-
Leicester, Leics, Reino Unido, LE1 5WW
- Recrutamento
- University Hospitals of Leicester
-
Investigador principal:
- Matthew Lee
-
Contato:
- Site Contact
- E-mail: matthew.lee3@nhs.net
-
-
Lincolnshire
-
Lincoln, Lincolnshire, Reino Unido, LN2 5QY
- Recrutamento
- Lincolnshire Community and Hospitals NHS group
-
Investigador principal:
- Ciro Rinaldi
-
Contato:
- Site Contact
- E-mail: crinaldi@nhs.net
-
-
Tyne and Wear
-
High Heaton, Tyne and Wear, Reino Unido, NE7 7DN
- Recrutamento
- The Newcastle Upon Tyne University Hospitals Foundation Trust
-
Contato:
- Site Contact
- E-mail: michelle.lannon@nhs.net
-
Investigador principal:
- Michelle Lannon
-
Sunderland, Tyne and Wear, Reino Unido, SR4 7TP
- Ainda não está recrutando
- South Tyneside and Sunderland Foundation Trust
-
Investigador principal:
- Scott Marshall
-
Contato:
- Site Contact
- E-mail: scott.marshall3@nhs.net
-
-
-
-
-
Lund, Suécia, 221 85
- Recrutamento
- Skane University Hospital - Lund, Department of Hematology and Vascular Disorders
-
Contato:
- Site Contact
- Número de telefone: +46 (46) 171 000
- E-mail: lars.nilsson@skane.se
-
Investigador principal:
- Lars Nilsson
-
-
A-rebro County
-
Örebro, A-rebro County, Suécia, 70185
- Ainda não está recrutando
- A-rebro University Hospital, Hematology Department
-
Contato:
- Site Contact
- E-mail: bengt.rasmussen@regionorebrolan.se
-
Investigador principal:
- Bengt Rasmussen
-
-
Stockholm County
-
Huddinge, Stockholm County, Suécia, 141 57
- Recrutamento
- Karolinska University Hospital
-
Investigador principal:
- Magnus Tobiasson
-
Contato:
- Site Contact
- Número de telefone: 46-8-123-700000
- E-mail: magnus.tobiasson@ki.se
-
-
VG
-
Gothenburg, VG, Suécia, 41345
- Ainda não está recrutando
- Sahlgrenska University Hospital
-
Contato:
- Site Contact
- E-mail: lena.von.bahr@vgregion.se
-
Investigador principal:
- Lena Von Bahr
-
-
-
-
-
Bern, Suíça, 3010
- Ainda não está recrutando
- Insel Gruppe AG, University Clinic for Hematology and Central Hematological Laboratory
-
Contato:
- Site Contact
- E-mail: natalia.baran@insel.ch
-
Investigador principal:
- Natalia Baran
-
Zurich, Suíça, 8091
- Recrutamento
- Universitatsspital Zurich, Klinik fur Medizinische Onkologie und Hamatologie
-
Contato:
- Site Contact
- E-mail: stefan.balabanov@usz.ch
-
Investigador principal:
- Stefan Balabanov
-
-
Canton of Basel-City
-
Basel, Canton of Basel-City, Suíça, 4031
- Ainda não está recrutando
- University Hosptial Basel
-
Contato:
- Site Contact
- E-mail: gregor.stehle@usb.ch
-
Investigador principal:
- Gregor Stehle
-
-
-
-
-
Bangkok, Tailândia, 10330
- Recrutamento
- King Chulalongkorn Memorial Hospital
-
Contato:
- Site Contact
- Número de telefone: +66 (2) 251 6704
- E-mail: drnoppacharn@yahoo.com
-
Investigador principal:
- Noppacharn Uaprasert
-
Bangkok, Tailândia, 10400
- Recrutamento
- Ramathibodi Hospital
-
Contato:
- Site Contact
- Número de telefone: +66 (2) 201 2373
- E-mail: Nickero059@hotmail.com
-
Investigador principal:
- Piyajaroenkij Thanakrit
-
Bangkok, Tailândia, 10400
- Recrutamento
- Rajavithi Hospital
-
Contato:
- Site Contact
- Número de telefone: +66 (2) 206 2900
- E-mail: kunapa@gmail.com
-
Investigador principal:
- Kunapa Iam-arunthai
-
Bangkok, Tailândia, 74210
- Recrutamento
- Banphaeo General Hospital
-
Investigador principal:
- Busakorn Sae-Aeng
-
Contato:
- Site Contact
- Número de telefone: 034-419555-6
- E-mail: Himatologist55@gmail.com
-
Chiang Mai, Tailândia, 50200
- Recrutamento
- Maharaj Nakorn Chiangmai Hospital
-
Contato:
- Site Contact
- Número de telefone: +66 (53) 945 482
- E-mail: thanawat_r@outlook.com
-
Investigador principal:
- Thanawat Rattanathammethee
-
-
-
-
-
Taichung, Taiwan, 407219
- Recrutamento
- Taichung Veterans General Hospital
-
Investigador principal:
- Cheng-Hsien Lin
-
Contato:
- Site Contact
- Número de telefone: 886-4-2359-2525
- E-mail: briefsummer@gmail.com
-
Tainan, Taiwan, 704302
- Recrutamento
- National Cheng Kung University Hospital
-
Investigador principal:
- Tsai-Yun Chen
-
Contato:
- Site Contact
- Número de telefone: +886 (6) 235 3535
- E-mail: teresa@mail.ncku.edu.tw
-
Taipei, Taiwan, 100225
- Recrutamento
- National Taiwan University Hospital
-
Investigador principal:
- Wen-Chien Chou
-
Contato:
- Site Contact
- Número de telefone: 886-2-2312-3456
- E-mail: wchou@ntu.edu.tw
-
Taoyuan City, Taiwan, 333
- Recrutamento
- Linkou Chang Gung Memorial Hospital
-
Investigador principal:
- Ming-Chung Kuo
-
Contato:
- Site Contact
- Número de telefone: 886-3-328-1200
- E-mail: kmc12069@gmail.com
-
-
Changhua County
-
Changhua, Changhua County, Taiwan, 500209
- Recrutamento
- Changhua Christian Hospital
-
Contato:
- Site Contact
- Número de telefone: 886-4-723-8595
- E-mail: 155627@cch.org.tw
-
Investigador principal:
- Ruo-Han Tseng
-
Changhua, Changhua County, Taiwan, 50544
- Recrutamento
- Chang Bing Show Chwan Memorial Hospital
-
Investigador principal:
- Cheng-Shyong Chang
-
Contato:
- Site Contact
- Número de telefone: 886-4-781-3888
- E-mail: cs4816@gmail.com
-
-
-
-
-
Brno, Tcheca, 625 00
- Recrutamento
- University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
-
Investigador principal:
- Jiri Mayer
-
Contato:
- Site Contact
- Número de telefone: + (420) 532 231 111
- E-mail: Mayer.Jiri@fnbrno.cz
-
Hradec Králové, Tcheca, 500 05
- Recrutamento
- University Hospital Hradec Kralove, 4th Internal Clinic of Hematology
-
Contato:
- Site Contact
- Número de telefone: + (420) 495 833 837
- E-mail: petra.belohlavkova@fnhk.cz
-
Investigador principal:
- Petra Belohlavkova
-
Ostrava, Tcheca, 70852
- Recrutamento
- Charles University General Hospital
-
Investigador principal:
- Anna Jonasova
-
Contato:
- Site Contact
- E-mail: anna.jonasova@vfn.cz
-
Ostrava, Tcheca, 70852
- Recrutamento
- University Hospital Ostrava and Faculty of Medicine, University of Ostrava
-
Contato:
- Site Contact
- E-mail: barbora.dluhosova@fno.cz
-
Investigador principal:
- Zdenek Koristek
-
Prague, Tcheca, 100 00
- Recrutamento
- University Hospital Kralovske Vinohrady, Clinic of Internal Hematology
-
Contato:
- Site Contact
- Número de telefone: + (420) 267 162 887
- E-mail: olga.cerna@fnkv.cz
-
Investigador principal:
- Olga Cerna
-
Prague, Tcheca, 12800
- Recrutamento
- Institute of Hematology and Blood Transfusion, Division of Training and Development
-
Investigador principal:
- Marketa Stastna-Markova
-
Contato:
- Site Contact
- Número de telefone: 420-221-977-296
- E-mail: marketa.markova@uhkt.cz
-
-
-
-
-
Adana, Turquia (Türkiye), 01370
- Recrutamento
- Adana City Hospital
-
Contato:
- Site Contact
- Número de telefone: +90 (542) 630 8353
- E-mail: elifsuyani@hotmail.com
-
Investigador principal:
- Elif Suyani
-
Ankara, Turquia (Türkiye), 06170
- Recrutamento
- Ankara Etlik City Hospital
-
Investigador principal:
- Merih Kizil Cakar
-
Contato:
- Site Contact
- Número de telefone: 90-362-312-1919
- E-mail: merihkizil@yahoo.com
-
Ankara, Turquia (Türkiye), 06600
- Ainda não está recrutando
- Ankara University Medical Faculty Cebeci Hospital
-
Investigador principal:
- Selami Toprak
-
Contato:
- Site Contact
- Número de telefone: 90-312-595-6000
- E-mail: sktoprak@yahoo.com
-
Antalya, Turquia (Türkiye), 07100
- Recrutamento
- Antalya Education and Training Hospital
-
Investigador principal:
- Volkan Karakus
-
Contato:
- Site Contact
- Número de telefone: +90 (505) 765 6778
- E-mail: dr_v_karakus@yahoo.com
-
Mersin, Turquia (Türkiye), 33200
- Recrutamento
- Mersin Medicalpark Hospital
-
Investigador principal:
- Anil Tombak
-
Contato:
- Site Contact
- Número de telefone: +90 (532) 346 0767
- E-mail: aniltombak@hotmail.com
-
Sakarya, Turquia (Türkiye), 54290
- Recrutamento
- Sakarya University Medical Faculty Hospital
-
Investigador principal:
- Cenk Sunu
-
Contato:
- Site Contact
- Número de telefone: 90-4445400
- E-mail: SunuCenk@gmail.com
-
Samsun, Turquia (Türkiye), 55139
- Recrutamento
- Ondokuz Mayis University School of Medicine, Department of Hematology
-
Contato:
- Site Contact
- Número de telefone: +90 (505) 272 2289
- E-mail: engink@omu.edu.tr
-
Investigador principal:
- Engin Kelkitli
-
-
-
-
-
Cape Town, África do Sul, 7580
- Recrutamento
- Haemalife
-
Contato:
- Site Contact
- Número de telefone: +27 (21) 581 0717
- E-mail: michael.cass@haemalife.co.za
-
Investigador principal:
- Michael Cass
-
Durban, África do Sul, 4091
- Recrutamento
- Capital Haematology Hospital
-
Investigador principal:
- Jaimendra Singh
-
Contato:
- Site Contact
- Número de telefone: 27-31-832-9700
- E-mail: jaimendra.singh@gmail.com
-
Johannesburg, África do Sul, 2193
- Recrutamento
- Charlotte Maxeke Johannesburg Academic Hospital, Hemophilia Comprehensive Care Center
-
Contato:
- Site Contact
- Número de telefone: +27 (11) 489 8413
- E-mail: johnny.mahlangu@nhls.ac.za
-
Investigador principal:
- Johnny Mahlangu
-
Pretoria, África do Sul, 0181
- Recrutamento
- Alberts Cellular Therapy
-
Investigador principal:
- Andrew McDonald
-
Contato:
- Site Contact
- Número de telefone: +27 (12) 993 2555
- E-mail: andrew@actlife.co.za
-
-
-
-
-
Delhi, Índia, 110085
- Ainda não está recrutando
- Rajiv Gandhi Cancer Institute & Research Centre
-
Contato:
- Site Contact
- Número de telefone: 9971500861
- E-mail: Bhurani@gmail.com
-
Investigador principal:
- Dinesh Bhurani
-
Gūrgaon, Índia, 122018
- Recrutamento
- Medanta the Medicity
-
Contato:
- Site Contact
- Número de telefone: 9717265111
- E-mail: nitin.sood@medanta.org
-
Investigador principal:
- Nitin Sood
-
-
Gujarat
-
Ahmedabad, Gujarat, Índia, 380009
- Recrutamento
- Heamto Oncology Clinic Ahmedabad Pvt. Ltd.
-
Contato:
- Site Contact
- Número de telefone: 9824041170
- E-mail: sandip60@yahoo.com
-
Investigador principal:
- Sandip Shah
-
Ahmedabad, Gujarat, Índia, 382428
- Recrutamento
- Apollo Hospital International Ltd
-
Contato:
- Site Contact
- Número de telefone: 9920273063
- E-mail: profvelunair@gmail.com
-
Investigador principal:
- Velu Nair
-
-
Kerala
-
Ernākulam, Kerala, Índia, 682041
- Ainda não está recrutando
- Amrita Institute of Medical Sciences
-
Contato:
- Site Contact
- Número de telefone: 9946047464
- E-mail: neerajsidharthan@aims.amrita.edu
-
Investigador principal:
- Neeraj Siddharthan
-
-
Maharashtra
-
Mumbai, Maharashtra, Índia, 400012
- Ainda não está recrutando
- Tata Memorial Centre
-
Contato:
- Site Contact
- Número de telefone: 9632006180
- E-mail: dralokshetty@gmail.com
-
Investigador principal:
- Alok Shetty
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, Índia, 110029
- Recrutamento
- All India Institute of Medical Science
-
Contato:
- Site Contact
- Número de telefone: 911126588499
- E-mail: drtulikaseth@gmail.com
-
Investigador principal:
- Tulika Seth
-
-
Punjab
-
Ludhiana, Punjab, Índia, 380006
- Recrutamento
- Christian Medical College, Ludhianana
-
Contato:
- Site Contact
- Número de telefone: 8054959525
- E-mail: mjosephjohn@gmail.com
-
Investigador principal:
- Joseph John
-
-
Tamil Nadu
-
Vellore, Tamil Nadu, Índia, 632004
- Recrutamento
- Christian Medical College
-
Contato:
- Site Contact
- Número de telefone: 4172224553
- E-mail: biju@cmcvellore.ac.in
-
Investigador principal:
- Biju George
-
-
Uttar Pradesh
-
Ghaziabad, Uttar Pradesh, Índia, 201012
- Ainda não está recrutando
- Max Super Speciality Hospital Vaishali (A Unit Of Crosslay Remedies Ltd.)
-
Contato:
- Site Contact
- Número de telefone: 9451405842
- E-mail: pradeep.kumar9@maxhealthcare.com
-
Investigador principal:
- Pradeep Kumar
-
-
West Bengal
-
Kolkata, West Bengal, Índia, 700014
- Recrutamento
- NRS Medical College and Hospital
-
Contato:
- Site Contact
- Número de telefone: 9874890275
- E-mail: tkdolai@hotmail.com
-
Investigador principal:
- Tuphan Kanti Dolai
-
Kolkata, West Bengal, Índia, 700156
- Recrutamento
- Tata Medical Center, Kolkata
-
Contato:
- Site Contact
- Número de telefone: 3366057620
- E-mail: arijit.nag@tmckolkata.com
-
Investigador principal:
- Arijit Nag
-
-
Critérios de participação
Critérios de elegibilidade
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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]).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Número de braços
Armas e Intervenções
Grupo de Participantes / BraçoGrupo de Participantes / Braço |
Intervenção / TratamentoIntervenção / Tratamento |
|---|---|
|
Experimental: 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.
Outros nomes:
|
|
Comparador de Placebo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants Achieving Transfusion Independence (TI) for ≥8 Weeks
Prazo: 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
|
Medidas de resultados secundários
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants Achieving TI for ≥24 Weeks
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Diretor de estudo: Study Director, Takeda
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Início do estudo
Conclusão Primária (Estimado)
Conclusão Primária
Conclusão do estudo (Estimado)
Conclusão do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Primeira postagem
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última Atualização Postada
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
Outros números de identificação do estudo
- KER-050-D301
- 2024-516009-22-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Critérios de acesso de compartilhamento 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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
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