Last updated 22 days ago

A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment

320 patients around the world
Available in Argentina, United States, Brazil
This is a multicenter study with 2 arms, and will include 3 phases: a) screening phase of up to 28 days before randomization during which participants will complete a 14-day washout period from all prior therapies including JAK-inhibitor treatment, and the participant's eligibility will be reviewed; b) treatment phase, from randomization until study treatment (imetelstat or BAT) discontinuation; and c) post treatment follow-up phase, that begins when the participant discontinues treatment, and will continue until death, lost to follow-up, withdrawal of consent, or study end, whichever occurs first. Participants will be randomized (2:1) into 2 Arms (Arm A will receive imetelstat and Arm B will receive BAT). Participants who meet progressive disease criteria and discontinue BAT, may crossover to receive imetelstat treatment after sponsor's approval.
Geron Corporation
16Research sites
320Patients around the world
This study is for people with
Myeloproliferative syndromes
Myelofibrosis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Sites
Sanatorio de la Mujer - Rosario
Recruiting
San Luis 2493, Rosario, Santa Fe
Sanatorio Allende (Nueva Córdoba)
Recruiting
Hipolito Yrigoyen 384, Córdoba
Hospital Universitario Austral - Pilar
Recruiting
Av. Juan Domingo Perón 1500, Pilar, Buenos Aires
Hospital das Clínicas da Universidade Federal de Goiás - UFG
Recruiting
Rua 235 QD. 68 Lote Área, Nº 285, s/nº - Setor Leste Universitário, Goiânia - GO, 74605-050
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Recruiting
Rua Ramiro Barcelos, 2350, Av. Protásio Alves, 211 - Santa Cecília, Porto Alegre - RS, 90035-903
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Recruiting
Porto Alegre, 90110-270
Centro Pesquisas Oncologicas - CEPON
Recruiting
655 Rio Itacorubi Florianópolis SC BR 88034-000, Rod. Admar Gonzaga - Itacorubi, Florianópolis - SC
Instituto de Educação, Pesquisa e Gestão em Saúde
Recruiting
Avenida Das Americas 06205 Loj e Barra da Tijuca Rio de Janeiro RJ 22793-080
Hospital Israelita Albert Einstein - Fortaleza, Ceara
Recruiting
Avenida Albert Einstein 627/701, 2° Subsolo - Bloco A, Centro de Pesquisa Clínica, São Paulo, Sao Paulo
Hospital Amaral Carvalho
Recruiting
R. Doná Silvéria, 150 - Chácara Braz Miraglia, Jaú - SP, 17210-080, Brazil
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