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
17Research 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
Hospital Alemán
Recruiting
Av. Pueyrredón 1640, CABA, Buenos Aires
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