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A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat (GRN163L) Versus Best Available Therapy (BAT) in Patients With Intermediate-2 or High-risk Myelofibrosis (MF) Relapsed / Refractory (R/R) to Janus Kinase (JAK) Inhibitor
The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory (R/R) to Janus Kinase (JAK)-Inhibitor treatment.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of California-San Diego/Moores UCSD Cancer Center
La Jolla, California, United States
UCLA David Geffen School of Medicine
Los Angeles, California, United States
Smilow Cancer Center at YNHH
New Haven, Connecticut, United States
BRCR Medical Center Inc
Plantation, Florida, United States
University of South Florida
Tampa, Florida, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Maryland Oncology Hematology
Rockville, Maryland, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Start Date
April 12, 2021
Primary Completion Date
June 30, 2028
Completion Date
June 30, 2028
Last Updated
December 4, 2025
327
ACTUAL participants
Imetelstat
DRUG
Best Available Therapy (BAT)
DRUG
Lead Sponsor
Geron Corporation
NCT06859424
NCT06343805
Data Source & Attribution
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