Purpose of this Study
We are doing this study is to find out if an investigational drug called imetelstat (the study drug) can lead to better outcomes in people who have myelofibrosis (MF) when it is compared to other available therapies.
Who Can Participate?
Eligibility
Adults ages 18+ who are diagnosed with myelofibrosis (MF).
For more information about who can join this study, please contact the study team at peggy.alton@duke.edu or 919-684-9220.
What is Involved?
Description
This study is divided into 3 periods: the screening period, the study regimen period, and the follow-up period.
If you choose to join the study, during the screening period you will:
- Have a physical exam
- Have blood draws
- Have a scan of your abdomen
- Have a bone marrow sample taken
- If you are assigned to study regimen A, you will get the study drug
- If you are assigned to study regimen B, you will get the best available therapy
- Visit our clinic for regular check-ups
- Have blood draws
- Answer questionnaires
- Keep a diary of your symptoms on an electronic device
Study Details
Full Title
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
Principal Investigator
Lindsay
Rein
Protocol Number
PRO00109191
NCT ID
NCT04576156
Phase
III
Enrollment Status
Open to Enrollment