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.
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?
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:<ul>
<li>Have a physical exam</li>
<li>Have blood draws</li>
<li>Have a scan of your abdomen</li>
<li>Have a bone marrow sample taken</li></ul>
If you are found to be eligible during the screening period, you will continue on to the study regimen period. During this period, you will get a random assignment (like a coin flip) to 1 of 2 study regimens:<ul>
<li>If you are assigned to study regimen A, you will get the study drug</li>
<li>If you are assigned to study regimen B, you will get the best available therapy</li></ul>
Regardless of assignment, all study participants will:<ul>
<li>Visit our clinic for regular check-ups</li>
<li>Have blood draws</li>
<li>Answer questionnaires</li>
<li>Keep a diary of your symptoms on an electronic device</li></ul>
Your study doctor will discuss the best available therapy options to treat you if you are assigned to regimen B. If your disease does not improve while you receive regimen B, you might be eligible to switch to regimen A and get the study drug.
The study regimen period will last for as long as you continue to receive a positive benefit from either regimen.
The follow-up period will begin when you or your study doctor decides to stop the study regimen. We will call you every 12 weeks during this period to see how you are doing and ask some questions.
If you choose to join the study, during the screening period you will:<ul>
<li>Have a physical exam</li>
<li>Have blood draws</li>
<li>Have a scan of your abdomen</li>
<li>Have a bone marrow sample taken</li></ul>
If you are found to be eligible during the screening period, you will continue on to the study regimen period. During this period, you will get a random assignment (like a coin flip) to 1 of 2 study regimens:<ul>
<li>If you are assigned to study regimen A, you will get the study drug</li>
<li>If you are assigned to study regimen B, you will get the best available therapy</li></ul>
Regardless of assignment, all study participants will:<ul>
<li>Visit our clinic for regular check-ups</li>
<li>Have blood draws</li>
<li>Answer questionnaires</li>
<li>Keep a diary of your symptoms on an electronic device</li></ul>
Your study doctor will discuss the best available therapy options to treat you if you are assigned to regimen B. If your disease does not improve while you receive regimen B, you might be eligible to switch to regimen A and get the study drug.
The study regimen period will last for as long as you continue to receive a positive benefit from either regimen.
The follow-up period will begin when you or your study doctor decides to stop the study regimen. We will call you every 12 weeks during this period to see how you are doing and ask some questions.
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