Navtemadlin + Ruxolitinib for Myelofibrosis
(POIESIS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be new to JAK-inhibitor treatments like ruxolitinib. You will continue taking ruxolitinib during the trial.
What is known about the safety of Navtemadlin and Ruxolitinib in humans?
Ruxolitinib, also known as Jakafi or Jakavi, has been studied extensively and is generally safe for treating myelofibrosis, though it can cause anemia (low red blood cell count) and thrombocytopenia (low platelet count), which are usually manageable. No new safety concerns have been identified in large studies, and these side effects rarely lead to stopping the treatment.12345
How does the drug Ruxolitinib differ from other treatments for myelofibrosis?
Ruxolitinib is unique because it is an oral medication that specifically inhibits JAK1 and JAK2, which are proteins involved in the development of myelofibrosis. It is the first and only approved drug for this condition, providing significant benefits like reducing spleen size and improving symptoms and quality of life, with a survival advantage over previous therapies.56789
What data supports the effectiveness of the drug combination Navtemadlin and Ruxolitinib for treating myelofibrosis?
Are You a Good Fit for This Trial?
This trial is for patients with Myelofibrosis who haven't had a good enough response to Ruxolitinib. Participants should be new to JAK inhibitor treatments and meet specific health criteria not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants receive ruxolitinib alone to assess response
Randomized Treatment
Participants receive either navtemadlin or placebo as add-on to ruxolitinib in 28-day cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Navtemadlin
- Ruxolitinib
Ruxolitinib is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kartos Therapeutics, Inc.
Lead Sponsor