Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis (NCT07750574) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis
105 participantsStarted 2026-11
Plain-language summary
The goal of this clinical trial is to learn which of three different doses of Flonoltinib Maleate taken by mouth daily works best to treat adult patients with myelofibrosis in whom the most common approved therapy has failed to adequately control the disease. It will also learn about the safety of the three different daily doses of Flonoltinib Maleate. The main questions it aims to answer are:
Which dose is the best at controlling the symptoms and signs of organ damage caused by myelofibrosis? What medical problems do participants have when taking the three different doses of Flonoltinib Maleate? Researchers will compare the three different doses of Flonoltinib Maleate to see which dose is best to treat patients with myelofibrosis.
Participants will:
Take Flonoltinib Maleate every day for as long as it seems to be of benefit to them in terms of controlling myelofibrosis.
Visit the clinic for checkups and tests after giving fully informed written consent confirming that they would like to consider entering the study.
Visit the clinic for checkups and tests when on the study once every 2 weeks for the first 2 months, every 4 weeks after that, and when coming off study therapy.
Keep a diary of their symptoms.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Have signed the current relevant ICF prior to any study related procedures;
. Understand and commit to comply with study requirements;
. Be ≥18 years of age;
. Be able to swallow and retain oral medications;
. Be diagnosed with PMF according to the 2016 WHO criteria, or PPV-MF or PET-MF according to International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria;
. Have Intermediate-1 to high-risk myelofibrosis (as per Dynamic International Prognostic Scoring System \[DIPSS\] risk categories) and be either JAKi-naïve or JAKi-resistant. JAKi-naïve patients include those with JAKi exposure of no more than 14 days. The JAKi-resistant patients need to meet 1 of the following criteria: a) Treatment with JAKi for 3 months with inadequate efficacy response defined as \< 10% spleen volume reduction (SVR) by Magnetic Resonance Imaging (MRI) or \<30% decrease from baseline in spleen size by palpation or regrowth to these parameters following an initial response; b) Treatment with JAKi for ≥28 days complicated by any of the following: development of a red blood cell transfusion requirement (at least 2 units/month for 2 months) or cytopenia-related intolerance requiring ≥2 dose reductions or discontinuation of a JAKi; c) Persistent MF-related symptoms defined as less than 50% reduction in TSS (MFSAF V 4.0) after 3 months of JAKi therapy;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants with ≥35% reduction in spleen volume as assessed by imaging from baseline to week 24
. Not be intended to undergo stem cell transplantation for at least 6 months;
. Have life expectancy per investigator assessment ≥ 12 weeks;
Exclusion criteria
. Have failure to recover from toxic effects of prior anticancer therapy to Grade 1 or below (except alopecia), or failure to fully recover from prior surgery (major surgery within 4 weeks);
. Have known hypersensitivity to the investigational product or its excipients;
. Have any significant clinical or laboratory abnormality that would interfere with accurate safety evaluation on study, including: