A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis (NCT06773195) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis
United States37 participantsStarted 2025-01-07
Plain-language summary
The researchers are doing this study to find out whether the combination of ruxolitinib and ulixertinib is a safe and effective treatment for people with myelofibrosis. The researchers will test different doses of ulixertinib to find the highest dose that causes few or mild side effects in participants when given in combination with ruxolitinib.
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:
* Patients with a diagnosis of primary myelofibrosis, post-ET myelofibrosis, post-PV myelofibrosis, or post-pre-fibrotic myelofibrosis by WHO 2016 criteria.
* Age ≥18 years.
* Receiving ruxolitinib monotherapy for at least 3 months with stable dose (10 mg BID to 20mg BID) for at least 4 weeks before first dose of study drug. Note: stable ruxolitinib dosing should be achieved according to strict adherence to dose modification/reduction guidelines detailed in the ruxolitinib package insert, for patients with renal impairment, and/or hepatic impairment.
* Must have DIPSS+ intermediate 2 or greater risk disease, or MIPSS70+ intermediate or greater risk disease
* Persistent disease despite ruxolitinib monotherapy, as demonstrated by:
o Grade 2 or 3 reticulin/collagen fibrosis on bone marrow AND
* Splenomegaly (palpable at least 5cm below subcostal margin/or spleen volume \> 450cm\^3) OR
* Active symptoms (MPN-SAF TSS score \>10 with at least one MPNSAF TSS score \>5 or two scores \>3) OR
* ECOG performance status ≤2
* Participants must have adequate organ and marrow function as defined below unless the elevated laboratory values are attributable to Gilbert's Syndrome with Sponsor review and approval:
* Absolute neutrophil count ≥ 0.5 K/mcL
* Platelets ≥ 50 K/mcL
* Direct bilirubin ≤ 1.5 times institutional upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN
* AST(SGOT)/ALT(SGPT) ≤ 3 × institution…
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.