A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis
Trial Parameters
Brief 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.
Eligibility Criteria
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 t