Actively Recruiting
A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-03
37
Participants Needed
9
Research Sites
155 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
B
BioMed Valley Discoveries, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of primary myelofibrosis, post-ET myelofibrosis, post-PV myelofibrosis, or post-pre-fibrotic myelofibrosis by WHO 2016 criteria
- Age 18 years or older
- Receiving ruxolitinib monotherapy for at least 3 months with a stable dose (10 mg BID to 20 mg BID) for at least 4 weeks before starting study drug
- DIPSS+ intermediate 2 or higher risk disease, or MIPSS70+ intermediate or higher risk disease
- Persistent disease despite ruxolitinib, shown by grade 2 or 3 fibrosis in bone marrow and either splenomegaly (spleen palpable at least 5 cm below rib margin or spleen volume over 450 cm³) or active symptoms (MPN-SAF TSS score >10 with specific symptom thresholds)
- ECOG performance status 0 to 2
- Adequate organ and marrow function with specified blood counts and liver/kidney function unless elevated due to Gilbert's Syndrome with approval
- Agree to use adequate contraception prior to, during, and for 4 months after study treatment
You will not qualify if you...
- Use of experimental drug therapy for myelofibrosis or other drugs except hydroxyurea or ruxolitinib within 2 weeks before starting combination therapy
- Prior or current malignancy that could interfere with safety or efficacy assessment
- Unwillingness to receive red blood cell transfusion if needed
- Receiving other investigational agents
- History of allergic reactions to ruxolitinib or ulixertinib or similar compounds
- Use of medications that strongly interact with CYP3A4, CYP1A2, CYP2D6, or P-glycoprotein unless stopped 14 days before study
- Pregnancy or breastfeeding
- Active bacterial, fungal, or viral infection needing treatment
- Chronic HIV or hepatitis B or C infections unless well controlled
- Active interstitial lung disease or pneumonitis
- Certain cardiovascular risks including uncontrolled arrhythmias, QTc >480 ms, recent acute coronary events, significant heart failure, or uncontrolled hypertension
- History or risk of retinal vein occlusion or central serous retinopathy
- Psychiatric illness or substance use interfering with study compliance
- Any condition interfering with study participation or safety
- Eligible for stem cell transplantation at enrollment
- Unable or unwilling to sign informed consent
- Disease transformed to accelerated or blast phase including myeloid sarcoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Massachusetts General Hospital (Data Collection Only)
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
9
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
Research Team
R
Raajit Rampal, MD, PhD
CONTACT
P
Prioty Islam, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here