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New treatment option for Myelofibrosis
Official title A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis
ClinicalTrials.gov ID: NCT06773195
What this study is testing
What is Ulixertinib?
Ulixertinib is an investigational medicine, being studied as a potential treatment for myelofibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with a diagnosis of primary myelofibrosis, post-ET myelofibrosis, post-PV myelofibrosis, or post-pre-fibrotic myelofibrosis by WHO 2016...
- 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...
- 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
You likely can't join if
- Use of experimental drug therapy for MF or any other standard drug with the exception of hydroxyurea or ruxolitinib within 2 weeks of starting...
- Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it...
- Unwilling to receive red blood cell transfusion to treat low hemoglobin.
- Participants who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib and ulixertinib.
- Participants requiring any medications or substances that are strong inhibitors or inducers of 3A4, strong inhibitors of CYP1A2 and CYP2D6, and...
See the full eligibility criteria
Who can join
- 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...
- 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 × institutional ULN
- Creatinine clearance ≥ 50 mL/min as calculated by institutional standard
- Bone marrow and peripheral blood blast count \<10%
- Agreeable to the use of adequate contraception to avoid pregnancy (Appendix D). Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth contro) prior to...
What rules you out
- Use of experimental drug therapy for MF or any other standard drug with the exception of hydroxyurea or ruxolitinib within 2 weeks of starting combination therapy and/or lack of recovery from all toxicities from...
- Participants with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen
- Unwilling to receive red blood cell transfusion to treat low hemoglobin.
- Participants who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib and ulixertinib.
- Participants requiring any medications or substances that are strong inhibitors or inducers of 3A4, strong inhibitors of CYP1A2 and CYP2D6, and inhibitors of Pglycoprotein (P-gp). Strong inhibitors or inducers of 3A4...
- Participants who are pregnant or breastfeeding.
- Pregnant women are excluded from this study because ruxolitinib and ulixertinib are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events...
- Active bacterial, fungal, or viral infection requiring treatment.
- Participants with chronic Human immunodeficiency virus (HIV) or hepatitis B or C viral infection.
- HIV-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: testing does not have to be performed during screening unless participant...
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Presence of active interstitial lung disease or pneumonitis.
- History of cardiovascular risk factors:
- Clinically significant, uncontrolled arrythmias and/or conduction abnormalities. Participants with controlled atrial fibrillation \>30 days prior to study initiation are eligible.
- QTc \> 480 msec.
- History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to study entry;
- Class II congestive heart failure or greater or ejection fraction ≤50% on baseline echocardiogram.
- History of uncontrolled hypertension.
- A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
- Psychiatric illness/social situations, active drug, alcohol or substance use that would interfere with study compliance.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending study visits; pose a significant risk to the participant; or...
- Participants eligible for allogeneic stem cell transplantation in the opinion of the treating physician at the time of enrollment.
- Inability to comprehend or unwilling to sign the informed consent form.
- Transformation to accelerated or blast phase disease, including myeloid sarcoma.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.