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Kinase Inhibitor

Ruxolitinib + Ulixertinib for Myelofibrosis

Boston, MA

Phase 1 & 2

Recruiting

Led By Raajit Rampal, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Persistent disease despite ruxolitinib monotherapy, as demonstrated by: Grade 2 or 3 reticulin/collagen fibrosis on bone marrow, Splenomegaly (palpable at least 5cm below subcostal margin/or spleen volume > 450cm^3), Active symptoms (MPN-SAF TSS score >10 with at least one MPNSAF TSS score >5 or two scores >3), 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%

Must not have

Unwilling to receive red blood cell transfusion to treat low hemoglobin

Active bacterial, fungal, or viral infection requiring treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if the combination of ruxolitinib and ulixertinib is a safe and effective treatment for people with myelofibrosis. Researchers will try different doses of

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Who is the study for?

This trial is for individuals with myelofibrosis, a type of bone marrow cancer. Participants should be suitable for treatment with ruxolitinib and ulixertinib but the specific inclusion and exclusion criteria are not provided in the details given.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of combining two drugs: ruxolitinib, which is already used to treat myelofibrosis, and ulixertinib. Different doses of ulixertinib will be tried alongside a fixed dose of ruxolitinib to find the safest high dose.See study design

What are the potential side effects?

While specific side effects are not listed, participants may experience varying degrees of side effects from mild to severe based on different dosage levels of ulixertinib when taken with ruxolitinib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a type of myelofibrosis according to WHO 2016 criteria.

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I am 18 years old or older.

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I have been on a stable dose of ruxolitinib for at least 4 weeks.

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My condition is classified as intermediate 2 or higher risk.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I refuse to get blood transfusions for low hemoglobin.

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I am currently being treated for an active infection.

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I have or am at risk for eye conditions like RVO or CSR.

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My blood cancer has progressed to a more aggressive stage.

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I have active lung inflammation or disease.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Toxicity evaluable participants

Response to therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: JAK/MEK inhibition with Ruxolitinib and UlixertinibExperimental Treatment2 Interventions

Phase 1: There are 3 planned dose levels of ulixertinib (450 mg BID, 300 mg BID, or 150 mg BID) in combination with ruxolitinib for 28 day cycles. A 3+3 dose escalation design will be used to determine the RP2D of ulixertinib with ruxolitinib. Phase 2: Participants will be treated with ulixertinib at the RP2D determined from the phase 1 part of the study in combination with ruxolitinib for 28 day cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

2018

Completed Phase 3

~1170

Ulixertinib

2020

Completed Phase 1

~20