RecruitingPhase 1NCT05714072

A Study of Ruxolitinib in Combination With Abemaciclib for the Treatment of Myelofibrosis

A Phase I Study of Ruxolitinib Plus Abemaciclib for Patients With Primary or Post-polycythemia Vera/Essential Thrombocythemia Myelofibrosis


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

18 participants

Start Date

Jan 25, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being done to see if the combination of ruxolitinib and abemaciclib is a safe and effective treatment for people with primary or post-polycythemia vera/essential thrombocythemia myelofibrosis.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two medications — ruxolitinib (already used to treat myelofibrosis) and abemaciclib (a cancer drug that targets cell growth) — works better than ruxolitinib alone for people with myelofibrosis who are not responding adequately to ruxolitinib. Myelofibrosis is a bone marrow cancer that causes scarring, an enlarged spleen, fatigue, and other debilitating symptoms. You may be eligible if: - You have myelofibrosis (primary or secondary after polycythemia vera or essential thrombocythemia) classified as intermediate or high risk - You have been on ruxolitinib for at least 12 weeks at a stable dose of 10 mg or 15 mg twice daily - You still have an enlarged spleen (5 cm or more below the left rib margin) and/or significant symptoms despite ruxolitinib treatment - You are 18 or older with adequate organ function - You are able to use effective contraception if you can become pregnant or father a child You may NOT be eligible if: - You have previously been treated with a CDK4/6 inhibitor - You have been in another experimental treatment trial in the past 30 days - You have active brain involvement from the cancer (CNS leukemia) - You have an active serious infection (bacterial, fungal, or HIV/hepatitis B or C) - You are pregnant or breastfeeding - You have serious heart conditions including a history of ventricular arrhythmia, sudden cardiac arrest, or syncope from a heart cause - You cannot swallow pills or have a serious gastrointestinal condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRuxolitinib

10mg BID or 15mg BID

DRUGAbemaciclib

50, 100 and 150 mg


Locations(7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05714072


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