RecruitingPhase 2NCT07033598

Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia

A Randomized Phase 2 Study of Pacritinib vs. Hydroxyurea in Patients With Advanced Proliferative Chronic Myelomonocytic Leukemia


Sponsor

Theradex

Enrollment

66 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if pacritinib works better than hydroxyurea to treat advanced proliferative chronic myelomonocytic leukemia in adults. The main questions it aims to answer are: * Does pacritinib improve disease control compared to hydroxyurea? * What medical problems do participants have when taking pacritinib or hydroxyurea? Researchers will compare pacritinib to hydroxyurea to see if pacritinib is more effective and better tolerated in people with advanced proliferative chronic myelomonocytic leukemia. Participants will be randomly assigned to receive either pacritinib twice a day or hydroxyurea for up to 48 weeks. After treatment ends, participants will be followed for up to one year.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments — pacritinib (a newer targeted drug) versus hydroxyurea (a standard drug) — in people with a rare blood cancer called proliferative chronic myelomonocytic leukemia (CMML), where the white blood cell count is dangerously elevated. **You may be eligible if...** - You have been diagnosed with CMML-1 (a specific, early form of this blood cancer) - Your white blood cell count is 13 billion per litre or higher - Your disease is considered advanced, shown by an enlarged spleen, significant symptoms, or low platelet count **You may NOT be eligible if...** - You have more than 10% blast cells (immature cancer cells) in your bone marrow - Your disease does not meet the criteria for advanced or proliferative CMML - You have significant other health conditions that affect eligibility 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

DRUGPacritinib

100-mg capsules

DRUGHydroxyurea

capsules or tablets


Locations(4)

Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute at Emory

Atlanta, Georgia, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07033598


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