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Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia

NCT07033598 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-03-05

No results posted yet for this study

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.

Conditions

  • Leukemia, Myelomonocytic, Chronic

Interventions

DRUG

Pacritinib

100-mg capsules

DRUG

Hydroxyurea

capsules or tablets

Sponsors & Collaborators

  • MDS/MPN International Working Group (UK Sponsor)

    collaborator UNKNOWN

  • Sobi, Inc.

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • Theradex

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-07-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07033598 on ClinicalTrials.gov