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NCT07033598 · ClinicalTrials.gov registry record · Phase 2
Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia
A Phase 2 study of Leukemia, Myelomonocytic, Chronic, sponsored by Theradex.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 4
- Study locations
NCT07033598: Recruiting Phase 2 study of Leukemia, Myelomonocytic, Chronic, sponsored by Theradex.
NCT07033598 is a Phase 2 study of Leukemia, Myelomonocytic, Chronic that is actively recruiting participants, run by Theradex. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07033598, a Phase 2 study of Leukemia, Myelomonocytic, Chronic, is actively recruiting participants, sponsored by Theradex.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
For participants with baseline hemoglobin \<10 g/dL, response is defined as either a ≥1.5 g/dL hemoglobin increase lasting ≥8 weeks without red blood cell transfusion, or, if transfusion-dependent at baseline (≥4 units in the 8 weeks pre-enrollment), achieving ≥8 weeks of red blood cell transfusion independence, excluding transfusions given for pretreatment Hb ≤8.5 g/dL. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or deve
Conditions Studied
Interventions
- DRUG Hydroxyurea
- DRUG Pacritinib
Study Locations (4)
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Winship Cancer Institute at Emory - Atlanta
Minnesota
- Mayo Clinic Rochester - Rochester
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2026-01-01 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What NCT07033598 shows while recruiting
NCT07033598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Leukemia, Myelomonocytic, Chronic appearing as the primary indexed condition, and to 2 interventions - of which Hydroxyurea is the first listed.
NCT07033598 reports a single indexed study location in Florida, Georgia, Minnesota.
Frequently Asked Questions
What is clinical trial NCT07033598 about?
NCT07033598 is a clinical study titled "Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia". 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 ...
What is the current status of trial NCT07033598?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2026-01-01. Estimated completion is 2028-12.
What conditions does trial NCT07033598 study?
This clinical trial studies the following conditions: Leukemia, Myelomonocytic, Chronic.
What interventions are being tested in trial NCT07033598?
The interventions under investigation include: Hydroxyurea (DRUG), Pacritinib (DRUG).
Who is sponsoring clinical trial NCT07033598?
This trial is sponsored by Theradex, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07033598 being conducted?
This trial has 4 study locations across Florida, Georgia, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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