Actively Recruiting
Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia
Led by Theradex · Updated on 2026-03-05
66
Participants Needed
4
Research Sites
152 weeks
Total Duration
On this page
Sponsors
T
Theradex
Lead Sponsor
M
MDS/MPN International Working Group (UK Sponsor)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CMML-1 with less than 10% bone marrow blasts and less than 5% peripheral blood blasts
- Proliferative disease with white blood cell count of 13 x 10⁹/L or higher
- Advanced disease with at least one of: spleen palpable 5 cm or more below ribs, total symptom score 20 or higher, or platelet count less than 100 x 10⁹/L
- ECOG performance status of 2 or lower
- Adequate organ function including specific limits for liver enzymes, bilirubin, creatinine clearance, neutrophil count, and clotting times
- Women of child-bearing potential must have a negative pregnancy test within 7 days before enrollment and agree to use effective contraception during and 90 days after treatment
- Male participants must also agree to use effective contraception during and 90 days after treatment
You will not qualify if you...
- Active cancer diagnosed within the past 2 years except certain treated non-invasive cancers
- Allogeneic stem cell transplant within 12 months or need for immunosuppressive therapy within 6 months
- Expected stem cell transplant within 6 months
- Prior treatment with any JAK inhibitor
- Treatment with hypomethylating agents or chemotherapy (excluding hydroxyurea) within 28 days
- Participation in other interventional studies or experimental therapies within 28 days or 5 half-lives
- Use of hematologic support drugs within 28 days (supportive care allowed)
- Use of strong CYP3A4 inhibitors or inducers within 14 days
- Use of systemic anticoagulants or antiplatelets (except low-dose aspirin) within 14 days
- Significant bleeding or cardiac events within 3 months
- QTcF interval above specified limits
- Symptomatic heart failure limiting activity
- Uncontrolled infection
- Moderate or severe liver impairment or active viral hepatitis
- Uncontrolled HIV infection
- Known allergy to pacritinib or its ingredients
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
Winship Cancer Institute at Emory
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Z
Zach Albaugh
CONTACT
M
Melissa Fischer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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