A Randomized Phase 2 Study of Pacritinib vs. Hydroxyurea in Patients With Advanced Proliferative Chronic Myelomonocytic Leukemia
Theradex
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.
Description
This is a randomized, multicenter, open-label Phase 2 clinical trial evaluating the efficacy and safety of pacritinib compared to hydroxyurea in adult participants with advanced proliferative chronic myelomonocytic leukemia (CMML). Approximately 66 participants will be randomized in a 2:1 ratio to receive either pacritinib 200 mg twice daily (n=44) or hydroxyurea (n=22) for up to 48 weeks. Randomization will be stratified based on prior therapy (i.e., prior use of hydroxyurea or hypomethylating agents vs. no prior therapy). The study includes: * A 28-day screening period * A 48-week treatmen…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of CMML-1 (5th WHO classification), with \<10% bone marrow blasts on morphology and \<5% peripheral blood blasts. * Proliferative disease, defined as white blood cell count ≥13 × 10⁹/L. * Advanced disease, defined as at least one of the following features during screening: spleen palpable ≥5cm below the lower costal margin in the midclavicular line; TSS ≥20; or platelet count \<100 × 10⁹/L. For participants in whom spleen palpation is not feasible, an ultrasound exam may be performed for assessment of spleen craniocaudal length (length ≥12 cm by ultrasound is c…
Interventions
- DrugPacritinib
100-mg capsules
- DrugHydroxyurea
capsules or tablets
Locations (4)
- Moffitt Cancer CenterTampa, Florida
- Winship Cancer Institute at EmoryAtlanta, Georgia
- Mayo Clinic RochesterRochester, Minnesota
- MD Anderson Cancer CenterHouston, Texas