Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia
ConditionLeukemia, Myelomonocytic, Chronic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTheradex
About this trial
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 criteria
Qualifiers
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 considered splenomegaly).
ECOG performance status ≤2.
Disqualifiers
Active malignancy diagnosed within the past 2 years, except for curatively treated non-invasive cancers (e.g., basal/squamous cell skin cancer, low-risk prostate cancer on stable endocrine therapy with PSA stable ≥3 months).
Allogeneic hematopoietic stem cell transplant within 12 months prior to enrollment, or requiring immunosuppressive therapy within 6 months before enrollment.
Likely to undergo allogeneic hematopoietic stem cell transplant within 6 months, per investigator assessment.
Prior systemic treatment with any JAK inhibitor.
Trial design
Treatments tested in this trial
- Pacritinib
- Hydroxyurea
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
Theradex
Lead sponsor
MDS/MPN International Working Group (UK Sponsor)
Collaborator
Sobi, Inc.
Collaborator
H. Lee Moffitt Cancer Center and Research Institute
Collaborator
Source ClinicalTrials.gov