Back to search results

Pacritinib vs. Hydroxyurea for Advanced Chronic Myelomonocytic Leukemia

This study is looking at whether pacritinib works better than hydroxyurea to treat advanced proliferative chronic myelomonocytic leukemia (CMML), a type of blood cancer. Researchers want to see if pacritinib is more effective and has fewer side effects. You might be able to join if you are an adult with CMML-1, have a high white blood cell count, and advanced disease (like an enlarged spleen). The study will measure success by looking at improvements in your red blood cells, platelets, and neutrophils (types of blood cells) without the leukemia getting worse. The study status is unclear, and it plans to enroll about 66 participants.

Study design
This is an open-label, randomized Phase 2 study where about 66 participants will be assigned to receive either pacritinib or hydroxyurea. Participants will be randomly assigned in a 2:1 ratio, meaning more people will receive pacritinib.
What's involved
You would go through a 28-day screening period, receive treatment for up to 48 weeks, and then have a 30-day follow-up after treatment ends.
Compensation
Not stated in the trial record.
Follow-up
After treatment ends, participants will be followed for up to one year to monitor their health and survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07033598

Pacritinib vs. Hydroxyurea in Advanced Proliferative Chronic Myelomonocytic Leukemia

Recruiting
PHASE2Ages 18+InterventionalTreatment
Theradex
~66 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:PacritinibHydroxyurea

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical benefit at Week 24, defined as achieving erythroid response in the absence of leukemic transformation.
Measured over Measured from Week 24 through the end of treatment, up to 48 weeks.
+4 more outcomes measured

Conditions

Leukemia, Myelomonocytic, Chronic

Explore related trials

Chronic Myelomonocytic Leukemia

NCT07033598

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • King's College Hospital, NHS Foundation Trust

    London, Greater London, United Kingdomstudy coordinator listed

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesotastudy coordinator listed

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • Moffitt Cancer Center

    Tampa, Floridastudy coordinator listed

    Recruiting

  • The Christie, NHS Foundation Trust

    Manchester, Greater Manchester, United Kingdomstudy coordinator listed

    Recruiting

  • Winship Cancer Institute at Emory

    Atlanta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Zach Albaugh
[email protected]
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
Adequate organ function: AST and ALT ≤3 × ULN, total bilirubin ≤4 × ULN (≤8 × ULN in participants with Gilbert's syndrome), creatinine clearance \>30 mL/min, absolute neutrophil count ≥0.5 × 10⁹/L, PT and PTT ≤1.5 × ULN.
Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and, along with male participants, must agree to use a highly effective method of contraception from the first dose through 90 days after the last dose.

Exclusion

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.
Treatment with hypomethylating agents or cytotoxic chemotherapy (excluding hydroxyurea) within 28 days prior to enrollment.
Participation in another interventional study or use of experimental therapy within 28 days or 5 half-lives, whichever is longer.
Use of hematologic support drugs within 28 days prior to enrollment. Supportive care permitted.
Use of strong CYP3A4 inhibitors or inducers within 14 days or 5 half-lives before enrollment, whichever is shorter.
Use of systemic anticoagulants or antiplatelets (except aspirin ≤100 mg/day) within 14 days prior. Therapeutic anticoagulation allowed if stable for ≥90 days without bleeding events.
CTCAE Grade ≥2 bleeding within 3 months prior to enrollment, unless due to a reversible cause (e.g., trauma, surgery).
QTcF \>450 ms (men) or \>470 ms (women); QTcF up to 480 ms allowed if QRS \>100 ms. QTcF may be repeated if affected by reversible factors.
CTCAE Grade ≥3 cardiac event within 3 months before enrollment.
Symptomatic heart failure with limitations on ordinary activity.
Uncontrolled infection at study entry.
Moderate/severe hepatic impairment (Child-Pugh B or C), or active viral hepatitis:
HBV: Exclude if HBsAg+ or HBV DNA detectable. HBV antiviral therapy allowed if HBV DNA undetectable.
HCV: Allowed if HCV Ab+ but RNA negative.
Uncontrolled HIV or detectable viral load while on antiretrovirals.
Known hypersensitivity to pacritinib or its excipients (microcrystalline cellulose, polyethylene glycol, magnesium stearate).

What this trial measures

  • Clinical benefit at Week 24, defined as achieving erythroid response in the absence of leukemic transformation.Measured from Week 24 through the end of treatment, up to 48 weeks.

    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 development of granulocytic sarcoma.

  • Clinical benefit at Week 24, defined as achieving platelet response in the absence of leukemic transformation.Measured from Week 24 through the end of treatment, up to 48 weeks.

    For participants with baseline platelet counts \<100 × 10⁹/L, response is defined as one of the following: an increase to ≥20 × 10⁹/L and by ≥100% for ≥8 weeks without platelet transfusion (if baseline \<20 × 10⁹/L); an increase of ≥30 × 10⁹/L for ≥8 weeks without transfusion (if baseline 20-\<100 × 10⁹/L); or, if transfusion-dependent at baseline (≥4 units in the 8 weeks pre-enrollment), achieving ≥8 weeks of platelet transfusion independence. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.

  • Clinical benefit at Week 24, defined as achieving neutrophil response in the absence of leukemic transformation.Measured from Week 24 through the end of treatment, up to 48 weeks.

    For participants with baseline ANC ≤1 × 10⁹/L, response is defined as either an increase to \>0.5 × 10⁹/L and by ≥100% for ≥8 weeks without myeloid growth factors (if baseline ANC ≤0.5 × 10⁹/L), or an increase by ≥50% for ≥8 weeks without myeloid growth factors (if baseline ANC \>0.5 to ≤1 × 10⁹/L). Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.

  • Clinical benefit at Week 24, defined as achieving spleen response in the absence of leukemic transformation.Measured from Week 24 through the end of treatment, up to 48 weeks.

    For participants with baseline spleen ≥5 cm below the left costal margin (midclavicular line), spleen response is defined as a ≥35% reduction in spleen volume at endpoint assessment by MRI or CT. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.

  • Clinical benefit at Week 24, defined as achieving symptom response in the absence of leukemic transformation.Measured from Week 24 through the end of treatment, up to 48 weeks.

    Among participants with baseline Total Symptom Score (TSS) ≥20 per the MPN-SAF TSS: achieving ≥50% TSS reduction from baseline at the time of endpoint assessment. Leukemic transformation is defined as ≥20% blasts or blast equivalents in the peripheral blood or bone marrow biopsy, or development of granulocytic sarcoma.