Recruiting
Phase 2

Pacritinib vs. Hydroxyurea

Sponsor:

Theradex

Code:

NCT07033598

Conditions

Leukemia, Myelomonocytic, Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pacritinib

Hydroxyurea

Study Details

Brief 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.

Conditions

Leukemia, Myelomonocytic, Chronic

Study ID

NCT07033598

Start date

Jan 1, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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 Criteria:

  • 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).

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pacritinib

Pacritinib 200 mg twice daily

active comparator: Hydroxyurea

Hydroxyurea at doses up to 4 g daily

Interventions

Pacritinib

100-mg capsules

Hydroxyurea

capsules or tablets

Primary outcome measure

  • Clinical benefit at Week 24, defined as achieving erythroid response in the absence of leukemic transformation. [ Time Frame: Measured from Week 24 through the end of treatment, up to 48 weeks. ]
  • Clinical benefit at Week 24, defined as achieving platelet response in the absence of leukemic transformation. [ Time Frame: Measured from Week 24 through the end of treatment, up to 48 weeks. ]
  • Clinical benefit at Week 24, defined as achieving neutrophil response in the absence of leukemic transformation. [ Time Frame: Measured from Week 24 through the end of treatment, up to 48 weeks. ]
  • Clinical benefit at Week 24, defined as achieving spleen response in the absence of leukemic transformation. [ Time Frame: Measured from Week 24 through the end of treatment, up to 48 weeks. ]
  • Clinical benefit at Week 24, defined as achieving symptom response in the absence of leukemic transformation. [ Time Frame: Measured from Week 24 through the end of treatment, up to 48 weeks. ]

Central Contacts and Locations

Central contacts

Zach Albaugh

zalbaugh@theradex.com

Melissa Fischer

mfischer@mdsmpn.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Valentina Pileczki

Valentina.Pileczki@moffitt.org

Principal Investigator:

Zhuoer Xie, MD

Winship Cancer Institute at Emory

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Suzanne Scott

suzanne.e.scott@emory.edu

Principal Investigator:

Anthony Hunter, MD

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015

Principal Investigator:

Tariq Kewan, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Stephany Hendrickson

SLHendrickson@mdanderson.org

Principal Investigator:

Guillermo Montalban-Bravo, MD

More Information

Sponsor

Theradex

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Theradex on 2026-08-18.