Pacritinib with Standard Treatments for Myeloproliferative Neoplasms
This study is testing if adding pacritinib to standard treatments like azacitidine or decitabine can help more patients with accelerated or blast phase myeloproliferative neoplasms (a type of blood cancer) successfully receive a stem cell transplant. Pacritinib may work by stopping cancer cell growth. Azacitidine and decitabine help the body make normal blood cells and kill abnormal ones. Cedazuridine helps decitabine work better. The study aims to see how many patients can get a stem cell transplant within 9 months of starting treatment. You may be eligible if you are 18 or older and have a confirmed diagnosis of accelerated or blast phase myeloproliferative neoplasm.
- Study design
- This study plans to enroll 27 participants. It is an interventional study, meaning participants will receive specific treatments as part of the research.
- What's involved
- You would receive pacritinib by mouth twice daily, and azacitidine or decitabine either intravenously (into a vein) or subcutaneously (under the skin) as determined by your doctor. This treatment would continue for up to 6 cycles, with each cycle lasting 28 days. You will also have bone marrow and blood samples taken during the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- After your study treatment ends, you will be followed periodically for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07148947
Pacritinib With Standard of Care Azacitidine or Decitabine as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant for Patients With Accelerated and Blast Phase Myeloproliferative Neoplasms
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of WashingtonInvestigator-initiated
~27 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:PacritinibDecitabineDecitabine and CedazuridineAzacitidineSurvey AdministrationBiospecimen Collection
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients who receive hematopoietic stem cell transplant
Measured over Up to 9 months from starting treatment
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Anna Halpern, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age ≥ 18 years
History of myeloproliferative neoplasms (MPN) as defined by the 2016 and 2022 World Health Organization criteria, with now pathologically confirmed ≥ 5% blasts in the bone marrow or peripheral blood. Prior MPNs could include polycythemia vera, essential thrombocythemia, primary myelofibrosis, secondary myelofibrosis, MPN-unclassifiable, and myelodysplastic syndrome (MDS)/MPN overlap syndromes
Outside diagnostic material is acceptable. Internal review at the study institution of outside peripheral blood and/or bone marrow slides is recommended. Flow cytometric analysis of peripheral blood and/or bone marrow should be performed according to institutional practice guidelines
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 OR Karnofsky ≥ 60%
Serum creatinine clearance ≥ 50 ml/min calculated by the Cockcroft-Gault Equation (assessed within 14 days of study day 1)
Total bilirubin ≤ 3 (total bilirubin \> 3 is allowable if thought due to Gilbert's disease, hemolysis, or MPN disease) (assessed within 14 days of study day 1)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 3 x upper limits of normal (ULN) (total bilirubin \> 3 is allowable if thought due to Gilbert's disease, hemolysis, or MPN disease) (assessed within 14 days of study day 1)
Patient is considered a potential transplant candidate. The attending/treating physician will determine transplant candidacy at the time of consent
Intention to initiate therapy with an HMA per treating physician's standard institutional practice. Allowable HMAs include:
Azacitidine given IV or SC
Decitabine given IV, and
Decitabine given orally (as Inqovi \[cedazuridine/decitabine\]). If the HMA was already initiated, patients must be registered and start pacritinib within 30 days of initiation
Hyperleukocytosis, white blood cell (WBC) \> 100,000/μL, or with concern for other complications of high tumor burden or leukostasis (e.g. hypoxia, disseminated intravascular coagulation) can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg/m\^2/dose) any time prior to enrollment
Women of child-bearing potential and men must be agree to use a highly effective method of contraception, starting at the first dose of study therapy through 90 days after the last dose of study therapy
Capable of providing valid informed consent
Exclusion
Previous treatment with chemotherapy (e.g. hypomethylating agents or cytarabine-based regimens) for MPN (does not include the first cycle of treatment with an allowable HMA initiated within 30 days prior to start of pacritinib). Prior temporary measures to control blood counts is allowed. Prior treatment with hydroxyurea, interferons or JAK inhibitor therapy (including pacritinib) is allowed
Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and/or controlled or stable (e.g. if specific, effective therapy is not available/feasible or desired \[e.g. chronic viral hepatitis, HIV\])
Known hypersensitivity to any study drug
Females who are pregnant or breastfeeding (Women of childbearing potential \[WOCBP\] must have a negative serum pregnancy test within 14 days prior to enrollment)
Treatment with any other anti-MDS/leukemia investigational agent within 2 weeks of start of study drugs
Corrected QT interval (QTC) \> 480 msec as measured by the Fridericia formula (changing of medications/supplementing electrolytes is allowed to determine if this helps QTc reduce to \< 480 msec)
Concurrent use of a strong CYP3A4 inhibitor or inducer at enrollment that cannot be discontinued (washout period ≥ 5 half-lives prior to day 1)
What this trial measures
- Number of patients who receive hematopoietic stem cell transplantUp to 9 months from starting treatment
Will be estimated and reported with a 95% confidence interval using methodology to account for the two-stage design.