Pacritinib plus azacitidine or decitabine to help people with accelerated or blast‑phase myeloproliferative neoplasms reach stem cell transplant.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial gives oral pacritinib alongside standard hypomethylating therapy (azacitidine or decitabine/cedazuridine) for adults with accelerated or blast‑phase myeloproliferative neoplasms who are candidates for allogeneic transplant. Pacritinib is taken twice daily in 28‑day cycles while hypomethylating agents are given per local standard practice; pacritinib can begin 7 days before or up to 30 days after HMA initiation and treatment continues for up to six cycles. Patients have bone marrow and blood tests during treatment to monitor disease response and safety. After treatment, patients are followed for up to five years to document transplant rates and long‑term outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

• Fred Hutch/University of Washington Cancer Consortium
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Anna Halpern, MD — Fred Hutch/University of Washington Cancer Consortium
• Study coordinator: Anna Halpern, MD
• Email: halpern2@uw.edu
• Phone: 206-606-1978

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MPN PROGRESSion Registry — tracking symptoms, treatments, and disease progression in people with MPNs.

  Track long-term symptoms, treatments, and disease progression in adults with myeloproliferative neoplasms to see how these conditions evolve over time.

  Recruiting at 2 sites MPN Research Foundation · Chicago, Illinois and 1 other locations · NCT07362225

• Comparing ASTX727 with and without Iadademstat for advanced blood cancers

  This study is testing whether adding iadademstat to the ASTX727 treatment can help people with advanced blood cancers feel better and live longer compared to just using ASTX727 alone.

  Recruiting at 32 sites Phase 2 National Cancer Institute (NCI) · Irvine, California and 31 other locations · NCT06661915

• Pacritinib Effectiveness in Real-world Settings

  This real-world study will see how pacritinib works for adults with myelofibrosis by looking back at medical records from several centers.

  Recruiting at 5 sites Swedish Orphan Biovitrum · New Haven, Connecticut and 4 other locations · NCT07774455

• Pacritinib and Selinexor in JAK-inhibitor naive myelofibrosis with anemia and low platelets

  This trial tests whether combining pacritinib and selinexor helps patients with myelofibrosis who have anemia and low platelets and have not yet tried a JAK inhibitor.

  Recruiting Phase 2 Icahn School of Medicine at Mount Sinai · Westwood, Kansas and 2 other locations · NCT07447817

• Pacritinib for bone marrow fibrosis in myelofibrosis with low platelets

  This trial will test if pacritinib can reduce bone marrow fibrosis and help restore blood counts in adults with myelofibrosis who have low platelets (50–120 × 10^9/L).

  Recruiting at 12 sites Phase 2 Grupo Español de Enfermedades Mieloproliferativas Crónicas PH Negativas · Barcelona, Barcelona and 12 other locations · NCT07394153

• Pacritinib for metastatic castration-resistant prostate cancer after ARSI

  This trial tests pacritinib in adults with metastatic castration-resistant prostate cancer that has progressed after ARSI treatment to see if the drug can help.

  Recruiting Phase 2 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT07226713

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.