Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04282187

Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms

Led by University of Washington · Updated on 2026-03-16

25

Participants Needed

1

Research Sites

346 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This phase II trial studies how well decitabine with ruxolitinib, fedratinib, or pacritinib works before hematopoietic stem cell transplant in treating patients with accelerated/blast phase myeloproliferative neoplasms (tumors). Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ruxolitinib, fedratinib, and pacritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a donor hematopoietic stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Decitabine, with ruxolitinib, fedratinib, or pacritinib may work better than multi-agent chemotherapy or no pre-transplant therapy, in treating patients with accelerated/blast phase myeloproliferative neoplasms.

CONDITIONS

Official Title

Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • History of myeloproliferative neoplasm with at least 5% blasts in bone marrow or blood
  • Prior MPN types include polycythemia vera, essential thrombocythemia, primary or secondary myelofibrosis, MPN unclassifiable, or MDS/MPN overlap
  • Diagnostic materials reviewed by study pathologists including peripheral blood or bone marrow slides
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 or Karnofsky score of 60% or higher
  • Kidney function with creatinine clearance of 50 ml/min or higher
  • Total bilirubin less than or equal to 3 unless due to Gilbert's disease, hemolysis, or MPN disease
  • Liver enzymes (AST/ALT) less than 3 times the upper limit of normal unless related to MPN disease
  • For fedratinib patients, thiamine level at or above lab lower limit of normal (>= 70 nmol/L) before therapy
  • Considered a potential candidate for stem cell transplant by treating physician
  • Use of hydroxyurea allowed before study entry
  • Patients with high white blood count or complications may receive leukapheresis or up to 2 doses of cytarabine before enrollment
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Previous chemotherapy treatment for MPN with 5% or more blasts in blood or marrow (prior hydroxyurea, interferons, or JAK inhibitor allowed)
  • Active systemic infections unless controlled or stable
  • Known allergy to any study drug
  • Pregnant or breastfeeding females
  • Treatment with other investigational anti-MDS/leukemia agents within 2 weeks before study drugs
  • For fedratinib patients, use of strong/moderate CYP3A4 inducers or dual CYP3A4 and CYP2C19 inhibitors that cannot be stopped
  • For ruxolitinib patients with platelets below 50,000/mm3, use of strong CYP3A4 inhibitors that cannot be stopped
  • For pacritinib patients, corrected QT interval (QTc) greater than 480 msec despite medication adjustments
  • For pacritinib patients, use of medications that are CYP1A2, CYP3A4, P-gp, BCRP, or OCT1 substrates that cannot be stopped

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

N

Noah Pinke

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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