Decitabine with Ruxolitinib, Fedratinib, or Pacritinib for Myeloproliferative Neoplasms
This study is looking at how well a combination of medicines works for people with accelerated or blast phase myeloproliferative neoplasms (MPN), which are blood cancers. You would receive decitabine (a chemotherapy drug) along with one of three other drugs: ruxolitinib, fedratinib, or pacritinib. These drugs aim to stop cancer cells from growing. The main goal is to see how many patients can then receive a hematopoietic stem cell transplant (a procedure to replace unhealthy blood-forming cells with healthy ones). This study is for adults aged 18 and older who have a confirmed MPN with at least 5% blast cells in their bone marrow or blood. The current recruitment status is unclear.
- Study design
- This study plans to enroll 25 participants. It is an interventional study, meaning participants will receive specific treatments.
- What's involved
- You would receive decitabine intravenously (into a vein) for 10 days, and either ruxolitinib, fedratinib, or pacritinib by mouth for 28 days. This cycle repeats every 28 days for up to 6 cycles. You will also have blood and bone marrow samples collected.
- Compensation
- Not stated in the trial record.
- Follow-up
- After your study treatment, you will be followed for up to 5 years.
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NCT04282187
Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of WashingtonInvestigator-initiated
~25 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:DecitabineRuxolitinibFedratinibQuestionnaire AdministrationPacritinibBiospecimen 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
Proportion of patients enrolled who receive hematopoietic stem cell transplantation (HCT)
Measured over Up to 5 years
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Anna Halpern · 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 MPN as defined by the 2016 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, MDS/MPN overlap
Outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution by pathology. 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 unless due to Gilbert's disease or hemolysis (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 limit of normal (ULN) unless thought to be due to MPN disease process (AST/ALT \> 3 is allowable if thought due to MPN disease) (assessed within 14 days of study day 1)
For patient receiving fedratinib, thiamine level should be above the laboratory lower limit of normal (\>= 70 nmol/L in the University of Washington \[UW\]/Seattle Cancer Care Alliance \[SCCA\] lab). If it is low, it may be repleted but should be rechecked and demonstrated to normalize prior to initiation of therapy
Patient is considered a potential transplant candidate. The attending/treating physician will determine transplant candidacy at the time of consent
The use of hydroxyurea prior to study registration is allowed. Patients with symptoms/signs of hyperleukocytosis, white blood count (WBC) \> 100,000/uL, 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) anytime prior to enrollment
Capable of providing valid informed consent
Exclusion
Previous treatment with chemotherapy (e.g. hypomethylating agents or cytarabine-based regimens) for MPN with \>= 5% blasts in the blood or marrow. Prior temporary measures to control blood counts is allowed. Prior treatment with hydroxyurea, interferons or JAK inhibitor therapy 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 \[e.g. chronic viral hepatitis, human immunodeficiency virus (HIV)\])
Known hypersensitivity to any study drug
Females who are pregnant or breastfeeding
Treatment with any other anti-MDS/leukemia investigational agent within 2 weeks of start of study drugs
For patients planning to receive fedratinib: concurrent use of strong and moderate CYP3A4 inducers or dual CYP3A4 and CYP2C19 inhibitors that cannot be discontinued
For patients planned to receive ruxolitinib AND platelets \< 50,000/mm\^2: concurrent use of a strong CYP3A4 inhibitor that cannot be discontinued
For patients planned to receive pacritinib, corrected QT interval (QTc) \> 480 msec (changing of medications/supplementing electrolytes is allowed to determine if this helps QTc reduce to \< 480 msec)
For patients planned to receive pacritinib, concurrent use of medications that are CYP1A2, CYP3A4, P-gp, BCRP, OCT1 substrates that cannot be discontinued
What this trial measures
- Proportion of patients enrolled who receive hematopoietic stem cell transplantation (HCT)Up to 5 years