Actively Recruiting
Decitabine Combined With a JAK-Inhibitor as a Bridge to Stem Cell Transplant in Patients With Accelerated or Blast Phase Myeloproliferative Neoplasms
Led by University of Washington · Updated on 2026-03-16
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a phase II trial studying the effects of decitabine combined with one of three drugs: ruxolitinib, fedratinib, or pacritinib, for patients with accelerated or blast phase myeloproliferative neoplasms, a type of tumor affecting blood cell production. These drugs work by stopping tumor cells from growing or spreading. The study aims to see if this combination before a hematopoietic stem cell transplant works better than other treatments or no pre-transplant therapy. Participants receive decitabine intravenously once daily for 10 days, along with either ruxolitinib twice daily, fedratinib once daily, or pacritinib twice daily for 28 days. This treatment cycle repeats every 28 days for up to six cycles unless the disease progresses or side effects become unacceptable. Throughout the trial, blood and bone marrow samples are collected to monitor the patients' condition. After treatment, patients are followed for up to five years to track outcomes such as the proportion who receive stem cell transplants, remission rates, survival, relapse-free survival, and genetic changes. The study involves regular assessments, including laboratory tests and questionnaires, to evaluate patient responses and safety. The total participation duration varies with the treatment and follow-up periods.
CONDITIONS
Brief Title
Decitabine With Ruxolitinib, Fedratinib or Pacritinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of myeloproliferative neoplasm with at least 5% blasts in bone marrow or peripheral blood
- Prior MPN types include polycythemia vera, essential thrombocythemia, primary or secondary myelofibrosis, or MDS/MPN overlap
- Diagnostic materials must be reviewed by pathology at the study institution
- Performance status ECOG 0-2 or Karnofsky score 60% or higher
- Creatinine clearance of 50 ml/min or greater
- Total bilirubin less than or equal to 3 unless due to Gilbert's disease or hemolysis
- AST/ALT less than 3 times upper limit of normal unless due to MPN disease
- For fedratinib patients, thiamine level must be normal or corrected before treatment
- Considered a potential candidate for transplant by treating physician
- Use of hydroxyurea allowed prior to study registration
- Ability to give informed consent
You will not qualify if you...
- Previous chemotherapy treatment for MPN with 5% or more blasts in blood or marrow
- Active systemic infections not controlled or stable
- Known allergy to any study drugs
- Pregnant or breastfeeding females
- Use of other investigational anti-MDS/leukemia agents within 2 weeks before study drugs
- For fedratinib recipients, concurrent use of certain CYP3A4 inducers or CYP2C19 inhibitors that cannot be stopped
- For ruxolitinib recipients with low platelets, use of strong CYP3A4 inhibitors that cannot be stopped
- For pacritinib recipients, corrected QT interval over 480 msec despite medication adjustments
- Concurrent use of medications affecting drug metabolism pathways that cannot be discontinued for pacritinib patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each
Participants receive decitabine intravenously once daily over 1 hour on days 1 to 10, combined with either ruxolitinib twice daily, fedratinib once daily, or pacritinib twice daily on days 1 to 28. Treatment repeats every 28 days for up to 6 cycles if there is no disease progression or unacceptable toxicity. Blood and bone marrow samples are collected throughout the trial.
Visits occur at least every 28 days during treatment cycles
Duration - Up to 5 years
After completing study treatment, participants are followed for up to 5 years to monitor long-term outcomes and collect additional data.
Periodic visits during the follow-up period
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
N
Noah Pinke
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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