Accelerated Phase Myeloproliferative NeoplasmPhase 2NCT07148947
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
A Phase 2 study testing Pacritinib, Decitabine and Decitabine and Cedazuridine in people with Accelerated Phase Myeloproliferative Neoplasm and Blast Phase Myeloproliferative Neoplasm, run by University of Washington at 1 site in United States.
Trial summary
This phase II trial tests if adding pacritinib to standard of care azacitidine or decitabine increases the number of patients able to proceed to hematopoietic stem cell transplantation (bridging) for patients with accelerated and blast phase myeloproliferative neoplasms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accelerated Phase Myeloproliferative Neoplasm, Blast Phase Myeloproliferative Neoplasm
- What is being tested?
- Pacritinib, Decitabine and Decitabine and Cedazuridine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to 31 Dec 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 15Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Anna Halpern, MD, 206-606-1978, halpern2@uw.edu
Anna Halpern, MD
About this study
Official title: A Phase 2 Trial Investigating the Addition of Pacritinib to a Hypomethylating Agent as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant in Patients With Accelerated and Blast Phase Myeloproliferative Neoplasms
This phase II trial tests if adding pacritinib to standard of care azacitidine or decitabine increases the number of patients able to proceed to hematopoietic stem cell transplantation (bridging) for patients with accelerated and blast phase myeloproliferative neoplasms. Pacritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Azacitidine and decitabine are in a class of medications called hypomethylation agents. They work by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Adding pacritinib to standard of care azacitidine or decitabine may increase the number of patients able to proceed to hematopoietic stem cell transplantation for patients with accelerated and blast phase myeloproliferative neoplasms.
Read the detailed description
OUTLINE:
Patients receive pacritinib orally (PO) twice daily (BID) on days 1-28 of each cycle, starting 7 days before or 30 days after standard of care hypomethylating agent (HMA) bridge therapy. Cycles repeat every 28 days for 6 cycles. Patients receive HMA bridge therapy per treating physician's standard institutional practice with azacitidine intravenously (IV) or subcutaneously (SC), or decitabine IV or cedazuridine/decitabine PO per standard of care. Treatment is given in the absence of unacceptable toxicity. Patents also undergo bone marrow aspiration and/or biopsy and blood sample collection during screening and as clinically indicated throughout the study.
After completion of study treatment, patients are followed up periodically for up to 5 years.
- Being tested
- Pacritinib, Decitabine, Decitabine and Cedazuridine, Azacitidine, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PacritinibDrug
Also called Oral JAK2 Inhibitor SB1518, SB 1518, SB-1518, SB1518
Given PO
DecitabineDrug
Also called 5-Aza-2'-deoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine
Given IV
Decitabine and CedazuridineDrug
Also called ASTX 727, ASTX-727, ASTX727, C-DEC
Given PO
AzacitidineDrug
Also called 5 AZC, 5-AC, 5-Azacitidine, 5-Azacytidine
Given IV or SC
Survey AdministrationOther
Ancillary studies
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected
Undergo blood sample collection
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration
Bone Marrow BiopsyProcedure or surgery
Undergo bone marrow biopsy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (pacritinib and HMA bridge therapy) | Experimental | Patients receive pacritinib PO BID on days 1-28 of each cycle, starting 7 days before or 30 days after standard of care HMA bridge therapy. Cycles repeat every 28 days for 6 cycles. Patients receive HMA bridge therapy per treating physician's standard institutional practice with azacitidine IV or SC, or decitabine IV or cedazuridine/decitabine PO per standard of care. Treatment is given in the absence of unacceptable toxicity. Patents also undergo bone marrow aspiration and/or biopsy and blood sample collection during screening and as clinically indicated throughout the study. Receives: Drug: Pacritinib; Drug: Decitabine; Drug: Decitabine and Cedazuridine; Drug: Azacitidine; Other: Survey Administration; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who receive hematopoietic stem cell transplant
Will be estimated and reported with a 95% confidence interval using methodology to account for the two-stage design.
Measured: Up to 9 months from starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start2 Mar 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accelerated Phase Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Orphan Biovitrum
- Responsible party
- Sponsor
- Investigators
- Anna Halpern, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148947
- Sponsor's protocol ID
- RG1125470
- Other IDs
- NCI-2025-05720, FHIRB0021044
- Status last verified
- Aug 2026
- First submitted
- 22 Aug 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No