Trials / Recruiting
RecruitingNCT07148947
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 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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pacritinib | Given PO |
| DRUG | Decitabine | Given IV |
| DRUG | Decitabine and Cedazuridine | Given PO |
| DRUG | Azacitidine | Given IV or SC |
| OTHER | Survey Administration | Ancillary studies |
| PROCEDURE | Biospecimen Collection | Undergo blood sample collection |
| PROCEDURE | Bone Marrow Aspiration | Undergo bone marrow aspiration |
| PROCEDURE | Bone Marrow Biopsy | Undergo bone marrow biopsy |
Timeline
- Start date
- 2026-03-02
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
- First posted
- 2025-08-29
- Last updated
- 2026-03-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07148947. Inclusion in this directory is not an endorsement.