NCT04282187

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

A Phase 2 Trial Investigating Decitabine in Combination With a JAK-Inhibitor as a Bridge to Allogeneic Hematopoietic Stem Cell Transplant in Patients With Accelerated/Blast Phase Myeloproliferative Neoplasms

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OUTLINE: Patients receive decitabine intravenously (IV) once daily (QD) over 1 hour on days 1-10, and either ruxolitinib orally (PO) twice daily (BID), fedratinib PO daily, or pacritinib PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood and bone marrow samples throughout the trial. After completion of study treatment, patients are followed up for up to 5 years.

Conditions

• Acute Myeloid Leukemia
• Essential Thrombocythemia
• Myelodysplastic Syndrome
• Myelodysplastic/Myeloproliferative Neoplasm
• Myeloproliferative Neoplasm
• Myeloproliferative Neoplasm, Not Otherwise Specified
• Polycythemia Vera
• Primary Myelofibrosis
• Secondary Myelofibrosis

Interventions

Type	Name	Description
DRUG	Decitabine	Given IV
DRUG	Ruxolitinib	Given PO
DRUG	Fedratinib	Given PO
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Pacritinib	Given PO
PROCEDURE	Biospecimen Collection	Undergo collection of blood and bone marrow samples

Timeline

• Start date: 2020-03-24
• Primary completion: 2026-11-11
• Completion: 2026-11-11
• First posted: 2020-02-24
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study