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.
Additional locations may be listed on ClinicalTrials.gov for NCT04282187.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Anna Halpern
Phone: 206-606-1978
PRIMARY OBJECTIVE:
I. To determine whether patients with myeloproliferative neoplasm (MPN)-accelerated phase (AP)/blast phase (BP) being treated with decitabine and a JAK-inhibitor are more likely to proceed to hematopoietic stem cell transplant (HCT) than historical control patients treated with multi-agent chemotherapy or not receiving pre-transplant therapy.
SECONDARY OBJECTIVES:
I. To assess the time from diagnosis of MPN-AP/BP to HCT, compared to historical control patients treated with multi-agent chemotherapy or no pre-transplant therapy.
II. To assess whether patients with MPN-AP/BP who are treated with decitabine and a JAK-inhibitor are more likely to be in remission at day 100 post HCT than historical control patients treated with multi-agent chemotherapy or not given pre-transplant therapy.
III. To determine whether patients with MPN-AP/BP who are treated with decitabine and a JAK-inhibitor are more likely to be alive at 12 months post HCT than historical control patients treated with multi-agent chemotherapy or not given pre-transplant therapy.
IV. To assess the longitudinal mutational landscape in these patients at different stages of disease.
V. To describe response rates to this regimen and overall and relapse-free survival following this regimen, regardless of subsequent transplant status.
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.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorAnna Halpern