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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT04282187
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 24, 2020
Status verified
Mar 2026
Primary completion
Nov 11, 2026
Completion
Nov 11, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (decitabine, ruxolitinib, fedratinib, pacritinib)
    Patients receive decitabine IV QD over 1 hour on days 1-10, and either ruxolitinib PO 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.

Primary Outcome Measure

Proportion of patients enrolled who receive hematopoietic stem cell transplantation (HCT) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Noah Pinke
[email protected]
206-606-4942
Anna Halpern (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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