RecruitingPhase 2NCT04282187

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


Sponsor

University of Washington

Enrollment

25 participants

Start Date

Mar 24, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests three different drug combinations — each pairing a chemotherapy drug (decitabine) with a targeted drug (ruxolitinib, fedratinib, or pacritinib) — for patients whose bone marrow disease (myeloproliferative neoplasm, or MPN) has progressed into a more aggressive phase resembling leukemia. **You may be eligible if...** - You are 18 or older - You have a history of MPN (such as polycythemia vera, myelofibrosis, or essential thrombocythemia) that has now progressed to show blast cells (abnormal immature cells) in your bone marrow or blood - A pathologist has reviewed your bone marrow or blood slides at the study center **You may NOT be eligible if...** - Your blast cell count does not meet the threshold - You have conditions that prevent safe use of the study drugs - You cannot travel to the study institution for evaluation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDecitabine

Given IV

DRUGRuxolitinib

Given PO

DRUGFedratinib

Given PO

OTHERQuestionnaire Administration

Ancillary studies

DRUGPacritinib

Given PO

PROCEDUREBiospecimen Collection

Undergo collection of blood and bone marrow samples


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT04282187


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