Study on Decitabine with Ruxolitinib, Fedratinib, or Pacritinib for Treating Advanced Myeloproliferative Neoplasms

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04282187

Provider View

This clinical trial is exploring how well a combination of decitabine with either ruxolitinib, fedratinib, or pacritinib works before a stem cell transplant in patients with advanced myeloproliferative neoplasms, a type of blood cancer.

Patient Parameters

Program Overview

This study is testing a treatment plan that uses decitabine along with one of three other drugs—ruxolitinib, fedratinib, or pacritinib—to see if it can better prepare patients with advanced myeloproliferative neoplasms for a stem cell transplant. These drugs work by stopping cancer cells from growing and spreading. The goal is to see if this combination is more effective than other treatments in helping patients get ready for a transplant, which involves replacing diseased cells with healthy ones from a donor.

Description

In this study, patients will receive decitabine through an IV once a day for 10 days, and one of the other drugs (ruxolitinib, fedratinib, or pacritinib) by mouth for 28 days. This treatment cycle can be repeated up to six times unless the disease worsens or side effects become too severe. After finishing the treatment, patients will be monitored for up to five years to track their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a history of a specific type of blood cancer called myeloproliferative neoplasms (MPN) with at least 5% cancer cells in the blood or bone marrow.
  • Must have a good performance status, meaning they can carry out daily activities with little or no assistance.
  • Have adequate kidney and liver function based on specific blood tests.
  • Be a potential candidate for a stem cell transplant.
  • Can have used hydroxyurea before joining the study.
  • Must be able to provide informed consent.

Exclusion Criteria

  • Have received certain chemotherapy treatments for MPN with 5% or more cancer cells in the blood or marrow.
  • Have an active infection that is not controlled or stable.
  • Have an allergy to any of the study drugs.
  • Are pregnant or breastfeeding.
  • Have used another experimental treatment for MDS/leukemia within two weeks before starting the study drugs.
  • For those taking fedratinib, cannot use certain other medications that affect how the body processes drugs.
  • For those taking ruxolitinib, cannot use certain medications if platelet levels are low.
  • For those taking pacritinib, cannot have a specific heart condition or use certain medications that affect heart rhythm.

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