Study on Pacritinib with Standard Treatments as a Bridge to Stem Cell Transplant for Patients with Advanced Myeloproliferative Neoplasms

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07148947

Provider View

This clinical trial is testing whether adding the drug pacritinib to standard treatments azacitidine or decitabine can help more patients with advanced myeloproliferative neoplasms proceed to a stem cell transplant. These drugs work by stopping cancer cell growth and helping the bone marrow produce normal blood cells.

Patient Parameters

Program Overview

The purpose of this study is to see if adding pacritinib to the usual treatments, azacitidine or decitabine, can increase the number of patients with advanced myeloproliferative neoplasms who can go on to have a stem cell transplant. Pacritinib may help stop cancer cells from growing by blocking certain enzymes. Azacitidine and decitabine help the bone marrow make normal blood cells and kill abnormal ones. Cedazuridine helps decitabine work better by preventing its breakdown in the body. The study aims to find out if this combination can help more patients reach the stage where they can have a stem cell transplant.

Description

In this study, patients will take pacritinib by mouth twice a day for 28 days in each cycle, starting either 7 days before or 30 days after beginning standard treatment with azacitidine or decitabine. Each cycle lasts 28 days, and patients will go through 6 cycles. The standard treatment can be given as an injection or taken by mouth, depending on the drug. Patients will also have bone marrow tests and blood samples taken during the study. After finishing the study treatment, patients will be followed up for up to 5 years to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a history of myeloproliferative neoplasms (MPN) with at least 5% abnormal cells in the bone marrow or blood.
  • Must have a good performance status, meaning they can carry out daily activities with little or no assistance.
  • Have good kidney and liver function based on specific blood tests.
  • Be considered a potential candidate for a stem cell transplant by their doctor.
  • Plan to start treatment with azacitidine or decitabine as part of their standard care.
  • Women and men must agree to use effective birth control during the study and for 90 days after the last dose.
  • Must be able to provide informed consent to participate in the study.

Exclusion Criteria

  • Have had previous chemotherapy for MPN, except for the first cycle of azacitidine or decitabine started within 30 days before pacritinib.
  • Have an active infection that is not controlled or stable.
  • Have an allergy to any of the study drugs.
  • Are pregnant or breastfeeding.
  • Have taken another investigational drug for MDS or leukemia within 2 weeks before starting the study drugs.
  • Have a heart condition that affects the QT interval on an ECG, unless it can be corrected.
  • Are taking certain medications that affect how the body processes drugs and cannot stop taking them before starting the study.

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